F. Hoffmann-La Roche AG and Genentech Inc. v. Mundipharma Pharmaceuticals B.V., Judge in interlocutory proceedings, District Court The Hague, The Netherlands, 20 February 2019, ECLI:NL:RBDHA:2019:1486

Preliminary injunction proceedings re biosimilar.

Hoffmann-La Roche and Genentech both are part of the Roche group. Genentech developed Herceptin® for the treatment of breast cancer, with the anti-HER2 antibody trastuzumab as active ingredient. Genentech holds European patent EP 1 308 455 B9 (hereafter ‘EP 455’ or ‘the Patent’) for “A composition comprising anti-HER2 antibodies”. Hoffman-La Roche is exclusive licensee under EP 455.

Mundipharma in spring 2018 added Herzuma® to the so-called ‘G-standaard’. The G-Standaard is a database comprising ordering information on products that are available with wholesalers and pharmacists in the Netherlands. Hofmann – La Roche now seeks to obtain a preliminary injunction in the Netherlands alleging that Herzuma® infringes the Patent.

The Judge states that even though Herzuma® is biosimilar to Herceptin®, this does not necessarily mean that both substances are identical. Mundipharma argues that Herzuma® does not infringe, as the amount of acidic variants of trastuzumab therein is not less than about 25% as required by Claim 1. The Judge follows Mundipharma.

Parties agree that the amount of acidic variants in Herzuma is around 33%. By not defining the measuring method in the claims, the man skilled in the art will understand that the percentage mentioned in the claim is absolute. This is confirmed by the description. A reasonable protection for the patentee will not help Hoffman – La Roche as the claims have an absolute character and were willingly drafted that way.

A copy of the judgment (in Dutch) can be read here.