Israel Patent Number 94634, Extending and Shortening Patent Term Extensions

Rapamune Sirolimus

Under Section 64 of the Law, basic pharmaceutical patents may be extended for up to five years past the 20 years standard maximum term, in order that the drug developer is able to market the drug exclusively for a period of up to nine years. Since the Patent Term extension was first introduced, granting patent term extensions, but enabling generic competitors to try to synthesize but not stockpile the patented drug, the Law has been amended a couple of times. The first time was the seventh amendment, designed to allow Israel generics to compete with generic companies in other jurisdictions by reducing the term of patent term extension in Israel, to the shortest term allowed in another jurisdiction having patent term extensions (Bolar Countries). Under US pressure that the Israel Law was too generous to generic companies, the Law was amended again in the eleventh amendment in 2014.

Sir Roy Calne filed Israel Patent Number 94634 for COMPOSITIONS INHIBITING TRANSPLANT REJECTION IN MAMMALS USING RAPAMYCIN AND DERIVATIVES AND A CHEMOTHERAPEUTIC AGENT in June 1990, claiming priority from a case filed in June 1989. The patent issued in July 1996.

In June 2001, the applicants requested an patent term extension and in September 2002, a sole license was granted to Wyeth.

The drug was registered in January 2001 and an extension was granted in January 2004. The extension covers the drug RAPAMUNE and the active ingredient SIROLIMUS. The drug term extension was granted on the basis of the corresponding US patent no. US 5,100,899 whose product received marketing approval back in September 1999.

In the request for patent term extension, the applicant reserved the right to change the basic patent they were basing the application on, if a different patent of a Bolar country should lapse earlier.

the patent term extension issued on 25 January 2004 and the applicant was informed that it would publish in the January 2004 journal. No oppositions were filed against this extension. In the same letter, the Examiner requested that the applicant update regarding any patent term extension of the basic patent in the US, and any other patent extensions.

In November 2004, the applicant responded that the US patent application was still pending and that he required a time extension to respond to the Examiner. Furthermore, the applicant noted that it was examining the possibility of basing the patent term on the corresponding Australian patent.  After further correspondence, it transpired that the Australian patent term was extended until 5 June 2015 and the applicant therefore requested a full five-year extension in Israel based on the Australian patent.

After the 7th amendment of 2006, to the Patent Law, the applicants were required to detail all patent term extensions and to provide copies of the documentation regarding the license to sell the drugs and the patent term extensions. Neither the applicants or their representatives responded to this request.

In January 2013, the Association of Israeli Pharmacists filed a request to cancel the extension order, which was accompanied by an affidavit from Dr Ron Tomer (a director of Unipharm), who is a member of the committee of the chemical and pharmaceutical division of the Association of Israeli Pharmacists.

In June 2013, Wyeth responded to the cancellation request, submitting an affidavit of Dr Alvin David Joran, the legal adviser of Pfizer Inc. who had purchased Wyeth in 2013. The Association of Israeli Pharmacists filed a counter argument that included an Opinion by Elizabeth J Holland, an attorney at Kenyon and Kenyon, and also a further affidavit of Dr Ron Tomer. Pfizer decided not to cross-examine  Elizabeth J Holland on her affidavit but both Dr Alvin David Joran and Dr Ron Tomer were cross-examined in a hearing on 27 May 2013.

The Association of Israeli Pharmacists maintain that under the 7th Amendment, the longest available extension should be no more than 7 July 2013. Furthermore, this was the longest period available before the 7th Amendment, i.e. based on US 5,100,899. Furthermore, there is a specific and explicit requirement for equitable behaviour in Section 64B(i) and the applicants failure to respond tot he requirement to detail all patent term extensions and to provide copies of the documentation regarding the license to sell the drugs and the patent term extensions was itself grounds to deny any further extension.

The patentee argued that the interim arrangement of the 7th amendment damaged their property rights and was thus illegal. The patent term extension was legally obtained and the patentee followed their legal advisors. Their whole business plan was based on the patent term extension that was granted.

The Ruling

The interim period is covered by Section 22 of the 7th amendment:

“(a) The rulings of the Law, including Section 164a and Section 18 apply to pending requests for extension periods that were applied for before this law comes into effect, providing that the basic patent has not yet lapsed.

(b) Despite that written in part(a) above, the period of patent term extensions that issued prior to this amendment entering into effect, will not suffer due to them not fulfilling the constraints of parts (5) and (6) of Section 64(d) of the main Law, as it appears in part 3 of this law.

On the face of it, the interim period applies to the present case, where the patent term extension was granted on 5 June 2005, and the patent would have lapsed on 6 june 2010, which is after the amendment entered into force in January 2006. That said, the patentees claim that this is illegal in that there property rights are retroactively cancelled.

The Commissioner noted that this was not the first time that the validity of the various amendments to the patent term extension of the Patent Law has been challenged. See for example 70390 Wyeth vs. Dexcel LTD (ruling by then Deputy Commissioner Axelrod), 83148 Roche Diagnostics GmbH (ruling by then Commissioner, Dr Meir Noam). In those rulings the interim arrangement and its legality in the face of Section 8 of the 1980 Basic Law “Human Honour and Freedom”.  In those cases, it was ruled that the interim arrangement was legal and did not contravene the property rights enshrined in the Basic Law.

Without entering the basic issue of retrospective legislation, it is clear that the interim arrangement includes balances. In Wyeth, Axelrod summarizes “in all cases where there is a point in time that legislation comes into effect, there will always be parties that find themselves on the right and wrong sides of this time period.”

Similarly in Roche, Dr Noam ruled that the entire edifice of Intellectual Property is built on balances between competing interests, and the legislators are allowed to periodically change the point of balance. This is still the case if the balance is to address the disadvantage of the Israel generic drug industry. Furthermore, he went on to rule that interim periods are sometimes to address discrimination against one party or another, and sometimes simply to enable a smooth transition from one regime to another. Although the interim period has to be constitutional, judges should minimize their interference with legislation. (3734/11 Dodian et al.. vs State of Israel).

The current Commissioner, Asa Kling could not see justification in deviating from his predecessors regarding their positions concerning the interim period. He also noted that this wasn’t an issue of the interim period at all, but of the whole amendment, which moved the point of balance in favour of the generic industries.  Since the court had accepted the legality of the amendment in Lundbeck I and Lundbeck II, Novartis and Neurim he considered the issue moot. It is for the legislative body to determine the correct balance between competing interests, and he should be very careful before encroaching on that power. Particularly concerning the economy, one should be particularly circumspect. It is not for the courts to determine economic policy, determine economci preferences or to change internal balances. see 4769/95 Menachem vs. Ministry of Transport and 3145/99 Bank of Israel vs. Hazan.

The Commissioner noted that the amendment was not being challenged, implicitly accepting that the balance struck was fair. Rather, the issue was only that of changing the period. Anyway, the Supreme Court has noted that adversely affecting predicted sales was not to be considered as detrimentally affecting property rights, and Joran’s affidavit was insufficient to base a counter-claim.

The Commissioner also noted that the amendment itself was amended again in Amendment 11 of 2014, although this does not materially affect the issue.

Section 64(9)a states that the Extension period will remain in force, subject to Section 64(10), for a period comparable to the minimum period of any extension granted to the basic patent in a country having patent term extensions. Section 64(10) states that despite Section 64(9), (3) the patent term extension will lapse no later than the period under which the first patent term extension lapses in on a recognized country.

There is no argument that the US patent was extended for 1492 days and lapsed on 7 July 2013. This was the first patent to lapse and is the shortest period of any extension allowed.

Both Holland and Joran claimed that there was also an additional six months pediatric exclusivity period in the US . The Commissioner rejected this claim noting that Section 64(10)3 relates to the patent term extension and does not relate to other exclusive rights. This interpretation is in accordance with the ruling concerning Kirin-Amgen, Inc. 110669.

As the request for cancelling the further extension was accepted, the claims concerning the equitable behaviour of the patentee were considered moot.

In light of the above, Commissioner Asa Kling ruled that the patent in question will lapse in July 2013 and notice of this will issue in the July 2014 journal.

Israel Patent Number 94634, The Association of Israeli Pharmacists vs. Sir Roy Calne  and Wyeth, Ruling Asa Kling 13, July 2014.

 

 

 

 

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