In February 2009, the Registrar of Patents accepted an opposition filed by Unipharmand the union of the local generic companies (including Teva), and refused to extend the term of a patent for S-citaloparm, the active ingredient the left handed stereoantomer of an anti-depressive; Cipralex.
The ruling has now been affirmed on appeal.
Under Israeli law, a patent for a pharmaceutical substance may be extended beyond the 20 year from filing for up to 5 additional years if it meets certain requirements. Under Section 64d(3) the extension is only available for the first pharmaceutical preparation registered with the Israeli with the Ministry of Health. However, in this case, the patentee owned a previous registered pharmaceutical preparation coveringthe racaemic mixture of left and right handed molecules of citaloparm. Based on this, the Registrar ruled that the active ingredient in the present case was ‘known’, and that the isolated left handed molecule could not be considereda new material, and denied the motion for patent term extension.
Lundbeckthen filed an appeal with the Jerusalem District Court, contendingthat section 64d(3) of the Patent Act should be interpreted in accordance with the Pharmacists’ Ordinance, whereby the pharmaceutical preparation which consists solely of S-citaloparm was treated as a “new” substance over the old registered preparation consisting of a mixture containing it. The District Courtin Appeal 223/99 Lundbeck v. Unipharm et al. rejected this argument. In a detailed overview of the purposes of these provisions in the Patent Act, the Court clarified that they should be interpreted under the principles set forth in the Patent Act, and not those of the Pharmacists’ Ordinance. The courtruled that this was not the first registered drug including the active ingredient and the appealwas denied. A motion for leave to appeal to the Israeli Supreme Court has been filed.
Apparently, the lobbying group ‘Pharma Israel’, which represents the ethical pharmaceutical companies have petitioned the Supreme Court to file an Amicus Brief in the proceedings.
Personally, I believe that the originalruling, upheld on appeal was correct. The 2004 ammendment to the Patent Term Extension clauses of the Patent Law show that the Knesset intended to limit patent term extensions to the maximum period allowed elsewhere, rejecting Acting Commissioner Israel Axelrod’s interpretation of the badly written first amendment. In this case, I do not think the new material is a first patent for the drug from a patent law perspective, and believe that this is the correct standard to apply. Inote, however, that the Supreme Court has a long and established history of reaching IP related decisions that I disagree with, including Tsrori, A.Sh.I.R. and Rav Bareakh II, so I can’t tell how this will go.
I think that there is a problem inthat the Supreme Justices in Israel tend to know very little about Patent Law, which is a specialist and technical area, and the considerations used to appoint high court judges are not those likely to produce good, impartial case law based on objective criteria. I would be surprised if this decision is overturned, but who knows? certainly, I think there is a good case for a specialist IP Court with expert judges.