Case No. S2107_006 ¦ Hearing of 9 October 2017
It’s not the first time that the parties litigate about this SPC. Nullity proceedings are co-pending; see this Blog here and here. A major issue at stake now is the alleged infringement of the SPC. The FPC had granted ex parte interim injunctive relief; see this Blog here. Note, however, that the SPC concerns (emphasis added):
tenofovir disoproxilfumarat + emtricitabin
Defendant’s attacked embodiment instead comprises tenofovir disoproxil phosphate.
Now, is that still ‘the product’ in the sense of Art. 140d PatA?
Plaintiff essentially argues that an SPC would always extend to all salts of (a component of) a product, irrespective of its wording. On the contrary, defendant argues that this is a misunderstanding of the ‘Farmitalia’ decision of the ECJ (C-392/97): In that case, the market authorisation related to a specific salt, but the ECJ had allowed the registration of an SPC also for salts and esters. It had been held in ¶27 that
[…] where an active ingredient in the form of a salt is referred to in the marketing authorisation concerned and is protected by a basic patent in force, the certificate is capable of covering the active ingredient as such and also its various derived forms such as salts and esters, as medicinal products, in so far as they are covered by the protection of the basic patent.
The ECJ’s judgment only concerned the requirements for grant of an SPC, but not the scope of protection. The FPC will now have to decide on the scope of an SPC directed to a combination product wherein a first component is identified as a specifically named salt (fumarate) which is not used in the attacked product (using a phosphate instead); and wherein the second component (emtricitabin) is not mentioned at all in the basic patent.
The President noted that no expert opinion of the judge-rapporteur will be established. The parties did not enter into settlement discussions.
Reported by Martin WILMING
Header image reproduced with kind permission and copyright of the Swiss Federal Administrative Court (St. Gallen) where the hearings of the FPC take place.
Case No. O2107_001 ¦ Hearing of 9 October 2017
Gilead Sciences Inc. ./. Mepha Pharma AG
Panel of Judges:
- Dr. Dieter BRÄNDLE
- Dr. Tobias BREMI
- Marco ZARDI
- Susanne ANDERHALDEN
Representative(s) of Plaintiff:
- Dr. Simon HOLZER (MLL)
- Dr. Kilian SCHÄRLI (MLL)
- Dr. Andreas SCHÖLLHORN (LS Partner), assisting in patent matters
Representative(s) of Defendant:
- Andrea MONDINI (TIMES Attorneys)
- Dr. Andreas WELCH (Hepp Wenger Ryffel), assisting in patent matters
THE BASIC PATENT
COURT INFORMATION ABOUT THE HEARING
BE ON THE KNOW