IL 206845 to BioMarin Pharmaceuticals Inc. was refused under Section 21a of the Israel Patent Law 1967. The patent application was the national phase of a PCT application submitted on 6 January 2009. The national phase entry was submitted on 6 July 2010 and claims priority from US applications filed on 7 January 2008 and 22 April 2008.
On 30 January 2013, the Applicant was sent an Office Action to which the Applicant had four months to respond. No response was forthcoming. Following the extensions available under Circular 005/2011 then in force, on 5 March 2014 the Applicant was informed that the file would be closed if no response was submitted within 30 days. This letter went unanswered and the file was closed on 23 June 2014.
Three years and three months later, on 15 October 2015, the Applicant requested a retroactive extension to respond to the notice of abandonment.
The request was accompanied by an Affidavit that testified to the developments leading to the case becoming abandoned.
- In 2005, Merck Serono purchased all rights to the Kuvan medical product, and to the process for manufacturing the active ingredient claimed in the application.
- This transfer of rights was not recorded in the patent register and the Application was filed in the name of Biomarin.
- In 2012, Merck Serono decided that it was not interested in the patent issuing in Israel and told Biomarin not to respond to the Office Action.
- In 2015, Biomarin repurchased their rights to the invention and in 2016-2017 reviewed the usefulness of getting the patent to issue in Israel.
- Following the reconsideration, the present request for extension of time to respond was submitted in October 2017.
The Applicants argued that their repurchasing of their rights and their reconsideration of the portfolio provides sufficient justification for reconsidering the refusal of the patent. Furthermore, unlike in the US and Europe, there is no legal requirement for abandonment so thus, even if the abandonment was following an intentional decision by Applicants or the predecessor thereof, this does not mean that, following a change of circumstances, this cannot be reconsidered and they are entitled to a further opportunity
The Applicants presented their arguments at a hearing on 14 February 2018, during which they claimed that the Applicants can be considered as having made a mistake that they now wish to rectify. They also claimed that returning the application to examination will not cause damage to third parties. Finally, they argued that in Appeal 8127/15 Association of Israel Industrialists vs. Merck Sharp & Dohme Corp. et al. (15 June 2016), certainly is no more important than other considerations.
Sections 21 and 21a of the Law set out the normative arrangement for these matters as follows:
21. If the Applicant did not remove the grounds for the Application not being approved within the timetable set out in the regulations or did not correct the lacunae under Section 20, the Commissioner will refuse to allow the patent.
21a. If the Commissioner refuses the patent under Section 21, he can, at the request of the Applicant, reconsider the refusal provided that the request to do so was submitted within 12 months of the refusal.
The period laid out in Section 21a of the law is extendable under Section 164 of the Law at the Commissioner’s discretion. The Commissioner’s discretion is summed up in the phrase “if he sees a reasonable basis for so-doing” which is found in Section 164a. The Commissioner’s considerations will change with circumstances, and as Judge Naor stated in Appeal 826/04 Commissioner of Patents vs. Recordati Ireland Ltd (26 June 2004):
The policy regarding different requests for extending deadlines that are brought before the Commissioner, will change with circumstances and with the nature of the proceedings for which an extension is requested.
Similarly, the Commissioner has the authority to make the extension dependent on “conditions that he considers to be correct” as stated in Section 164b of the Law.
In cases such as this, there are two main interests. Firstly, that of the Applicant who wishes to protect his invention and, secondly, that of the public which can benefit from inventions that are not patent-protected and are thus in the public domain. It is noted that this case is the national phase of a PCT application and the application and its status is published under section 16a of the Law.
The Deputy Commissioner Ms Jacqueline Bracha considers that the period given in Section 21a, though long, is limited. This protects the public and brings matters to a close. The period given in the Law is a balance between the competing interests.
To extend the 12 month period after the file closes under Section 164 requires ‘reasonable grounds’, as defined in Opposition to IL 110548 Shmuel Sadovsky vs. Huglat Kimberly Marketing ltd, 12 August 2010. The relevant considerations for ‘reasonable grounds’ are the duration of the extension requested and the existence of a real cause for the delay.
Ms Bracha does not consider that the Applicants’ request can be considered reasonable with respect to the delay incurred or the justification to reopen the file. The request to reopen the file was received 39 months after the case was closed. This is 27 months after the usual deadline which is a long time.
As to the submission that the client changing their mind is grounds for opening an intentionally abandoned application, the Deputy Commissioner does not find this convincing. She finds support in Appeal 83/86 Sokol vs. Yismach, p.d. 40(1) 577 cited in the Sadovsky case, where it is stated that:
The discretionary authority to extent deadlines is intended to overcome mishaps and externalities that are beyond the litigant’s control.
One cannot consider a decision not to continue prosecuting as being an external cause, a mishap or an error. Ms Bracha notes that the circumstances described in the Affidavit show that the error we are dealing with is imported from Contract Law and is at best “a mistake in the equity of the deal” which is not grounds for cancelling a contract.
In a similar manner, it has been determined that not paying a renewal of a patent due to a determination that it is not worthwhile to do so is NOT considered as a reasonable ground for reinstatement, and that is where we are dealing with an actual right that the patentee was awarded and not with a pending application as in this case. See Request for Reinstatement of IL 177522 of “Yad Conena Ltd from 9 June 2014:
The circumstances of the case before me do not fulfill the above requirements. A decision was taken not to pay the Renewal fee. The patentee knew that the there was a need to pay the renewal fee as this was not the first time that he had needed to pay it. One can assume that after the case lapsed and was reinstated in 2011, the patentee made inquiries regarding the next renewal. From the Affidavit it transpires that the patentee made an informed decision NOT to pay the fee. In these circumstances one cannot conclude that the fee was not paid in reasonable circumstances that justify reinstatement. The economic difficulties that the Applicant noted are not considered reasonable grounds for not paying the renewal, particularly where no evidence of the debit was submitted.
As a footnote, Ms Bracha relates to the claim that the request finds support in Appeal 8127/15 Association of Israel Industrialists vs. Merck Sharp & Dohme Corp. et al. (15 June 2016), that in patent law, fidelity and consistency is no more important than other considerations. Ms Bracha considers that certainty is not all-seeing and that sometimes certainty will be sacrificed for other interests. In re Association of Israel Industrialists, it was stated:
True, there is validity to the suspicion that certainty may be damaged when a court comes to interpret the Law (Aharon Barak Legal Interpretation, Interpreting Legislation Volume 2 583 (1993). Nevertheless, this is one consideration amongst many that can be used where there is nothing in the wording of the Law or elsewhere to directly contradict this. In this instance, it appears that the legislators did not put the question of certainly regarding when a patent lapses as the main consideration.
In other words, the consideration of certainty is an important consideration but where the wording of the Law or its purpose indicate that the legislators preferred some other consideration, the Court will interpret the Law accordingly.
Ms Bracha does not consider that in this instance the Law or the case-law expounding the Law indicate that the legislators preferred the interest of the Applicant over that of public certainty, She considers that to the extent that there is a legal tradition for interpreting Sections 21a and 164 of the Law, it is one that requires the Applicants to provide a real and reasonable cause for incurring a delay, and this is necessary since there is public reliance on the patent lapsing.
The Applicants also requested to learn from what is stated in foreign legislation, that what is not stated in our Law is not a requirement. That is, that whereas other laws explicitly state “unintentional” this implies that there is no such requirement in Israel Law. Whilst it is true that Section 21 does not require abandonment to be unintentional, it does provide a normative timeframe for reinstatement, whereas the US and European law do not. Any deviation from this period is considered in the mirror of Section 164 which is interpreted in light of the nature of the deadline to be extended and the type of proceeding before the Commissioner. This was detailed above, and will not be repeated. It is sufficient to note that one cannot rely on the inclusion or omission of a word in the Israel Law as the basis for its interpretation whilst ignoring the case-law.
It seems that the circumstances are such that the case was abandoned intentionally and can only be rectified if this was not legal. The request is refused.
IL 206845 to Biomarin: refusal to reinstate application, Deputy Commissioner Ms Jacqueline Bracha, 17 April 2018.
COMMENT
In extraordinary circumstances, long-dead applications have been reinstated. See for example IL 194015 to Natapov, Perstnev, Perstnev and Vilacer titled “the Insulating Material”. Here the patent had lapsed three years earlier, but had not published. The record is probably Israel Patent Number 139892 “INNER WORKINGS FOR A WATER TREATMENT UNIT” to Yigal Tsabri which was revived seven years after it lapsed.
I am frankly surprised by the audacity of the Applicants’ representative for trying to argue that this knowingly abandoned patent application could be revived more than 12 months after going abandoned and am pleased that the Deputy Commissioner came to the decision that it could not be.
Posted by Dr Michael Factor 
Alkermes Pharma Ireland LTD has an exclusive license from Novartis to manufacture a drug in accordance with IL 142896 and its divisional patent no. IL 179379 entitled “Multiparticulate Modified Release Composition”. The active ingredient is Methylphenidate and is commonly known as Retalin. It is used for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy.
Medice Arneimittel GmbH filed a request to cancel the relevant patents and the claim scope was narrowed in a preliminary action by Alkermes, but the cancellation actions were unsuccessful. Now Alkerermes has requested costs of $1,029,561.95 which comes to 3,626,118.18 Shekels costs.
I was contacted by a trainee patent attorney who wishes to attend one of the forthcoming IP conferences in Israel but is not sure which one is better value for money. The firm where she works are prepared to recognize her attendance as a day of work rather than a vacation, but are not prepared to pay for her participation.
The
The 
Nevertheless, on the salary of a trainee, particularly one with family commitments, both conferences are costly. A significant number of trainees are new immigrants that are self-not living with their parents. Those unluckily enough to be on a percentage of salary may not earn a minimum wage and I believe their ‘mentors’ should be struck off. But even those earning a reasonable fixed trainee salary may find that laying out 850 Shekels for a day of training lectures, is difficult to justify, despite the high quality lunch and coffee breaks and the possibility to pick up a couple of pieces of swag from exhibitors.
This does not mean that either conference is objectively expensive when considering the standard of the program and the costs involved in hosting such events in expensive hotels, the quality of the refreshments and the cost of such programs abroad. However, I can certainly see why someone paying for himself or herself may not be able to justify for both events.
Licensed In-House practitioners may well be able to get their companies to pick up the tab for them to attend both conferences, and unless swamped with urgent work, I can see many IP managers preferring to schmooze with colleagues and to attend lectures rather than sitting in their offices. I suspect the coffee break refreshments and lunches provided also compare well to the canteen food or lunch voucher allowance of most hi-tech companies.
IP boutiques are, of course, able to evaluate the relevance of the training for their different staff members, and will no-doubt consider this when deciding who to send to which conference.
The Best Practices in Intellectual Property conference hosted by Kim Lindy and the IPR is perhaps mis-named. Apart from one session on trade-secrets, the entire program is dedicated to patents and the conference is very much focused on practical aspects of patent management. The conference is particularly targeted at In-House counsel in industry and has much to interest independent patent attorneys in private practice, partners and attorneys at IP firms. However, it seems to have little of interest to those who earn their living managing trademark or copyright portfolios. Sadly in my opinion, it also does not address design law which is a rapidly changing field in Israel.
There will be little at the “Best Practices in Intellectual Property” conference to interest academics. However, the program is jam-packed with relevant sessions for prosecuting patents and managing patent portfolios which is what very many in-house IP managers do, and also is the bread-and-butter work of most patent attorneys in private practice.
The AIPPI conference titled “The Economics of Innovation” uses the term innovation very widely and is much broader in scope than the “Best Practices in Intellectual Property” conference In that features sessions on trade-secrets, design law, trademarks, Copyright, traditional knowledge, taxation of IP and Internet & Privacy. Many of the sessions look at the issue of overlapping types of protection.
Certainly patent attorneys, whether in-house or in private practice, should be familiar with the different types of protection available to be able to advise or at least refer clients. Patent Attorneys should also be aware of tax issues, at least broadly, to be able to refer their clients to accountants where appropriate to do so. There are very many large US firms registered in Delaware that conduct R&D in Israel. There are also many firms that are physically based in Israel, but decide to incorporate in the US for political reasons, and these include start-ups as well as larger firms. I have clients that have fairly small staff but are incorporated as an IP holding company that owns the patents, trademarks, copyrights and designs and a separate manufacturing company that licenses the IP assets. The tax issues are not something that a patent attorney deals with, but attorneys-in-law may practice IP and tax law, and in-house legal counsel may deal with IP and taxation. Apart from understanding how tax issues affect their own income and how various taxes can be legally avoided and what is considered illegal evasion and criminal, I believe that IP professionals not practicing tax law should nevertheless have a general grasp of the tax issues that face their clients to be able to advise them where they should seek guidance from a tax attorney, accountant of tax-consultant.
Israel Patent Application No. 176831 to Novartis is titled “COMPRESSED PHARMACEUTICAL TABLETS OR DIRECT COMPRESSION PHARMACEUTICAL TABLETS COMPRISING DPP-IV INHIBITOR CONTAINING PARTICLES AND PROCESSES FOR THEIR PREPARATION ” the patent application is a national phase of PCT/EP/2005/000400. It relates to a pharmaceutical used in the treatment for diabetes known as Vildagliptin (previously LAF237, trade names Galvus, Zomelis,) which is an oral anti-hyperglycemic agent (
Unipharm’s opposition to this evidence is that Professor Davis relied on test results from tests that he himself did not conduct, and they express wonderment that Novartis did not produce the drug developers to be cross-examined. In response, the Applicants claim that the disclosure process should be allowed in cases where it is proven that the documents in question are relative to the proceeding in general and to the point of contention between the parties, and in this instance the Opposer did not justify his request for disclosure of documents and did not explain how the disclosure would help clarify the question under debate.
In response, Unipharm claims that the Applicant’s expert, Professor Davis, did not merely testify that the document was included in the file wrapper of the European Patent Application, but also reached conclusions in his expert opinion that were based thereon. As far as anything connected to the scope of the disclosure, Unipharm focuses their request and asks to receive the documents relating to the experimentation with the particle distributions and efficacy of formulations made with the specific distributions.
In court proceedings in the United States there is wide discovery and the parties effectively go on fishing expeditions with trawlers and haul up everything and then have to wade through the bycatch. This is not the case in Israel. One can ask for specific documents, but have to justify the request. Thus I have used the term disclosure and not discovery.
I try to be factually accurate and helpful to my readership. However, occasionally mistakes happen. A couple of days ago I posted about the 
I’d like to think that the conference organizers follow my advice, and I do note that some of my criticisms of the first and second International Conferences have been addressed this time around, but I doubt that within a couple of days of my posting my criticism, the organizers would disinvite two such distinguished speakers. Nevertheless, they are not coming.
Instead the current program as advertised has a video greeting from Mr. Francis Guri [sic], WIPO president – a gimmick I enjoyed at a premiere cercle IP conference last year. Watching a VIP on-screen is not that exciting as in the flesh, and to be honest, I don’t think there is a major demand for autographs from WIPO presidents. (Indeed, when I was Guest of Honour at 
The opening session is instead being given by Judge (retired) Asher Grunis, President of the Supreme Court of Israel 2012 – 2015 on “Judge made law in the field of intellectual property”. Judge Gronis gave several IP decisions over his long and illustrious career, such as Toffiffee, Adidas, 
Judge Grunis’ talk is being followed by one by Mr. Aharon Aharon, CEO, Israel Innovation Authority. The title of Mr. Aharon Aharon’s talk is not published in the program, but it is clear that he has some influence over Israel govt. policy regarding promoting innovation.
