Lundbeck —
Cipralex
Patent No. 90465 · patent term extension proceedings
Unipharm and the Manufacturers Association opposed Lundbeck’s request to extend the term of the patent covering S-citalopram, the active ingredient in Cipralex.
Which marketing authorization counts as the first registration for patent-term extension purposes?
The Registrar considered whether the earlier registration of Cipramil, a racemic mixture containing both S- and R-citalopram, constituted the first registration of S-citalopram in Israel.
The dispute concerned the statutory conditions governing eligibility for a patent-term extension in the pharmaceutical field.
The request for a patent-term extension was rejected.
On 3 February 2009, the Patent Registrar rejected Lundbeck’s request. Lundbeck appealed to the Jerusalem District Court; the appeal was dismissed on 25 May 2009. A further application for leave to appeal was dismissed by the Supreme Court on 15 March 2010. The appellate rulings left intact the conclusion that an earlier registration of a medicinal product containing the same active substance can prevent a later product from qualifying as the first registration for patent-term-extension purposes, even where the active substance appears in a different form or composition.