When a patent application goes abandoned due to a misunderstanding between Attorney and Applicant

August 8, 2018

This case relates to a request to revive an abandoned Application, where the Agent of Record was under the impression that he was instructed to abandon, and thus failed to respond to the office action and to the Notice of Imminent Abandonment and the Notice of Abandonment (which gives a 12 month window to reopen the case as of right). He also failed to report the issuance of these notices to the client. The client denies instructing the Agent to abandon the case.

Israel Patent Application Number 191364 to Pro Natura Gesellschadt for Gresunde Ernahdrung MBH is titled “Agent for Reducing the Usable Calorie Content of Food and for Therapeutic Reduction of Weight in particular in the case of Adiposity (Obesity)”.

The Application was filed on 16 September 2015, and when an Office Action was not responded to, a notice of Imminent Abandonment was sent to the Applicant’s Agent on 2 November 2016, and a Notice of Abandonment was sent on 8 February 2017.

(This wasn’t the first time that this application was considered abandoned due to a lack of response being filed. On 20 August 2015, the case was abandoned, but shortly afterwards, on 16 September 2015, it was reopened by the Chief Examiner under Circular 026/2014 ”Returning Closed or Abandoned Applications to Examination).

On 14 March 2018, i.e. over 12 months after the case was closed a second time, the Applicant petitioned for it to be reopened under Section 164 of the Law.

Applicant’s Claims

Daniel Feigelson, the Agent of Record, claimed that Mr. Virovnik, the Applicant’s representative, only learned that the case had been abandoned in January 2018. The request for reinstatement was submitted two months later because he had to submit affidavits in support of the Application to reinstate the case, together with a detailed response to the Office Action.

Mr Feigelson also claims that in a meeting with Mr. Vorovnik in December 2015, the Applicant requested to delay the Examination in Israel for as long as possible, pending a decision on patentability of the corresponding Application before the European Patent Office. In a phone call of August 2016, Mr. Feigelson understood that he should not do anything to further the allowance of the Israel Application.

The request to revive the case was supported by two Affidavits; one from Mr. Vorovnik and the other from Daniel Feigelson, the legal representative. Mr. Vorovnik’s Affidavit stated that contrary to Daniel Feigelston’s understanding, he never ordered him to let the Israeli Application lapse. Contrary to that stated in Mr. Vorovnik’s Affidavit, Patent Attorney Feigelston stated that he’d understood from the August 2016 conversation, that Mr. Vorovnik was not interested in pursuing allowance of the Israel Application. However, unlike his usual practice, Mr. Faigelston did not document the conversation or send a written notice stating that he would abandon the case as instructed, for Mr. Vorovnik to confirm.

In a hearing on 25 April 2018, Mr. Feigelston clarified that following the conversation of August 2016, he did not update Mr. Vorovnik regarding correspondence from the Israel Patent Office, thus Mr. Vorovnik did not know that the case had become abandoned. At that hearing, the Deputy Commissioner Ms Jacqueline Bracha ordered that Mr. Faigelston obtain a further Affidavit from Mr. Vorovnik expanding on what he did remember from the August 2016 conversation.

In accordance with this order, a further Affidavit from Mr. Vorovnik was submitted on 27 May 2017. However, this Affidavit does not clarify that there was a conversation in August 2018, as Mr. Vorovnik neither confirms nor denies that this conversation took place. It merely states that Mr. Vorovnik does not remember instructing that the case be abandoned. It is noted, however, that in the original Affidavit, Mr. Vorovnik was unequivocal that he did not give such an instruction.

Hearing

Section 21a of the Law defines the time period for requesting reinstatement of an abandoned patent as follows:

Where the Commissioner refuses a patent under Section 21a, he can reconsider the refusal if requested to do so within 12 months.

Section 164a of the Law allows the Commissioner to extend this period on reasonable grounds:

The Commissioner has the discretion, if he sees fit to do so, to extend any deadline of the Patent Office or proceedings before the Commissioner….

Considerations for extending a time period should be based on context and the interests in question. This was clarified by Judge Naor in Appeal 2826/04 Commissioner of Patents vs. Recordati Ireland Ltd, 26 September 2004:

The policy for ruling on the various requests before the Patent Office will change with the context, and depend on the deadline under consideration.

In a ruling concerning extending the 12 month period for reconsideration of a decision to close a file concerning IL 221116 Yaakov Dichtenberg et al. from 7 September 2016, the Deputy Commissioner stated that such requests should consider the interest of the Applicant on one hand, and that of the public interest for certainty on the other.

The relevant considerations are whether reasonable grounds for granting the extension were provided, the size of the delay and the reasons for the delay. See Opposition to IL 110548 Shmuel Sadovsky vs. Hugla Kimberly Marketing ltd, 122 August 2010, and the ruling concerning IL 157563 to Icos Corporation from 21 October 2013.

As to the first consideration, the period of the extension is only a little more than one month over the 12 month period set out in Section 21a, which makes it relatively easy to allow such a short extension.

On the other hand, the case went abandoned due to an apparent misunderstanding between client and attorney that could have been avoided by sending a written summary of the conversation or similar documentation. Furthermore, it was not even properly clarified what instructions the Applicant understood he’d given his attorney during that conversation which he doesn’t remember.

Ms Bracha notes that relying solely on a telephone conversation as grounds for abandoning an application does not seem to her to be reasonable or appropriate behavior. This should be clear since this isn’t even the first case that this application was closed due to not responding to an office action, and consequently one could expect the Agent for Applicant to be more careful.

Furthermore, on discovering that the case had become abandoned, the Applicant could have acted immediately, within the 12 month window under Section 21a. However, she accepts that he preferred to submit a full response to the office action, as was finally submitted.

When weighing up the relatively short delay on one side, and the nature of the mistake on the other, which is far from being reasonable, Ms Bracha applies her discretionary authority under Section 164 to allow the case to be reopened, but on condition that there will be no further extensions whatsoever, for any reason.

Ruling re reopening abandoned application IL 191364, 18 June 2018.

COMMENT

Apart from the stated desirability to confirm instructions of this sort in writing, I would add that even when having received instructions to abandon a case, it is good practice for the Agent of Record to report the Notice of Imminent Abandonment and/or the Notice of Abandonment as a courtesy, since even if there was no misunderstanding and the Applicant does request abandonment, applicants have been known to change their minds.

In cases where a client’s desire to reinstate a mark becomes known to the Agent of Record within 12 months, the request should be made before the 12 month window closes, even if an extension is requested to obtain affidavits and to prepare a response to the outstanding Office Action.  It makes sense to obtain reinstatement as a matter of legal right under the law rather than to attempt to reinstate based on the Commissioner’s discretion. This is particularly the case where there is a contradiction between the testimonies of the Applicant and that of the Agent of Record regarding the chain of events leading to the case becoming abandoned. In this instance, the Deputy Commissioner was amenable. Had she not been, the client could sue the Attorney for malpractice, and his defence would be that he was acting on verbal instruction that he did not bother confirming. Not the best situation to be in.

 


Cancelling a Trademark – K Washer

August 8, 2018

This is an interim ruling regarding whether a sole distributor in Israel of trademarked goods has standing to request cancellation of a mark that is confusingly similar to the trademark covering the goods they distribute, and under what conditions can the owner of the trademark that is the basis of the challenge join the proceeding? Do they need to post a bond for costs? Does the counter-statement of case need substantive amendment and can the owner of the challenged mark requests costs for so doing?

KWASHER

Kärcher is a French company that has requested the cancellation of Israel Trademark No. 258749 to B.M. Peled-Technical Supplies LTD for the stylized “K-Washer” mark shown.

The basis for the cancellation request is that the K-Washer mark is confusingly similar to the Kärcher Mark.

Karcher

The request for cancellation was submitted by Dan Sheldon Ltd, which claimed to be the sole distributors of Kärcher in Israel. The Applicant for cancellation informed Kärcher about the issue and that they intended taking steps against the mark holder.

A letter of consent and a POA from Kärcher was attached to the cancellation request. In the letter of consent, Kärcher noted that they were not a party in the cancellation request but they agree to it occurring. In the POA it was emphasized that Dan Sheldon is the sole distributor of Kärcher products in Israel and that Kärcher delegates the right to take legal steps against K-Washer.

In response to the cancellation request, the trademark owner claimed that the party requesting cancellation of the mark had no connection to the registered Kärcher mark and no rights in the mark. In particular, the mark owner claimed that Sheldon had no standing and no legitimate interest that could serve as a basis for the cancellation request. Furthermore, he argued that the letter delegating authority showed that Kärcher had no interest in defending their mark in Israel.

In counter-response, to remove any doubt, Kärcher requested to be a party to the cancellation proceeding.

The cancellation request was submitted together with evidence from the requesters for cancellation and after the parties had submitted their statements of case. The mark owner has not yet submitted his evidence, and has already received an extension of time to do so.

The claims of the parties

Kärcher claims that their joining the cancellation request is essentially the same as if they had been a party from the beginning. It would not create damage, delay or affect the proceeding that has already started in any way, and their joining the proceeding does not in any way change the cancellation request.

Kärcher explained that their joining is merely a precaution to avoid the mark holder’s allegation that they have no interest in this proceeding, or in an infringement proceeding, Appeal 38680-11-17 in the District Court.

The mark holder counter claims that the fact that Kärcher has requested to join the proceeding is not a reason for them to do so, and Kärcher does not claim to be a necessary party in the proceeding. Furthermore, the mark holder notes that Kärcher has not explained how they would be hurt if their request to join the proceeding is refused, and the only reason why they requested to join the proceeding is that the respondent alleged that the party requesting cancellation has no rights in Kärcher’s mark and thus cannot themselves be a party to the proceeding.

Discussion and Ruling

First the Commissioner, Ofer Alon notes that he doesn’t think that the cancellation proceeding submitted by Dan Sheldon was submitted without right of standing. Section 38 of the Trademark Ordinance 1972 states that:

38.(a) Subject to the provisions of this Ordinance, any person aggrieved by the non-insertion or omission from the Register without sufficient cause, or by any entry wrongly remaining on the Register, or by any error or defect in any entry in the Register, may make application in the prescribed manner to the Supreme Court or may, at his option, make such application in the first instance to the Registrar.

The term any person aggrieved has been broadly interpreted, see Seligsohn “Trademark and Related Laws, 1973, page 105 and Appeal 94/05 The Vineyards of Rishon L’Zion and Zichron Yaakov Cooperative vs. The Vineyard Company ltd. P.d. 61(3), 350 (2006) and paragraphs 9 and 10.

The term “who is aggrieved” has been explained very liberally in the case-law, and includes all business competitors who lose out by a competitor benefitting from a trademark that he does not have rights to. This explanation is based on the explanation of the term Person Aggrieved in the English Law.

This was cited in Bagatz Klil vs. Commissioner of Patents and Trademarks, p.d. 42(1) 309 on pages 316 and 317 where the court related to the fact that the mandatory authority amended the term “person interested” that appeared in the original law to “party aggrieved” in  the 1938 Ordinance, and the term remained broad as explained above.

To demonstrate the trend to explain the term broadly, it is noted that in the new UK Trademark Law 1994, the term “person aggrieved” is also deleted, and anyone can request cancellation of a mark.

If there is a risk of misleading the public to think that K-Washer is connected to Kärcher, then Sheldon, who is Kärcher’s distributor in Israel, is within the ambit of a ‘person aggrieved’ and has the right to request cancellation of the mark.

It is noted that the mark owner simultaneously claims that there is no point adding Kärcher to the proceeding, and that only Kärcher has the right to request cancellation, implying that there is indeed a point in allowing him to join the proceeding.

It seems that the parties concur that Kärcher has the right to request cancellation of the mark, since they are also ‘aggrieved” by it being registered (should it be determined that there is indeed a danger of misleading as to the source of the goods).Consequently, if we were to refuse to allow them to join this proceeding, they could simply file a separate request to cancel the mark(which logically would be combined with this proceeding), and this justifies allowing them to join this proceeding at this time.

Regulation 72 of the Trademark Regulations 1940 lays out the conditions for a third-party to join a cancellation or correction proceeding for an issued trademark that are set out in regulation 70:

  1. Any person other than the registered owner, claiming a benefit in a registered trade mark in respect of which an application was made under clause 67, may apply to the Registrar, using the prescribed form, to permit it to intervene in the matter, and the Registrar may refuse or accede to the granting of permission for such, after hearing the parties in respect of the matter, on such terms as the Registrar may see fit. Prior to dealing with such application in whatever manner, the Registrar may demand that the applicant give an undertaking to pay the Registrar’s expenses incurred in deciding to the benefit of one of the parties under the circumstances.

The purpose for Regulation 72 is to allow third parties that claim a benefit in the registered mark, to have their day before the Commissioner. As then Commissioner Asa Kling stated, this is the right to a substantive hearing (see registered Israel trademark no. 216,916 (request to include a third-party) Danny Argon vs. Strauss Culture Factories ltd, 1 November 2012:

Where the third party claims apparent rights to a mark and excluding him from the proceeding would have negative consequences, it seems appropriate to include him in the proceedings as it seems improper to prevent him for stating his case.

As stated above, the cancellation proceedings is based on claims of misleading and unfair competition with respect to Kärcher products.so it seems appropriate to allow Kärcher to join the proceeding, and this accords with Regulation 72. Thus Commissioner Alon orders that Kärcher can join the proceeding as a third-party.

The trademark owner requested on 2 July 2018, that should Kärcher be allowed to join the proceeding, a procedural regime should be introduced wherein amended statements of case and amended evidence be resubmitted in consequence of them being added. Furthermore, the mark owner requests that should Kärcher be allowed to join the case, that they be required to deposit a bond to cover the mark owners costs and should bear the costs of the mark owner correcting their statement of case.

The parties requesting cancellation object to this procedural regime and contend that adding Kärcher does not require making substantive changes to the statement of case, and adding Kärcher does not require moving from where the case has got to and does not introduce new claims. As to requiring Kärcher to deposit a bond, they note that Kärcher is a company with a yearly turnover of billions of dollars and in the court proceedings Kärcher was added as a plaintiff without preconditions.

With respect to the posting of a bond, the mark owner did not provide justification for this request. However, the request to add Kärcher as a plaintiff was also not submitted with justifications for them not to post a bond other than their alleged turnover which was also not supported by any evidence.

In the Commissioner’s ruling of 19 June 2018, the time frame for the mark owner to submit evidence was set to 30 days after the requester for cancellation submit their evidence in a discovery procedure that the Commissioner initiated. It appears from the documents before him, that the requested documents were transferred to the mark owner on 26 June 2018, so the mark owner has until 26 July 2018 to submit their evidence.

In light of the above, the Commissioner rules as follows:

  1. The statement of case of the requester for cancellation of the mark shall be amended only by adding Kärcher as a co-plaintiff. The mark owner will have 21 days to amend their counter-statement of case from the date of this ruling.
  2. The challenger can amend their evidence by adding Kärcher as a plaintiff, and can add any new claims to their statement of case that result from this addition. The additional evidence should be submitted within 30 days of the amended counter-statement of case of the mark owner.
  3. The mark owner should submit their evidence within 30 days of the submission of the amended evidence by the original and the additional challenger. In accordance with Regulation 40 of the trademark regulations, the original requester for cancellation and the additional party will be able to submit their counter-evidence in accordance with the schedule laid out in the regulation.
  4. Despite allowing the addition of a second party to the challenge, no costs will be awarded for any need to amend the statement-of-case, or other reason.
  5. In light of the above, at this stage, the Commissioner does not see it appropriate to require Kärcher to post a bond to cover costs of the mark owner, should they prevail. If however, the mark owner considers it appropriate to require the challengers to post a bond, they can submit a detailed request and it will be considered on its merits.

Interim Ruling in Cancellation Proceeding of Israel Trademark No. 258749 “K-Washer” by Ofer Alon, 19 July 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.     


The three month Trademark Opposition period is calculated from the day it starts

July 31, 2018

288045

The three month Trademark Opposition period is calculated from the day it starts

On 3rd June 2018, Israel Trademark Number 288045 to R & S Food Import Export published as issued. The mark is shown alongside.

Barilla Ger Fratelli requested that their trademark opposition submitted on 30 May 2018 be considered.

deadlineThe Israel Trademark Department considered that the final date for opposing the mark was 28 May 2018, three months after the mark published for opposition purposes on 28 February 2018. Furthermore, the Commissioner of Patents and Trademarks does not have the authority to extend the deadline for filing oppositions. So the Opposition submitted on 30 May 2018 was not considered as being timely filed and was ignored.

BarillaBarilla Ger Fratelli, represented by Dr. Shlomo Cohen Law Offices argued that the deadline for filing the opposition was the end of May, and they had until 31 May 2018, so the opposition was timely filed. To support their contention, Barilla’s representatives referred to Section 10b of the Law of Legal Interpretation 5641 and argued that Patent Office Circular M.G. 46 titled “Calculating Deadlines provided in Months or Years” contradicts the law and adversely affects Barilla’s rights. Barilla’s legal representatives claimed that the Opposition was filed after they had consulted with the trademark department and appended an Affidavit of Adv. Talia Punchick, a former employee of Dr. Shlomo Cohen Law Offices.

Section 24a of the Trademark Ordinance 1972 states:

Within three months of the date of publication, anybody can submit an Opposition to a trademark issuing.

Section 23 states that:

If a trademark application is accepted, whether as filed or with limitations, the Commissioner will publicize in the determined manner, that the mark was accepted and any limitations applied.

The date that the mark published under Section 23 for opposition purposes, was 28 February 2018. Since the period for submitting an Opposition is three months from 28 February 2018, and under the Section reproduced above, the final date for submitting Oppositions is 28 May 2018. This is the date required by Section 10b of the Law of Legal Interpretation which states:

A period provided as a number of months or years after a specific event will end on the final month on the day having the same date as the event, and if that month does not have that day, on the last day of the month.

Barilla’s representative’s claim is surprising, as if this law reduces the period given in the law, since the months provided for the opposition (March, April and May) that were at Barilla’s disposal, are all full months. Barilla chose not to take advantage of this time period.

Beyond that required, it is noted that the final date for submitting the opposition, i.e. 28 May 2018, was noted in the publication of the notice of allowance in the journal and also on the second page of the journal itself.

To remove any doubt, it is noted that Section 10(a) of the Law of Legal Interpretation which states that where a period is provided in days or weeks, the day that the period starts is not included in the calculation is not relevant to the present case, since it relates to days and weeks and not to a number of months, unlike Section 24(a) of the [Trademark] Ordinance. Thus the claim that the number of months starts from the 1 March 2018 (and should therefore finish on 1 June 2018), rather than starting on 28 February and finishing on 28 May is groundless.

This conclusion would be changed if, for example, an allowance was published on 30 November of some year, and thus the final day does not exist since February has only 28 (or 29 days). In such a case, the deadline would be 1 March.

In light of the above, the example given in Circular M.G. 46 is correct, and the final date for publishing an opposition to something that publishes on 28 February is 28 May.

There is no request to extend the Opposition period, which in any event is not within something that the Commissioner of Patents has the authority to do as is evidenced in a long list of Patent Office decisions. Commissioner Ofir Alon’s ruling in the request for extending the Opposition period in re Israel TM Application number 283942 Mindspace ltd vs Merkspace Europe BV from 28 June 2017:

As explained in the Decision of then adjudicator of IP concerning the Opposition to Israel Trademark Application Numbers 182779 and 182780 for stylized marks to Baltika Breweries vs. S & G Intertrade ltd from 5 November 2006:

Retroactive extensions of opposition periods is what Section 7 of the fifth amendment to the Ordinance was designed to prevent, as can be learned from the words of explanation of the Proposed Law 34 from 16 June 2003, on page 492:

It is proposed to cancel the Commissioner’s authority to extend the Opposition period. This step is intended to increase the efficiency of the consideration of the registerability of trademarks.  

Similarly, see for example, the decision regarding the Request to extend the Opposition for Israel Trademark Application Number 245038 Dynasoi Elastomeros, SA de CV bs. SK Global Chemical Co. Ltd, from3 October 2013.

From examination of the Opposition file, it transpires that a notice of the untimely filing of the trademark Opposition was sent to Barilla’s representatives on 30 May 2018, immediately after the opposition was filed. The Adjudicator does not accept that the opposition was submitted after consulting with the Trademark Department. The Affidavit by the attorney states that the matter was told to her to the best of her knowledge. No details of when and how the alleged conversation was supposed to have taken place are provided, the identity of the Examiner who allegedly gave the wrong advice is not provided. Nor are the exact contents of the alleged conversation. Due to this lack of clarity, the Adjudicator is unable to rely on this affidavit to support Barilla’s contention. Anyway, the Law itself over-rides any other guidance. Any attorney, and particularly one with trademark expertise, is expected to refer to and rely on the Law and not on vague guidance to the extent that such existed.

It is noted that Barilla still has legal options, and can request that the mark be cancelled under Sections 38 or 29 of the Ordinance. In such a cancellation proceedings, all their arguments and contentions will be fully considered.

The request for accepting the Opposition as timely filed is refused.

Decision by Ms Yaara Shoshani Caspi re Barilla’s Opposition to Israel Trademark No. 288045 to  to R & S Food Import Export.   

COMMENT

This is not the first time that the Patent Office has ruled that the three month trademark opposition period is not extendible. See here for another example.


Panama Jack Cancellation Proceeding – Proving Something Did not Happen

July 1, 2018

Panama JackOn 30 November 2016 Panama Jack International Inc  filed a request to cancel Israel TM No. 79829 for Panama Jack in class 25. The registered trademark, then owned by Grupp Internacional S.A.,  is shown alongside.

Back in March 2017, the Adjudicator of Intellectual Property Ms Yaara Shoshani Caspi issued an interim ruling  that since Grupp Internacional S.A., though represented by an Israel Law firm, did not file a response to the cancellation proceedings instituted by Panama Jack International Inc., Panama Jack can supply their evidence and she would rule on the cancellation proceeding if the arguments were persuasive.

On 2 April 2017, Panama Jack International submitted an Affidavit from Mr Erez Drucker, director of Access (Xes? Axes? Excess?) Private Investigators, to support their allegation that the mark was not in use by Grupp. Again Grupp failed to respond, despite having legal representation back then.

On 21 August 2017, Panama Jack International requested a decision despite the lack of response.  On 28 March 2018 they requested to add a further Affidavit, this time from Mr Ronen Menashe, director of “”Information Services of Israel”.  Again, the owner failed to respond.

(On 2 October 2017, Grupp’s attorneys requested to cease representing their client for various reasons that Ms Shoshani Caspi considers justified. On 10 October 2017 they submitted an affidavit to the effect that the client’s local attorney in Spain knew about the hearing. On 23 October 2017, Ms Shoshani Caspi assented to the request).

Now, on 23 May 2018, a hearing was held before Ms Shoshani Caspi, which Grupp and their representatives did not bother attending, despite knowing about the date thereof. Panama Jack International requested to withdraw the Affidavit by Mr Erez Drucker and to replace it with that of Mr Ronen Menashe who was available for questioning at the hearing. This request was granted. During the hearing, a recording of conversations between Mr Menashe and the Spanish office that was referred to in the Affidavit was also listened to.

Discussion and Ruling

The question in this instance is whether there is justification to cancel the issued mark. Section 41(a) of the Trademark Ordinance states:

  1. [a] Without prejudice to the generality of the provision of indicate sections 38 to 40, application for the cancellation of the Registration Madrid of a trade mark regarding some or all of the goods or classes of amendments goods in respect of which a trade mark is registered (hereinafter – goods regarding which the cancellation is requested) may be made by any person interested on the ground that there was no bona fide intention to use the trade mark in connection with the goods for which it is registered in connection with the goods regarding which there is a request to cancel the registration and that there has in fact been no bona fide use of the trade mark in connection with those goods in connection with the goods regarding which there is a request to cancel the registration, or that there had not been any such use during the three years preceding the application for cancellation. [b] The provisions of subsection (a) shall not apply where it is proved

Thus the relevant period regarding usage of the mark by Grupp is from 30 November 2013 to 30 November 2016 when the cancellation request was submitted.

In this instance, as stated above, the mark owner failed to respond to the cancellation request, and did not even request extensions. Panama Jack International, did however, submit their evidence.

During the hearing, Mr Menashe’s integrity was examined and from his evidence and responses, Ms Shoshani Caspi was assured that he was trustworthy. Mr Menashe’s opinion included a survey and investigation of the relevant markets in Israel (i.e. clothing and footwear) in an attempt to find stores that sold goods bearing the Panana Jack man in the relevant time-period. In addition, his office searched the Internet for evidence that goods bearing  the mark were available in Israel at the relevant time. He determined who owned the mark and the identities of the leading employees of the company to contact them directly to determine usage of the mark in Israel. Within the framework of Mr Menashe’s investigation, neither he nor his investigators found any indication of sale of goods under the Panama Jack trademark in the relevant time period.

It is established case-law that a registered trademark is a property right for all intents and purposes, that cannot be whittled away without cause. The burden of proof that a mark was not used lies with the challenger of the mark. See for example, Bagatz 476/82 Orlogd ltd vs. the Commissioner of Patents p.d. 39 (2) 148. During a proceeding, the burden of proof passes back and forth. Thus the requester for cancellation of a mark has to bring evidence that a mark is not in use. If this is proven, the burden of proof then falls on the mark owner to attack the challenger’s evidence and to establish that the mark is indeed in use.

The challenger has more than met the initial level of proof required to establish a prima facie case that the mark is not in use, and the mark owner failed to even attempt to rebut this position, and thus the apparent lack of use remains unchallenged.   The Adjudicator considers the evidence that the mark has not been in use for three years prior to filing the cancellation submission and thus it is fitting to cancel the mark.

In light of the above and in like of claims made at the hearing, it is clear that the mark owner has intentionally ignored the challenge to the mark and the cancellation proceedings submitted to the Israel Patent and Trademark Office.  In addition to concluding a lack of usage, one can only conclude that the mark owner is simply holding the mark for no purpose. One would expect the mark owner to acknowledge and respond to the cancellation proceedings by abandoning the mark, thereby rendering this proceeding unnecessary.

The mark is therefore cancelled. Using her authority under Section 69 of the Ordinance, Ms Shoshani Caspi has also issued relevant costs in the proceeding, based on the work done by the challenger, and rules 9000 Shekels costs, which the mark owner is informed of via the address in the register.


The Admissibility of Late Submitted Evidence

July 1, 2018

Competing Marks Proceeding – DMI Dental Supplies vs. DMI Innovative Medic al Technologies ltd.

Where there are two competing pending trademark applications in Israel, unless the parties can agree to co-exist under conditions acceptable to the Israel Patent and Trademark Office (i.e. not confusing to the public), a special proceeding occurs under Section 29 of the Trademark  Ordinance 1972, to determine which application should be examined first, usually barring the other application from registration. The first to file is considered less important than the usage of the mark and the investment in promoting it. As always, inequitable behaviour trumps other considerations, and where proven, the mark of the guilty party is generally cancelled.

This interim ruling focuses on admissibility of late submitted evidence.

On 15 April 2018 there was proceeding under Section 29a of the Trademark Ordinance 1972 during which DMI Dental Supplies was ordered to produce an audited financial statement for 2017 showing sales of the company in Israel.

On 15 May 2018, DMI Dental Supplies submitted the document together with additional documentation not requested, including a balance sheet, profit and loss account and explanations.

The same day, DMI Dental Supplies submitted an urgent request to add further evidence. The evidence in question was a short statement from Mr Zaza Debershvilli that attempted to establish that the name was registered since 2012. This was appended to the Affidavit of Mr Alon, a witness for DMI Dental Supplies whose Affidavit was already on file. The affidavit itself was appended to the request to allow its submission.

On 21 May 2018, DMI Innovative Medic al Technologies ltd requested that this additional submission be removed from the file, or they be allowed to submit their balance sheet. Prior to obtaining permission, DMI Innovative Medic al Technologies ltd simply submitted their balance sheet.  DMI Innovative Medic al Technologies ltd opposed the additional submissions from DMI Dental Supplies claiming that they were attempting to strengthen their position and this was not allowable at that stage of the proceeding. Simultaneously they claimed that the additional evidence did not add anything new, and that its submission was acceptable if given negligible evidentiary weight as an affidavit that is not cross-examined, and that costs be awarded to them.

On 28 May 2018, DMI Dental Supplies responded to DMI Innovative Medic al Technologies ltd, objecting to the awarding of costs for the additional submission. Furthermore, they argued that since DMI Innovative Medical Technologies ltd’s balance sheet was not audited, it could not be considered as evidence, particularly as it related to foreign entity that was not a party to the proceeding.

Section 41 of the Trademark Ordinance 1940 states:

No party may submit additional evidence in any hearing before the Commissioner, however the Commissioner may, at any time permit the Applicant or Opposer to submit any evidence under conditions that he considers appropriate, regarding costs or other matters.

In general, parties should submit all their evidence in one go, and not in a trickle (Appeal 579/90 Rozin vs. Bin Nun, p/d/ 46(3) 738, 742 (1992), and Zusman, Civil procedures 509-510, 7th edition, 1995. Whilst it is true that the court can accept additional evidence during the proceeding and even during summations, (Appeal Shenzer vs. Rivlin, p.d. 45(2) 89, 95 (1991) and even during Appeal (Shenzer 95. Regulation 457 of the Civil Court Procedure Regulations, 1984).

Together with this, the court has to be very wary and careful when exercising this discretion “and in general should be careful to follow civil procedures, including the submission of evidence at the appropriate time” (Shenzer, page 95). The rationale for this principle is general efficiency of the handling of the case and of the court system in general.

There are four criteria to allow the submission of evidence at a different stage than that specified in the Civil Court Procedures:

  1. The most important is the importance of the evidence to ensure that justice is dispensed. This requires consideration of the new evidence in deciding the case, and the weight given to it, since it was not timely submitted.
  2. The amount of damage (evidentiary and with regard to the hearing) that would be caused to the opposing party if the evidence is accepted, which would alter the balance between the parties.
  3. The reasons why the evidence was not timely submitted and the responsibility of the submitting party for the lateness of the submission and whether they can be considered as acting inequitably by withholding the evidence until its late submission. (see Appeal Shasha Securities ltd vs. Adanim Mortgages and Loans ltd. p.d. 42(1) 14, 18)
  4. The damage to the effective management of the proceeding (re Rozin, page 743).

Applying these principles to the present case leads to the decision not to allow either party to submit additional evidence regarding the extent of their sales, since she does not consider that the evidence helps determine making a correct ruling or uncovering the truth. The deadline for the timely submission of evidence has passed, and neither party provided justification for their late submissions.  The evidence has been heard and the parties should be making their summations.

Ms Shoshani Caspi is less than enamoured with the behaviour of the parties, who chose to submit their additional evidence without waiting for authorization to do so. It is well-known that one should only submit late evidence after receiving authorization. Submitting the evidence together with the request does not accord with the Supreme Court ruling in Appeal 6658/09 Multilock ltd. vs Rav Bareakh ltd, 12 January 20110 on page 11 paragraph 12:

Until there is a judicial ruling allowing submission of additional evidence, a party to a proceeding is not allowed to relate to that evidence in his claims. Under the guidance 1/92 published by the Chief Justice, a request to submit additional evidence should “describe the purpose of the evidence without attaching it (section 1 of the guidance). This guideline attempts to strike a balance between the requirement not to expose the court to the additional evidence prior to being authorized to do so, and the need for the court to have an understanding of the nature of the evidence in order to consider whether it is relevant and significant.

As to the additional affidavit that DMI Dental Supplies wished to submit, Ms Shoshani Caspi considers that it should be allowed, despite it being submitted prior to receiving authorization. This is since DMI Innovative Medic al Technologies clearly stated that they do not object to its submission. However, DMI Innovative Medic al Technologies are correct that it should be given little weight since they cannot cross-examine the witness. However, she does not agree that DMI Innovative Medic al Technologies should be allowed to continue to cross-examine, as the new evidence does not add anything new. Since DMI Innovative Medic al Technologies did have to relate to the new evidence, they are indeed entitled to costs.

In conclusion, DMI Dental Supplies cannot submit the new material. DMI Innovative Medical Technologies are not allowed to submit their balance sheet.  DMI Dental Supplies can submit their Affidavit and costs of 350 Shekels (just under $100) are ruled to DMI Innovative Medic al Technologies.

The period for submitting summations starts today, 29th May 2018.

Interim ruling by Ms Shoshani Caspi re DMI competing marks proceeding, 29 May 2018.


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.