After losing at the Patent Office – see https://blog.ipfactor.co.il/2009/03/05/israel-patent-…n-for-cipralex/ and then again on appeal to the District Court -s ee https://blog.ipfactor.co.il/2009/08/06/lundbeck-loses-appeal-for-patent-term-extension-for-cipralex-in-jerusalem-district-court-and-requests-to-appeal-to-supreme-court-patent/ Lundbeck, represented by Adv. Richard Luthi, appealed to the Supreme Court who have affirmed the original ruling and the appeal.
The issue is whether S-citaloparm, the active ingredient and the left handed stereoantomer of an anti-depressive Cipralex including both the left handed stereoantomer and the right handed molecule can be considered a new material warranting patent term extension.
Under Israel Law, the requirement for patentability is novelty, inventive step and utility. For patent term extension, the patent must be for the first patent protecting a material.
The Commissioner of Patents ruled that the S-citaloparm was a patentable invention, but, due to the earlier patent for Cipralex, could not be considered the first patent as far as patent term extensions are concerned. On appeal, the decision was upheld. At this second opinion, Supreme Court Judge Edna Arbel refused to allow the Israel Pharma Organization represented by David Gilat to join as co-appelant or amicus brief, ruling that the issue in question was factual rather than legal – i.e. both sides accepted that first use of a new material was required, and the dissagreement was whether this is indeed a new material or not.
Arbel went on to accept Adi Levit’s argument on behalf of the opposer, Unipharm, that subsequent to the original appeal and before filing for a second appeal to the Supreme Court, the patent had lapsed, rendering the question academic.
She was critical of Lundbeck and their attorney, Luthie, for filing new arguments and contradicting statements made in the original request for extension. Although the case could be dismissed on a technicality that the patent had lapsed, she went on to point out that since the issue at stake was factual rather than legal, there was no reason to review the decision by the Commissioner of Patents, who had clearly weighed up the evidence and was the competent authority to do so.
She noted that the Dutch patent on whcih extension was granted had meanwhile been voided. Finally, she was critical of attempts to persuade the court that they should conform to US and European decisions on the issue, as the Israel court was independent, and the UK court had already dismissed the Israel decision as being based on a different legal system.
The other two judges on the panel accepted her analysis and the Appeal was dismissed, with NIS 30,00o awarded to Unipharm in costs, and a further NIS 10,000 to the industrial society.
Although with Adv. Tal Band representing the industrial manufacturers – i.e. the generic industry as a whole, backing Unipharm, it seems fair for Bareket of the RCIP group to support Lundbeck and Richard Luthi, Justice Arbel is correct. All generic manufacturers have an interest in a patent term not being extended as they can all then compete in a free market, so they are naturaly sides to the debate. The Israel Pharma Association were not a side and had no real interest, since the court is supposed to interpret and apply the Law, and lobbying shoudl be done at the Knesset, not at the court.
The decision is a correct one. There were no legal grounds for further appeal, merely financial ones. This is a case of evergreening.
Appeal to Supreme Court 5267/09 Lindbeck vs. Unuipharm, Association of Israel Industrialists (pharmaceuticals) with Pharma Israel – the umbrella group respresenting Drug Developers in Israel requesting to join or to file amicus brief.