19 May 2014

UK Patent Court grants Declaration of Non-Infringement of a European Patent across multiple European

In a significant judgment handed down on 15 May 2014, the UK Patent Court granted a declaration of non-infringement in respect of the UK, French, Italian and Spanish designations of a European Patent.

Actavis was seeking a declaration that their proposed launch of a generic pemetrexed product containing pemetrexed diacid, pemetrexed dipotassium or pemetrexed ditromethamine, to compete with Lilly’s cancer treatment product Alimta, would not infringe Lilly’s European Patent 1313508 covering pemetrexed disodium in combination with vitamin B12 and optionally a folic binding protein. Actavis had indicated that they would seek marketing approval for their competing product by reference to Alimta and were seeking to clear the path of any obstacles that would prevent this.

Claim 1 of the patent was directed to

Use of pemetrexed disodium in the manufacture of a medicament for use in combination therapy for inhibiting tumor growth in mammals wherein said medicament is to be administered in combination with vitamin B12 or a pharmaceutical derivative thereof, said pharmaceutical derivative of vitamin B12 being hydroxocobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-chlorocobalamin perchlorate, azidocobalamin, chlorocobalamin or cobalamin.

Since the claims refer to pemetrexed disodium, the issue was not one of literal infringement and indeed both parties acknowledged that the product would not fall within the scope of the claims based on a literal interpretation of the claims. The issue was whether there would be infringement based upon The Protocol for Interpretation of Article 69 of the EPC. After a detailed review of claim construction in the UK,  Mr Justice Arnold held that none of pemetrexed diacid, pemetrexed dipotassium or pemetrexed ditromethamine fell within the scope of the claims of the UK part of the patent. The judge then analysed the approaches taken in all of the other jurisdictions using expert witnesses from each of France, Spain and Italy and came to the same conclusion in respect of the corresponding European designations. Interestingly, the judge also referred to the prosecution history of the patent at the European Patent Office in coming to his decision and indicated that there was no good reason why the Court should not refer to the prosecution history in determining the scope of a patent claim as that is what third parties generally do in a real world situation. While the prosecution history can be used as an aid to construction in the UK courts it is generally discouraged.  However, Arnold J stated that consideration of the prosecution file by the court would ensure that patentees did not accept narrower claims during prosecution and try to argue for a broader claim construction in any subsequent infringement proceedings.

The decision is at odds with a judgment dated 3 April 2014 by the Dusseldorf Regional Court. In that decision it was found the use of pemetrexed dipotassium would indeed infringe claim 1 of the German designation of the patent. Arnold J recognised this conflict but considered the approach by the Dusseldorf Court  to be an incorrect application of the Protocol and it was not permissible to treat the claims as mere guidelines.

The case is significant in a number of respects. Firstly, it confirms that UK Courts have jurisdiction to grant cross-border declarations of non-infringement not only for the UK designation but also in respect of the non-UK designations as well. This will offer cost savings to parties wishing to clear the path before they launch products in multiple European jurisdictions. Secondly, in arriving at his decision the judge reviewed the prosecution history of the patent. Lilly, during the prosecution of the patent had deliberately limited the claim to pemetrexed disodium. Therefore, according to the judge

“[c]onstruing the claim as extending to (at least) any form of pemetrexed which is pharmaceutically acceptable and sufficiently soluble would not provide a reasonable degree of certainty for third parties. Any other conclusion would fail to give effect to the Protocol and would be tantamount to treating the claims as a mere guideline”.

Finally, and as Arnold J was keen to point out early on in the judgment, the case was heard in a matter of four days with cross examination of all five witnesses being completed in just over one court day.