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.


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


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…

Read the rest of this entry »

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.

Read the rest of this entry »

Can a Patent Opposition be Suspended?

June 14, 2016

On IL 181596 to Insight Biopharmaceuticals LTD titled “PROCESS FOR PREPARATION OF MIXTURES OF POLYPEPTIDES USING PURIFIED HYDROBROMIC ACID” publishing for opposition purposes, Teva Pharmaceutical Industries LTD filed an Opposition.  However, just before publication, Insight filed a Divisional Application (IL 241702).

Teva requested that the Opposition be suspended, pending Examination of the Divisional application claiming that the claims of the two cases are substantially identical and that Insight agreed to the suspension.

Ms Jacqueline Bracha has given Insight 14 days to agree to concur to the request to suspend the Opposition and to explain why it is an appropriate action to take in this case.


Glaxo Receive Patent Term Extension but Warned to be Polite

May 16, 2016

patent term extension


The Application was filed on 27 April 2005 and was granted on 1 September 2011 and registered in the name of the Applicant. On 21 April 2015 the Applicant requested a Patent Term Extension based on the medication called ANORO ELLIPTA. According to the Ministry of Health, this medication includes two active ingredients: Vilanterol and Incruse Ellipta which includes the active ingredient Umeclidinium which was registered for sale on 8 February 2015.

The active ingredient Umeclidinium is the subject of claim 1 of the patent and the medication itself is claimed in claim 3.

An Affidavit from Mr Fowler, a Glaxo representative, was appended to the Extension request. This affirmed that Anoro Ellipta was the first medication registered for usage in Israel which included the active ingredient Umeclidinium.

The earliest approval for Anoro Ellipta was from the FDA in the United States and issued on 18 December 2013. Even now, the drug has not received a Patent Term Extension in the US, and the request for a Patent Term Extension in Israel is under Section 64 e(5) of the Israel Patent Law 1967 as currently amended.

The Patent Term Extension abroad that is the basis of the request in Israel is the Patent Term Extension Italy, which until the filing of the request for a Patent Term Extension was the only extension given by a recognized (Bolar) country. Since then, France and Spain have issued similar extensions.

In a letter from the Deputy Chief Examiner dated 19 May 2015, the Applicants were asked whether the combination of  Vilanterol and Umeclidinium in Anoro Ellipta creates a new active ingredient, since claim 1 claimed one active ingredient and claim 3 claimed the combination. In the same letter, the Deputy Chief Examiner noted that Vilanterol was already the subject of a patent term extension request and therefore the Application was not the first application as per Section 64(d)4.

In response and with a further Affidavit from Mr Fowler, the Applicant countered that on the basis of this being the first medical usage of Umeclidinium, the medication Umeclidinium deserved a patent term extension and this was the first time this active ingredient was registered. That Vilanterol had previously been registered was immaterial.

The Deputy Chief Examiner disagreed. and on 28 July 2015 ruled that this could not be considered the first usage under the Law, since the Applicant failed to show that the combination created a new medication. Furthermore, if a new medication is indeed created then the basic patent does not support this combination. She went on to affirm that in her opinion, the previous registration of Vilanterol rendered the combination of Vilanterol and Umeclidinium impossible to be considered as a first use and thus entitled to a Patent Term Extension.

The request was rejected and the Applicant appealed to the Commissioner, submitting a further affidavit, this time signed by Helen Quillin, the Deputy President of Glaxo and an employee thereof since 1993. the Affidavit affirmed that Anoro Ellipta is a ground breaking drug for the treatment of chronic lung blockage. The Applicant contends that the application for a patent term extension is legitimate. As far as the request relates to Umeclidinium as claimed in claim 1 of the ‘152 patent; the registration of this drug on 28 January 2015 was the first registration in Israel. Even if Umeclidinium combined with Vilanterol creates a new medication, it still fulfils the requirements of Section 64d(1) of the Law since bot the combination and Umeclidinium alone cannot be considered to have been registered earlier. It is noted that this is the first time that Applicant related to the question raided by the Deputy Chief Examiner.

The Question of the first registration of a drug combination has been related to a number of times by the patent office. What is required is that the registration in question is the first registration of the active ingredient.

Thus, for example, concerning Novartis AG 97219 (decision from 26/12/2005), the then Commissioner ruled that the term composition in section 64a is in the singular, and intends a single active ingredient. The then Commissioner stated that where a patent term extension is applied for on the basis of a patent for a combination of active ingredients and at least one of these had not benefited from prior Ministry of Health Approval, a patent term extension was possible. Furthermore, the District Court related to this in an appeal of the above case to the Tel Aviv District Court (1062/06 Novartis vs. Commissioner of Patents 26/2/2007) where it is stated that the term  חומר – material or matter implies the active ingredient and not the specific formulation, so long as the formulation is not more than the sum of its parts. Furthermore, in the Lundbeck decision concerning Cipralex, the isolated right hand molecule was not considered a new substance when compared to the  racemic mixture.  the court explained that the active ingredient may assume different forms, such as salts, and even if a drug is the first use of a particular form of the active ingredient, if the active ingredient has previously been registered in a different form, the second registration cannot be considered as the first registration of the active ingredient.

Based on the above, one can conclude that Anoro Ellipta is the first permitted usage of Umeclidinium and may be entitled to a drug term extension under Section 64d(3).

Vilanterol has been previously registered. As explained in 117459 Merck vs. Sharp and Dohme Corp. the previous registration of one active ingredient that is found in a new mediation that includes several active ingredients need not necessarily prevent the new medication from benefitting from a Patent Term Extension.

Anoro Ellipta,  like Umeclidinium, is entitled to a patent term extension and claim 3 which states: 

“3. A pharmaceutical composition according to claim 2, which further comprises one or more other therapeutic ingredients.”

does not detract from the fact that the composition contains Umeclidinium and is entitled to protection for that reason.

The Applicant does not consider that  Umeclidinium and Vilanterol form a new compound. This in Ms Quillin’s statement:

“The combination of these two active pharmaceutical ingredients does not create a new compound that differs from each of its components. In fact, each of these active ingredients is stored as a separate dry powder composition within the ELLIPTA™ inhaler of the ANORO™ ELLIPTA™ inhalation product.

The inhaler prevents the two ingredients from coming into contact with each other.

On the basis of the above analysis, the basic patent for ANORO™ ELLIPTA™  is extended by 965 days until 18 December 2027 and this decision will be published for opposition purposes in the forthcoming journal. The calculation is based on the Italian patent term extension and from the first published use in the US.

As an after-note, the Commissioner cautioned the Applicant for making disparaging comments about the Deputy Chief Examiner which should not have been made, and that a certain decorum is required when interacting with examiners.


I think the Deputy Chief Examiner was concerned that allowing a patent term extension for a combination of drugs or a cocktail could enable the unscrupulous to obtain an extension for a drug previously published by combining it with something new or at least not previously published.