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Thursday, 12 December 2013

Patent term extension in Europe: short notes on three big rulings

The Court of Justice of the European Union
considers whether patents, like cats, should
have the benefit of nine lives ...
Some years ago this Kat discovered that not all readers of this weblog were as excited by the subtle nuances of pharmaceutical and agrochemical patent term extension in the European Union and beyond as he was. It was thus a great relief when The SPC Blog was set up, so that readers of this blog could read about their favourite IP topics without being burdened by supplementary protection certificates (SPCs), while SPC enthusiasts could focus on their pet niche without being disturbed by distractions such as trade marks, copyright, designs and most of the rest of patent law.

Be that as it may, today has been a big day for SPCs, what with the Court of Justice of the European Union delivering not one, not two, but three whole rulings on references for preliminary rulings on the extension of patent term.  All three are posted on The SPC Blog which will, in the fullness of time, also be posting some expert comment on them.  In the meantime, here they are in outline:
  • Case C‑443/12Actavis Group PTC EHF, Actavis UK Ltd v Sanofi, Sanofi Pharma Bristol-Myers Squibb SNC intervening, noted on The SPC Blog here. In short, where the patent holder has already obtained an SPC on the basis of a patent protecting an innovative active ingredient and a marketing authorisation for a medicinal product containing that ingredient as the single active ingredient, and that SPC entitles him to oppose the use of that active ingredient, either alone or in combination with other active ingredients, Article 3(c) of the SPC Regulation must be interpreted as precluding that patent holder from obtaining –- on the basis of that same patent but a subsequent marketing authorisation for a different medicinal product containing that active ingredient in conjunction with another active ingredient which is not protected as such by the patent –- a second supplementary protection certificate relating to that combination of active ingredients [nb this is a corrected version of an earlier post].
  • Case C‑493/12Eli Lilly and Company Ltd v Human Genome Sciences Inc., noted on The SPC Blog here. At base, for an active ingredient to be regarded as ‘protected by a basic patent in force’ within the meaning of the SPC Regulation, that active ingredient needn't be identified in the claims of the patent by a structural formula -- a functional formula will do just as well, so long as you can conclude, on the basis of those claims, that they relate "implicitly but necessarily and specifically" [these words tempt further references to the CJEU, thinks Merpel] to the active ingredient in question.
  • Case C‑484/12Georgetown University v Octrooicentrum Nederlandnoted on The SPC Blog here Essentially, where, on the basis of a basic patent and a marketing authorisation for a medicinal product consisting of a combination of several active ingredients, a patent holder has already obtained an SPC for that combination of active ingredients, protected by that patent, Article 3(c) of the SPC Regulation doesn't stop him also obtaining an SPC for another of the active ingredients which is also covered by that patent.
So now you know!


Anonymous said...

Sorry to be a bore, and so quickly too(!), but C-443/12 wasn't decided on that point. The CJ-EU declined to answer that question and refused the SPC under Article 3(c).

Jeremy said...

Anonymous: you're quite right -- I was reading the arguments ...

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