Opposition to IL 187923 to Xeda International – keeping fruit and vegetables free from penicillium mould

August 26, 2018

Penicillium on orangePhosphite ions have been long used to prevent infection of citrus fruits with penicillium mold. The treatment is less than successful for treating fruit that is already infected and typically additional chemicals have been used, but these are carcinogenic and thus it is preferable to phase out. This opposition considers the novelty, efficacy and inventiveness of the treatment, including secondary tests for inventiveness.  The awkward terminology of ‘solely comprising’ is also construed.

IL 187923 to Xeda International is a patent that relates to treatment of fruit and vegetables by application of phosphite ions to prevent penicillium.

On allowance, Pimi Aggro Cleantech ltd opposed the application issuing. IL 197923  claims priority from FR 0610688 filed on 7 December 2006 and is a divisional application of Il 191496 which has issued.

The patent application includes three independent claims (1, 14 and 15) which all relate to treating fruit and vegetables to prevent penicillium growth solely by the application of H2PO3 ions at a temperature of between 30ºC and 60ºC.

The independent claims are as follows:

“1. Method for treating fruit or vegetables against penicillium comprising applying solely a treatment composition comprising a compound which allows the release of a phosphite ion H2PO3 at a temperature of between 30° and 60° C”

“14. Kit comprising:

a system comprising:

means for packaging the fruit or vegetables in a retention means,

means for forming a bath containing a treatment composition of a compound which allows the release of a phosphite ion H2PO3 at a temperature of between 30° and 60° according to any one of claims 1 to 7,

means for lowering and raising the retention means, and

a unit for controlling the lowering and raising means adapted, on the one hand for controlling the following steps:

lowering the retention means so the fruit or vegetables contained therein are completely immersed in the bath, and

raising the retention means so the fruit or vegetables are completely removed from the bath, and, on the other hand, for controlling, between these two steps, the following intermediate steps:

raising the retention means of the fruit or vegetables contained therein emerge at least in part from the bath, and

lowering the retention means so the fruit or vegetables contained therein are once again completely immersed on  [sic] the bath;”

“15. Kit comprising:

A system comprising:

a chamber comprising a band of lateral walls extending in a longitudinal direction, the band delimiting inside the chamber, a housing for receiving the fruit and vegetables to be treated, at least one of the lateral walls being deformable between a configuration for engagement and a configuration for release of a load arranged inside the housing,

a device for feeding treatment composition into the chamber and for removing treatment composition from the chamber,

means for heating the treatment composition, and

a system for deforming the deformable walls

and

  1. A treatment composition comprising a compound which allows the release of a phosphite ion H2PO3, said treatment composition having a temperature of between 30° and 60° according to any one of claims 1 to 7.”

The Evidence of the Parties

Pimi  Aggro Cleantech ltd submitted affidavits from their CEO Mr. Nimrod Ben Yehuda, Mr. Amnon Sivan and Dr. Yuval Binyamini, and an expert opinion from Dr. Nizan Nadav. The Applicant provided an expert opinion of Professor Ruth Ben Aryeh.

The grounds for the Opposition were lack of clarity of claim 1 and lack of novelty.

Lack of Clarity in Claim 1

The parties disagree regarding the interpretation of claim 1. The Applicant considers that the claim should be understood as relating to a method for treating fruit and vegetables against penicillin infestation with a treatment that only includes a formulation that releases phosphate ions in the specified range of temperatures.

In contradistinction, the Opposer considers that claim 1 should be understood as further comprising other active ingredients. However, the Opposer considers that even if one were to interpret the claim as the Applicant wishes, it is still lacking in novelty

The basis of the disagreement is the combination of the term ‘comprising’ together with ‘applied solely’. The term comprising is generally understood as broader than consisting and implies ‘consisting but not necessary limited to ingredients mentioned in the claim’. This was clarified by the former Commissioner in IL 194774 LANTMANNEN AS-FAKTOR AB

The term comprising is wider than consisting.

“A requirement that a claim “comprises” certain elements does not mean that other elements may not be present: “comprising” does not mean “only consisting of”.“ (Terrel on the Law of Patents, 17thed., pp. 288)”

In light of the above, the Opposer considers that claim 1 should be construed such that the word ‘comprising solely’ indicates that only the treatment composition is used, whereas the second comprising implies that the composition is not limited to a compound which allows the release of a phosphite ion H2PO3 but can include one or more additional ingredients that perform other functions in the stated temperature range.

The Opposer finds support for this construction in the specification, and refers to page 13 which combines calcium phosphite with imazalil which acts against penicillium in a different manner, and applies the two ingredients at 52ºC, and it appears from the table on that page, that the combination is rather better than calcium phosphite alone.

It is noted that the current phrasing of claim 1 was finalized after the opposition was submitted. The amendments accord with Sections 29, 65 and 66 of the Patent Law, 1967. Prior to the amendment, claim 1 included claims directed to combinations of the phosphite ion releasing agent with other fungicides (see claims 2-4, 14-16). The Deputy Commissioner Ms Jacqueline Bracha notes that while the specification does support combining the calcium phosphite ion releasing agent with other materials, it appears that the intention of the amendment was to limit the claim to the phosphite ion releasing agent. This was also how the Patent Office understood the amendment in their Office Action of 8 September 2013.

The Applicant notes that the Opposer did not claim anything regarding the clarity of claim 1 when the Application was amended, and argues that this estoppels the Opposer from raising the issue in Opposition proceeding.

Even if the Opposer did not raise the issue when the amendment was made, this does not prevent him from challenging the meaning of the claims or arguing that they are unclear. This claim was in the corrected Statement of Case whose purpose is to clarify the points of contention between the parties after the amendment and it is reasonable for the Opposer to raise issues after the amendment, caused by the amendment, that were not issues earlier.

It is noted that Regulation 102(vi) of the Patent Regulations (Patent Office Procedures, Procedures before the Court of the Patent Office, Submissions and Fees 1968 allows a hearing to be postponed by amending the specification and then continuing the hearing, assuming that the amendment is compatible with the Law. It is obvious that this state of affairs allows the Opposer or the Commissioner to consider the amendment within the main proceeding.

Additionally, there is no doubt that the Commissioner who is sitting in judgment on an Opposition has to ensure that an allowed patent will be as clear as possible, to avoid the relevant community being confused as to its scope and regarding the amount of protection it gives.

Currently the claim is self-contradictory in that it requires treatment solely by phosphate ion releasing agent but allows addition of other materials that are not detailed. To the extent that the applicant submits that the correct interpretation is treatment solely by phosphate ion releasing agent without additional agents, the Deputy Commissioner is willing to go with that interpretation, but should the Applicant prevail in the Opposition proceeding, the claim should be amended to remove the ambiguity and to clarity this point.

The discussion focuses on claim 1. However, claims 14 and 15 include the term ‘comprising’ but don’t include the term ‘solely’, and thus appear to allow the phosphite ion releasing agent to be combined with other ingredients. In light of this, the discussion will assume that claim 1 is limited to a formulation including the phosphite ion releasing agent only, whereas claims 14 and 15 relate to kits that include other active ingredients.

Lack of Novelty

Section 4 of the Law states that:

An invention is considered novel if it has not been made available to the public in Israel or abroad, prior to the Application date –

  • by a description in writing or by exhibition, or by an oral presentation or by another way, such that persons of the art can implement it based on the description.
  • By being applied or demonstrated such that persons of the art can implement based on this disclosure.

There is a general rule that a claim will be considered as lacking novelty if there is a single publication that reveals all its elements in a way that is enabling to a person of the art (see 345/87 Hughes Aircraft vs. State of Israel, 105 (2 July 1990). In this regard, it should be noted that a publication is not considered as novelty destroying unless each and every aspect of the invention is taught by the one publication:

The first general rule is that to prove a prior publication that is sufficient to be novelty destroying, one has to be able to point to a document that includes the entire invention and not create a mosaic of teachings taken from different publications to fabricate a collage that teaches the invention.

Also taught in Hughes:

It is not enough for there to be a general description that does not teach how to do the invention, and one cannot rely on signposts that lead towards the invention described in the patent.

The Opposer claims that claim 1 of the Application lacks novelty, whether understood broadly or narrowly. He claims that the lack of novelty is a result of publication of the invention in a number of ways, and each of the publications, when taken alone, are novelty cancelling:

  • The label on the PH nidation equipment
  • Publication by way of demonstration of the PH nidation equipment
  • A publication in writing Y. Gutter, Supplementary Antimold Activity of Phosethyl AL, A New Brown Rot Fungicide for Citrus Fruits, Phytopath. Z., 107 301-308 (1982)
  • Publication of the invention in the PHG and Gutter publications.

The elements of Claim 1

Claim 1 includes the following elements:

  • Treatment of citrus fruits or vegetables
  • Against penicillium
  • Solely by a formulation that allows release of phosphite ions
  • In the temperature range of 30º to 60º.

The Statements of Case and the summations show that the parties concur that these are the elements, apart from the disagreement concerning the scope of (c), related to above.

Lack of Novelty Due to Use of the PH Nidation Equipment

The PH Canon is a machine that is intended to treat the fungus that causes heat rotting of citrus fruits. There is no disagreement that this machine was known before the filing date of the patent application; that the formulation releases phosphite, and that it is used in a hot water bath. The Opposer alleges that this alone negates the novelty of claim 1 under Section 4(2) of the Law.

Under cross-examination, Professor Ben-Aryeh agreed with the Opposer that even prior to the patent application being filed, persons of the art were using the machine. Professor Ben-Aryeh agrees that this usage includes all the elements of claim 1, however notes the caveat that the usage was against heat rot and not against penicillium. (protocol 3.8 page 8 lines 36-39).

Since one of the elements of claim 1 is that the treatment is against penicillium, and the previous usage was against another problem, this publication is not enough to anticipate the invention.

Cancelling novelty due to the label on the PH Nidation Equipment.

The packaging of the PH nidation equipment includes a label which provides instructions and a description of the purpose. Examination of the label from 2006, which is relevant to the priority date (see the appendix to Nimrod Ben Yehuda’s statement), shows that this includes an instruction that the equipment is intended for use against heat rot, and that it should be used in a hot water bath. It describes combining the phosphite with imazalil. Furthermore, this label notes that ‘the formulation does not prevent infection by rotting fungus and so should be combined with an appropriate formulation” and later on relates to combination with imazalil.

In light of the warning regarding heat rot and that for treatment of fungal rot it should be combined with some other ingredient, it cannot be considered as anticipating treatment of penicillium as claimed in claim 1.

The Report of the Committee for Marketing Citrus Fruits

In the Committee Report which is Appendix 31 of Ben Yehuda’s affidavit, experiments using the PH nidation equipment together with other materials for preventing post-harvest rotting of citrus fruit are described. The researchers conclude that the PH Nidation equipment acts in synergy with an aqueous imazalil solution to reduce penicillium. Thus there is nothing in this document that anticipates treatment by the phosphite ion releasing agents alone. 

The Gutter Publication

The Gutter publication deals with treatment of citrus fruits against heat rot by use of Phosethyl Al which is known to release phosphite ions at 36ºC. In the conclusion section of this paper, Gutter notes that use of Phosethyl Al can hinder the development of penicillium (green rot). However, the same paragraph later states that this material can be used against heat rot without causing an increase in penicillium.

The Applicant argues that this publication does not anticipate the invention. The Applicant argues that the publication deals with use of Phosethyl Al only as a pesticide against heat rot, whereas its effect against penicillium is only to prevent its spreading, rather than to remove it. The Applicant does not deny that the publication includes all the elements of the invention, only that the purpose of the formulation and treatment is different than that claimed, and it is thus not novelty destroying.

In the abstract at the beginning of Gutter’s paper the following is stated:

“…In vitro and in vivo experiments have shown that phosethyl Al is capable – although to lesser extent than SOPP and TBZ – of inhibiting growth of P. digitatum and reducing the incidence of decay of citrus fruits, caused by a wild-type, and apparently also by a benzimidazole-resistant strain of this fungus.”

The parties concur that Phosethyl Al allows release of the phosphite ions. So it is clear that the paper teaches (a) treatment of citrus fruit (b) against penicillium (Penicillium digitatum) and (c) that the formulation releases phosphite ions.

In some of the experiments conducted by Gutter and described in his paper, (tests IV and V) the fruit is dipped at 36ºC, which is in the range claimed in claim 1. So this element is also found in the paper.

It is also clear that Gutter examined the efficacy of Phosethyl Al against other formulations such as SOPP and TBZ as restricting the development of penicillium in oranges. The researcher concludes that Phosethyl Al without additional ingredients has an efficacy for preventing penicillium development in oranges. So it appears that all the elements of claim 1 are described in Gutter’s publication.

Certainty

Professor Ben-Aryeh acknowledged that the Gutter publication teaches the claimed invention to persons of the art. However, he considers that since Gutter does not come to the clear understanding that the formulation can treat penicillium, it is not novelty destroying.

  1. Amended Claim 1 of the Application is before me, and assuming that it does relate to the formulation without additional active ingredients, can you point out what is claimed that is NOT taught by Gutter?
  2. Gutter does what is written here.
  3. But he does not unambiguously conclude that this treatment may adequately prevent penicillium infection.
  4. Agree with me that the wording of claim 1 is what he does, and he does that which is written in the Application in claim 1 thereof.
  5. He does.
  6. Thanks, and he published?
  7. He published.

Protocol 3.8 pages 45-26 lines 8-35.

The Patent Application describes experiments that the Applicant conducted to show efficacy of the treatment of penicillium in oranges that were not affected, in oranges that were affected. The Applicant’s expert witness argues that Gutter did not show sufficient efficacy of Phosethyl Al in infected oranges. This argument makes it worth looking at the results obtained by the Applicant himself and reported in the Application. In the table on page 13, it is stated that using phosphoric acid alone on infected fruit at 52ºC gave a yield of 42.5% of rotten fruit. The Applicant further claims that the combination of imazalil and phosphoric acid has a symbiotic affect:

“As is evident from the table above, the rate of decay was halved when each product was applied individually (42.5% in contrast to 85%), whereas the rate of decay was 8.5 times lower with a combination of the two products.

These results clearly show the synergistic effect of the combinations according to the invention.”

When Mr. Ben Yehuda was asked what the infection rate should be for a person of the art to consider a treatment successful, he responded:

Deputy Commissioner: What bothers me, and the previous expert asked a similar question, I understand that if one applied phosphite ions at 52ºC then 42.5% which is currently infected will rot, correct? This is a high percentage?

Witness Mr. Ben-Yehuda: It is insane.

Deputy Commissioner: What is the percentage that I should strive for with a treatment that is considered effective? What is the approach of the market, it is clear to me from the previous witness that to dream of 100% remaining fit for sale is an unreasonable expectation, so what should be striven for? 90%?

Witness Mr. Ben-Yehuda: 10% rotten, how was it achieved? phosphite ions and imazalil.

Deputy Commissioner: I understand how that was attained, but you state that 42.5% is not something to be aspired to, and is not a good result.

Witness Mr. Ben-Yehuda: No industry can absorb losses of that magnitude.

From this one can understand that an effective treatment is one that significantly reduces the percentage of fruit that is infected.

One cannot accept the Applicant’s claim that Gutter does not show certainty of the treatment when the Application itself only demonstrates very partial success. Furthermore, the success of penicillium treatment is not actually part of claim 1 as Deputy Commissioner clarifies below:

A further claim that the Applicant raised in the summation, is that while the invention deals with a treatment against penicillium, the Gutter publication deals with a “material that does not accelerate penicillium development”. This claim is only raised in the summation and does not find any support in the Applicant’s evidence. As is clear from Professor Ben-Aryeh’s cross-examination, it does not distinguish between materials that do not accelerate development, and those that actively combat the fungus.

Beyond that which is necessary, the Deputy Commissioner notes that we appear to be talking about synonyms, since fungicides both prevent infection and treat existing infection. To the extent that the Applicant’s claims are that Gutter’s publication does not detail the success of removing penicillium but merely of preventing its spreading, and so one cannot rely on this publication as anticipating the application, one has to reject the argument. The Application describes experiments where 42.5% of the oranges rotted, so it is clear that the Application is only partially effective at treating penicillium with phosphoric acid.

Furthermore, the Deputy Commissioner notes that Claim 1 does not use the term fungicide or preventing the spread, but simply refers to treating, which does not imply a 100% success in killing off the penicillium. In this context she notes that to consider novelty, one can use the ‘infringement test’ wherein one considers whether the publication would be considered as infringing the patent if it were to issue. The answer to this question is positive, and this implies that the claimed invention is not novel. This test does not require usage of the same terminology in the publication and the patent application. It is sufficient that doing that stated in the publication would necessarily infringe the patent to render the patent lacking novelty:

“When the prior inventor’s publication and the patentee’s claim have respectively been construed by the court in the light of all properly admissible evidence as to technical matters, the meaning of the words and expressions used in the art and so forth, the question whether the patentee’s claim is new for the purpose of section 32(1)(e) falls to be decided as a question of fact. If the prior inventor’s publication contains a clear description of, or clear instructions to do or make, something that would infringe the patentee’s claim if carried out after the grant of the patent, the patentee’s claim will have been shown lack of novelty, that is to say, it will have been anticipated.”  (Terrel p. 118)

See also that stated in the Opposition to IL 179995 Camtek vs. Orbotech ltd, paragraph 56, 20 July 2014.

I accept the Opposer’s claim that the semantic differences between the patent and the invention are not differences relevant to Novelty and Inventive Step. In other words, if the same inventive concept is described in different words in a prior publication, the difference in wording is not sufficient…

Applying this test in the current case by following word for word what Gutter describes in his publication necessarily infringes claim 1 of the patent application, which supports the finding that the claimed invention is not novel.

Finally, the Deputy Commissioner relates to the Applicant’s claims that since prior to filing the Application, penicillium infection was not treated solely by phosphoric acid and heat, the prior art publications cannot anticipate claim 1.  She disagrees with the client’s claim. The novelty requirement in claim 4 of the Law does include a requirement to use the prior art for anticipation purposes. It is enough for them to be publically available. In this regard, that which Terrel states is very relevant:

“It has sometimes been said that if prior disclosure is contained only in a document and there is no evidence that such disclosure has given rise to any practical result, this is “mere paper anticipation” and must be appraised in some specially strict manner. It is difficult to understand the relevance of this observation. If the document in fact discloses the invention and is to be found in a place (e.g. a public library) to which the public have access, it is wholly immaterial that in fact no one had ever read it.” (TERREL, ON THE LAW OF PATENTS, 123-124 (1994))

As stated above, independent claims 14 and 15 deal with kits that include formulations that I addition to phosphite ion releasing ingredients, further comprise additional ingredients. So, since claim 1 lacks novelty, claims 14 and 15 clearly do as well. To remove any doubt, all the references brought by the Opposer, individually anticipate claims 14 and 15.

Inventive Step

Having found the claims lacking novelty, it is superfluous to consider whether they are inventive. Nevertheless, the Deputy Commissioner notes that she considers the claims as lacking inventive step.

Unlike Novelty, which was discussed above, in re Hughes it was stated that inventive step is considered in light of different prior art publications that can fairly be cobbled together to obtain a general picture of that known in the relevant field.

A basic general rule concerning obviousness is that the complete professional knowledge in the field is considered, and that it is acceptable to discount inventiveness on the basis of several prior art publications taken together to give a general picture. (See 314/77 [1] above, on page 209. However, one must always consider that the combining has to be obvious to persons of the art at the relevant time and if the combination is inventive; if an inventive step is required to couple the teachings together; particularly in cases where crumbs of knowledge are gathered from different places – the general picture is not self-evident and one cannot say that the patented evidence is lacking in inventive step.

Thus for an invention to be considered inventive, one has to consider the prior art taken together and whether the combination of the prior art is inventive or self-evident to persons of the art. (See Appeal 47/87 Hasam Defence and Reliability Systems ltd. vs. Abraham Bahri, p.d. 45(5) 194, and whether a person of the art would be motivated to combine the different teachings – See Opposition to IL 138347 Sarin Technologies led. Vs. Ugi Technologies ltd, 14 January 2008.

In this instance, the parties agree that at the relevant time, persons of the art used phosphoric acid and heat to treat against head rot. Nevertheless, Applicant contends that those same persons of the art would NOT have considered it obvious to try this treatment against penicillium due the significant differences.

However, as is apparent from the citations, the difference in organisms would not have prevented persons of the art from trying the heat rot treatment against penicillium. The parties disagree regarding the conclusions that can be drawn from the experiments, but the fact that the parties attempted the treatment against penicillium indicates that it was a fitting research possibility to explore.

Knowledge in the Field

Once can summarize the evidence of the parties as showing that at the relevant date it was known that putting the active ingredients in a warm water bath increased their efficacy. (see Professor Ben-Arieh’s statement on page 33 lines 4-8 of the protocol). The regular fungicides had caused a resistance to such materials, and imazalil, which was the most effective agent, was considered as carcinogenic and so alternative agents were sought; phosphoric acid was considered as having some efficacy against penicillium. The Deputy Commissioner considers that the combination of these facts would lead persons of the art to attempt the claimed invention, and, as shown in Gutter, this in fact happened.

Publications that Teach Away

The Applicant also argued that at the relevant date, there were a number of publications that taught away from the invention.

For example, G. Eldon Brown, Evaluation of Iprodion and Fosethyl-Al and Other Fungicides for Postharvest Citrus Decay Control, 1992 describes a number of experiments that were made to compare different fungicides. The results in tables 2 and 5 show that imazalil is the most effective treatment against penicillium. The author concludes that “green mold in degreened (Table 2) and non-degreened (Table 5) Valencia oranges was not controlled by Phosethyl -Al “

The main tables that summarize Brown’s experimental results show the following:

Imazalil leaves 3.8% of the fruit rotten. A 4000 concentration of Phosephyl–A1 was shown to leave 8.3% of rotten fruit. At an 8000 concentration, 15.2% of the fruit was rotten, whereas a control group had 14.3% rotten fruit.

The Deputy Commissioner is doubtful whether these results would cause persons of the art to stop researching Phosephyl–A1. Although imazalil is more effective, Phosephyl–A1 does seem to have an effect compared to the results of the control group. The Deputy Commissioner notes that Mr. Nimrod Ben Yehuda considered that Brown’s research did NOT show a clear preference for imazalil, but Brown himself considered that imazalil was preferable. That as may be, Mr. Ben-Yehuda is not an expert in this field, and his testimony can only be considered as interpretation.

Brown’s results are actually better than Applicant’s since the Applicant obtained better results with a combination of imazalil and Phosephyl–A1 than with the phosphite releasing agent alone. One could argue that persons of the art reading the application would conclude that it does not support using a phosphite releasing agent alone for treating penicillium. This conclusion is not surprising, since the original claims related to a combination of the phosphite releasing agent together with imazalil. Consequently, one cannot accept the claim that Brown’s research teaches away from the invention, since the Applicant himself did not show better results.

A further publication considered as teaching away is US 6,797,301 from 2004. The Applicant considers that this publication teaches away from the invention since it teaches that Phosephyl–A1 is not effective against penicillium at room temperature, even if imazalil is added.

As Professor Ben-Yehuda noted in his opinion, this paper related to various fungicides and to treatment of fungi based on an understanding that each operated in a different manner, and with an attempt to widen their efficacy range. In his counter-statement in response, Mr. Ben-Yehuda claimed that the experimental results show that the addition of the Phosephyl–A1 made the difference. It is thus difficult to accept that this publication would distance persons of the art from the invention. Reviewing the results shows that most of the experimentation took place at room temperature and not at elevated temperatures which is generally accepted as improving the efficacy of the treatment. The efficacy of Phosephyl–A1 alone was not tested. The results for Phosephyl–A1 together with fenamidone at room temperature are not far from the Applicant’s results using the PK nidation equipment at elevated temperatures. From here it is not reasonable to conclude that persons of the art would conclude that using a phosphite ion releasing agent alone would not be effective against penicillium.

A further publication that the Applicant refers to is US 5,998,910 from 1999 (Appendix 3 of Ben-Yehuda’s Affidavit). which the Opposer also cited. In this publication it is stated that using phosphite ions creates more pathogens than the fungus. As the Opposer notes, this publication deals with treating the fruit prior to harvesting and so will not be done in an elevated temperature surroundings. Furthermore, of five samples brought in the publication, only one relates to penicillium treatment. For these reasons, this publication cannot be considered as teaching away.

Applicant also relates to J.M. Gaulliard et R. Pelossier “Efficacite de Phosethyl Al en trempage des agrumes (fruits) contre Phytophora parasitica agent de la pourriture brune et contre Penicilium digitatum.” Fruits, 1983, vol. 38, No 10, p. 693-697(Appendix 42 of Ben-Yehuda’s affidavit which claims that use of Phosethyl –Al against penicillium is secondary. The publication shows that the researchers tested Phosethyl –Al against both heat rot and penicillium. The main use was indeed against heat rot, but it was also tested against penicillium and the researchers concluded that it had a prophylactic effect against penicillium rather than an effectiveness against an established infestation. The Deputy Commissioner does not find this publication teaches against use of the material since the results are similar to those obtained by Gutter with the PH nidation equipment.

In this context it is difficult to accept the Applicant’s allegation that these teach away since they were published over a 20 year period, in 1983, 1992, 1999 and 2004, and this shows that despite the ‘adverse publications’, persons of the art continued to consider this research path. After the Opposer has shown that this material has been considered for 30 years and the Applicant has not shown a different trend, one cannot accept that the publications teach away from the invention.

 Supplementary Tests for Inventiveness

Although unnecessary, the Deputy Commissioner has considered Applicant’s claims that the invention is inventive due to the ‘long-felt need’ secondary consideration. The Applicant is correct that there is a long-felt need to find non-carcinogenic fungicides, and the prior art supports this, and they date back to the 1980s and on to the 21st century. All the publications describe researchers’ attempts to treat penicillium solely by phosphite releasing agents, but only with partial success.

The “solution” that the Applicant suggests is to use the PH nidation equipment against penicillium, and the label on the equipment advises using it together with imazalil, which was the recommended treatment up until the relevant date. In these circumstances, the Deputy Commissioner cannot accept that their invention was the response to a long-felt need.

In their summary, the Applicants claimed that they had submitted evidence that showed that their solution was commercially successful, and supported this was an Affidavit of their CEO that was submitted during the Examination of the corresponding application in the US and appended to the current proceedings at the request of the Opposer. Since this was not submitted in the evidence stage and the CEO was not cross-examined on the Affidavit, it has little evidentiary weight. That as may be, Mr. Ben-Yehuda testified before the Deputy Commissioner that rotting to the extent described in the Application is not commercially acceptable, and the Deputy Commissioner finds this convincing.

A final attempt to show inventiveness is that the persons of the art responded favorably to the invention. No evidence of this was submitted beyond a statement of Professor Ben Aryeh to the effect that he was not thinking of the invention itself. See cancellation proceedings against IL 155671 to Rontal Engineering Applications 2001 ltd vs. Dr. Elad Barkan, paragraph 122, 23 August 2017. This statement is insufficient to conclude that persons of the art considered the invention revolutionary.

Conclusion

In light of the above, the Opposition is accepted and XEDA International will cover Pimi Aggro Cleantech’s costs of 15000 Shekels and legal fees of 150,000 Shekels + VAT. These costs are based on the complexity, amount of evidence and arguments, number of days of hearing and the complexity of the summations. Payment is due within 30 days.

Ruling by Deputy Commissioner Ms Jacqueline Bracha re Opposition to IL 187923 to XEDA International, 26 June 2018    

 


Suspending a Patent Opposition Pending Examination of Divisional Application

August 12, 2018

janssen pharma.jpgApplication for patent IL 253468 to Janssen Pharmaceuticals is a divisional application of IL 206448, filed under Section 24 of the Law. The parent application is being opposed by TEVA.

TEVA has asked that the Opposition against the parent application be frozen for 18 months from when the Opposition was submitted, in accordance with Circular 020/2012 which regulates oppositions to allowed patents where there is a pending divisional application.

The Opposer claims that there is an overlap between the invention claimed in the parent and that claimed in the divisional.  Thus it is reasonable to assume that if an Opposition is filed against the Divisional application, similar factual and legal issues will arise, and the expert witnesses will likely be identical. Consequently, freezing the opposition to the parent application until the examination of the divisional application is completed will contribute to the efficiency of both the current proceeding and the expected future proceeding.

TEVA further claims that if the current opposition is not frozen, the Applicant will obtain an advantage since he can manipulate the prosecution process of the divisional application in response to issues revealed in the Opposition process of the parent.

The Applicant does not consider it appropriate to freeze the procedure. Nevertheless, they agree that conclusions reached in the Opposition to the allowed parent application will apply to the divisional application if the Opposer should file an opposition against it. The Applicant considers that this agreement makes freezing the Opposition unnecessary, since if an opposition is filed against the divisional, the findings of the present opposition will apply to it, and this makes the process efficient.

Discussion

The Commissioner thinks that on the grounds of efficiency, the request to freeze the Opposition proceedings should be accepted. As explained in the ruling concerning the Opposition to IL 195030 Teva Pharmaceuticals ltd vs. Boehringer Ingelheim International GMBH, 28 January 2002, paragraph 3 of the ruling:

The authority of the courts to delay a proceeding whilst a different proceeding occurs, raises similar issues that are not contentious. These issues are authority to do so, and discretion, which are applied to ensure efficiency of the proceeding, efficiency of the legal system, saving time and resources, preventing conflicting decisions from issuing, convenience for the parties, fast resolution, balance of convenience and the like. These are true, not only when the parties in the two proceedings are identical, but also when there are different parties but similar issues, similar legal considerations, and the interests to be considered are identical.

In this instance, the parties concur that there is a similarity between the inventions in question. In this case, if an opposition would eventually be filed against the divisional application, it is indeed likely that the similar issues will be raised, similar witnesses will be required to testify and the prior art will be the same in the two proceedings.

The Applicant’s consent that findings in the parent opposition be applied to the divisional, does not adequately address these issues. From a practical perspective, it is unreasonable to make a determination concerning the parent opposition before an opposition is filed in the divisional.

Such a situation would create a state of affairs wherein it is necessary to manage two proceedings with similar witnesses and experts, and similar issues will be considered, or that either the opposition in the divisional case be suspended until the issues are determined in the parent case, or the opposition in the parent case be suspended until the issues are determined in the divisional case or the cases are combined.

Furthermore, even if even various determinations are made in the parent case, it will be appreciated that the parent and the divisional will not have identical claims, and so uncertainty will arise as to whether conclusions from the parent case can be applied to the divisional, and what is the decision in similar but not identical matters to those raised in the parent case.

The commissioner rejects the Opposer’s claim that freezing the opposition is essential to prevent the applicant from applying lessons from the Opposition to the prosecution of the divisional application. Whilst there is some truth in this, it is insufficient, in and of itself, to justify freezing an opposition proceeding. It will be remembered that the Opposer can oppose the divisional application and in that framework, issues relating to the patentability of the divisional application will be considered.

In light of the above, the Commissioner rules that the Opposition proceeding to the parent application be suspended for 18 months from when it was filed, i.e. until 29 September 2019.

The Secretariat of the Patent Office will ensure that the Examiner of the divisional application is aware that there is an opposition against the parent case, and that the divisional application should ,therefore, be examined in accordance with Circular 020/2012.

No costs are awarded at this stage.

Interim ruling regarding suspension of an Opposition to a parent application pending examination of a divisional application, in re IL 206448 to Jenssen, opposed by Teva, ruling by Commsioner Ofer Alon, 19 June 2018.


Opposition to IL 190827 to Pfizer – A request to delete paragraphs from Expert Opinion as Widening Front of Attack

August 8, 2018

In evidence submissions, parties can support contentions made in statements of case, but are not allowed to widen their position by introducing new matter. When evidence relating to allegedly new issues is submitted by an Opposer, the Applicant can be expected to oppose the submission. Opposition proceedings are typically characterized by skirmishes regarding the admissibility of evidence, that are discussed in interim rulings. This is one such ruling.

Opposition to IL 190827 to Pfizer

Lyrica

IL 190827 to Pfizer relates to a pharmaceutical composition prescribed for once a day dosage comprising Pregablin and a matrix forming agent of PVP or PVA and CPVP as a swelling agent.

Teva opposed the patent.

This interim ruling relates to a request by Pfizer to remove paragraphs 13-15, 16, 94, 105 and 130 from the Opposer’s Counter-Evidence in Response of Professor Golomb, acting as an expert witness for Teva.

Pfizer claimed that paragraphs 13-15 of the Opposer’s Counter-Evidence in Response stress gelling agents which are not mentioned on the Opposition or in Professor Golomb’s main Opinion. In paragraph 15 of the Opposer’s Counter-Evidence in Response, Professor Golomb alleges that selective reporting on stability, swelling and hardness is arbitrary and they claim that these paragraphs should be struck as they were not submitted in answer to anything in their response.

Pfizer alleged that Paragraph 16 of Teva’s Counter-Evidence in Response raises issues not previously raised: that there is no comparison between the claimed invention and known formulations and no indication of any advantage thereover.
Pfizer requested that paragraph 94 be struck since it makes allegations not found in the original evidence submission. Similarly, paragraphs 105 of the Opposer’s Counter-Evidence in Response relates to Cmin values in the simulation summarized in table 15, and paragraph 130 thereof, are not by way of response and should be struck from the record.
Teva responded that the request to have these paragraphs in their Opposer’s Counter-Evidence in Response cancelled was submitted for improper reasons. Paragraphs 13 and 15 are supported by the patent application itself and do not raise new subject matter. They come in response to paragraph 9 of Dr. Tomber’s opinion. That mentioned in paragraph 15 regarding swelling, stability and harness comes in direct response to Dr. Tomber’s claim that these characteristics are advantageous. The claim that this is an advantage of the claimed invention was first raised in Dr. Tomber’s opinion as expert witness of the Applicant and so the first opportunity for the Opposer to refute this allegation is in their Counter-Evidence in Response.
Teva further submitted that Section 16, when read in context, is a response to Dr. Tomber’s claim that there is an advantage in the claimed formulation of the application. Professor Golomb considers that without comparison to other formulations, one cannot claim the present invention provides an advantage thereover. Similarly that stated in Section 95 of the opinion; that the application does not provide stability data, comes in response to Dr. Tomber’s claims regarding the efficacy of the formulation. The Opposer adds that the application and the Applicant’s claims in the Statement of Case do not relate to any advantage provided by the swelling or the hardness.
Section 105 deals with the Cmin value in table 15 and comes in response to Dr. Tomber’s claim that tablets having a 6 hour release window are not appropriate for once-a-day dosage. Teva claims that when reading this paragraph in the Opposer’s Counter-Evidence in Response together with the previous paragraphs one can only conclude that they come in response to Dr. Tomber’s claim.

As to paragraph 130, the Opposer claims that the expert opinion cited comes in response to the Applicant’s claim that formulation is resistant to the compaction pressure which is based on experimental evidence first submitted by Dr. Tomber.

The Applicant considers that the Opposer’s Counter-Evidence in Response was not a fair response to their counter statement of case and the Opposer allegations that Dr. Tomber’s statements went further than required to respond to the Opposition, whereas the Applicant claims that Professor Golomb simply expanded on statements made in the original Opposition, that could have been made in the original opposition.

Discussion

The parties are in no disagreement regarding the Law, but only in how it should be applied in this instance. Consequently, the relevant case law regarding the application of Regulation 62 is only summarized briefly.

This regulation orders that evidence in response must fulfill one of the following conditions: They should relate to the issues that are specifically denied by the Applicant in their counter-evidence, or are raised for the first time in their counter-evidence. In the response to the Applicant’s evidence, the Opposer may not submit evidence that should have been part of their main submission of evidence (See Opposition to IL 178141 Unipharm vs. Bristol Myers Squibb Company, 12 January 2015 following the ruling of the then Deputy Commissioner in the opposition to IL 127833 Teva vs. Abbott, 12 February 2007 (Oppositions to IL 177724 and 205606, request to delete sections from the Opposer’s Counter-Evidence in Response DSM IP Assets B.V. vs. Refine Technology LLC, 16 March 2015).  

The Deputy Commissioner, Ms Jacqueline Bracha considers that, on examining the paragraphs in question, Pfizer’s request to have them struck from Teva’s Counter-Evidence in Response should be rejected.

In Paragraphs 13 and 14 of the Opposer’s Counter-Evidence in Response, Professor Golomb relates to Dr. Tomber’s examples. Most of the criticism is directed to Dr. Tomber not relating to the fact that the examples include additional ingredients that are not claimed, and which could affect the release of the active ingredients.

In paragraph 15 of the Opposer’s Counter-Evidence in Response, Professor Golomb alleges that there is nothing in Dr. Tomber’s Opinion to explain why examples 24, 25 and 40 of the Application were chosen to show stability, swelling and hardness of the formulations claimed. Professor Golomb further claims that the Opinion does not relate to the other components of the examples, apart from those that are likely to affect the hardness and swelling of the tablets. The additional components are defined in the specification as gelling agents. From this, Professor Golomb deduces that the chosen examples do not exemplify formulations that only include the elements of claim 1.

In these examples, Professor Golomb relates to things mentioned in Dr. Tomber’s opinion. However, this is not a new issue first raised in the Response Opinion. In fact, a similar statement to that of paragraph 15 of the Response Opinion is found in paragraph 81-83 of Professor Golomb’s first opinion where he explains why, in his opinion, none of the Examples of the patent match that claimed. The difference is the switching of the words “additional assistive materials” in the first Opinion, with the phrase “gelling agents” in the second opinion. Professor Golomb also explains in paragraph 15 of the Opinion that the additional materials are defined as “gelling agents” in the patent application itself.

From that stated, it is clear that paragraphs 13-15 of the Response Opinion do not raise any new issue but rather come in response to that said previously, and so the request to delete these paragraphs is rejected.

In paragraph 16 of the Response Opinion, Professor Golomb relates to the claim in Dr. Tomber’s Opinion, that the claimed invention is advantageous in terms of stability, swelling and hardness of the tablets as compared to those formulated by the standard methods for obtaining delayed release in the stomach that is described in example 29. In the Opinion of the expert, the comparative data provided is insufficient to prove this advantage. The Applicant claims that Dr. Tomber did not make this claim and so this response comes to reject a claim not made.

Examination of Dr. Tomber’s Opinion shows that in part 9.4 of his Opinion, the expert relates to example 29 of the Application as a comparative example. Dr. Tomber explains that the release of the active ingredient in example 29 after 12 hours is 65%, compared to 80% for formulations of the invention, and so some of the active ingredient in the formulation of example 29 is wasted. It appears that paragraph 16 of the Opinion is an attempt to respond to this contention of Dr. Tomber and is thus a response to an issue raised by the Applicant. To the extent that the Applicant considers that Dr. Tomber’s opinion was not properly understood by the Opposer, they can relate to the alleged misunderstanding in cross-examination. In light of this, the request to delete paragraph 16 is rejected.

Paragraph 94 of the Opinion in Response by Professor Golomb raised the issue that Examples 15-23 which look at Lactam formation over time does not indicate the efficiency of the claimed formulation. In this paragraph, Professor Golomb responds to Dr. Tomber’s claim that was raised in paragraph 30 of his opinion, that “the results demonstrate the efficacy of the claimed invention.” Dr. Tomber continues that the examples show the efficacy of the invention under various conditions. In Paragraph 95, Professor Golomb adds that the Application lacks stability data for Example 29 which also does not include all the elements of the invention. According to Professor Golomb, without stability data, Example 29 cannot be used for comparative purposes as Dr. Tomber had suggested in Section 9.4 of his Opinion. The Deputy Commissioner does not think that Paragraph 95 goes beyond the issues under discussion, since it specifically relates to Dr. Tomber’s Opinion which related to Professor Golomb’s original Opinion. In light of this, the request to cancel section 95 is refused.

In paragraph 104 of the Expert Opinion in Response, Professor Golomb summarizes that stated in paragraph 32 of Dr. Tomber’s opinion regarding adapting the formulation for once-a-day dosage, with reference to the release duration and the amount of active ingredient in the blood over the period of release by the tablet. In paragraph 105, Professor Golomb explains why he disagrees with that stated by Dr. Tomber in Paragraph 32 of his opinion, and supports this with reference to publications cited in his original Opinion. This is sufficient to show that Paragraph 105 of the Response Opinion relates to matters raised by the Applicant and is in accordance with Regulation 62 of the Patent Regulations.

In paragraph 104 of the Expert Opinion in Response, Professor Golomb summarizes that stated in paragraph 32 of Dr. Tomber’s opinion regarding adapting the formulation for once-a-day dosage, with reference to the release duration and the amount of active ingredient in the blood over the period of release by the tablet. In paragraph 105, Professor Golomb explains why he disagrees with that stated by Dr. Tomber in Paragraph 32 of his opinion, and supports this with reference to publications cited in his original Opinion. This is sufficient to show that Paragraph 105 of the Response Opinion relates to matters raised by the Applicant and is in accordance with Regulation 62 of the Patent Regulations.

In Section 130 of the Response Opinion, Professor Golomb claims that the Application emphasizes the wear data and hardness of the formulation as ways to optimize the release rate of the active ingredient, but he disagrees that the evidence supports this contention. Here again, the Deputy Commissioner accepts the Opposer’s argument that this paragraph comes in response to Dr. Tomber’s statement in paragraph 26 of his Opinion, that CPVP manufacturing provides a significant advantage. In fact, Dr. Tomber dedicated a number of paragraphs to the stability of the tablets, and so the Deputy Commissioner does not consider that Paragraph 130 goes beyond Regulation 62 of the Patent Regulations.

In Section 130 of the Response Opinion, Professor Golomb claims that the Application emphasizes the wear data and hardness of the formulation as ways to optimize the release rate of the active ingredient, but he disagrees that the evidence supports this contention. Here again, the Deputy Commissioner accepts the Opposer’s argument that this paragraph comes in response to Dr. Tomber’s statement in paragraph 26 of his Opinion, that CPVP manufacturing provides a significant advantage. In fact, Dr. Tomber dedicated a number of paragraphs to the stability of the tablets, and so the Deputy Commissioner does not consider that Paragraph 130 goes beyond Regulation 62 of the Patent Regulations.

In light of this, the request to cancel the various paragraphs is refused.

Since the parties informed the Patent Office a few days ago that they are negotiating a way to end this Opposition procedure, no costs are awarded at this time.

Interim ruling re admissibility of various paragraphs in a Response by Opposer to Applicant’s Opinion concerning IL 190827 to Pfizer, opposed by Teva, ruling by Deputy Commissioner Jacqueline Bracha,  6 June 2018.     


Opposition to IL 201320 to Pfizer & limits to amending the Statement of Case

July 2, 2018

Patent Application IL 201320 to Pfizer is titled “CRYSTALLINE FORMS OF 6-[2- (METHYLCARBAMOYL) PHENYLSULFANYL]-3- E -[2- (PYRIDIN2- YL] ETHENYL] INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS”.

On allowance, it published for Opposition purposes, and Unipharm submitted an Opposition.

Prior to publication following allowance, Applicants have very wide discretionary powers to amend claims or submit new claims, provided the claimed mater is supported from the specification. After publication, in response to Oppositions, or even after grant, the Applicant/Patentee is only allowed to correct obvious typographical errors or to narrow the scope of protection by cancelling claims or by amendments that clearly narrow the scope of protection. Nothing that protects matter previously not within the ambit of the claims can be allowed.

In this instance, during the Opposition proceeding, Pfizer requested a narrowing amendment to the specification to clearly define the term ‘substantially pure’ that appears in claim 2. Commissioner Alon allowed the amendment in a ruling of 5 March 2018, and gave the parties a window to amend their Statements of Case to take the amendment into account.

Unipharm, who had already submitted their evidence, decided not to amend the statement of claims, but Pfizer submitted an amended Statement of Claims that was wide ranging.  This included background to the development of the invention and eleven appendices.

Unipharm then requested that Pfizer’s amendment be struck from the record, arguing that amendments to the claims following amendments to the specification should be based on those amendments to the specification. Pfizer disagrees. They note that the Law does NOT require that amendments to the counter-statement of claims be related to the earlier amendments to the statement of claims at the start of the Opposition proceedings, or that they be based on the amendments to the specification. Furthermore, the interim ruling allowing amendments to the statement of case did not include such limitations.

The Applicant drew a parallel to civil court proceedings, however the Commissioner does not accept this since in civil court proceedings, when the plaintiff amends his Statement of Case, he can expect the defendant to be allowed to amend their Statement of Case, whether in direct response, or to broaden their position, and this is the risk taken when amending the Statement of Case once the proceeding is underway.

In contrast, in Patent Opposition proceedings, it is the Applicant that has a right to amend the specification, not the Opposer. In this instance, it is the Applicant that causes the Statement of Case to need to be amended, and he can therefore expect that the Opposer will also amend his Statement of Case , and will not restrict himself to amendments resulting from the Applicant’s amendment. If the Opposer does amend their Statement of Claims, the Applicant can make their amendments.

So what is the appropriate Law if the Opposer does NOT amend their Statement of Case? The Commissioner reasons that the Applicant can certainly correct their Statement of Case with respect to anything that needs correcting. Whenever the specification is amended, the main points of disagreement often shift. The Opposer deciding not to amend the Statement of Claims does not prevent the Applicant from relating to new issues raised by the amendment to the Specification, and to redirect his allegations to these issues. This serves the procedure and focuses the Statement of Case on the real issues. The Commissioner considers that the term “issues arising from the amendment” should be interpreted broadly, in light of the relevant case-law.

Nevertheless, where the amendment to the Statement of Case is totally disconnected to the amendment to the specification, it becomes a regular amendment to the Statement of Case which should be subject to the regular criteria. The submission should be accompanied with a statement justifying the amendments and explaining why they could not have been included originally, and why they should be allowable. This is necessary to prevent the amendment to the Specification becoming a technical tool for allowing unlimited amendments to the Statement of Case whenever the Specification is amended.

In this instance, the amendment to the Statement of Case was the addition of background relating to the development of the XLI formulation. From Examination of the amended Statement of Claims, the Applicant did not indicate any connection, even minimal, between the amendments to the specification and the amendments to the Statement of Case. Furthermore, the Applicant did not justify why the amendment was required now, and was not part of the original Statement of Case, or why the Statement of Case was not amended earlier.

In these circumstances, the Commissioner considers that the Opposer is correct, and the amendments as submitted should not be allowed. The Applicant is given 15 days to refile an amended Statement of Case whose claims are related to the amendment to the Specification, or to state that they do not wish to file an amended Statement of Case. Alternatively, the Applicant may submit a request to amend the Statement of Claims justifying the amendments submitted.

The deadlines for submitting evidence that were given in the interim ruling of 5 March 2018 are canceled. New deadlines will be given once the Applicant files his Statement of Case.

Costs for this will be considered when ruling costs for the main ruling.

Interim ruling by Commissioner Ophir Alon Concerning Unipharm’s Opposition to IL 201320 to Pfizer


New Patent Commissioner overturns Patent Term Extension decision by Predecessor

June 28, 2018

Manufacturers_Association_of_Israel.pngThe Manufacturers Association of Israel opposed an ex-partes decision to allow a patent term extension for Dexlansoprazole, and New Commissioner Ofer Alon has disallowed the extension accepted by his predecessor.

Background

Dexlansoprazole.pngDexlansoprazole is used for treating gastro-reflux and for treating or preventing digestive ulcers.

IL 145996 to Takeda is a patent for Dexlansoprazole that claims various crystalline forms of the salt, a pharmaceutical preparation including the forms, and methods of treatment or prevention of digestive ulcers.

After Takeda successfully obtained regulatory approval for Dexilant™. (Dexlansoprazole) which is the R enantiomer of Lansoprazole, they applied for a patent term extension, which was refused by the Deputy Chief Examiner on 30 June 2016 on the grounds that the registration of Dexlansoprazole is not the first approved medical usage of the active ingredient in Israel, as the racemic mixture of the same active ingredient (Lansoprazole) is already registered.

Left and right antiomers in a lattice arrangement.jpg

Racemic Lattice for Shoes

In a response filed on 28 August 2016, the Applicant acknowledged that the racemic mixture Lansoprazole includes the R-enantiomer Dexlansoprazole, but the R-enantiomer cannot be separated from the racemic mixture since the crystals themselves contain both the right and the left enantiomers within the same lattice, creating a new complex that is different from the separate enantiomers.

The Applicant submitted that previously registered Lansoprazole is thus not a racemic mixture but rather a racemic compound and consequently the Dexlansoprazole crystals are substantially different from those of Lansoprazole and should, therefore, be registerable.

The Applicant distinguishes between racemic mixtures and racemic compounds with reference to Mitchell AG, Racemic drugs: Racemic Mixture, Racemic Compound, or Pseudoracemate? J. Pharm Pharmaceut Sci 1(1):8-12, 1998).

Dexasportshoe Lattice Arrangement

Dexasportshoe Crystalline Structure

On 27 October 2016, the Deputy Chief Examiner understood the argument as stressing that the enantiomer is more efficacious than the racemic mixture and rejected the request for the patent term extension citing former Commissioner Meir Noam’s ruling concerning Unipharm’s opposition to IL 90465 to A/S Lundbeck (3 February 2009), which ruled that the higher efficacy of enantiomer with respect to the racemic mixture was patent worthy, but did not provide a new material in the sense required for a basic patent that is eligible for patent term extensions.

On 24 November 2016, the Applicant appealed this decision to the Commissioner of Patents, reiterating the arguments that were rejected. Then Commissioner Asa Kling accepted that the enantiomer was not found in the racemic compound and agreed to a patent term extension of 959 days until 30 January 2023 (see ruling re IL 145996 to Takeda from 12 Feb 2017:

In paragraphs 24 to 26 of his decision, then Commissioner Kling stated:

I have been convinced that Lansoprazole is a compound of the enantiomers and it is not possible to isolate Dexlansoprazole from the racemic compound, in contradistinction to the state of affairs in Unipharm vs. Lundbeck where the racemic mixture could be separated into the enantiomers.

Where the relative efficacy is different, Applicants assertion that Lansoprazole is NOT a racemic mixture but rather that the enantiomers share the crystalline structure, one cannot isolate the R enantiomer.

Opposer’s Argument

On 25 May 2017, the Association of Israeli Industrialists opposed the ex-partes decision to issue a patent term extension, based on Section 64g(a) of the Israel Patent Law 1967 for the following reasons:

  • the registration in the register of medical formulations which was the basis for the patent term extension was not the first registration for the active ingredient, contrary to Section 6d(3) of the Law.
  • The Applicant concealed significant relevant facts from the Patent Office. So the Application for a Patent Term Extension is contaminated with inequitable behaviour and is contrary to Section 64b(1) of the Law.

These claims were supported by an expert opinion from Professor Menachem Kaftori dated 24 May 2017.

The Opposer relies on the Lundbeck ruling (Appeal 223/09 Lundbeck vs. Unipharm ltd from 25 May 2009 which asserted that the various terms for material in Section 64a include enantiomers, and wherever the material is an active ingredient or form of the active ingredient that is found in a prior medical formulation that is listed in the register, it cannot be considered as being a first registration under Section 64d(3) of the Law.

The Opposer further alleged that the applicant had already acknowledged that the active ingredient Dexlanoprazole is included in the racemic Lansoprazole in the pharmacology report for Kapidex in a request to market a formulation including Dexlansoprazole in the US (NDA 22,287) which was appended to the ex-partes submission.

Based on Professor Kaftori’s opinion, the Opposer further alleged that coupling between the different molecules in the crystal were inter-molecular bonds and not intra-molecular bonds, so that on dissolution into water a racemic mixture of the enantiomers results.

DexilantThe active ingredient of Dexilant™ is Dexlanoprazole and not the crystal, and the morphological structure of the crystal has no relevance to the issue of patent term extensions. The racemic compound is no different to a racemic mixture as has as the difference between its components, apart from the crystal structure of the raceme. The inclusivity of the re Lundbeck decision does not relate to the isolation of the material by separating the basic cell of the crystalline structure whilst in a solid state, but to the possibility of any separation.

The Opposer further argues that the efficacy of the enantiomers when considered separately or as part of the racemic mixture is not relevant to the question of whether the application in question relates to the first formulation that allows the material to be used for medical purposes in Israel.

LansopropazoleThe Opposer further claims that the Applicant concealed the fact that the material was previously registered in the Lansoprazole registration, and the experimental evidence used to justify the registration were those using Lansoprazole which the Applicant had asked to be relied upon. Similarly, the Applicant had concealed the fact that Lansoprazole had been defined by themselves as being a racemic mixture and not, as they now claimed, a racemic compound, for example, before the Canadian Federal Court of Appeal.

Applicant’s Argument

Takeda reiterated the arguments submitted in the ex-partes hearing by former Commissioner Kling, his ruling of 12 February 2017, and an Opinion of Professor Avi Bino of 19 September 2017.

Furthermore, Takeda rejected the allegation of inequitable behaviour noting that the racemic material Lansoprazole was disclosed and related to in their submission for a patent term extension, and reiterated that it was a different material.

optically active.jpegFurthermore, in their response of 28 August 2016, they clarified that Lansoprazole is racemic compound that is optically active in a different manner to that of the enantiomer. The XRay diffraction pattern of Dexlansoprazole is different, and it is a different chemical entity. The Applicant further claims that the request for a Patent Term Extension is based on a registered product and not on a material after subsequently undergoing any type of process within the human body [apparently dissolution is intended – MF].

The Applicant alleged that the Opposer did not provide support for the contradiction in Mitchell’s paper, and did not provide scientific textual support, experimental evidence or research to challenge the validity of the evidence submitted by themselves in the ex-partes proceeding.

In the pharmacology submission for Kapidex which includes Dexlansoprazole there was experimental evidence relating to pregnant women which included one test conducted with Dexlansoprazole and one test conducted with Lansoprazole. Thus contrary to Opposer’s assertion Dexlansoprazole was examined, and the testing of Lansoprazole was additional data.

Although the therapeutic results themselves are insufficient to prove that a patent term extension is justified, they do teach that there is a difference between the materials that allows a patent term extension.

raceme.jpgTakeda referred to the definitions of racemic mixture, raceme and racemic compound in the IUPAC gold book which is the definitions used by the International Union of Pure and Applied Chemistry and which they claim accords with Mitchell’s paper.

Finally, Takeda submits that the Commissioner is not able to sit in judgment and rule on a ‘kind of appeal’ of his own decision, or that of his predecessor.

Discussion and Ruling

For sake of clarity, the Commissioner notes that the term raceme relates to racemic mixtures of S and R molecules in equal amounts, or to racemic compounds where there is a repeating arrangement of the two enantiomers in different proportions within a crystal,

The legal authority of the Commissioner to rule on the Opposition

legalCommissioner Alon dismisses the allegation that he cannot hear this case. Section 64f of the Law allows anybody to oppose patent term extensions or their duration. Under section 64g, ANY reason that the Commissioner should not grant a patent term extension is a valid reason for opposing the extension. The right of the Opposer is independent of whether the extension was the result of an ex-partes ruling or otherwise.

The logic is clear. In the ex-partes hearing, one side presents THEIR arguments, evidence and documentation supporting the issuance of the PTE. The opposition is an adversarial proceeding whose purpose is to allow third parties to challenge the granting of the PTE, Once an Opposition is filed, the Commissioner is obliged to consider the issues raised and to reconsider the determination that a PTE is justified in light of the claims and evidence of the parties.

Registration of Lansoprazole allowed usage of Dexlansoprazole

Section 64d of the Law sets out the conditions for obtaining a Patent Term Extension. Inter alia, it states that one can only obtain an extension for a material listed in the pharmaceutical register, and only if that registration is the first registration of the material for medical use.

It does not appear that there is any dispute between the parties regarding the following facts:

  • The crystal of the Lansoprazole raceme is a racemic compound, which is difference from the enantiomer of Dexlansoprazole (Cross-examination of Professor Kaftori page 12 lines 12-18).
  • When the raceme Lansoprazole is in a crystalline form, one cannot separate the enantiomers into Dexlansoprazole and Levolansoprazole.
  • One can separate a solution of Lansoprazole into its enantiomers by known and established procedures for separating enantiomers. (Opinion of Professor Bino, paragraphs 13-14).
  • When Lansoprazole is separated into its enantiomers one obtains the R-enantiomer Dexlansoprazole and the S enantiomer Levolansoprazole.

As to the possibility of separating the enantiomers. Under cross-examination, Opposer’s expert Professor Bino agreed:

Attorney Tal Band:  Take, let’s repeat this, take a crystal of Lansoprazole, dissolve it in water and what do you get? I suppose you will allow me…

Professor Avi Bino: With pleasure

Adv. Band: You will obtain a solution that includes the R-enantiomer

Prof Bino: the R-enantiomer and the S enantiomer

Adv. Band: and the S enantiomer, which is the active ingredient if we now know that the active ingredient is the R enantiomer? It is the R enantiomer, right?  

Prof Bino: the R-enantiomer in solution

Adv. Band: the R enantiomer I solution is the active ingredient?

Prof Bino: Correct.

Protocol of 9 January 2018, page 53 lines 17-26.

In a different stage of the cross-examination, 9 January 2018, page 46 line 6:

Attorney Tal Band:  It can, that means to say, it can dissolve into the solution…

Professor Avi Bino: Yes

Adv. Band: And this change from crystalline to solution is not a chemical change but a physical one, correct?

Prof Bino: True.

Adv. Band: Good. So in the two states the chemical compound maintains its identity, correct?

Prof Bino: Correct.

See also paragraph 60 of the Applicant’s claims from 19 September 2017 and paragraphs 9-15 of Professor Bino’s Opinion.

right hand.pngThus there is no argument that the R-enantiomer included in Dexilant™ is the same R-enantiomer included in Lansoprazole.

In the Lundbeck ruling, the District Court ruled that registration of a raceme would be considered the first registration for the enantiomers.

The Applicant considers that the Lundbeck case is different since there one could separate the enantiomers as the patent covered a racemic mixture. However, in the present instance, one cannot separate the enantiomers whilst solid, but have to dissolve them in water first, and only then can the enantiomers be separated.

To clarify the point, the Applicant submitted the following schematic illustration on 28 August 2016 to the Deputy Chief Examiner:

Lansopropazole imageThe Applicant claims that the law relates to the active ingredient of the medical formulation, which is crystalline and so should be considered in this form.

lefty.jpgIn re Lundbeck, a mixture was considered, and the unit cell of r-enantiomer structure is found in the mixture (right side) and in the enantiomer (center top), whereas in the present case, (illustrated on the left), there is no r-enantiomer unit cell so one has to dissolve the crystal and then separate and recrystallize to obtain the separate enantiomers in crystalline form.

Applicant claims that the Law relates to the active ingredient of the medical formulation. The medical formulation includes the crystalline structure, and so it should be [examined for patent term extension purposes] in this manner.

The Examiner considers that the fact that one cannot separate the R and L enantiomers whilst crystalline is irrelevant. In paragraph 17 of the District Court ruling in re Lundbeck the court differentiates between inter- molecule bonds and intra-molecular bonds.

Even if we were to accept the Applicant’s claim that the Lansoprazole is a racemic molecule, there are no intra-molecular bonds, but only bonds connecting the molecules to each other, and each enantiomer molecule maintains its identity within the crystal. The attractive forces between the S and R molecules creates the crystal by inter molecular bonds (see paragraph 18 of Professor Kaftori’s opinion and Professor Bino’s remarks on page 48 lines 6-12 of the protocol. As Commissioner Alon clarifies below, it is incorrect to consider the material at the crystalline layer, and so the R-enantiomer is NOT to be considered a new material as far as Patent Term Extensions are concerned.

If one were to consider the crystalline form of the pharmaceutical formulation as being a new material as far as Patent Term Extensions are concerned, the consequence would be that one could dissolve Lansoprazole and consider the solution as being a pharmaceutical formulation, the solution contains both enantiomers in solution would be considered as a different formulation and thus subject to a Patent Term Extension, and it is difficult to accept this result.

Furthermore, the definition of material in Section 64a of the Law is:

“Material” – the active ingredient of the medical formulation or its salt, ester, hydrate or other crystalline structures of the same component.

Commissioner Alon considers that one should read Section 64a as all the forms of the active ingredient being considered the same material. This definition implies that the identity of the material is NOT considered in terms of its form in the formulation. The case-law has ruled that the fact that different enantiomers and crystalline structures have different physical properties does not make them considered as being different materials as far as patent term extensions (PTEs) are concerned – see District Court ruling in re Lundbeck, section 20.

This interpretation sits well with the rationale of the Law as stated in the Patent Term Extension ruling concerning IL 124123 to Bayer Healthcare LLC, 16 April 2018:

With regards to active chemical ingredients, one can claim that the legislator defined enantiomers that, although not structurally identical, can be considered as being the same active ingredient, since the experiments on the active ingredient will shorten the way or help develop drugs based on the same active ingredient. So different salts of the same active ingredient are defined as being the same active ingredient with respect to Section 64D(3) of the Law (it is noted that in other jurisdictions, a different conclusion was reached).

Additionally, there is an explicit connection between the breadth of patent protection under Section 64h(d) of the Law and the interpretation of the term ‘material’. Section 64h(d) states:

  1. d) If the Registrar granted an extension order, then the holder of the basic patent may – during the period in which the extension order is in effect – prevent any person from marketing or from producing in order to market without his permission the medical equipment or the medical preparation that incorporates the material, as far as the material, the process of its production, its use or the medical preparation or the process for its production were claimed in the claims for the basic patent.

Recognizing all forms of the active ingredient as being a new material as far as Patent Term Extensions are concerned would result in Patent Term Extensions being granted, not for all forms but only for the form of the active ingredient in the medical formulation. Commissioner Alon considers that proper policy is to provide wide protection for the party developing a new drug, and recognizing the physical form of the material as being different would result in narrowing the breadth of the patent term extension.

The Applicant argues that from the ruling of former Commissioner Noam regarding the Patent Term Extension for IL 97219 Novartis AG (26 December 2005) one can conclude that two active ingredients acting together could be considered as being a new material that is different from the two ingredients considered separately.

Commissioner Kling does not agree. In re Novartis, Commissioner Noam considered the eligibility for a Patent Term Extension for a formulation including two active ingredients that were previously separately recorded in the pharmaceutical register, and concluded that even were there to be a synergetic effect and not merely an additive effect (aggregation), this is only relevant for the question of patentability but not for the question of eligibility of Patent Term Extension, nothing further is stated.

It appears that Commissioner Kling’s ruling of 12 February 2017 was largely based on the conclusion that one cannot separate the enantiomers of the racemic compound. As shown in the Opposition by the statements of case and evidence, is that the compound can be separated into its enantiomers, and that the form is not significant. In other words, the factual basis for Commissioner Kling’s ruling has been eroded and we can thus change the decision.

In light of above, Commissioner Alon rules that the R enantiomer is found in Lansoprazole and the registration of Lansoprazole is the first registration of the R-enantiomer Dexlansoprazole which is the active ingredient of Dexilant™.

The Allegation of Inequitable Behaviour

The Opposer’s allegation that Takeda’s behavior was inequitable, contrary to Section 64b(1) of the Law, is supported by two props. One is the statement appended to the request for a patent term extension that was written by Miyuki Hora which states that Dexlansoprazole is the first registration that allows the use of the product for medical purposes in Israel, without going into details, which comes later.

In addition, the Oppose claims that the Applicant concealed the fact that the examination of the request for registration in the pharmaceutical formulation register relied on tests performed on Lansoprazole, and that the Applicant itself relates to Lansoprazole as being the racemic mixture in a proceeding before the Federal Court of Appeal in Canada, and regarding the date of the claim that Lansoprazole is a racemic compound.

The Applicant’s response to these claims was that the experiments were clearly indicated in the pharmacology report mentioned above, and Commissioner Kling even related to it in his ruling of 12 February 2017. As to the Canada decision, the Applicant acknowledges that they were inaccurate in their terminology regarding mixtures and compounds, but this was due to the fact that case related to a different issue and not to something relevant to the issue of whether the Lansoprazole raceme is a compound or mixture. The same inaccuracy is found in the FDA regulatory approval in the US.

When considering Miyuki Hora’s affidavit, it is true that it relates to the Lansoprazole raceme:

“… Although racemic Lansoprazole was previously approved for medical use, enantiomerically pure Dexlansoprazole has never been approved …”.

Additionally, it seems that the Applicant themselves muddled up the terms in the definition of the raceme, and sometimes referred to it as a mixture and sometimes as a compound, however the Commissioner does not consider that this is indicative of inequitable behaviour. Furthermore, in light of the above ruling, it is irrelevant whether we refer to the raceme as a mixture or a compound, since the question of whether the molecule were previously registered exists in the raceme, which we have established to be the case.

Conclusion

In light of the above, the Commissioner accepts the Opposition and cancels the patent term extension. The Applicant will pay 15000 Shekels costs and 100,000 Shekels legal fees to the Manufacturers Association of Israel.

Opposition by the Manufacturers Association of Israel  to Patent Term Extension for IL 145996 to Takeda, ruling by Commissioner Ofir Alon, 24 May 2018  

COMMENT

I think this decision is completely correct and is also well written and whilst comprehensively addressing the issues raised, is relatively concise.

Since the racemic compound dissolves into the free molecules, the discovery that the R-enantiomer is active may be inventive, but the clam that this is a new material that warrants a patent term extension is ludicrous in light of the previous cases related to by the Commissioner and linked to above.


Can Non-Israelis be Subpoenaed to testify in Opposition Proceedings?

June 10, 2018

novartis

Israel Patent Application No. 176831 to Novartis is titled “COMPRESSED PHARMACEUTICAL TABLETS OR DIRECT COMPRESSION PHARMACEUTICAL TABLETS COMPRISING DPP-IV INHIBITOR CONTAINING PARTICLES AND PROCESSES FOR THEIR PREPARATION”. It is the national phase entry of PCT/EP2005/000400.

Unipharm

On allowance, Unipharm filed an Opposition to the patent application being granted.  Within the Opposition proceeding, Unipharm, who for this case, have dispensed with the services of Adv. Adi Levit, their legal counsel and have been handling the Opposition unaided by attorneys, have requested that the Israel Patent Office subpoena  John Hutchinson and Mr Kowalski, workers at Novartis to give testimony.

This request follows an earlier request to reveal documentation regarding testing that was appended to the Expert Witness testimony of Professor Davies, Novartis’ expert witness, which was ordered in an earlier interim ruling of 3 January 2018.

Discovery

In response to the discovery request, Novartis submitted an Affidavit with various appended papers. In light of this, Unipharm now alleges that the Affidavit implies that Novartis has not revealed all documents it should have. Unipharm further indicates that the explanation proffered by Hutchinson, who is signed on the Affidavit, “appears to be odd”. Therefore, Unipharm wish to Subpoena him to cross-examine him on this.

lab bookUnipharm further claims that a document titled “Certificate of Authenticity” was included with respect to the laboratory notebook, parts of which were included in the appendices attached to the affidavit. According to Unipharm, Mr Kowalski, who was one of the named inventors, is signed on this document. Consequently, Unipharm requested to cross-examine him as well.

Novartis requests that Unipharm’s request be rejected. They claim that the Commissioner does not have the authority to subpoena witnesses not within the judicial territory of the State of Israel, who are not direct parties in a proceeding. Novartis also notes that Mr Hutchinson’s signature on the Affidavit accompanying the discovery documents was done in the framework of his employment as a patent attorney in the Legal Department of Novartis. Novartis claims that ALL information regarding the management of the proceeding is subject to legal confidentiality and may also be considered as being a trade-secret.

As to Mr Kowalski, he never signed an Affidavit of Evidence in the process and is not a party to it. Similarly Novartis claims that Unipharm has not stated why they need to cross-examine that inventor who was one of three named inventors.

Discussion

The witnesses that the Opposer wished to interrogate are beyond the territorial jurisdiction of Israel and are not parties in the case. Thus the Applicant is correct that Section 163b of the Patent Law 1967 that Unipharm referred to is not a legal basis for their being subpoenaed. The references that Unipharm related to in their request, dealt with witnesses that gave Affidavits or expert witness testimony, and thus could be subpoenaed for cross-examination purposes.

A party that wishes to subpoena a citizen or foreign resident to testify must do so under the International Inter-State Legal Assistance Law 1998. See Appeal 3810/06 Dori and Zacovsky Building and Investments Ltd vs. Shamai Goldstein, paragraph 17, 24 September 2007.

Section 47 of the Legal Assistance Law states:

The Authority is allowed to request from another country, that testimony be collected, including that physical evidence be transferred for display in Israel, if the court allows that the evidence is required to hold the trial in Israel; regarding this law, and where the case is pending, the term court refers to the tribunal that is hearing the case.

From the wording of this Section, it transpires that the court will open a proceeding to summon foreign witnesses to a hearing only if it is convinced that their testimony is necessary to conduct the proceeding. In this instance, the Commissioner considers that there is significant doubt as to whether the presence of the witnesses for cross-examination purposes is really required.

Unipharm has requested to cross-examination Mr Kowalski regarding an Affidavit for discovery that he is signed on. The purpose of the discovery process is to enable the main proceeding to be handled efficiently; legal proceedings with face-up cards where each party knows what documents the other parties hold to prevent surprises at the hearing. By this means, unexpected delays are prevented, allowing the court to reveal the truth. Appeal 4235/05 Bank Mizrachi United vs. Ronit Peletz, 14 August 2015.

Opposite the principle of discovery, there are other interests such as efficiency of the court proceeding, defense of the legitimate interests of the party revealing documents, and preventing damage to the interests of third parties – See Appeal 2534/02 Yehuda Shimshon vs. Bank HaPoalim ltd. p.d. 56(5) 193. So the case-law has ruled more than once that it will not allow cross-examination of affidavits of this kind, if they are properly presented (see Appeal 2376/13 Rami Levy Shikma Marketing Ltd vs. Moshe Dagan 8 July 2014, and Zusman Civil Procedures 7th Edition, page 436.

This general rule has two exceptions: The first is that where reading of the Affidavit alone or with reference to its citations, that the Affidavit is defective, the court can order the party revealing documents to file a further Affidavit. Second, where the issue of confidentiality is used, the court can examine the document and decide if this claim is reasonable (see for example, Appeal 240/73 Baruch Vilker vs. Dov Tishler, 205, 2 December 1971 and Appeal 6823/05 Abraham Roimi vs. Bank Leumi of Israel, 12 January 2016.

In this instance, Unipharm did not append an Affidavit, detail or justify why they considered that the current case is one of these exceptions. Thus the Commissioner cannot rule that this is the case, and so the request is rejected.

As to the evidence of Mr Kowalski, Unipharm did not claim that there was any connection between the documents appended to the Affidavit of the Discovery and to the experiments that were appended to Novartis’ evidence, which was the basis of the original discovery request. Note, Mr Kowalski’s signature is only on the Certificate of Authenticity taken from the lab-book that was appended to some pages therefrom that were submitted in the discovery documents. In these circumstances, it is not clear what value Mr Kowalski’s testimony has, even were he to be subpoenaed.

In light of this, the Commissioner does not consider that the requirements of Section 47 of the Law of Legal Assistance are fulfilled with regard to Mr Hutchinson or Mr Kowalski.

The Request is refused. Unipharm will cover Novartis’ costs and their legal expenses to the tune of 2000 Shekels + VAT. These costs will be paid within 30 days.

Interim Ruling in Opposition to IL 175831 Ofer Alon, 30 April 2018.

Comment

It is possible that Mr Tomer has indeed bitten off more than he can chew by handling legal issues procedural issues such as requesting subpoenaing witnesses without legal counsel. However, the costs ruled against him are trivial when considering the issue in question. The Unipharm’s Expert Witness cannot testify to things that he does not know such as what else was in the lab-book, and in Opposition proceedings there is no assumption of validity of the patent. Thus it would be premature to write this request off as a strategic or even a tactical error.


When does the ninety day period for requesting a patent term extension commence?

May 29, 2018

Extension for IL 124123 to Bayer. When does the ninety day period for requesting a patent term extension commence?

In this ruling, the Commissioner accepts that the 90 day period for requesting a patent term extension should be calculated from the date at which the Ministry of Health informs the Applicant of the issuance of the decision to grant a patent term extension, and NOT from the date on the certificate. We now wait for someone to request that all sorts of cases be reopened, and extension fees refunded.

There is a second part to this ruling, in which the Commissioner rules on whether this is indeed the first registration of the drug. For blogging purposes, I am relating to the issues separately.

Kovaltry

The Application for the Extension for IL 124123 to Bayer was filed on 7 August 2016 and relates to the KOVALTRY formulation in the medical products registry from 8 May 2016, and which contains Recombinant Human Coagulation Factor VIII (no relation).

The Deputy Chief Examiner sent an Office Action on 13 September 2017 in which she raised the following objections:

  • The Application does not fulfill Section 64xv(a) of the Patent Law 1967 since it was received 9 days after the formulation was registered in the pharmaceutical registry.
  • The Application does not fulfill section 64d(3) of the Patent Law 1967, since it is not the first registration of Recombinant Human Coagulation Factor VIII in the pharmaceutical register.

The Applicant was also required to provide additional details regarding extension orders in the US and in recognized European countries.

On 11 December 2017, the Applicant responded to the Office Action. Following the Request for Patent term extension being rejected on 3 December 2017, the Applicant challenged the grounds for rejection. In their response, they submitted a detailed list of allegations on 7 February 2018 and a summary on 20 February 2018. The Applicant also attended a hearing on 25 February 2018. After the hearing on 1 March 2018 the Applicant submitted a completion of their case.

Bayer raised two main claims. The first was the way of calculating the timing of the request for the extension conducted by the Deputy Senior Examiner in accordance with Section 64xv(a) of the Law. The second related to the previous registration of bioactive ingredients for medical purposes in accordance with Section 64iv(3) of the Law.

Timeline for Submitting the Request for Patent Term Extension

When the Application was submitted on 7 August 2017, the Application wrote that “This Application based on the Kovaltry formulation that was registered on 8 May 2016, and so the Application is submitted within 90 days of registration.”

Ms Assem Mehta Deputy President, Head of the Department of Patents and Licenses, and Assistant to the Secretary, affirmed in an Affidavit supporting the request for patent term extension, dated 22 August 2016, noted in Section 4 of the Affidavit, that the medical device was registered on 8 May 2017.

However, from the Office Action, the Registration Date that appears on the Certificate of Registration is indeed 8 May 2017, but the request for the Patent Term Extension was only filed on 7 August 2017 which is 91 days from the registration date. Based on this data, the Deputy Chief Examiner ruled that the request does not conform to Section 64xv(a) of the Law which requires that:

Section 64xv(a)A request for a patent term extension should be submitted in the appropriate manner, after paying the fee, and not more than 90 days from registration in the Pharmaceutical Registry.

In the response to the Office Action from 11 December 2017, the Applicant claimed that although 8 May 2017 is the date at which the registration for marketing Kovaltry appears in the register, the Authorization only issued on 10 May 2017, and this was the date at which the Manager of the Register for Pharmaceutical Formulations informed the Patentees of the Approval. The Applicant appended a further Affidavit dated 14 January 2017, from Mr Gal Friedman, the Head of Regulation of Bayer Israel, which markets the Applicant’s products in Israel. In the Affidavit, Gal Friedman asserted that regulatory approval was only received on 10 May 2017. An email notification from the Head of Registration of Pharmaceutical Formulations, Dr Einbinder was appended. The email address was given as the formal electronic mailing address of Bayer Israel.

The Applicant claims that from their attempts to clarify the matter, that in the past, the date on the certificate was the only date available for calculating the 91 day period. However, nowadays, one can use the date of informing the Applicant as the starting period of the 90 days.

The Applicant claims that neither the Patent Law nor the Pharmacists Ordinance 1981 define the registration date that appears on the registration certificate. They thus allege that there is no basis to explaining that the 90 day period stated with this date is the correct date for calculating the 90 day period for requesting a patent term extension from a the Deputy Commissioner ruled, rather than the date at which the Applicant was informed (i.e. 10 May 2017).

The Applicant went on to claim that time periods for calculating things that depend on the Authority are generally to be calculated from when the citizen is made aware of the action of the Authority or when the notice is sent.

The Applicant wishes to draw a parallel to the C-471/14 Seattle Genetics from 6 October 2015, where it was ruled that the period for giving marketing approval under the European regulations, is from the day that the Applicant is informed, i.e. the date of notification. The Applicant claims that the basis for this determination is that the marketing approval does NOT enter into effect from the day that the decision is taken, but rather from the date that the Applicant is informed of the decision. Consequently, certificates of registration have two dates and the Applicant believes that one should prefer the later of the two, which fulfills the intention of the legislation, which is to provide a sufficient window for Applicants who have a basic patent, to request a patent term extension – something that they cannot do before knowing that a marketing approval has issued.

The Applicant alleges that this position is supported by the District Court ruling in 32321-10-16 Bristol Myers Squibb Holdings Ireland vs. Commissioner of Patents and Trademarks 26 December 2017, where Section 64x(2) of the Law was interpreted to mean that the period of marketing approval commences with the informing of the decision to the Applicant and not with the date that the Approval was made. The Applicant considers that this should apply to Section 64xv(a) of the Law as well.

The Applicant also considers that the explanation of the Law made by the Deputy Chief Examiner could result in many cases where the patent term extension period was determined by the date appearing on the certificate and the number of days would need to be recalculated.

DISCUSSION AND RULING

The issue in question is the correct explanation of the term “Day of Registration of the Medical Formulation” as mentioned in Section 64xv(a) of the Law.

In legislating that the Applicant should submit their request for a patent term extension within 90 days from registration in the Pharmacist’s Register, the legislators attempted to achieve two purposes:

  1. To give the Applicant sufficient time to prepare their application
  2. To allow the public to know with certainty whether a patent term extension was being sought for a particular product, thereby providing market certainty.

Section 64xv(a) has been amended. In the earlier version under the third amendment to the Law, the period for applying for a patent term extension was 60 days from registration of the formulation under the Pharmacist Regulations (formulations) 1986.

In the seventh amendment from 2006, 3 January 2006, Book of Laws 2048, page 195-197, the Section was amended to extend this period to 90 days. The Pharmacist’s Regulations were similarly amended and now state “from the day of recordal under the Pharmacist’s Ordinance. In the 11th amendment the Authority of the Commissioner to extend the period was taken away, so the period is non-extendible (Amendment 11, 2014, Law book 2430, 27 January 2014, pages 274, 278.

From the Applicant’s claims it transpires that there are four periods that could be considered the period of registration from which the 90 days are calculated:

  1. That given as the date of registration
  2. The day that the approval is printed on the certificate
  3. The date when the Pharmaceutical Division informs the owners of the registration – the sending date. and
  4. The date of knowledge – the day on which the owners of the registration receive notification of the registration.

The date of registration is that appearing on the certificate from which the ninety day period has traditionally been calculated when calculating the deadline for requesting a patent term extension (considering the certificate as it stands today).

The date of printing is presumably the date when the Ministry of Health produces the certificate. This is the date on page 3 of the Kovaltry certificate which states printed on 10 May 2017.

The claims and evidence before me do not support the contention that the date of printing of the certificate is necessarily the date on which the Ministry of Health informed the Applicant that their request for registration was successful. Indeed, one can assume that the date of printing will actually change each time that the same document is sent to the printer and so the same certificate could exist with different printing dates. Consequently, the Commissioner does not think that this date can be relied upon as the date for registration with regard to the correct explanation of Section 64xv(a) of the Law.

As to the period of sending or the period of becoming aware, the Commissioner accepts the Applicant’s allegation that calculating the deadline from the Official Date is problematic where the Applicant only becomes aware of the date retroactively, since it is difficult to require someone to take an action within a time period from an event occurring that he does not know about.

The issuance of a marketing authorization is an administrative action as defined in Section 3 of the Law of Interpretation:

An administrative action is an order or an appointment, notice, license, approval and the like, that is given in writing under Law and is not a legislative action.

In his book Administrative Authority, Y Zamir states that (Zamir, Administrative Authority Vol. 2 Second Edition, 201 on page 1320):

Common sense tells us that there are things where not being informed of an administrative decision that adversely affects a person’s rights, should not be in effect at all, or in certain circumstances, if the person was not informed of the decision. For example, let’s consider that an Administrative Authority cancels the work permit of a person but does not inform him of this, is it conceivable that the person will be tried under criminal law for running a business without a license? If an Authority applies a tax and does not tell him, can he be held liable for not paying that tax? Where a Law states that a person is allowed to Appeal or to critique an administrative ruling in some other way within a specific period from that decision issuing, and the person is not informed, should he be prohibited from criticizing the ruling? In summary, it appears that the present situation requires a legislative solution or case-law, that relates to publication of civil rulings. The underlining is by Commissioner.

Logic obliges that giving notification to someone regarding an administrative action relating to him cannot be applied without the person being aware of the administrative action. This is also stated in regulation 4 of the Patent Regulations 1968:

The calculation of the time period for doing an action the Law or regulations require or allow, following actions of the Commissioner or subsequent thereto, should enter into effect from the date when the requirement is given to the postal service and addressed to the client or agent-of-record at the official address, or sent by electronic mail, as per Regulation 16(b). This period starts with the sending of the electronic mail, unless it is established to the Commissioner’s satisfaction, that the message was not delivered.

True, in this instance, we are NOT talking about an action that the Patentee is required to take following an action of the Commissioner of Patents, but due to the action of a different Authority, the Ministry of Health, however the underlying logic is appropriate. It is noted that where the Pharmacists’ Regulations themselves give a time period for an action, the time period is from when the action of the Authority is made known to the person concerned, see, for example, Regulation 9(3) of the Pharmaceutical Ordinance:

 (b) If the director considers that the registration of the formulation in the register should not be renewed, he should inform the registered owner before the registration lapses, the notification should be by registered mail to the official address of the registered owner.  

(b1) If the manager informs that he does not intend renewing the registration, he should extend the registration by no more than six months.

(c) The owner of the registration is allowed to appeal the decision not to renew the registration within six months from receipt of the notification under Regulation (b).

So the patent regulations specifically state that where someone has to respond to an action of the Authority, the period for responding will be calculated from the day of sending or from the day of receipt of the notification if it is proven that the notification did not reach its destination. The pharmaceutical regulations state that the period is calculated from notification.

In the ruling of re Bristol, Judge Magen Altovia related to the “submission approach”.

 It is noted that the serving of papers approach sits well with the administrative law that stresses that the period of serving of papers is more important than the reaching of the administrative decision by the deciding party with respect to setting into practice that allowed.

As Judge Magen Altovia stated in re Bristol, the purpose of the civil law procedures is to fulfill real rights. See Appeal 6708/00 Aharon vs. Aharon p.d. 54(4) 702:

At the end of the day, the civil procedures are there to serve substantive rights, and they are there for a purpose. The wider substantive approach, of which good faith is the wellspring, cannot be accompanied by overly strict civil procedures. The legal culture is not only judged by protected rights, but also sometimes by the ways of approaching situations and the status of those being judged.

Consequently, Commissioner Ofir Alon considers that the 90 day period for requesting a patent term extension be calculated in a similar fashion to other deadlines in the Patent Law, i.e. in accordance with Regulation 4 of the regulations, that the date is to be calculated from when the notification is sent to the applicant / patentee, unless the Applicant can prove that the notice was never received, and in such cases, the period is to be calculated from when the consumer learned about the decision.

The Commissioner does not consider that calculating the period from the day that the Notice was given to the Applicant undermines the second purpose of the legislators; the need for certainty. This interest is not damaged if the date is calculated from the day of sending, since this is usually close to the day that the decision was taken by the Ministry of Health. It should be noted that Section 64 of the Patent Law has to be very carefully interpreted, to reflect the balances intended by the legislators.

In this instance, in the request for registration and in the affidavit, the Applicant noted the date of registration as 8 May 2018, even though Mr Friedman did not note that the notification was first sent to the Applicant on 10 May 2017, which the Commissioner is willing to assume was his intention in light of the Applicant’s claim, and noting the date of the printing appears on the certificate. In light of all of the above, the Commissioner rules that the response was timely filed under Section 64xv(a) of the Law.

COMMENT

This ruling seems to indicate that the Current Commissioner is less formulistic than his predecessors. I was rather taken aback by this ruling since I think that the 90 day period is ample to cover regular postage delays and his deadline should be no different from all the others that are calculated from the date on the certificate.

The Patent Office has very many deadlines triggered by an action they take, including the deadline for responding to Office Actions (typically 3 or 4 months, and extendible), the final deadline for responding to all Office Actions for registering a design (one year from the date of the first office action), the deadline for paying the first renewal (three months from issuance of the patent certificate), the deadline for filing oppositions, the deadline for filing abroad under Paris, etc. ALL of these calculate the deadline from the official date, despite the fact that, in practice, the Applicant will only be aware of the date once he/she receives notification which may be some time later.

The 90 day period is sufficient to cover delays of days in the authority informing the Applicant and the time for the Applicant to inform his client. If it can be shown that there were extraordinary delays involved, then there is due cause to argue that the delays were unavoidable and the Commissioner could reasonably give a discretionary extension. If the Law limits the grounds for discretionary extensions, it does so for good reason. In light of this ruling, ALL the deadlines triggered by Patent Office actions are now suspect.

There is no need for this. The 90 day period is sufficient to cover minor delays and, in this instance, the delay was three days. Sixty days used to be considered enough for filing a request. This period has been extended to ninety days. Ninety days is ample.

The 90 day period should not be extendible. The Law requires unavoidable delays and there was nothing unavoidable in this instance. However, although I think the ruling was horrible, there is a precedent for extending the 90 day period based on errors by agent of record being unavoidable. In XXXX, Reinhold Cohn missed the date due to docketing errors. If Pearl Cohen had claimed that they made a docketing error and calculated the date from receipt of notification, it is difficult to see how the present Commissioner could avoid giving the extension given to Reinhold Cohn. Of course, to do this requires knowledge of the previous decision which requires reading the decisions or following this blog.

Even without this, if the Commissioner simply ruled that the delay was unavoidable, he could simply have granted an extension based on payment of an extension fee. Instead, he has ruled that all deadlines are to be calculated from date of sending, or if not received, from date of notification. We predict that this will open a hornets’ nest.

Actually, there is a second issue here, which is whether this was the first publication. On that ground, discussed in the next blog posting, the extension was rejected. The Commissioner could, therefore, have ruled on that case and left the present issue open.