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%.


Revival of IL 211245 to Neurovision Imaging Inc.

August 17, 2016

he's dead jimIL 211245 to Neurovision Imaging Inc. issued on 1 December 2014 but the Applicant failed to pay the first renewal that was due within three months, by 1 March 2015. After the grace period passed the patent lapsed on 1 September 2015, the patent lapsed and the fact that it had lapsed published in the October 2015 Journal.

On 12 July 2016 a request for reinstatement was submitted. An affidavit from Steven Verdooner, the CEO of the company was appended. According to the Affidavit, back in May 2014, the US patent attorney who handled their portfolio informed them that the patent had issued and requested payment of issue fees and service charges. The issue fees were paid in June 2014.  In January 2016, after the patent had lapsed, the Applicant received a second letter from the same attorney informing them again that the patent had issued(!?). From examination of the section of the email notification appended, Deputy Commissioner Ms Jacqueline Bracha could not determine that the appended notification related to the Israel application, although the corresponding PCT application number was mentioned. Nowhere in the section of the email appended was a specific jurisdiction mentioned. From this there is no indication that the email related to Israel, where the patent had issued a year and a half earlier.

The Affidavit further stated that at some stage, the patent portfolio was transferred to a different US firm. On 2 May 2016, the second US firm informed the Applicant that the patent had lapsed due to failure to pay the Renewal. The request for reinstatement was filed two months later.

In the circumstances described, the Deputy Commissioner was not persuaded that the conditions for reinstatement detailed in Section 60 of the Law were fulfilled. Firstly, more than two months passed from when the Applicant was aware of the patent lapsing and their request to reinstate it. The Applicant made no effort to justify this amount of time passing and to explain what steps had been taken in the meantime. It is not clear that they acted promptly to restate the patent once they were aware that it had lapsed.

The Affidavit did not clarify if the Applicant had received the Patent Certificate and if the Associate (Shilon Zuckerstein) had reported the obligation of paying the first renewal. Even if the Applicant did not receive the Certificate, it is not clear why they did not ask for it once they were informed that the certificate had issued.

The Applicant was represented locally at that time (Shilon Zuckerstein) but not evidence was presented by the attorneys. It is not clear if the Applicants (now represented by Colb) had contacted them prior to producing their affidavit, if they didn’t have information or were not contacted. Thus the Applicant has failed to show that the renewal fee was not paid for reasons that may be considered ‘reasonable’ as required under Section 60 of the Israel Patent Law 1967.

Consequently, the application for reinstatement is rejected.

Request for Reinstatement of IL 211245; ruling by Ms J Bracha, 14 July 2016


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 »


Shabbat Lifts Not for the Public Good

July 18, 2016

 

shabbat liftG.L. Glatt Lift Company Ltd. filed a patent application for a Shabbat Lift; an elevator that may be used on the Jewish Sabbath without transgression of the holy day. (The term Glatt relates to a standard for Kosher beef that the generally accepted Ashkenazi authorities consider a stringency. By transference, the term implies super-Kosher, or something similar. Many Jewish authorities allow usage of a lift that stops automatically, or riding in a lift in a hospital or similar if someone assumed to be non-Jewish operates it for their benefit. Other authorities are stricter. More discussion on this is given at the end of this article).

Maalit ShabbatIn this instance, the Applicants have filed a patent for a technological Hallachic solution that is allegedly novel and inventive and that is claimed to overcome the reservations of those Hallachic authorities that do not allow usage of the type of ‘Shabbat Lifts’ that are common in apartment blocks with religious residents.

Israel Patent Application No. IL 221842 titled “Shabbat Lift” was submitted on 9 September 2012. The application claims priority from a US provisional application number 61/533,244 that was filed on 11 September 2011, and a corresponding PCT application, No PCT/IB2012/054604 was also filed.

On 13 October 2015, the Applicants received a Notice Prior to Examination to which they responded on 1 February 2016 with a list of prior art. The submission of a response to the Notice Prior to Examination creates a state of affairs by which the application is ready for examination (see section 5.3 of the Examination Procedure for Examiners).

On 1 February 2016 the Applicant also submitted a request for accelerated examination, which is a petition to make special. The justification for the request was that awarding the patent was in the public interest.

The Applicant claimed that the lack of appropriate Shabbat lifts prevented high-rise accommodation for the Ultra-Orthodox and the proposed solution would overcome this barrier. The Applicant considered that his invention would facilitate high-rise Ultra-Orthodox accommodation and thereby minimize land usage (by increasing the population density) and would thereby lower building costs.The solution would also make life easier for the ill, the elderly and children who could not use elevators on Shabbat. Various articles regarding the lack of accommodation for the Ultra-Orthodox were appended.

The statement was not specific, but it appears that the legal support was claimed from Section 19a (v) and (vi) that state that:

An applicant for accelerated examination with reasonable arguments may submit a reasoned request, together with a statement supporting the facts; all of the following, inter alia, may be considered reasonable justification:

(5) common good;

(6) special justifying circumstances.

Generally patents are examined in turn so ‘first come, first served’ as per Section 9 of the Patent Law:

If more than one applicant request a patent for the same invention, he that first applied will prevail. 

The order of examination is generally on a ‘first come, first served’ basis as per Section 34a of the regulations:

34a the applications will be allocated to each internal classification group and within each classification group, will be examined in turn. 

Examination in turn both facilitates Section 9 and also ensures that relevant prior art is available to the Examiner. The first come, first served regime is itself in the public interest – See ruling re Petition to make special Israel Patent Application no. IL 216870 to Cimas Limited, 24 March 2014.

The possibility for making an application special is an exception to the general rule. It undermines the principle of ‘first come first served’, makes the examination more difficult and arguably damages the quality of the examination.  For example, a queue-jumping application may be examined and allowed without realizing that an earlier filed application that was not examined challenges the novelty or inventiveness of the claims. Any fast-tracking results in other applications being delayed and is thus against the public interest.

Fast-tracking risks unfairness, but the legislators allow it under circumstances detailed in Section 19a of the Law where there is an over-riding public interest or special circumstances. Section 19a was legislated in the 10th amendment to the patent law that came into effect on 12 July 2012. From examination of the discussion at the committee state it is clear that the Commissioner has the discretion to explain the law. It is clear that the type of justification that is acceptable is extreme circumstances. For example: there could be circumstances that a dramatic discovery is like an earthquake and is positive for the State of Israel. Isaak Herzog, Knesset legislative committee discussion of 13 March 2012.

The justifications listed in Section 19a were actually those for third parties to request an application be fast-tracked but there is no reason to suppose that they are not applicable to requests by the Applicant himself. Nevertheless it appears that what the legislators intended was something of interest to the entire population as of national interest for the whole population and not for micro-economic interests of one sector or another. There is an underlying assumption of public interest in all patents. The only justification for ever granting a patent (i.e. a monopoly, albeit limited in time and geographical application) is that there is a national interest in micro-economic profits and technological progress.

No-one challenges the fact that each patent provides a different public interest depending on the type of invention and its application. There is no clear economic or social scale that can be used to rank different patents. However the same term is generally understood in the same manner in different legislation to provide coherency (see Aharon Barak, Volume 2, Legislative Interpretation, Nevo 1993 pages 313 and 321. Thus the term “common good” in Section 19a of the patent law is a priori similar to the term in Section 122 which discusses forced licenses. Section 122 states:

The Commissioner, where he comes to consider the request for a compulsory license under Section 117 should consider, inter alia:….

….

(2) the common good generally obliges that all inventions should provide the protected goods by manufacturing or import, so enable widest possible supply in the circumstances, without delay.. 

The District Court ruled in 881/94 Eli Lilly and Company vs. TEVA Pharmaceuticals LTD 25 November 1998:

In the field of patents, the common interest is the main and dominant cause for determining balances and rights. There may be a specific basis for worrying for private interest of the specific owners, and a patent an be considered as a reward that the legislators bestows on the entrepreneur. But the main justification of the patent system is the public considerations of utility and profit that affect the community taken as a whole. Whilst it is true that a patent provides protection to an individual, the existence of the right and its extent are determined by how much they fulfill the public interest. In this regard a patent is like a compulsory license. In both cases a personal right is provided to an individual but the underlying rationale for granting the rights is the common good. Just as the compulsory license is not granted for the benefit of the applicant, similarly a patent is only granted to the owners because it is in the public interest. It is not a balance between private rights and the public interest, but rather a balance between different public interests that together define the common good.

Thus the common good in this instance, as with compulsory licenses, is the result of balancing different public interests. Where the Applicant desires to depart from the general balance of interests including the principle of ‘first come first served’, the justification for jumping the queue has to be something weighty of significance to the wider public or a positive macro economic effect.

Furthermore, from when the application is filed until it eventually issues as a patent, there is nothing preventing the applicant from implementing the invention described in the patent application, enabling the public to benefit immediately. The enforcement of a patent is of economic interest to the patentee only. First tracking is not in the public interest at all. It only serves the applicant.

Without addressing the issue of patentability at all at this stage, the Commissioner does not thing that the present invention is more ‘public good’ than other inventions and, as the applicant himself testified, it serves a specific population segment only. The petition to make special did not include any economic calculation to show why it was justified.

Although the above arguments relate to the ‘public good’ they are equally applicable to the ‘special reasons justifying advancing the examination’. Consequently the application for fast-tracking is rejected and the application will be examined in turn.

Ruling by Commissioner Asa Kling Concerning Making Special Israel Patent Application Number IL 221842 to Glatt Lifts LTD., 14 June 2016 

COMMENTS

Very few inventions positively affect everyone. If something could help 10% of the population, it seems to me that it should be considered of significance, whether the population is women, AIDS sufferers, people living near the Gazan border, parents of small children or the Ultra-Orthodox. I don’t see any reason why common good should be interpreted as of value to people across the population without regard to race, age, religion, religiosity or sexual orientation.

The underlying presumption of the Applicant is that conventional elevators do more electrical work for each passenger riding in the elevator and that this is against the laws of Shabbat to rely on Shabbat settings on lists. If this assumption is true, it affects all Jews and most of Israel’s population is Jewish. Even if many Jews are not Observant, and many more are not persuaded that using currently available Shabbat lifts are not acceptable I suspect that from the Applicant’s perspective, Shabbat observance is of value and desecration is problematic regardless of the religious philosophy of the Jew in question. It may be what’s preventing the Messiah from coming. Furthermore, the State of Israel accepts the principle of Shabbat observance as being of national interest by not allowing trading on Shabbat and by not having Shabbat desecration by the Head of State, ambassadors, etc. and by requiring Shabbat observance on army bases apart from where security considerations take precedence.

For more details of the ruling (wrongly???) attributed to Rav Elyashiv, see here. See also a report in the Yeshiva World (sic) and one from the UK’s Daily Telegraph. Rabbi Yisrael Rozen’s ruling allowing both ascending and descending in Shabbat Elevators and listing what modifications are required to enable an elevator to be used on Shabbat may be found here (Tchumin 5, 75; see also article by Professor Lev in same volume, page 58).

I took the liberty of reviewing IL 221842 to Glatt Lifts LTD and its claims. If I was examining it for patentability, I would disallow it as not being enabled. It may be enabled from the perspective of the Hallachic problem it is trying to solve, but in my opinion, it does not provide a solution that enables a person of the art to go away and build a working lift without undue experimentation which is the standard for which patent applications are judged.


Amending the Specification of an Opposed Patent Application

July 7, 2016

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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 »


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.

 


Where Agent-of-Record Moves, Resulting in Patent Application Lapsing

June 14, 2016

dead

Where no response to an Office Action is received, the Israel Patent Office eventually sends a notice of imminent abandonment to the agent of record and then a month later sends the agent of record a notice of the file closing. Where a patent application is unintentionally abandoned, the Applicant may reinstate within 12 months. Beyond this time-frame, it is more difficult as the Patent Office considers that abandoned applications are in the public domain. But what happens where the Agent of Record does not receive the Notice due to a change of address?

IL 198531 to Cheil Industries INC was filed on 4 May 2009 as the National Phase Entry of PCT/KR/2006/005109 by Hizkiya-Hachmon Law Offices. The Israel Patent Office mistyped the Agent of Record’s name as Hizkiya-Hashmiyon Lawyers. The Deputy Commissioner blamed the lawyers for the mistake since they filled out the Application form with their name in English and not in Hebrew as they should have.

On 17 August 2010, the Agent of Record updated their address in a response to an Office Action.

The Patent Office sent an Office Action on 30 August 2012 and no response was received. Consequently, on 25 June 2013, a reminder was sent, again to the address of record, and when no response was submitted, the Application was deemed abandoned under Section 21 of the Law.

On 24 December 2015, Adv Tal Rosenthal, who works for the Agent of Record, filed a request for an extension for reconsideration, blaming the Israel Patent Office for the case going abandoned. Hizkiya-Hachmon Law Offices argued that they had informed the Patent Office about their address, but the Israel Patent Office had failed to update its records. Since the name of the Agent of Record was wrong, post was not forwarded to them. This prevented them responding in a timely manner. As evidence of their claims, they submitted an envelope with the wrong address that was returned to the Patent Office as undeliverable.

RULING

Sections 21 and 21a of the Israel Patent Law 1967 state:

21A. If the Registrar refused to accept an application under section 21, then he may— on the applicant’s application—reconsider the refusal, on condition that the application be submitted within 12 months after the day on which the Registrar refused to accept it as aforesaid.

21B. The applicant may cancel his patent application up to the grant of the patent; however, the Registrar may cancel the cancellation on conditions prescribed by him, on condition that he is satisfied that the application was cancelled unlawfully.

Where the 12 month period stated in Section 21 has passed, the Commissioner may, nevertheless, reinstate a patent application in exceptional circumstances under Section 164a which states:

164.—(a) The Registrar may, if he sees reasonable cause for doing so, extend any time prescribed by this Law or by regulations under it for the performance of anything at the Office or before the Registrar, except for the times prescribed in sections 30, 56, 57, 61, 64F, 64M…

As the Deputy Commissioner, Ms Bracha sees it, Section 21a gives the timeline for an Applicant to restore an Application. Section 164a gives the Commissioner sweeping powers to reinstate but has to be applied with consideration of the fine balance between the Applicant’s interest and that of the public; see 2806/04 Commissioner of Patents vs. Recodati Ireland LTD.

The Agent-of-Record is attempting to justify his request by blaming the Israel Patent Office for not updating his address and for getting their name wrong on envelopes sent by the Israel Patent Office.

Regulation 16 obliges the Applicant to provide an address. This may be changed, however in this instance, the Agent of Record has not been able to produce any request to the Israel Patent Office that they update their address. At a hearing on 27 March 2016, the Agent failed to produce any request to change the address of record and failed to show that they had paid the requisite fee. They were given a further 14 days to produce the paperwork but still failed to do so.

Essentially, the Agent of Record could have filed a request to correct the firm’s name and to update their address over a five-year period but failed to do so.

Whilst the response of 17 August 2010 was sent on headed paper bearing the new address, which indicates retroactively that the address had changed, this is insufficient to cause the Israel Patent Office to update its records. Furthermore, in that response the agent-of-record should have noted that the firm’s name and address were wrong and taken steps to rectify this.

Three years had passed from this case going belly up, and the Agent of Record could have checked the status on-line but failed to do so.

(It is also noted that Adv Tal Rosenthal claimed that the firm moved in 2011 and in the summary it transpired that it actually happened in 2010, so not only is the blame wrongly attributed to the Patent Office, but the Agent of Record could not even get their story straight).

In summary, the application went abandoned due to the Agent of Record making numerous mistakes. This makes it difficult to apply Section 164a to reinstate the Application; particularly due to the long period that has passed.  Unlike the  Penoles case (IL 211582) where PCZL requested a change of address of record, but the Israel Patent Office messed up, in this case, the Agent of Record ignored the wrong name of firm and made no effort to update their address.  There is no ‘reasonable grounds’ for reinstatement and the Public Interest is served by finality so something abandoned should stay abandoned. The request for reinstatement is rejected.

 

 


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