Novartis Patent Application Struck Down In Israel Opposition

January 11, 2017

glivec

Israel Patent Application No. 174082 to Novartis is titled “METHANESULFONATE SALT OF N – PHENYL – 2 – PYRIMIDINEAMINE DERIVATIVE, PROCESS FOR ITS PREPARATION AND USE THEREOF FOR THE PREPARATION OF A TABLET CONTAINING THE SAME”.

On allowance, Teva Opposed the patent. This decision relates to the utility requirements and to double patenting.

Background

The Israel Application is a divisional application of IL 133906 which is a national phase entry of PCT/EP1998/004427, claims priority from a Swiss application filed back in 2007. The case published as allowed at the end of May 2010, and an Opposition was filed by Teva on 28 August 2010.

Following Statements of Case from the parties, Novartis submitted a request to correct the claims, and narrowed the scope of claim 1, adding a dependent claim 2. This somewhat delayed the proceedings. In May 2012, the Applicant requested a further amendment to narrow the scope of claim 1. (During Opposition, and indeed after grant, claims may be narrowed, so long as doing so is clearly a narrowing in all cases).

Teva did not object to either amendments and submitted an amended statement of case in June 2013. Novartis responded in September 2013 and by November 2014 both sides had submitted their evidence.

Teva submitted an expert opinion by Dr. Mark Zakrzewski and Novartis filed expert opinions from Dr. Simon Bates and from Patent Attorney Dr. Gail Volman. However, in lieu of a hearing, the parties agreed that the Commissioner would rule on the case based on the submissions, and, following his agreement to so doing, the parties filed their summary statements and counter statements.

The subject matter of the patent is Imatinib (N-phenyl-2- pyrimidine-amine) which was developed in Ciba Geigy, later Novartis, and is marketed as Gleevec® in the U.S. or Glivec® in some other countries. It is a competitive tyrosine-kinase inhibitor used in the treatment of some types of cancers, most notably Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML).

(An opposition was lodged against the application in India by several Indian generic drug manufacturers including NATCO Pharma Ltd., CIPLA Ltd. Ranbaxy Laboratories Ltd., Hetro Drugs Ltd. and also by the Cancer Patients Aid Association. On April 1st, 2013 the Supreme Court of India dismissed Novartis’ patent application, so there are generic versions of the drug on the market. in India and the majority of the patients – 300,000 patients – are treated by the generic versions).

In Glivec, the Imatinib Methanesulfonate is found in the Beta polymorph which differs from the needle-like alpha polymorph and this affects various physical properties.

After the amendments described above, the claim set consisted of five claims, the first being independent.  The main claim is directed to non-needle-shaped crystals having certain diffraction peaks as follows:

174082-claimClaim 2 adds additional characteristic XRay diffraction peaks. Claims 3 and 4 respectively relate to capsules and tablets comprising the beta polymorph and claim 5 relates to a method of fabricating the tables of claim 4.

The Opposer’s Statement of Case

90The Opposer notes that the specification provides support for a material comprising at least 90% of a specific (beta) salt defined by a spectrum of peaks. The main claim, by merely specifying two characterising peaks, effectively claims other polymorphs not necessarily yet discovered and so the claims ‘greedily’ encompass more than the specification teaches.

beta.jpgThe justification for the patent is related to enhanced flow properties of the polymorph. However since the claims cover traces of the polymorph, the claimed material as a whole does not show enhanced flow properties.

Based on the introduction to the specification, the Opposer believes that the scope of the patent should be limited to at least 90% of the specific polymorph as characterized by all its peaks. In response to the Applicants claim that the introductory paragraph was included by mistake, the Opposer notes that such a ‘mistake’ is a factual error and to substantiate that it occurred requires factual support, not expert opinion, and so this claim of mistaken inclusion should be struck from the record or given negligible evidentiary weight. To support this argument, Teva notes that Dr Voleman was not the representative of Novartis during the patent prosecution when the paragraph was allegedly mistakenly included.

Furthermore, Teva posits that the average person of the art reading the application would conclude that the invention is for formulations including  at least 90% by weight of the (beta) salt of Imatinib Methanesulfonate rendering Dr Voleman’s opinion irrelevant.

Double-dip.gifFinally, the Opposer claims that there is overlap between the claims of this divisional and of the parent application, and thus the Applicant is trying to obtain two patents for the same invention. However, this line of reasoning was not related to in the summary and seems to have been abandoned.

The Applicant’s Position

just-another-exampleThe Applicant considers that the specific Example of 90% beta polymorph given in the specification is simply that. It is a non-limiting specific formulation that is provided by way of example.

The Applicant accuses the Opposer of cherry-picking statements from the specification to provide interpretation to the claims, rather than to interpret the claims in light of the specification taken as a complete document. The introductory paragraph was provided for administrative purposes and is not to be used to interpret the patent. Indeed, this paragraph was never intended to be part of the disclosure and was included in the specification by mistake. The parent application cherry-pickingclaimed the beta polymorph in concentrations exceeding 90% and at the time of filing, the Applicant considered that the practice was to conform the background to the claims, and then to file a divisional with the same specification as the parent, but with different claims. Consequently, the limitations of the introductory paragraph referred to the parent and not the divisional, were inherited from the parent, and are not to be considered as limiting the scope of the claims. Thus according to the Applicant, persons of the art would appreciate that the application in question is a divisional application and the paragraph in question related to the parent patent.

morphThe Applicant claims that the present application claims a new polymorph and is a product claim that is per se patentable. To argue the point they referred to TEVA applications for polymorphs that claim the desired properties of the polymorph, such as flow properties, compaction properties, and the like. These are characteristic of the polymorph but it is the polymorphs itself that is being protected as a new composition of matter.

The properties of the beta polymorph are inherent to the crystalline structure and not to the concentration of the polymorph in the formulation. Since the beta polymorph has inherent advantages, its discovery and manufacture has utility and is thus a patentable invention.

Discussion

The guidelines for patentable subject matter are given in the Supreme Court rule 345/87 Hughes Aircraft vs. State of Israel p.d. 44(4) 45, 65:

“true the interpretation of patents is not substantially different from the interpretation of any other document, and the standard laws of interpreting papers apply to it. However, due to the special nature and power of patents, additional care must be taken in interpreting since they effectively provide a monopoly in the marketplace. The basic principle is that the patent should be read as a document in its entirety to understand the inventor’s intention as it is expressed in the document…since the patent is primarily directed to professionals in the technological field that the patent considers to be the field of relevance, it should be interpreted using professional knowledge (state of the art) at the time of filing. However, since the patent is supposed to indicate the inventor’s intention, there is some flexibility in giving interpretation to phrases and terms that appear in the claims and the rest of the specification, such as the description, may be used as a dictionary for these phrases and terms. In other words, as a lexicography of the invention.”

Section 13a of the Law states that:

The specification will conclude with one or more claims that define the invention, however these claims must be fairly based on the specification.

Regulation (20)a(3) of the patent regulations 1968 expounds section 13 and requires that the claims are ‘succinct and clear’.

It will be appreciated that the claims define the scope of protection claimed. The claim interpretation should be based on the specification in its entirety – including the description and the figures (Hughes, page 65). However, one cannot import limitations from the specification into the claims:

“The starting point for the appropriate approach is that patent documentation is a one-sided document that the inventor himself writes and he has freedom to write it as he likes. (Catnic Components Ltd. [22] at 242).  A lack of clarity regarding the explanation of a phrase or term in the claims can be made by reference to the specification so long as this is done with reference to the specification as a whole and not selectively in a way to favour the applicant whilst disregarding other phrases in the specification that lead to a different interpretation (Electric & Musical Industries Ld. And Boonton Research Co. Ld. [21], at 41).”

Section 13(a) deals with the question of whether the claims of the application are fairly based on the specification and whether or not they are sufficiently enabled for persons of the art to practice. The Court of Appeals of the EPO has nicely summed this up as follows:

“Undue breadth is not a reason for refusing a claim under the EPC as long as its subject-matter is novel and inventive, and sufficiently disclosed in and supported by the description.” T 0593/96 INDIGO N.V. (18.11.1996). 

See also  T 0456/91 Syntex (USA) Inc. v. Debiopharm S.A., (3.11.1993).

In this instance, the Opposer alleges that the claims are not supported by the specification to the extent required by Section 13(a) of the Law since the claims are wider than that supported. The Opposer calls the claims ‘Greedy’. The extent that this term can be used with reference to the requirements of Section 13(a) is given in Appeal 1008/58 Alerican Cyanamid vs. Lepitit et al. page 261 from 4 April 1960. See also Opposition by Teva to IL 142809 to Pharmacia AB from 26 February 2015.

In his Opinion from 1 December 2013, Dr. Mark Zakrzewski (Teva’s expert witness) notes that the invention clearly specifies a 90% concentration of the beta phase.

“34. The alleged invention is explicitly described in the Patent Application as a methansulfonate salt of Imatinib Mesylate comprising “at least 90% by weight of crystals of the β-modification…” or “in essentially pure form”.

Based on this, the Opposer considers that claim 1 which lacks this limitation is wider than that supportable under Section 13(a).

Consideration of the Application itself shows that there is no certain preference to limit the concentration of the beta phase. For example, page 3 states:

“The invention relates to an acid addition salt of a compound of formula I comprising non-needle-shaped crystals, especially the β-crystal form of the methanesulfonic acid addition salt of the compound of formula I.

The invention relates especially to a particular, form of the monomethanesulfonic acid addition salt of a compound of formula I,

formula

comprising at least 90% by weight of crystals of the β-modification, said crystals of the β-modification showing on X-ray diffraction a peak at an angle of refraction 2theta of 20°, said peak having a relative line intensity of 65 as compared to the most intense line in the diagram”.

Further on, on page 4 of the specification, the following is stated:

“The term “essentially pure” is understood in the context of the present invention to mean especially that at least 90, preferably at least 95, and most preferably at least 99 per cent by weight of the crystals of an acid addition salt of formula I are present in the crystal form according to the invention, especially the β-crystal form.

…                                                  

The invention expressly relates also to those forms of the methanesulfonic acid addition salt of a compound of formula I in which crystals of the crystal form according to the invention, especially the β-crystal form, are present in essentially pure form…”.

From the above it is clear that the specification does relate to the beta phase in a manner that does not necessitate limiting it to a preferred concentration. Apart from the opening paragraph which will be discussed separately, the specification uses terms such as ‘particularly’ and ‘especially’ with regards to concentrations and does not limit to these desirada.

The reader will appreciate that the patent relates to the non-needle-like beta phase but not to specific concentration ranges. See Section 22 of Dr Bates’ opinion on behalf of the Applicant:

“22. Contrary to Dr. Zakrzewski’s assertions, the specification teaches and enables form β per se, without any purity limitations. An “essentially pure” form β is one of the preferred embodiments of the invention, but by no means reflects the entire scope of the invention. Dr. Zakrzewski apparently selects a couple of paragraphs which highlight a preferred embodiment, disregards the teaching of the specification as a whole will readily understand that the invention is the discovery and development of the novel form β and that the invention is not limited to form β only when it is “essentially pure”.”

As to the practice of claiming new polymorphs, Dr Bates opines:

“Indeed, just like new chemical entities, novel polymorphs are claimed per se without quantitative purity limitations. At the most, quantitative limitations are a preferred embodiment, as in the instant case. For the sake of demonstration, I instructed applicant’s counsel to search polymorph patents issued to Teva by the USPTO. Overall, 78 patents claiming polymorph forms were found. 77 patents out of 78 patents claim the polymorph forms per se, without “quantitative” or “purity” limitations…”

The Applicant explained that the introductory paragraph was the result of the Examiner requiring the specification of the parent to be conformed to the claimed invention, and then was inherited in the divisional application. This claim, related to in Dr Voleman’s opinion, relates to factual matters. Commissioner Kling concurs with the Opposer that Dr Voleman is not the ‘correct’ witness to testify that this was a mistake and does not have first-hand knowledge regarding that which she is about. Such a claim requires support by an affidavit and is a matter for first-hand testimony and not for an expert witness to hypothesize about.

That said, the state of affairs is not sufficient to warrant deviating from the general principle stated in the Hughes Aircraft Decision, that the specification should be considered ain its entirety. From this perspective, the Commissioner is willing to accept the Applicant’s claim that the introduction is not indicative of the scope of the invention and cannot be relied upon to the exclusion of the rest of the specification to explain that scope of the application. A person of the art who reads the document as a whole would not rely on the introductory paragraph alone, but would read the patent application in its entirety.

Utility

The Opposer alleges that the claimed invention does not have utility since it does not demonstrate the advantages of the beta polymorph when present in minor proportions.

It is true that amongst other requirements, in accordance with Section 3 of the Law, a patentable invention has to have utility. The utility is a requirement that the patent application as a whole must satisfy as stated by Judge Hendel in Appeal 5041/13 Anat Gabai et al vs. Aminach Mattresses, 21 January 2014:

Reading the main paragraph that gives the requirements for patentability teaches that “utility” is the second criterion of the four criteria for patentability. This is not by chance. All patent applications are expected to have utility.

The nature of the utility requirement is discussed by Judge Netanyahu in Appeal 665/84 Sanofi vs. Unipharm p.d. 41(4) 729:

At the time of filing the Application, it has to include a promise of utility. If this is the case, generally the requirements of Section 3 are met. Proof of this promise will be required at the Opposition stage, if this is submitted as grounds for Opposition, or in a cancellation proceedings or infringement action. In Oppositions, the burden of proof is on the Applicant since the patent has not yet issued; in cancellation or infringement proceedings the burden is on the challenger / infringer.

See also the Opposition to 179840 Aminach Furniture Industries Ltd vs. Anat and Moshe Gabai, 20 November 2012.

In this instance, it appears that the promise that is the basis of the Application is the advantage of the Beta phase regardless of concentration. (There is no dispute that the beta phase is novel and inventive). The advantages that Novartis’ witness Dr Bates has alleged are the improved flowability and compactability of the beta phase when compared with the alpha phase, and the parties concur that these properties are desirable in pharmaceutical formulations.

To the extent that the claimed properties are substantiated, they are substantiated for formulations with a greater than 90% concentration of the beta phase. The Applicant did not demonstrate or provide evidence of these properties in lower concentrations.

As stressed above, in the Sanofi ruling, the court emphasized that the claimed advantages have to be proven at the opposition stage if the utility is challenged. Some evidence is required to show that the promise is attained, although not necessarily the quantity of experimental evidence that would be required were the opposers to actively provide counter-evidence.

In this instance, the Applicant continues to allege that they deserve a patent for formulations with even minimal beta content. The Opposers have noted that there is no evidence that such low concentration formulations have advantages over the alpha phase and the Applicant has not provided evidence to support their claims or a reasonably convincing counter-argument in response to the Opposer’s reasoning. This is not to say that had the Applicant’s expert witness related to this, his arguments would have been found convincing – See Opposition ruling concerning IL 143977 Unipharm vs. AstraZenica AB paragraph 44.

In this instance, at the joint request of the parties, no witness is being cross-examined. From this it is clear that the Applicant has not substantiated their claim that formulations with low concentrations of the beta phase have sufficient utility  to be patentable.

The overlap between the claims of the Divisional Application and those of the Parent

In addition to the above, the present application is not patentable due to the significant overlap between the claims and those of the parent patent.

Whilst it is true that in their summation, the Opposer abandoned this line of reasoning, the Commissioner does not consider that this fact alone is sufficient for the matter to be dropped since oppositions are a continuation of the examination process and the patentability question is once again opened. The purpose of oppositions is to ensure the purity of the register and is a continuation of the administrative process (See Opposition to 136482 Bromium Compositions vs. Albermarle Corporation USA, 7 November 2010.

Section 2 prohibits granting a patent for an already patented invention. See also the IL 203972 Novartis decision. To address the issue of double patenting it is necessary to consider the scope of the invention. The scope of the invention may be learned from the total breadth of protection that the patentee receives (see 2626/11 Hassin Fire Industries vs. Koniel Antonio (Israel) Ltd. 14 November 2013 paragraphs 35-38.)

Independent Claim 1 of the parent application claims the beta phase of the Imatinib Methanesulfonate salt at concentrations of at least 90% with a strong 2theta XRay defraction peak at 20° as follows:

formula-parent

Thus the parent claims the same beta Imatinib Methanesulfonate salt concentrations of at least 90% whereas claim 1 of child patent does not include a minimum concentration. The specifications are the same apart from minor differences that are insignificant, and so the claim construction considerations used to define the terms are the same in both the parent patent and in the divisional application. Despite different phraseology the scope of the claims overlap.

The differences are in the non-needle like form of the crystal, the characteristic XRay diffraction peaks and the concentration limitation of the parent.  Careful examination indicates that the same polymorph is covered by both cases, although defined differently, with the sole difference being the concentration limitation in the parent is not in the divisional application and this removal of the concentration limitation is the feature that the Applicant points to as being the patentable feature. However no advantage is given for the low concentrations covered by the divisional application. The Applicant claims that the parent patent and divisional application cover different aspects of the invention. However, the concentration is not an aspect warranting separate registration.

The IL 174082 Application is refused. Costs are applicable as per Commissioner Circular M.N. 80.

Comments

It seems to me that the person of the art considering a patent publication to understand the scope of the claims is a patent attorney with pharmacological background, or a team including technical people and patent counsel. I don’t believe that any industrialist (except possibly Dr Zebulun Tomer of Unipharm who has been challenging blockbuster patents for years and has been known to file oppositions by himself) would construe the claims of a pharmaceutical patent without seeking legal advice so Dr Volman can be considered as an expert.

The Commissioner is correct that there is no obvious or demonstrated utility for the lower concentrations.


Requesting Enlargement of A Deposit of Costs

January 8, 2017

The Krasnyi Octybar and Rot Front Joint Stock Companies own four Israel trademarks: 184179, 182758, 182759 and 182763. Each covering a long list of goods in class 30, including such things as for waffles; confectionery for decorating Christmas trees; cakes; pastries; peanut confectionery; almond confectionery; pasty; cocoa; cocoa products; caramels [candy]; sweetmeats [candy]; liquorice [confectionery]; peppermint sweets; coffee; crackers; meat pies; farinaceous foods; candy for food; fruit jellies; marzipan; custard; honey; ice cream; sherbets [ices]; muesli; mint for confectionery; cocoa beverages with milk and coffee beverages with milk; coffee-based beverages, tea-based beverage, chocolate beverages with milk, chocolate-based beverages, cocoa-based beverages; lozenges; petits fours [cakes]; biscuits; pies; fondants; pralines; gingerbread; chewing gum, not for medical purposes; sugar; cake paste; confectionery; rusks; sandwiches; almond paste; tarts; cakes (Edible decorations for-); halvah; bread; tea.

Five companies including the Roshen Confectionery Corporation,  Dealer B&D International Ltd, Kjarkov Biscuit Factory, Dolina Group Ltd and Latfood Ltd have filed cancellation requests against these marks.

The marks owners have requested that the sum that the challengers are required to post as a guarantee against legal costs in the event that the mark owners prevail be increased by a further 130,000 Shekels, or by whatever sum the commissioner sees fit. The request was submitted together with 90 pages of appendices and a copy of an Affidavit from the legal counsel of the mother company, however the original Affidavit was not submitted. The challengers opposed the request to increase the guarantee. A hearing has been set for the 17th and 18th of January for cross-examining the various witnesses.

The background to the request for guarantees is two requests for cancellation of the marks. Roshen Confectionery Corporation and  Dealer B&D International Ltd have requested the cancellation of 184179, 182758 and 182759 trademarks, and the Kjarkov Biscuit Factory, Dolina Group Ltd and Latfood Ltd have requested cancellation of the 182763 mark.

Following requests for guarantees that were filed in March 2015, the Adjudicator of IP Ms Yaara Shshani Caspi ruled on 21 June 2015 as follows:

In light of the above, and considering all the circumstances of this case and the general considerations used to determine the magnitude of the appropriate deposit, the first two challengers are to jointly deposit 75,000 Shekels and the second group of three challengers are also to jointly deposit 75,000 Shekels, and this should be done within 21 days.

The present request includes suspension of the proceedings until the deposit is increased.

The Parties’ Allegations

The mark holder claims that increasing the deposit is required because following the original decision there have been changes in circumstances that warrant increasing the deposit. These new circumstances include the expectation of long and complex proceedings and a number of cross-examinations. Furthermore, the case is complex and it transpires that the costs are expected to be higher than originally anticipated. The additional costs are incurred by the two groups of challengers retaining separate counsel and making unnecessary requests. A further claim is that it was not previous clear but now is transparently so, that there will be a massive amount of evidence and documents and a hearing that will be conducted largely in Russian, requiring simultaneous translation. The mark owners nevertheless reiterate their opinion that the likelihood of challengers prevailing and the marks being cancelled are very slim. The amount of the deposit, standing at 150,000 Shekels, is too low and not proportional to the costs that will be requested if the cancellation attempts fail and so this is a classic example of where increasing the deposit is warranted.

Both group of challengers consider the request to increase the deposit should be refused since the ‘new circumstances’ were already fairly obvious when the original request for costs was made. The second group of challengers considers this to be a vacuous request filed in bad faith simply to stretch out the proceedings.

Ruling

Ms Yaara shoshani Caspi did not consider that the circumstances had changed since the original request for a deposit was ruled on. For example, where there are five parties challenging two groups of marks it is not unpredictable that there will be lots of witnesses to cross-examine. Since the challengers are Russian companies, it was always expected that their witnesses would testify in Russian and simultaneous translation would be needed, as is the fact that there are two groups of challengers. The massive amount of evidence was also expected and Ms Shoshani Caspi considered that these grounds were all considered by her in her original ruling regarding the size of an appropriate deposit.

With regard to the likelihood of the challenges prevailing and the marks being cancelled, there is no way to consider the likelihood or otherwise of the challenges be successful at this stage since the witnesses have not been heard and have not yet been cross-examined. At least this is the theoretical state of affairs. Since the challenges are on the basis of inequitable behaviour in the original filings, there is a high level of proof that the challengers will be required to submit to establish their case since they will have to positively show that many years ago the mark holders intentionally appropriated marks that were not theirs.

Nevertheless, the fact that the challengers have a difficult task ahead is not justification to increase the deposit that they have already placed. There are no unexpected circumstances not considered in the original ruling considering the size of the deposit.

The request to increase the deposit is refused. However, Ms Shoshani Caspi does not see the request as indicative of inequitable behaviour designed to make the trademark cancellation proceedings unnecessarily complicated. that said, the mark owners should nevertheless pay costs to the challengers for requiring them to respond to this request. The mark owners will therefore may 1500 Shekels to the first group of challengers and a further 750 Shekels to the second group and will do so by 15 January 2016 or interest will incur.

In cancellation proceedings concerning 184179, 182758, 182759 and 182763 trademarks, Ruling on increasing size of deposit by Ms Yaara Shoshani Caspi, 28 December 2016.


Requesting a patent allowance to be cancelled

January 8, 2017

reconsideration

Israel Patent Number 219586 to Fritz Collischan & Co. KG was allowed. The patent is titled “DEVICE FOR COUNTING OBJECTS FED AS BULK MATERIAL”and is the national phase entry into Israel of PCT/EP2010/067146 which published as WO2011/054974.

In a rather surprising move, Data Detection Technologies Inc, represented by Pearl Cohen Tzedek Latzer Brats requested that the allowance of the patent be cancelled. Actually this is not the first request of this type, for the present patent.  Back on 9 March 2015, following a request to have the allowance withdrawn on grounds that the applicant did not provide a list of prior art as required to under Section 18 of the Law, the same third party requested that the patent be disallowed, and on that occasion, the Applicant agreed for it to be returned to a state of pending allowance. Following that episode, the now pending patent application was returned to the Examiner and eventually was allowed on 29 September 2016 and published for Opposition purposes under Section 26 of the Law. Data Detection Technologies Inc have again requested that the case be returned to the Examiner as they have found additional citations and video clips that they claim reveal the invention and which were sent by themselves to the Applicant some month before allowance.

Despite bringing the additional material to the Applicant’s attention, the Applicants did not make this art of record and the patent was eventually allowed under Section 17c, on the basis of a corresponding issued patent (which presumably itself issued without the Examiner thereof considering the video clips and publications submitted by Data Detection Technologies Inc. Data Detection Technologies Inc argued that this failure is sufficient to prevent the patent issuing under Section 18c of the Law. Alternatively, since the citations are central to the patentability of the invention, Data Detection Technologies Inc considers that minimally the patent be returned to the Examiner for further Examination.

Data Detection Technologies Inc considers it inappropriate for them to have to fight an expensive opposition proceedings which was caused by the applicant failing in their duty of disclosure.

The Applicant claims that the appropriate way to raise issues relating to the duty of disclosure is via an opposition proceedings, and the arguments submitted by Data Detection Technologies relate to grounds for Opposition under Section 31 of the Law. The Applicant posits that withdrawal of allowance is an appropriate measure only in those rare cases where the decision to allow was flawed, or where a letter of allowance was issued by mistake. The Applicant does not consider this to be such a case.

The Applicant notes that the additional material was collected in an opposition proceeding that Fritz Collischan is fighting against an allowed patent of Data Detection Technologies. In that proceeding, Data Detection Technologies Inc requested an extension to respond to the Opposition and to amend the specification. The Applicant submits that the extension was applied for in bad faith and with factual inaccuracies in the justifications given. The Applicant further submits that the  Affidavit includes hearsay that is not acceptable as evidence.

Ruling

The parties concur that the Commissioner may cancel a notice of allowance and return an application to the Examiner if there is a major flaw in the decision to allow the patent. This authority is derived from Section 15 of the Law of Interpretation 1981 and was adopted by the patent office in the previous ruling concerning Data Detection vs. Collischan from 9 March 2015 and also in the Cellular Dynamics vs. Christopher Reed ruling from 29 April 2014.

The argument is whether the current situation is one where it is appropriate for the Commissioner to exercise their authority and to withdraw the notice of allowance, or whether the appropriate action is for Data Detection Technologies Inc to file an Opposition under Section 31 of the Patent Law 1967?

The Deputy Commissioner, Ms Jacqueline Bracha considers that the choice of appropriate course of action is to be found in the purposes of the two courses, which are also derived from their different ways of being initiated. The authority under Section 15 of the Law of Interpretation is something initiated by the administrative body to correct a mistake that they made in an earlier decision or t as a result of a change of circumstances, as an exceptional course of action where there is no other appropriate recourse authorized by the law (See Y. Zamir, Government Authority (1996) pages 1003-1006. In contradistinction, the purpose of the Opposition proceeding is to critique the Examination and to continue the Examination of a patent application in an inter-partes procedure initiated by the third party (see the Israel Patent Office Ruling re IL 136482 Bromium Compounds Ltd vs Albermarle Corporation of 7 November 2010.

 With all due respect, I consider that the courts approach has changed since then, and nowadays the Supreme Court considers the Opposition procedure as being complimentary to and a completion of the Examination since it is intended to serve the public interest and the accuracy of the register.

In the framework of cancellation of an allowance the amount that the public would have relied on the notice of allowance and the type of mistake that resulted in the allowance are to be considered. However, it should be appreciated that not ALL mistakes justify the cancellation of an administrative decision. A mistaken decision based on consideration of the facts and simply reaching the wrong conclusion, will not, in general, justify changing an administrative decision (see Zamir on page 1006). The Authority will generally reach this result in cases where there is a suspicion that someone has been awarded more than he deserves. Such a suspicion is not sufficient to justify cancelling the benefit by the  government body (see Zamir on Page 1007).

In contradistinction to the civil proceeding to cancel an administrative  decision, the Opposition is an adversarial judicial proceeding or sub-judicial proceeding that allows the parties to bring evidence in accordance with the law of evidence, allows opposing counsel to cross-examine witnesses and enables the patent office to come to a reasoned decision. In such a proceeding, the Patent Authority is not limited by the administrative decision and he can reexamine the patentability of the invention in light of the evidence and claims before it, even apart from the considerations that the Examiner used in reaching the decision of allowance.

From the above it is clear that where a mistake in a decision is not self-evident and requires substantive clarification, the administrative decision to cancel the allowance is inappropriate.

In this instance, to determine whether the applicant is required to alert the Examiner about the publications that Data Detection mention, one has to see whether the publications “relate directly to the invention” as required by Section 19(a)2 of the Patent Law. To do this, it is necessary to listen to the claims and evidence of the parties regarding the nature of the invention.

Even if a decision is reached that the Applicant should indeed have made these publications of record under the duty of disclosure, it is necessary to consider if a failure to have done so can be dealt with by the alternatives in Section 18 or if the decision to allow the patent [to proceed for opposition purposes] should be cancelled. In this regard, to the extent that a publication allegedly shows the patent being demonstrated or implemented, the Examiner is not duty bound to consider it.  Section 17b of the Law states that:

(a) an Examiner will consider if the Examination answers all the following:
(1) is for an invention considered patentable under Chapter 2;
….
(b) despite section (a)(1), there is no obligation to examine patentability in accordance with Section 4(2). 

In summary, the Deputy Commissioner Ms Bracha does not consider that the present case is a mistake that warrants cancellation of the Notice of Allowance and does not see how the legal and factual issues can be considered in a decision to cancel the allowance and how this advances the case to a final decision on patentability.

The final claim of Data Detection Technologies Inc, that Applicant’s failure to make art of record should not oblige them to enter a lengthy and costly opposition proceeding. It is true that oppositions are lengthy and the regulations provide at least 16 months from initiation of an opposition until a hearing is scheduled. The parties may request extensions and interim decisions, to correct the specification and more. Nevertheless, the Opposer can submit their evidence on filing their statement of case, thereby significantly shortening the procedure. Furthermore, on conclusion of the opposition, the prevailing party is awarded actual costs, if they are essential, reasonable and proportional See Bagatz 891/05 Tnuva Agricultural Cooperative vs. the Authority for Granting Import licenses, p/d/ 60(a) 600. From here it is clear that if Data Detection Technologies Inc are right, they can expense appropriate compensation.

Therefore it is not considered that the decision to allow the patent was clearly erroneous, justifying its cancellation without a factual inquiry, and it is precisely the anticipated costs that are incurred by an opposer for conducting an opposition that tilts the balance towards holding an opposition proceeding.

As an afterword, it is noted that this is not the place to consider the behavior of Data Detection Technologies in a separate opposition before the Patent Office.

Data Detection Technologies are ordered to pay 4000 Shekels + VAT in legal fees to Fritz Collischan.

Comment

This decision is a correct one. Since, nowadays pending applications publish 18 months from priority and the whole file wrapper is available for examination prior to allowance, maybe Israel should formally allow third party prior art submissions.

It seems that Data Detection Technologies Inc is trying to delay issuance without formally filing an opposition. I think that this decision, not allowing this is correct.

Previous opposition rulings that relate to failure to submit art generally did not invalidate the patent on this ground alone, but it is within the authority of the patent office to do so.


Is claim construction a matter of Law or is it related to the Art claimed?

January 6, 2017

Elad Barkan owns Israel Patent No. 133671 titled “CRYPTANALYSIS METHOD AND SYSTEM” and Rontal Engineering Applications 2001 (LTD) is attempting to have this patent canceled.

There are corresponding US patents US9038192 (B2)  and  US8295477 (B2), however there are some claim differences.

One question that arose in the cancellation proceedings is how the claimed invention differs from that of the corresponding US patent.

Rontal Engineering’s representatives engaged veteran Israel Patent Attorney Sanford T Colb to explain this, which he did in an Affidavit. Barkan’s attorneys requested permission to submit an expert opinion of their own and this was duly allowed.

Elad Barkan wrote the expert opinion himself, challenging Colb’s competence in cryptoanalysis. Rontal Engineering’s lawyers then submitted to have Barkan’s affidavit thrown out as it raised new issues, and, according to them, despite his competence regarding the technical subject matter, the correct reading of claims is a matter of law that was outside his competence. They also noted that as a party to the proceedings he could hardly be considered an impartial expert witness.

After referring to different sections of the affidavit that showed that Barkan was indeed ignorant of claim construction, the Deputy Commissioner Ms Bracha had his Affidavit struck from the record, and announced that costs for this skirmish would be taken into account at the end of the main proceedings.

 

COMMENT

In Israel we do not have specialist IP courts and any District Judge or Supreme Court judge may be called upon to rule on IP cases. Sometimes, the judge has no scientific background and has never studied IP law and occasionally the decisions are plane wrong. See here  for an example of a very wrong decision. The Commissioner and Deputy Commissioner are specialist IP judges. They have a team of Examiners that they can call on. they should therefore be able to construe the scope of protection of claims granted in Israel without the help of a practitioner in private practice, however experienced and competent.

I think that Luthi et al who represented Barkan should have understood or at least clarified what Ms Bracha wanted in a counter-opinion, and should know that clients are not impartial and generally make lousy witnesses.


When Israel is inadvertently considered part of EPO

December 25, 2016

31-monthsIL 244062 is a national phase entry of PCT/AU2015/000701 which claims priority from an Australian patent that was filed on 10 July 2013. There was, therefore, until 1o January 2016 to file a national phase entry of the PCT application into Israel.

A request to extend this period was filed on 11 February 2016, and an Affidavit from the Vladimir Jakovina who owns the holding company Merline Investment Management Property Ltd was filed a few days later on 2 March 2015.

The head of the PCT Division refused the application as the 30 month deadline had passed. The Applicants appealed on the basis of the Affidavit which stated that the Jakovina’s daughter had been responsible for the national phase entries and had mistakenly believed that Israel was a member state of the EPO and that the deadline was, therefore, 31 months.

Ms Bracha rejected this, as although the PCT deadlines can be extended at the discretion of the Commissioner of Patents, the standard that the Israel Law requires is Due Care, and not the lower standard of intention. She did not consider that assuming that Israel was a member of the EPO and not checking this was compatible with the requirement of Due Care.

COMMENT

10 years ago, a Korean client of mine made the same mistake. We submitted an Affidavit that he mistakenly thought that Israel was a member of the EPO, and noted that Israel competed in the Eurovision Song Contest and played in the European football league. That request to extend the national phase entry was refused. Unfortunately for me, then Deputy Commissioner, Noa Shmulevezh, discussed the difference between patents and Eurovision song contests and ignored the other arguments I brought.

Back then, it was worth attempting to effect a late filing, but I am surprised that the agent of record (Colb) attempted this now. Over the past 10 years the Israel Patent Office has consistently refused to allow late national phase entries on the grounds that Applicant believed that Israel had a 31 month regime or was part of the EPO.

I did not appeal the previous patent office ruling to the courts as the client didn’t authorize me to do so. I wonder if the applicant this time will file an appeal. In the meantime, although the Israel Patent Office is addopting a high standard, it is at applying the same standard consistently.

 


Online Design Filing in Israel

December 22, 2016

ilpo

The Israel Patent Office held a seminar today to introduce their new online design submission interface. Over the past five years the Israel Patent Office has gradually introduced online trademark, PCT and patent filing and prosecution and has published guidelines for examiners, which help applicants and their representatives.

The Design Department is the last department to become fully computerized, and, if all goes well, the interface will become ‘live’ on 29 December 2016.

alferd_teeThere were some 50 participants at the seminar. These included veteran Patent Attorney and Rabbi, Alfred Thee, known generally as Mr T, who, though rather less muscular and black than the character from the A Team, is, nevertheless, a very sprightly and highly experienced 85 year-old practitioner that I had the benefit of training and qualifying under. Mr T told me that he was finally leaving his long-term employment at Seligsohn & Gabrieli at the end of the year, but would carry on working as a self-employed consultant. I anticipate retiring before he does!

In addition to various friends, colleagues and competitors, I noted the presence of Zvi Teff who qualified under my tutelage, and who has recently opened his own firm. We wish him luck with this endeavour.

aippiThe seminar ran from 11:00 AM to 1:00 PM. Those that could be bothered rushed over to Tel Aviv for a General Meeting of the AIPPI that started at 2:30 PM. Holding the two events on the same day seemed to be both rather silly and also discriminatory against those practitioners that file design applications.  Had the AIPPI held their event at the Israel Patent Office at 2:30, many more people would have attended both events. There are only a few hundred IP practitioners in Israel, including lawyers, examiners and patent attorneys, that could join the Israel Branch of the AIPPI. Doing a General Meeting on the same day as an IP seminar at the Patent Office is like holding a general meeting during INTA. It is plain stupid.

Commissioner Kling opened the event and spoke about the pending Israel Design Law which is due to replace the hopelessly outdated Design Ordinance from 1922 that is currently in force. Amongst other ramifications of the pending legislation, it will pave the way for Israel to join the Hague International trademark registration system.

After the Commissioner finished, the Head of the Design Department, Alice Mahlis-Abramovich took the podium. However, the actual instruction on the new interface was given by someone from a software instruction agency who bore a slight resemblance to Israeli singer Roni Dalumi. Having someone who was used to explaining how to use software explaining how to use the software was a strategy with mixed results. Since she didn’t practice design law, she could relate to what the software did, but not how to do various things that practitioners might want it to do. Also, she referred to something submitted as being a design, whereas practitioners would call these design applications, and only refer to the examined and registered product as a ‘design.’

Those now familiar with filing and prosecuting patent applications via the online interface will experience little difficulty using design interface. The seminar wasn’t very exciting, but some of the questions were rather interesting. Apparently one of my colleagues submits patent applications, listing a-company-in-the-process-of-being-set-up as the applicant to avoid a tax incident occurring. That as may be, a not yet formed company is not a real person or a legal person (entity). If the company is not formed or if the name changes, who can assign rights to the application? How can one obtain a date without an applicant that actually exists?


More Novartis Shenanigans

December 22, 2016

When an Israel patent application is finally refused by an Examiner, the Applicant can appeal the decision to the Commissioner. This recently happened with respect to IL 213926 to Novartis, titled “USE OF COMBINATION COMPOSITIONS COMPRISING VALSARTAN AND AMLODIPINE IN THE PREPARATION OF MEDICAMENTS FOR THE TREATMENT AND PREVENTION OF DIABETES ASSOCIATED WITH HYPERTENSION”. The Application is a divisional of IL 140665, which is, itself, a national phase entry of a PCT application from 9 July 1999. The divisional application is concerned with a combination of VALSARTAN and AMLODIPINE. The parent application was allowed on 31 December 2012, and an Opposition was filed on 24 March 2013. The Opposition was successful. See here.

The divisional application in question was filed on 4 July 2011, and, the Examiner refused it on 12 November 2015 on the grounds of double patenting, since there was very significant overlap between the claims of the divisional application and those of the parent. The Applicant appealed the decision and a hearing was scheduled before the Deputy Commissioner. However, this was postponed at the Applicant’s request.

On 10 October 2016 the Applicant requested that following the cancellation of the parent application (thereby removing double patenting grounds), the present (child) application should be returned to the Examiner for reconsideration.

On 13 October 2016, Ms Bracha ruled that:

The hearing on double patenting grounds is canceled. The Applicant shall submit a written summary of their claims and why, despite the parent being found obvious, there was still grounds for allowing the divisional application to issue. The Applicant was given 30 days to submit their claims in writing and to indicate if they wanted an oral proceedings prior to a ruling issuing.

On 13 November 2016 the Applicant submitted written summary and declined the oral hearing. Consequently the present ruling is based on the submissions and the summary in the file.

The Applicant’s Claims

In a laconic statement, the Applicant claims that the Divisional is a separate entity from the parent and should, therefore, be examined on its merits.

Since the Applicant was working on an Appeal against the opposition ruling to cancel the parent application, the opposition ruling is not final. Since the Examiner had found novelty and inventiveness in the claims of the divisional but had canceled it as significantly overlapping the parent application, there were no longer grounds of double patenting.

Ruling

The Applicant does not disagree that there is significant overlap between the claims of the parent and those of the divisional, but considers the overlap irrelevant due to the opposition against the parent application being accepted.

Although considering it superfluous to do so, Ms Bracha affirmed that the two claim-sets did indeed overlap. For example, claim 1 of the parent application deals with a pharmaceutical composition including VALSARTAN or a pharmaceutically acceptable salt thereof, AMLODIPINE or a pharmaceutically acceptable salt thereof, and a carrier that is pharmaceutically acceptable.  In the divisional application, the same active ingredients are claimed but there is no reference to treating high blood pressure. In the second claim of the divisional, specific quantities of VALSARTAN are claimed, and the scope of claim 2 of the divisional is that of claim 3 of the parent.

Claims 4, 9  and 11 of the divisional recite ranges for the active ingredients. There is thus significant overlap, although the claim-scope is not identical. See the ruling regarding IL 203972 also to Novartisthe ruling regarding IL 203972 also to Novartis, and also appendix (v) of the Guidelines for the Applicant 23.1 from 29 March 2015 which deals with sections 2, 9 and 19 of the Israel Patent Law 1967 and states:

“Overlap between the claims of a patent application under Examination and those of another patent application exists where the scope of the claimed invention as defined by specific claim(s) is identical, includes or has similar scope to those of the other patent application.”

Even if the patentability of each patent is to be considered separately, where the scope is identical, that determined with respect to one application will be applied to the second application. Thus having determined that the parent application is not patentable, the ruling binds the Examiner, whether because of the civil administration hierarchy under which commissioner rulings bind Examiners (See Zamir Civil Authority, Vol 2 pages 598 (1996)), or since the ruling is a critical review of the Examiner’s decision regarding the parent application.

In the theoretical case that the divisional application be returned to the Examiner and she allows the application, the ramification would be that the Opposer would have to initiate opposition proceedings against a divisional application having similar scope to the parent that they had already successfully opposed.  Apart from the waste of resources in such a scenario, the Opposer can be expected to claim a court ruling or at least consider all aspects of the ruling estopelling the applicant (see Nina Zeltsman, Court Rulings in Civil Proceedings, page 9, 1991. For application of court rulings to Patent Office proceedings, see Cancellation Proceedings Against Trademark No 245411 “Golden Pearl Camel Rice (stylized). Yoram Sasa vs. Yehusit Matock 25 March 2015.  https://blog.ipfactor.co.il/2012/03/27/trademark-for-rice-cancelled/ From this it is clear, that were the divisional to be allowed, it would subsequently be successfully opposed on the grounds used to oppose the parent.

The Applicant claims that they intend to appeal the ruling accepting the Opposition to the parent application.  If they do so, there are only two possible outcomes: either the appeal will be successful, the ruling will be overturned and the divisional application will be considered as double patenting and refused, or the decision will be upheld and the parent refused, in which case the divisional application will be refused.

From the above it is clear that examination of the divisional application is over. The divisional remains refused following the opposition to the parent.

Ruling Ms Bracha, 20 November 2016.

COMMENT

Last year, the Israel Patent Office issued a similar ruling for another Novartis patent and divisional with overlapping claims. It rendered this proceeding redundant.

There is so much riding on pharmaceutical patents that applicants will try anything to get them allowed. In this instance, the Deputy Commissioner’s reasoning seems so obvious that I am surprised she didn’t rule costs for wasting her time.