The Advocate General Jàn Mazák today delivered his opinion in the AstraZeneca case. AstraZeneca (AstraZeneca AB and AstraZeneca plc) had appealed the judgment from the General Court of the European Union of July 2010 where the European Commission's fine for i.a. abusing the patent system was upheld, although it was reduced to 52,5 mill EURO. The Advocate General's opinion is in support of the former court decision. The opinion of the Advocate General is not binding on the Court of Justice, which will decide on the case later.
The case started with a complaint in 1999 from Generics (UK) Ltd and Scandinavian Pharmaceuticals Generics AB to the commission. The generics companies alleged that AstraZeneca was preventing them from introducing generic versions of omeprazole on the market in several European countries. The complaint resulted in the 60 million Euro fine six years later. The basis for the fine was twofold.
First, the Commission had found, and the General Court agreed, that when applying for Supplementary Protection Certificates for their product Losec (omeprazole), AstraZeneca had in some countries given a wrong date as the date of the first marketing authorization in the EEA. This resulted in SPC of a longer duration being obtained than would otherwise have been the case. The Commission and the General Court did not consider it a mitigating circumstance that the rules regarding which authorization to use were unclear.
The other basis for the fine was that AstraZeneca chose to deregister its old product Losec capsules, just before it went off patent, and introduced a new omeprazole product, Losec MUPS, in some countries. Such deregistration made it more difficult for competitors to obtain marketing authorizations for their products.
The opinion of the Advocate General can be found here.
About the authors:
Inga Kaasen is an attorney-at-law and partner at the Norwegian law firm Grette. She also holds a PhD. in biotechnology. She is the leader of Grette's Life Sciences team, and has extensive experience with patent disputes, pharmaceutical law, IP transactions and R&D agreements.
Håkon Austdal is an associate at the Norwegian law firm Grette. He also holds a Bachelor of Pharmacy. He is a member of Grette's Life Sciences team, working with patent disputes and pharmaceutical law.
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