Exforge Patent Successfully Opposed in Israel, despite surviving an Opposition based on similar citations in Europe

November 7, 2016

Exforge is a blockbuster drug sold by Novartis for lowering blood pressure that combiexforgenes two medications in a film-coated tablet It contains amlodipine, a dihydropyridine-type calcium channel blocker, and valsartan, an angiotensin II receptor antagonist (ARB or A2RA); typically formulated as the benzenesulfonate salt.

Israel Patent Application No. IL 140665 titled “USE OF COMBINATION COMPOSITIONS COMPRISING VALSARTAN AND AMLODIPINE IN THE PREPARATION OF MEDICAMENTS FOR THE TREATMENT AND PREVENTION OF DIABETES ASSOCIATED WITH HYPERTENSION” relates to the drug.

In an Opposition to the Patent Application issuing, the Deputy Commissioner, Ms Jacqueline Bracha, has ruled that the combination of two active ingredients, each individually known for treating high blood pressure, into one pill for ease of dosage is not inherently inventive where the separate efficacy of the active ingredients is known, as are other two component pills for treating hypertension. Though claimed by applicants, there is no evidence of a synergy between the active ingredients.  The Patent Application is therefore ruled not patentable in Israel and significant costs were awarded to Teva and Unipharm. We expect that the decision will be appealed. This decision may have a knock on effect regarding patents for the same drug abroad and may encourage Teva to proceed with at-risk launches of generic competitors in other jurisdictions.

A translation of the ruling follows:

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Are methods of calculating rediculous alleged legal costs trade-secrets?

November 1, 2016

novartis    teva

Teva successfully opposed IL 184027 to Novartis titled “COMPOUND TRISODIUM [3-((1S,3R)-1- BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1- BUTYLCARBAMOYL)PROPIONATE-(S)- 3¶METHYL-2¶PENTANOYL{2¶¶ TETRAZOL-5-YLATE)BIPHENYL- 4¶YLMETHYL}AMINO)BUTYRATE] HEMIPENTAHYDRATE, ITS PHARMACEUTICAL COMPOSITIONS, METHOD FOR ITS PREPARATION AND USE THEREOF IN THE PREPARATION OF MEDICAMENTS.”

The application was filed on 18 June 2007 as the national phase entry of PCT/US2006/043710. A divisional application was filed as IL 219782. The application published for opposition purposes on 30 November 2014, and on 25 February 2015 Teva Pharmaceuticals LTD filed an opposition. One day later Unipharm also filed an Opposition. Subsequently, since there was a pending divisional application and because the opposer had not filed their statement of case, the Opposers filed for suspension of the Opposition proceeding for 18 months as per Commissioner Circular 020/2012 “Opposition to a divisional patent or to a patent that is divided” from 18 November 2012. The Applicant opposed the request to stay the opposition. However, on 9 August 2014, the Commissioner agreed to stay the opposition proceeding.

On 7 September 2015, the applicant abandoned the divisional application and requested that the Opposition against the parent application be renewed and that the Opposer file their statement of case. The commissioner accepted this, and on 9 September 2015 gave the Opposers 60 days to file their statement of cases.

On 8 November 2015 Teva announced that they were withdrawing their opposition for “pure business reasons”. On 30 November 2016, the Commissioner ruled that the Teva opposition be closed and that the Unipharm opposition continue.

detailed-costsOn 11 January 2016, Novartis requested costs from TEVA. The costs request was supported by a statement from Liad Whatstein, Novartis’ counsel, but with many details thereof blacked out as they are allegedly business secrets and some are pertinent to the ongoing Opposition by Unipharm. They also requested a confidentiality order with respect to the blacked out data.

The Commissioner decided that Novartis had failed to make a case that the data should remain confidential, and issued a ruling on 4 February 2016 rejecting the confidentiality clause. Novartis’ counsel chose not to provide a time-sheet detailing the work done, considering this also as being a trade-secret.

Novartis’ Claims

The Applicant considers that TEVA’s withdrawing from their opposition puts them into the category of a party that loses their case. They do not think that the ongoing opposition by Unipharm should release TEVA from having to bear costs in a proceeding that they initiated. Thus Novartis alleges that TEVA should have to pay half the actual costs incurred by Novartis from when the opposition was filed until when it was abandoned, which comes to $17,136.72.

The Applicant claimed that due to the tight deadlines and the complicated scientific data they had to prepare for the opposition prior to the statement of case being filed. The complications are evidenced by Unipharm’s opposition and by the corresponding opposition filed in Europe. Furthermore, the Applicant claims that TEVA’s behavior and the time passed from when the opposition was filed until when it was withdrawn after the continuation was abandoned, created a state of affairs wherein TEVA could reasonably expect that Novartis would work on the opposition and incur costs thereby.

Novartis also claimed that TEVA had abused the opposition process by filing a baseless opposition simply to delay the patent issuing and to cause the divisional application to he withdrawn. Consequently Novartis considered that TEVA should pay costs.

 TEVA’s Claims

TEVA considers that Novartis is NOT entitled to costs at all and the cost request should be denied and Novartis should be charged for Teva having to respond to their costs claim. Alternatively, each side should bear their own costs.   Since the Opposition was terminated early it is by no means clear that were it to have continued, Novartis would have prevailed and would be entitled to costs for the preliminary part where Teva was involved. Teva alleges that if the Novartis application is refused, not only would Teva not have to compensate them, but conceivably Novartis would have to pay the costs  that Teva incurred in filing the statement of case.

Additionally, Teva considers that the Applicants actions and the costs incurred thereby in preparation of an anticipated opposition were needlessly incurred. Teva considers that from studying other statements of opposition, there is nothing to justify the preliminary and anticipatory actions that Novartis took, and certainly one cannot hold Teva responsible for such actions. Furthermore, the actions taken by the Applicant preceded the time when Teva had to submit their statement of case – which, in the event, were never submitted.

Teva went on to allege that the claimed expenses were unreasonable when considering the stage that the opposition procedure had reached. Furthermore, these so-called expenses were, in the main, not supported by an affidavit.

The Ruling

True, Teva filed an Opposition which was then abandoned early on. The Application is, however, still being opposed by Unipharm and has not issued as a patent. In this specific case, following review of the claims and counter-claims of the parties, Commissioner Kling concluded that the request for costs to be awarded to Teva should be deferred until the Unipharm opposition runs its course, depending on the outcome thereof.

The Commissioner has the authority to delay cost ruling under section 162b of the Law:

162b The commissioner is authorized to rule reasonable costs, to determine which partner should pay costs and how they should be paid.

Generally, the Commissioner rules costs in favour of the winning party. As a general rule, the side that abandons their case for whatever reason, and consequently a patent issues, is considered as having lost the proceeding and is to bear costs of the opposing party. (See 133957 cost ruling Pfizer Products Ltd vs. Teva Pharamaceuticals 14 February 2008). Nevertheless, the awarding of costs is left to the commissioner’s discretion and this is certainly the case where the abandoning of an Opposition does not necessarily lead to a patent issuing.

In this instance, despite Teva abandoning the Opposition the proceedings are ongoing. Unipharm’s opposition is still being fought and one cannot consider Novartis as being one who has won their battle. It is thus not the time for Novartis to claim costs. Consequently, at this stage the Commissioner is refraining from determining what costs the Applicant is entitled to, and what costs the Opposer is or may be entitled to. These will be determined once the fate of IL 184027 us known.

As an afterward and without final determination of the costs themselves, the Commissioner noted that it is rather difficult to rule on costs in the manner that they were submitted, with certain facts blacked out and no support for other contentions. This makes the reasonableness, necessity of and proportionality of the alleged expenses difficult to substantiate and makes it difficult to award real costs (see Supreme Court Ruling 891/05 Tnuva Cooperative for Marketing Israeli Produce vs. The Authority for Granting export Licences of the Department of Trade and Industry p.d 60(1) 600 (30 June 2005). This is particularly the case when considering the enormous costs claimed and the early stage at which the Opposition was abandoned by Teva, prior to submission of any substantive arguments.  See the ruling of the Then Deputy.  Commissioner re IL 113433 Smithkline Beecham Corporation (SKB) vs. Teva Pharmaceuticals (30 May 2005).

Interim Ruling re Costs in Il 184027 Teva vs. Novartis Oppostion Asa Kling 19 September 2016.

COMMENT

Whilst filing an opposition and then suspending until a divisional application issues or is abandoned could be considered as a delaying tactic, often filing such divisional applications is simply a means to keep an applications pending through parallel opposition proceedings, enabling a new claim approach not conceived at the time of filing to be considered. Since Unipharm is rather good at successfully opposing patents, it is a reasonable tactic for Teva to leave it to them to challenge the validity of the allowed claims. One suspects that Teva will have made relevant prior art and arguments available to Unipharm.

The successful opposer is entitled to claim costs from the applicant. Nevertheless, I am flabbergasted that Whatstein could make a claim for over $17,000 for costs incurred by having an opposition filed against his client prior to even having a statement of case requiring analysis being submitted. There were no patents or other prior art or other evidence that needed to be analyzed and no claims that needed consideration. Apart from informing Novartis that an Opposition had been filed, it is difficult to see what work was necessarily incurred.  Submitting a blacked out statement simply flags the fact that this is unreasonable. In desperation, I went to his website and discovered that as part of patent litigation “The firm orchestrated and designed complex experiments in patent infringement and opposition proceedings and uses a network of internationally acclaimed experts and external laboratories. In addition, the firm is involved in a large number of multi-jurisdictional patent proceedings.” This certainly goes some way to explain how $17,000 worth of costs could be accumulated, but one wonders if it was proportionate, reasonable and neccessary in response to an opposition being filed prior to relevant prior art and arguments being made of record.


Extending the Deadline to File Complaint

September 13, 2016

genentechIL 146954 to Genentech is titled “HUMANIZED ANTI-ErbB2 ANTIBODIES AND TREATMENT WITH ANTI-ErbB2 ANTIBODIES”. It is the national phase of PCT/US2000/07366. The active ingredient is Pertezumab.

Pertuzumab received US FDA approval for the treatment of HER2-positive metastatic breast cancer on June 8, 2012.[3] Pertuzumab was developed at Genentech and is now owned by Roche which acquired Genentech in 2009. The drug received regulatory approval in Israel on 8 July 2012, and on 21 February 2013 a patent term extension was requested and this was granted until 11 May 2021.

patent-extensionThe patentee requested an extension of time for responding to an Examiner’s action under Section 161 of the Israel Patent Law 1967. As explained below, the intended response relates to the intention to publish the grant of a patent term extension until the date awarded. However, the intention published in the July 2016 journal.

On 19 February 2013 the patentee requested a patent term extension for IL 146954. The conditions set out in Section 64e(5) of the Law were in place, but at that stage there was no extension to the basic patent in the US as required by 64d(5).  In the January 2015 journal there was an announcement of the intention to grant an extension under Section 64e(5) 1 of the Law.

Afterwards, when the Section 64d(5) requirement was met, the patentee gave evidence of the patent term extension of the basic patent in the US. In that notice the patentee noted that they expected that the Examination would be completed and a corresponding extension of the patent would be granted.

Consequently, the Deputy Senior Examiner completed her Examination and, on 4 July 2016, informed the patentee that the patent was entitled to a 353 day extension until 10 June 2021, which is the length of the extension in the US, and is the shortest of all the extensions granted by an extension granting state, as per Section 64i(1) of the Law.  The Patentee had until 18 July 2016 to respond to this notification.

calculating-sec-154-patent-term-adjustments-1-728-1On 18 July 2016, the patentee responded to this notification. From the wording of the response it is clear that the patentee does not have any problem with the mathematics used in  calculating the patent term extension. However, the patentee noted their position that the Examiner should take into consideration not just the Patent Term Extension period in the US (PTE), but also the Patent Term Adjustment (PTA) in the US.

Without substantive reference to the relevancy or otherwise of the Patent Term Adjustment, it is noted that until the patentee requested that the extension NOT be published, Genentech (Roche) had not raised Patent Term Adjustment (PTA) related issues and even now, did not provide details of the Patent Term Adjustment granted by the USPTO. So the Examiner was under no obligation to relate to this additional time period.

Once the period for responding had passed, and on receipt of the Patentee’s response, the Examiner informed the Patentee on 18 July 2016 that she intended extending the patent protection period in  Israel by the Patent Term Extension (PTE) awarded in the US as per Section 65(e)(5)(3) and that this decision would publish for opposition purposes in the July Journal, and this happened. The request to extend the period for filing a critique was submitted on 11 August 2016, after the publication of the extension order. The contents of the critique, which has not been submitted, is unknown.

The reason put forwards by the patentee for the patent extension is based on the allegation that the current law damages their property rights and they are considering the possibility of changing the current legislation. Thus it follows that the patentee does not contend that the Examiner’s actions were in accordance with current legislation. The requested Extension is until the basic patent lapses, which is until 23 June 2020, or a further year if the Patent Term Extension is also considered.

Thus the patentee does not argue that the Examiner was acting in contravention of the law and admits that the Examiner’s actions were in accordance with current legislation. The Commissioner, Asa Kling, does not believe that a patentee’s intention to try to change the legislation is sufficient reason for the Israel Patent Office to delay publishing its actions; particularly when the action has already happened and happened in accordance with the Law.

So the Commissioner does not see fit to extend the period prior to publication.

In a footnote, the Commissioner does not think that his refusal in any way adversely affects the patentee, since he can always submit a detailed request for recalculation under Section 164(c) of the Law.

COMMENT

In a recent decision the Supreme Court weighed in on a challenge to the patent term extension rules as being unconstitutional, and found that the legislative body can write the rules as it sees fit, to find  a balance between the competing need of the drug developers to be able to profit from their investment and have an incentive to conduct research and development and to file applications, with the public good provided by competition, non-monopolistic markets with generic competition.

The specific issue of the differences in Patent Perm Extensions and Patent Term Adjustments was discussed in a February decision.

I can understand the drug manufacturers considering the current law unfair, but, in light of the amendment to the amendment, it does seem to reflect what the Knesset wants and has been upheld by the courts. I don’t think that Genentech – Roche will be able to  have the Law changed.


Copaxone patents invalidated by the US Patent Trial and Appeal Board (PTAB)

August 27, 2016
copaxone 2

Following an inter-partes review brought by Mylan against two patents protecting Teva Pharmaceutical Industries’ Copaxone, a drug for treating multiple sclerosis, the US Patent Trial and Appeal Board (PTAB) has invalidated all claims of the ‘250 and ‘413 patents for double-dose 40 mg Copaxone (glatiramer acetate injection) multiple sclerosis treatment. However, on 24 August 2016, TEVA announced that it plans to appeal to the US Court of Appeals for the Federal Circuit.

Erez Vigodman, president and CEO of Teva, said: “We remain confident in the strength of our intellectual property surrounding Copaxone.”

“We are prepared to defend the full suite of our intellectual property through the PTAB and US courts regardless of the time required.”

copaxone 3“We believe patients, physicians and payers will continue to value the efficacy, safety and tolerability of Copaxone and that it will remain a proprietary, global market-leading product for the reduction of relapses in RRMS patients.”

Teva have also announced that the PTAB had declined a request for a post-grant review on an additional Copaxone patent.

Copaxone represents 20% of TEVA’s income and the invalidation sent shares plummeting by 3%.


Reconsideration of a Patent Extension Term

August 10, 2016

last minute shopping

In an odd development, but not one that without precedent – see here and here – Dr Shlomo Cohen Law Offices has asked the Israel Patent Office to reconsider a judicial ruling.

In this instance, the original ruling relates to the Patent Term Extension (PTE) of IL 169693 to “Bristol Myers Squibb” and Pfizer that issued under section 64(v)5 of the Israel Patent Law. The original ruling issued in September 2015, and granted a patent term extension of 974 days until 18 May 2025. That ruling followed a challenge by the patentees to Examiner’s decision of 5 March 2015.

The way that Patent Term Extensions (PTEs) are calculated in Israel is detailed in Read the rest of this entry »


Amending the Specification of an Opposed Patent Application

July 7, 2016

abbvie.png

Under Israel Law, allowed patent applications publish for opposition purposes for three months prior to issuing. If an opposition is filed, the issuance may be delayed for rather longer, if the patent issues at all.

As a general rule, the Applicant may amend ‘scribal errors’ i.e., typos in the specification and may narrow the scope of coverage of the claims, but cannot add material or widen the claims to cover something not previously within their ambit. In practice, applicants often request amendments that are allegedly permissible but which the opposer considers as somehow adding material or widening the monopoly sought. Sometimes amendments are opposed as a delaying tactic as until a patent issues, it cannot be enforced.

In the present instance, the application in question is IL 122546 to Abbvie Inc. titled “COMBINATION OF RITONAVIR AND A DRUG METABOLIZED BY CYTOCHROME P450 MONOXYGENASE AND PHARMACEUTICAL COMPOSITION COMPRISING THE SAME”, which was filed two decades ago on 28 June 1996 by Abbot Laboratories as the national phase of PCT/US1996/0011015 which itself claims priority from a US provisional application (no 60/000654) filed on 29 June 1995. The case was transferred to Abbvie in June 2013.

The case was allowed and published for opposition purposes on 31 January 2012, and on 29 April 2012 oppositions were filed by Vertex Pharmaceuticals and by Teva Pharmaceutical Industries LTD.

Abbvie petitioned to amend the claims and this interim ruling relates to the proposed amendment and examines whether it is supported and whether it is indeed a narrowing of the scope of the claims.

last minuteIn his ruling of 2 May 2016, the Commissioner Asa Kling allowed the amendments to the claims but this is an interim ruling anyway and the patent, if eventually granted, will lapse anyway 20 years from filing on 29th June 2016. This begs the question as to the point of continuing with the opposition?!

The ruling has been carefully translated and is reproduced below but I have added a break as it may not be of interest to everyone…

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Israel Commissioner Vindicated by Supreme Court

June 22, 2016

appealMerck & Co. LTD is the exclusive licensee of IL 110956 for Ezetimibe owned by Schering Corporation. The patent protects the active agent Ezetimibe as found in the pharmaceutical Ezetrol, or Zetia, which reduces the amount of cholesterol in the human body. The original 20 month patent term lapsed on 13 September 2014. However, on 22 September 2005 the patentee received a patent term extension until 23 June 2017. Later however, in September 2014, following a submission by the Association of Industrialists in Israel, the Commissioner of Patents, Assa Kling, ruled that the patent term extension for IL 110956 for Ezetimibe be shortened until 22 January 2016 on the basis of the subsequently issued, shorter patent term extension of the corresponding US patent, and awarded costs of 40,000 Shekels from Merk to the Association of Industrialists.

constitutionalMerck, represented by Liad Whatstein, appealed the ruling, using arguments that failed to persuade the Commissioner, including that the law itself was unconstitutional since it destroyed property rights which were recognized in basic laws (section 8 of the Basic Law of Human Dignity and Freedom. 1980. Furthermore, the fact that the subsequent amendment to this section is not retroactive supports the allegation of lack of constitutionality.

In Appeal number 5407-11-14, the Jerusalem District Court upheld the constitutionality of the Law but recalculated the extension until October 2016 based on the duration of the corresponding German patent.  On 11 April 2014, a tribunal of Supreme Court Judges Danziger, Hendel and Shaham heard an Appeal by Merck on the constitution issue, and one by the Association of Industrialists in Israel wanting the shorter term calculated by the Commissioner to be restored. The Association of Industrialists in Israel were represented by Adv. Tal Band, and the Legal Counsel to the Govt. Ms Shimrit Golan joined the Appeal on behalf of the government.

On Appeal Judge Hendel of the Israel Supreme Court reviewed and justified the various amendments and ruled that shortening the period of a previously ruled Israel Patent Extension Order during the 20 year pendency of the original patent was constitutionally sound, as was doing it on the basis of a subsequently issued shorter protection period from a recognized country.  Judge Handel painstakingly but beautifully explained the background to the patent term extension legislation and why it was filling to link Israeli extension periods on those granted abroad. He jsutified the extension regime which is an exception to patent norms, and threw out Merck’s argument. The rigorous analysis was concluded by a section on comparative law where Judge Handel first related to Mishpat Ivri (Jewish Civil Law) and showed that there were echos of intellectual property rights in the Talmud, and that scholars of the 19th to 21st centuries related to patent law. He argued that the Jewish tradition recognises both quasi-property rights in inventions and creative activity but frowns upon tradesecrets, particularly with respect to pharmaceuticals, noting the case of Rabbi Yohanan a handsome scholar that lived in Zipporis in the Galilee who contracted scurvy, and then broke the trust of a roman matron that cured him, revealing the cure in his sermon, because of the public interest. The analysis of the Jewish sources was masterful. Then Judge Hendel briefly reviewed the US law and its developments, concluded that the US and Israel were both trying to create a fitting balance between the needs of the drug developers to benefit from a real period of protection after obtaining regulatory approval to enable them to sell their drugs at a premium and recoup their investment, and the needs of local generic drug companies to be able to compete with their foreign counterparts but them being able to conduct acts required to obtain regulatory approval during the extension period. Judge Handel noted that there was public interest in encouraging drug development by pharmaceutical companies who had to make enormous investments to bring new treatments to the market. However, there was also significant public interest in widespread and affordable drugs.

Merck’s appeal was rejected by Judge Handel and Judges Danziger and Shaham concurred without comment. Judge Handel noted that were Merck NOT to have appealed, the Appeal by the industrialists on the District Court’s actual calculation would not have been heard, so Merck’s second appeal actually resulted in a shorter patent term extension than they would have received otherwise.

I consider this ruling objectively important and very well written. Due to the significance of the issues raised, I have translated the entire ruling to make it available to non-Hebrew speakers, noting that computer translations were of little value. I have posted the full translation below the following page break as a public service. I have not used the term ‘ethical’ which Judge Handel used to refer to the drug developing countries, and occasionally have not translated idioms, or used an English language metaphor where it appears to be appropriate. The illustrations to the ruling are my contribution. I think they liven things up a bit. If you find them distracting, adjust your settings to view text only! Please note, translating this took a few days and I put billable work aside to the chagrin of various clients. I would appreciate that anyone using this translation has the decency to attribute and to link to this blog.

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