UK: Synapse - Law For Life Sciences: Latest News - February 2016

Last Updated: 21 June 2016
Article by Taylor Wessing

Further cross-border declarations of non-infringement for pemetrexed product

There has been a further decision of Mr Justice Arnold in the long running dispute between Actavis and Eli Lilly relating to pemetrexed disodium. The decision concerns European Patent No 1 313 508 ("the Patent") for the use of pemetrexed disodium in combination with vitamin B12 or a pharmaceutical derivative thereof and optionally a folic protein binding agent. Last year, the Court of Appeal held that the claims of the Patent were restricted to pemetrexed disodium, and therefore dealings in Actavis' pemetrexed dipotassium product would not amount to direct infringement. However, the court also held that if Actavis' products were reconstituted and/or diluted in a sufficient quantity of saline, the resulting solution would fall within the claims of the Patent, because it contained both sodium ions and pemetrexed ions in a ratio of at least 2:1 -- an indirect infringement. Actavis then requested the Court of Appeal to remit for trial by the Patents Court the question of whether the supply of pemetrexed diacid would constitute indirect infringement of the Patent if marketed with instructions to dilute the product only with 5% dextrose solution instead of saline. Actavis' product is a liquid which does not require reconstitution, and the Summary of Product Characteristics (SmPC) specifies that it is only to be diluted with dextrose solution. Nonetheless, Lilly contended that it is foreseeable (and hence obvious) that the Actavis product will be diluted with saline by some customers (or at least, that Actavis have not proved that it is not foreseeable), although Lilly did not allege that Actavis are taking any steps to encourage the use of saline.

In his decision on this question, Arnold J has held that, at present, it is not foreseeable that the Actavis product will be diluted in saline. Accordingly, for the foreseeable future, the supply by Actavis of the Actavis product will not amount to an indirect infringement of the Patent. The judge added that there was no doubt whatsoever that Actavis have a real commercial interest in obtaining declarations of non-infringement and that granting declarations of non-infringement would serve a useful purpose, because it would make it clear that the supply of the Actavis product is lawful. Consequently, these declarations were ordered in respect of French, Spanish, Italian and UK designations of the Patent.

The decision

English court holds transgenic mice patents invalid

In Regeneron Pharmaceuticals Inc v Kymab Limited & Novo Nordisk A/S [2016] EWHC87 (Pat), Mr Justice Carr has dismissed Regeneron's claim for infringement of European Patent (UK) No 1,360,287 ("the 287 Patent") and a divisional of that patent, European Patent (UK) No 2,264,163 ("the 163 Patent"), and allowed Kymab's and Novo's counterclaim for revocation.

The patents both generally relate to transgenic mice that can be used as platforms for therapeutic antibody discovery. The judge found that all strains of the defendants' allegedly infringing Kymouse mice were or would be generated from a product within the scope of claims 5 and 6 of the 287 Patent. Furthermore, Kymouse mice strains having both modified IgH and IgK loci are within the scope of claim 1 of the 163 Patent. However, it was also held that all of the claims of the 287 and 163 Patents are invalid for insufficiency, on the basis that, at the priority date, the skilled person would not have been able to perform the invention over the whole area claimed in the patent without undue burden and without needing inventive skill.

The decision

Government to proceed with reforms to UK unjustified threats legislation

In April 2014, the Law Commission published a Report making 18 recommendations for reform to the unjustified threats provisions of UK law, including changes and clarifications to how these apply to patents. These reforms were accepted by the Government in principle in February 2015. The Law Commission then published a final report explaining the changes and a draft Intellectual Property (Unjustified Threats) Bill in October 2015. The Government has now accepted this report and is examining introducing the reforms via the special procedure which exists for Bills implementing uncontroversial Law Commission recommendations. Particular features of the draft Bill which are new to patents proceedings include:

  • a new two step test to determine whether a communication contains a "threat of infringement proceedings" (new section 70(1));
  • threats of infringement proceedings that are not 'express threats' are not actionable if contained in 'permitted communications' (defined in new section 70B);
  • A defence for 'professional advisers' who are acting on instructions and who identify their client (new section 70D).

The Law Commission Report and draft Bill

EU contracts study of SPC system

The European Union Directorate General for Internal Market, Industry, Entrepreneurship and SMEs is contracting a legal study on the supplementary protection certificates (SPC) system. The purpose of the study is to establish whether the current SPC rules "need to be recalibrated given identified limitations" – that is, whether it is fit for purpose.

The study comes as the EU Commission is considering how to adapt the SPC system to the new Unitary Patent.

The tendering document for the study is open until 4 February and can be found here:

Contract notice

German UPC ratification

It has been reported that the formal process by which Germany will ratify the UPC has begun. The ratification is expected to follow towards the end of this year. German ratification is mandatory for the UPC to come into force, together with ratifications by France and the UK. The UK ratification is currently outstanding.

UPC Preparatory Committee agrees Rules on Mediation

The Preparatory Committee has agreed a set of Rules on Mediation for use in the Patent Mediation and Arbitration Centre that will accompany the new UPC system. The mediation service is intended to offer support in the settlement of disputes relating to European patents and Unitary Patents. Any settlement under these Rules will have the binding effect of a contract rather than a ruling of the court. The Rules are described in the Committee press release as subject to further 'legal scrubbing' and possible work necessary to align them with other rules, but have been released in the interests of transparency.

The Rules

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