Sandoz B.V. and Hexal AG v. Bayer Schering Pharma Aktiengesellschaft, District Court The Hague, The Netherlands, 19 June 2013, Case No. C/09/413756 / HA ZA 12-255
Sandoz sought to invalidate Bayer’s patent regarding a method for manufacturing Drospirenon (a birth control drug) and intermediate products thereof. Opposition proceedings were lodged against the patent and the TBOA had upheld its claims in an amended form. Sandoz argued that the amended claims were invalid as a result of added matter. A step was added to the method claim that according to Sandoz had only been disclosed in close combination with other steps in the application as filed. Isolating it was thus deemed to result in an intermediate generalization. Sandoz furthermore held that in the amended claims, an allegedly essential step had been deleted.
The Court disagreed on both counts, and inter alia on this ground held the patent to be valid. Interestingly, the COurt also dismissed Sandoz’ appeal on the doctrine of “misuse of rights”. Apparently, Bayer had amended its claims to cover the manufacturing process of Sandoz’ API supplier, only after it had learned of a patent application covering that process filed by that supplier. The Court held that such an appeal on the doctrine of misuse of rights is doomed to fail in a case where a claim amendment does not result in added matter. After all, the Court held, Article 123(2) EPC was specifically intended to protect the legal certainty and interests of third parties.
Read the decision (in Dutch) here.
Head note: Geert Theuws