A Request for a Patent Term Extension for IL 117459 “DNA ENCODING HUMAN PAPILLOMAVIRUS TYPE 18″ to Merck

February 10, 2015

gardasil

IL 117459 “DNA ENCODING HUMAN PAPILLOMAVIRUS TYPE 18″ to Merck Sharp & Dohme Corp. was filed on 13 March 1996, and is due to expire on 13 March 2016.

Back in August 2007 a Request for Patent Term Extension was filed based on the commercially available preparation Gardasil. The pharmaceutical preparation contains four active ingredients: Protein L1, types 6, 11, 16 and 18.

The patent claims the Protein L1 type 18 as a product of genetic engineering. The patent relates to the other types of Protein L1 except for HPV 6 L1 for which no patent applications were submitted anywhere. The protein HPV 16 L1 was not claimed in any patent application filed in Israel. HPV 11 L1 was claimed in IL 117591 and expires on 21 March 2016. However, no applications for patent term extensions were filed for this protein.

The legal question that this decision addresses is whether a patent term extension can be requested for a patent that protects only one active ingredient of a pharmaceutical preparation.

The claims of IL 117459 cover a gene sequence of Protein L1 type 18, a vector including the gene sequence, a cell embodying the vector a process of expressing the gene sequence and a preparation that causes a vaccination to the protein including the gene sequence.

The senior examiner considers that Gardasil includes four proteins and any changes in any of them or preparations of three or less will result in a different medicament. Consequently, she considered that there is an inconsistency between the medicine and the claimed invention, in that not all the active ingredients of the claimed invention are in the basic patent.

The Applicant countered that claim 12 of IL 117459  covers a composition that includes (inter alia) HPV 18 L1 and thus the patent does not limit itself to this substance. Consequently, Applicant claims that IL 117459 is a basic patent as defined in Section 64a of the Israel Patent Law 1967 and as referenced in Section 64d. The Law does not require that a basic patent should include all active ingredients of a commercial product, and only one such active ingredient need be listed. Support for this interpretation was argued based on the wording of 64h(d) which relates to an active ingredient included in a preparation and claimed in the basic patent

The Applicant alleged that interpretations that a basic patent should include all active ingredients of the commercially available preparation is contrary to the underlying logic of the legislation and it is unreasonable to include such a limitation by judicial interpretation.

The senior examiner rejected these arguments and the Applicant requested an oral hearing which was held on 28 October 2014 and the Applicant was granted until 10 December 2014 to submit a summary of his arguments.

Section 64d states:

The Commissioner should not grant a patent term extension unless all the following apply:

  • the composition, process for its preparation and usage thereof, medical preparation including the composition, its process for preparation and medical equipment are claimed in a basic latent that is in force.

Section 64a defines the terms ‘composition, ‘medical preparation’ and ‘basic patent’ as follows:

  • Medical preparation – any form of medical drug that has been processed, including preparations for veterinarian applications and those having nutritional value that are injected intravenously.
  • Composition – the active ingredient or salts, esters, hydrates or crystals of the composition.
  • Basic Patent – a patent protecting any composition, production method, use, medical preparation including the composition, or any medical equipment requiring regulatory approval in Israel.

Based on the court ruling concerning the Appeal to patent term extension for IL 97219 to Novartis (26/12/2005) the term composition means a single active ingredient.

In Novartis, then Commissioner Dr Meir Noam (himself a chemist) ruled that the term basic patent in both Section 64a and 64d relates to the first patent that protects an active ingredient and that the term composition is in the singular, implying that one new ingredient is sufficient and that novel combinations of known ingredients cannot be considered as a basic patent.  A preparation that includes one new ingredient that requires regulatory approval may be protected by extending a basic patent. Combinations, aggregations and synergies of known ingredients may be patentable but such patents are not basic patents.

In this instance, the issue is the regulatory approval of a combination of active ingredients, not the basic patent. Gardasil includes four active ingredients. Each one provides a parallel vaccination effect and maintains its pharmaceutical character. The four proteins are separately synthesized by fermentation in recombinant Saccharomyces cerevisiae (a species of yeast) but are combined into one treatment for economical reasons and due to ease of use.

(HPV Type 16 L1 and HPV type 18 L1 are also components of the registered drug Cervarix registered to a third party, and the proteins are each separately active.  However, Cervarix was registered after Gardasil).

Since the drug Gardasil comprises four separately active ingredients that each has an independent effect and do not work as a synergy, the Commissioner accepted that Gardasil could serve as the first regulatory approval of HPV type 18 L1. He found support in the ruling fo Judge Dotan in the Novartis case. He noted that Merck could have requested regulatory approval for the four proteins separately and the discussion would be moot. Finally, citing the Neurim ruling (13281-06-12 based on the ECJ ruling that Melatonin for treating insomnia was not obvious in light of veterinary treatment for causing sheep to rut earlier), it is clear that the purpose of the Law is to provide patent term extensions for new types of treatment, and there was no reason why the Applicant should have had to register each active ingredient separately.

Furthermore, in Appeal 223/07 Lundbeck vs. Unipharm it was ruled that patent term extensions should be analyzed from an IP perspective and not from a pharmaceutical perspective. The Supreme Court upheld this ruling.

Furthermore, in the medical register, Gardasil is listed as including four active ingredients, including HPV 18 L1, and this is, indeed, the first medical registration of this ingredient in Israel.

Consequently, based on the extension awarded in the UK for EP 1359156, the Israel patent was extended 493 days to 19 July 2017.

Ex Partes ruling concerning patent term extensions to IL 117459 “DNA ENCODING HUMAN PAPILLOMAVIRUS TYPE 18″ to Merck Sharp & Dohme Corp. by Commissioner Asa Kling, 11 January 2015.

COMMENT

This is a publication of an ex-partes ruling. It is possible that local generic manufacturers such as Teva or Unipharm may challenge this.


On Blood Pressure and Diabetes. Can citations post-dating the effective Filing Date be used as evidence of what was known at the time of filing?

February 10, 2015

 

blood pressure

Israel Patent Application No. 140665 to Novartis relates to preparations including Valsartan and Amlodipine for treating high blood pressure and diabetes. The application is a national phase of PCT/EP/1999/004842 and claims priority from an earlier US patent application.

The patent was allowed and published for opposition purposes on 23 December 2012 and is being opposed by both Teva Pharmaceuticals LTD. and by Unipharm LTD.

The Opposers submitted an expert opinion from a Professor Chimlichman to the effect that the combination was known from various publications and his treatment of hyper-tension and thus were lacking novelty at the priority date.

On response to evidence by the Applicant, the Opposers submitted a second opinion in which he relied on two references that were published after the priority date to determine novelty and inventiveness at the time of the priority date. Since these publications were not prior art, the Applicant requested that they were deleted from the opinion and espunged from the record.

Professor Chimlichman claimed that his treatment before the priority date was supported by GYH Lip et al., “The `Birmingham Hypertension Square` for the Optimum Choice of Add-in Drugs in the Management of Resistant Hypertension”, Journal of Human Hypertension (1998) 12, 761-763. Whilst the publication itself was certainly published after the priority date, it relates to clinical tests using the combination of the two drugs and must have been written prior to being published and describes what the authors knew prior to the priority date.

Furthermore, a response to Lip et al. subsequently published in the same journal provides additional evidence that the combinatory effect was known

Whilst accepting that the two publications were not themselves prior art, the opposers argued that they indicated the state of the art at the priority date and should be examined on their merits and not expunged from the record. Furthermore, the additional evidence was brought in response to statements my Professor Daloph, the expert witness of the Applicant.

The Opponents cited Unipharm vs. SmithKline Beechan and Orbotech vs Camtek to support their argument that the papers should be examined on their merits.

Ruling

Opposers are limited in what they can submit in response to the patentee’s evidence. They are not allowed to widen the statement of case. In this instance the additional evidence is supplementary evidence to support their main grounds of opposition, i.e. that the combination was known. There is no evidence given to explain why these papers weren’t submitted in the original round of evidence. The Opposer submits his evidence first and is entitled to respond to the counter-evidence. This gives him a procedural advantage and allowing the submission of additional evidence that could have been submitted in the first submission unfairly disadvantages the applicant.

Comment

Although not allowed to be added to the record, as it could have been submitted earlier, this ruling does seem to indicate that such post priority publications may indeed be used to show what was prior art.


Can post priority-date publications that describe clinical practice be considered prior art?

February 5, 2015

exforce

Israel Patent Application No. 140665 to Novartis tited “Use of Combiantion Compositions comprising Valsartan and Amlodipine n the preparation of medicaments for the treatment and prevention of diabetes related hypertension” relates to preparations including  Valsartan and Amlodipine for treating high blood pressure and diabetes.

The application was a national phase of PCT/EP1999/004842 from 9 July 199 and claims priority from an earlier US patent application.  The patent was allowed and published for opposition purposes on 23 December 2012 and is being opposed by both Teva Pharmaceuticals LTD. and by Unipharm LTD.

The Opposers submitted an expert opinion from a Professor Chimlichman to the effect that the combination was known from various publications and his treatment of hyper-tension and thus were lacking novelty at the priority date.

On response to evidence by the Applicant, the Opposers submitted a second opinion in which he relied on two publications from after the priority date to determine novelty and inventiveness at the time of the priority date. Since these publications were not prior art, the Applicant requested that they were deleted from the opinion and expunged from the record.

Professor Chimlichman claimed that his treatment before the priority date was supported by GYH Lip et al., “The `Birmingham Hypertension Square` for the Optimum Choice of Add-in Drugs in the Management of Resistant Hypertension”, Journal of Human Hypertension (1998) 12, 761-763. Whilst the publication itself was certainly published after the priority date, it relates to clinical tests using the combination of the two drugs and must have been written prior to being published and describes what the authors knew prior to the priority date.

Furthermore, a response to Lip et al. subsequently published in the same journal provides additional evidence that the combinatory effect was known.

Whilst accepting that the two publications were not themselves prior art, the opposers argued that they indicate the state of the art at the priority date and should be examined on their merits and not expunged from the record. Furthermore, the additional evidence was brought in response to statements my Professor Daloph, the expert witness of the Applicant.

The Opponents cited Unipharm vs. SmithKline Beechan and Orbotech vs Camtek to support their argument that the papers should be examined on their merits.

The Ruling

Opposers are limited in what they can submit in response to the patentee’s evidence. They are not allowed to widen the statement of case. In this instance the additional evidence is supplementary evidence to support their main grounds of opposition, i.e. that the combination was known. There is no evidence given to explain why these papers weren’t submitted in the original round of evidence. The Opposer submits his evidence first and is entitled to respond to the counter-evidence. This gives him a procedural advantage and allowing the submission of additional evidence that could have been submitted in the first submission unfairly disadvantages the applicant.

In this case, the additional information is not prior art in the public domain, or it would not have been accepted for publication. It post-dates the application and is, therefore, not prior art. The Deputy Commissioner did not consider this material as indicating what was widely known prior to the priority date. The Opposers are trying to use the citations of Lip to show what was known prior to the priority date, and to do this, they should have submitted these citations in their statement of case.

Whilst not wishing to rule out using a paper that provides history of what was known earlier, the Deputy Commissioner warns against the danger of a hindsight bias and of reading the authors conclusions into the prior art.

As to the Opposers argument that the Applicant should have submitted an affidavit to support the evidence, Ms Bracha rejected this as the dates are not contested and so an affidavit is unnecessary.

In conclusion, Ms Bracha ruled that Sections 25-26 and 86-88 of the second opinion should be deleted. Legal costs of 5000 Shekels were ruled against the opposers.

COMMENT

In the DSM  vs. Mifalei Migun case, Judge Judith Schitzer of the District Court correctly ruled that one does not have to submit an affidavit with every piece of evidence or statement, so the Deputy Commissioner is correct on this account.

As to the late submission of evidence however, I think that the Opposers can fairly be penalized for not timely submitting these papers by having interim costs awarded against them for not submitting the evidence earlier, but the evidence should be related to substantively if it testifies to what was practiced prior to the patent being filed and not thrown out on procedural grounds. Ultimately the purpose of the Opposition proceeding is to clarify novelty and inventiveness to protect the public interest. If a drug becomes patented and should not be, the public will pay monopoly prices. Sure, the opposers have to answer as to why these papers were submitted late. Maybe the applicant should be given a second chance to respond and compensated for delays, but I disagree with this decision to throw out what could be key evidence.


US Supreme Court Overturns Federal Circuit’s Ruling Regarding Validity of Patent for Teva’s Copaxone

January 21, 2015

copaxone

Copaxone is a blockbuster drug based on the glatiramer acetate copolymer which was patented by Yeda (the Tech Transfer Company of the Weizman Institute) and licensed exclusively to Teva to manufacture.

On Tuesday 20 January 2014 the U.S. Supreme Court reversed an appeals court ruling that invalidated Teva Pharmaceutical Industries patent on the blockbuster multiple-sclerosis drug Copaxone, giving the drug maker a new opportunity to forestall generic competition.

The claims specify a particular molecular weight range but do not specify what method was used to measure the molecular weight. Sandoz argued that this is a fatal flaw and the claims are indefinite under §112. The District Court found for Teva, and was convinced by Teva’s argument that the claim clearly meant the “peak average molecular weight”, and not either of the two alternatives of “number average molecular weight” or “weight average molecular weight”.

On appeal, the Federal Circuit held to the contrary and found the patent invalid for indefiniteness. In reaching this conclusion, the Federal Circuit reviewed de novo all aspects of the District Court’s claim construction, including the District Court’s determination of subsidiary facts. The issue before the Supreme Court was whether that was permissible, or whether the Federal Circuit had impermissibly set aside the District Court’s findings of fact without the requisite finding of clear error on the part of the District Court (in violation of Federal Rule of Civil Procedure 52(a)(6), for what it is worth). The Supreme Court of the USA accepted TEVA’s appeal that found that the Federal Circuit had indeed impermissibly conducted a de novo factual review. So the Federal Circuit’s decision was vacated and the case remanded.

The Supreme Court Decision ruling was made by seven judges with two dissenting. Justice Breyer gave the Opinion with Justices Roberts, Scalia, Kennedy, Ginsburg, Sotomayor and Kagan affirming. Justice Thomas filed a dissenting opinion which Justice Alito concurred with. According the majority opinion the Federal Circuit had indeed impermissibly conducted a de novo factual review. So the Federal Circuit’s decision was vacated and the case remanded. In the dissenting view, the opinion was that the Federal Circuit had not overturned findings of fact, but had instead formed a different conclusion of law as to the claim construction. Therefore, there had been no breach of the Federal Rules of Civil Procedure. The case has been referred back to the Federal Circuit Court of Appeals.

COMMENT

The ruling will help TEVA prevent generic competitors from entering the Copaxone market until the patent expires in September. There seems to be a power struggle going on in the US court system with the Supreme Court reprimanding the Federal Circuit for assuming powers that are not rightfully theirs.


Double Patenting in Israel

January 15, 2015

novartis

The present ruling relates to the issue of identical of overlapping patents and patent applications, and examines the ramifications of double patenting.

IL 2039732 is a Divisional Application of IL 176831 “Compressed Pharmaceutical Tablets or Direct Compression Pharmaceutical Tablets Comprising DRR-IV Inhibitor Containing Particles and Processes for their Preparation”. Novartis have appealed a final Examiner’s rejection.

The Examiner considered that the parent and the divisional application are directed to the same invention. After this issue was first raised, the Applicant amended the claims, but the Examiner considered that the amended claim set (claims 1-23) covered the same invention as claims 23-26. Based on 5293/93 Welcome Foundation vs. Patent Commissioner (1993), the Examiner rejected the claims of the divisional application. A telephone conversation was to no avail. The Examiner issued a final rejection noting that there were substantive issues not addressed, whilst Applicant is appealing this decision claiming that the issue is one of interpretation of the law and has thus appealed to the commissioner.

The Commissioner held a hearing and allowed the Applicant to present a short summary of the comparative law in US, Europe, Australia, Japan, China and India. In this instance, the Examiner did not claim that the divisional had identical claims to the parent application, but that there was some overlap. According to the Commissioner, the issue is one of interpretation of Sections 2, 8 and 9 of the law. These state that an inventor is entitled to a patent, that a patent can only cover one invention and that where two or more applicants file for the same invention, the first to file is awarded the patent. The purpose of divisional applications is to prosecute additional inventions claimed within the same parent application.

In the Welcome case, claims 1-10 related to uses of a pharmaceutical preparation in the treatment of various diseases and claim 15 related to a method of preparation of the active ingredient.  Then Commissioner, the late Michael Ophir ruled a claim for use in preparing a medicament’ and ‘use in the treatment of’ were identical. He did not see that the application related to more than one invention. On appeal, Judge Winograd ruled that one can have one application for a material, a second one for the method of fabrication and a third one for uses, provided each application is directed to patentable subject matter and there is no overlap between the cases. There Judge Winograd went on to rule that one application cannot include more than one patentable invention, i.e. one should not award more than one patent for one invention, and this is a corollary of Section 8 that a patent should cover one invention. One can file a plurality of applications for a plurality of related patents provided that each one is directed to a patentable invention and the claims are not identical or overlapping.

In the present case, both the parent IL 176831 and the divisional application IL 203972 have the title. In IL 203972 there is one independent claim. Claims 23 and 24 of the parent IL 176831 each depend on claim 1, and claims 25 and 26 are dependent on claims 24 and 23 respectively. The independent claim of IL 203972 is directed to using a powder to form a pill for treating a wide range of ailments. Claims 23 – 26 of the parent IL 176831 are directed to forming tablets and a corresponding process. The divisional relates to various states that are not in the parent application, but both cases have the same specification. According to the Applicant, the parameters are identical but the parent claims the process whereas the divisional application claims use of the active ingredient to prepare a pharmaceutical.

According to the Examiner, the divisional application claims use of a formulation for treating a disease, where the formulation is given in claims 23-26 and the diseases treated are listed in claims 1-22. In both cases, the formulation is the same, the particle size is the same and the active ingredients and additives are the same as those given in claims 23-26 of the parent. Novatis found the Welcome decision poorly claimed and poorly reasoned and could not see why two applications could not claim identical or overlapping inventions. They argued that where applicants are the same, there is no need to relate to identical or significantly overlapping claims, holding that the Israel Patent Law does not prevent multiple patenting. Novartis argued that Section 2 is merely a declarative statement that the applicant may file a patent. It does not have legal ramifications, and certainly does not limit the number of patents that the applicant may file. Section 2 does include the word “one” and it should not be read into the claim such that one patent may be requested for one invention. Support for this interpretation is found by contrast to Section 9 which relates to different applicants with patent applications for the same invention.

The parties are in agreement that different applicants cannot be awarded separate patents for the same invention. Novartis holds that the same applicant can be awarded two or more patents for the same invention. The Examiner disagrees.  Novartis accepts that there is no economical justification or logic in an applicant having more than one patent, and even sees this behavior as unacceptable. However, so long as there is some difference between the two patents, it is legitimate to award the protection of both patents.

The commissioner upheld the Examiner’s conclusion and ruled that so long as there is nothing in claim 1 of the divisional that exceeds the scope of the claims of the parent, there is no reason to allow the divisional.

COMMENTS

In the US, the issue of double patenting is dealt with by filing a terminal disclaimer. Although that prevents extending a term of protection (sometimes  disparagingly called evergreening), it still has negative ramifications. Third-parties such as an alleged infringer may have to show that he is not infringing a number of overlapping patents. Likewise, a competitor may have to show a number of similar patents are invalid or not infringed. This places an unnecessary burden on third-parties.


Combining Similar Proceedings

November 19, 2014

combining hearings

C.T.S. LTD filed Israel trademark application numbers 2253382 and 253359 “Lactofil” and לקטופיל. The Mark covers Cosmetic preparations namely lotions, creams, mousses and soaps for nourishment and cleaning of the skin and face all in Class 3. “” Laboratorios Genesse, S.L. opposes the marks

Meanwhile, Laboratorios Genesse, SL. has filed Israel trademark application number 249389 for Lactivit for Soaps, gels, perfumery, essential oils, cosmetics, lotions for hair and skin care, creams for hair and skin care, and dentifrices also in Class 3. C.T. S. LTD are opposing this registration.

Both parties propose combining the hearings. The Lactofil hearing was scheduled for 29 October 2014.

The legal issue in both cases is likelihood of confusion with the similar product of the other party. The parties and the issues in both cases is the same. Combining the cases saves the parties time and expense, and saves judicial resources. In one case there are additional claims of inequitable behavior, but this is not seen as sufficient justification to hear the cases separately.

As both parties have equal rights, Ms Yaara Shoshani, Adjudicator at the Israel Patent and Trademark Office ruled the cases are to be combined, however in each case, at the combined hearing, the Opposer has the right to cross-examine the applicant’s witnesses and only then may the Opposer’s witnesses be cross-examined.

In the circumstances, no costs were awarded.

Decision to Combine Similar Trademark Proceedings, Yaara Shoshani Caspi 6 October 2014. 

COMMENT

Apart from the parties in question, there is a third party of importance, i.e. the public. It seems to me that combining the proceedings is not only economical for the parties and for the public purse in terms of judicial expense, but also is most likely to result in a sensible ruling.


Wyeth’s Patent Term Extension for Bazedoxifene Cancelled Prior to ReExamination

November 10, 2014
Rocking the boat...

Rocking the boat…

There was an amendment to the Israel Patent Law earlier this year. This amendment (11th amendment) relates to patent term extensions. The amendment was announced, but did not go into immediate effect.

Wyeth filed a request to correct a mistake in the Patent Extension Order concerning Israel Patent Number 120701. The extension Order was given on 23 February 2014, and extends the basic patent for Bazedoxifene which, without the extension, would have lapsed on 18 April 2017.  The intention to grant an extension until 26 August 2019 was given in October 2013 and published back then. The calculation was based on the Law prior to the eleventh amendment.

On 18 September 2014, Wyeth submitted a request to correct the Extension Order to provide protection according to the regime after the eleventh amendment.

Section 16 of the Amendment states:

16(a) this Law will apply to Extension Order requests that are pending before the Commissioner of Patents on the day that this Law comes into effect, and for future requests for patent term extension.

Wyeth’s contention is that the amendment to the Law came into effect on 27 January 2014 and due to the publication for opposition purposes, the period for opposition finished on 31 January 2014, so, at the time the Law came into affect no Patent Term Extension had been granted and the request for patent term extension for IL 120701 must, therefore, be considered as pending at the time the amendment came into effect.

The amendment narrowed down the list of countries that could be relied upon for Israel to grant a corresponding extension. Instead of anywhere in Europe that grants an extension, only Italy, UK, Germany, Spain and France could be taken into account. Significantly, Japan was no longer considered a relevant country in regards to patent term extensions. Wyeth’s patent was extended on the basis of the extension of the corresponding Japanese patent. By ignoring Japan, a longer term could be requested.

There is an interesting twist here. In October 2013, the FDA issued approval for Bazedoxifene together with conjugated estrogens as Duavee. This fact was not taken into account in calculating the Patent term Extension and could act against Wyeth. The Commissioner ruled that it would be improper to apply some sections of the amendment and not others, and that the Israel Patent Office should consider the ramifications of this FDA approval as well. In consequence, the Commissioner did not amend the ruling, but rather canceled it as a wrongfully given bureaucratic decision. He ruled that the published patent term extension was null and void and that the Application would be subjected to accelerated re-examination under the amended Law with the ramifications, if any, of the FDA approval of Duavee also considered.

Various legal precedents were given to support this contention and the solution it offered. The Commissioner noted that Patent Term Extensions are not final and could be reconsidered, even previous to the eleventh amendment.  He related to previous rulings concerning Teva vs. Abbott, Neurim, Lundbeck vs. Unipharm and Roche.

In addition to being able to oppose any subsequent patent term extension, the cancellation of the existing patent term extension may also be opposed by third parties.

Ruling Concerning Patent term extension to IL 120701 to Wyeth, 3 November 2014.


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