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EPO – European patent for Raltegravir revoked

12 Oct 2017

EPO, Technical Board of Appeal 3.3.01, T 1150/15, decision of October 11, 2017 – Merck & Co., Inc. v. SHIONOGI & CO., LTD

The grant of a compulsory license under § 24 of the German Patent Act was a legal instrument of hardly any relevance over many decades. Only once, the Federal Patent Court (BPatG) granted a compulsory license, a decision which was set aside on appeal by the Federal Court of Justice (BGH) in in its decision Interferon Gamma (GRUR 1996, 190). A compulsory license was never granted in preliminary proceedings.

In 2002, Merck and Shionogi filed European patent applications for integrase inhibitors. These antiviral agents are used in the treatment of AIDS. Both competitors produce pharmaceuticals comprising such agents. Shionogi’s patent EP 1 422 218 was granted in 2007. Merck’s product Isentress, on the market since 2007, contains the pharmaceutically active substance Raltegravir. After unsuccessful license negotiations, Shionogi filed an infringement action at the Düsseldorf Regional Court in 2015. In January 2016, Merck filed an action for the grant of a compulsory license at the BPatG. Shionogi objected and Merck requested to proceed in preliminary proceedings. On this request, the BPatG granted the license in its decision Isentress (GRUR 2017, 373). On appeal, the BGH in its decision Raltegravir (GRUR 2017, 1017) confirmed the decision under review.

After grant, Merck had opposed Shionogi’s European patent. In 2015, the Opposition Division decided that the patent as amended was allowable. In particular, the Opposition Division concluded that limitations in the formula for Raltegravir introduced in Claim 1 during examination did not add subject-matter. The Patents Court came to the same conclusion in its decision Merck Sharp and Dohme v Shionogi, [2016] EWHC 2989 (Pat). However, in these proceedings the patent was held invalid for insufficiency and lack of inventive step, see post of December 21st, 2016.
The contested limitations concerned definitions of the substituents, a selection from a list and restrictions by deleting alternatives. The Board disagreed with the first instance and, in the result, followed the argumentation of the Opponent that the person skilled in the art could not derive directly and unambiguously, using common general knowledge, the formula for Raltegravir as defined in Claim 1 from the application as filed.

Notwithstanding the revocation of the patent, the decision of the BGH will remain a landmark decision since it contains detailed considerations on the formal requirements for requesting a compulsory license and on the assessment of the necessary public interest. The reasoned decision of the Board of Appeal will be available from the electronic file of the patent in due course. It may be expected to give further advice how to apply the concept of disclosure in Article 83 EPC which is not only the key for interpreting the allowability of amendments but also for examining novelty and the validity of a priority.

Read the decision of the BGH – Raltegravir here.
Reported by Dr. Rudolf Teschemacher