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

Last Updated: 14 June 2016
Article by Taylor Wessing

Adalimumab declaratory relief action allowed to proceed

Fujifilm Kyowa Biologics Co., Ltd (FKB) v Abbvie Biotechnology Ltd concerns patents and divisionals for every other week, single dose, subcutaneous injections of adalimumab that are awaiting grant. In order to ensure that it can market its own product, a biosimilar to adalimumab, despite these patents, FKB has sought a declaration that its own product is anticipated or obvious. The purpose of the declaration is to provide a Gillette defence which would render any claim that is held to cover the FKB product also novel or obvious. Abbvie applied to have this claim struck out. However, the court has dismissed this application, finding that there is a realistic prospect that the trial judge will exercise his or her discretion to grant the relief sought.

The decision

Account of profits in convoyed goods cases

The English decision in Design & Display Limited v OOO Abbott & Anor [2016] EWCA Civ 95 is a relatively rare occasion on which the Court of Appeal addresses accounts of profits in convoyed goods cases. The case concerned a patent for snap-in inserts made from a resilient metal, which are used on display panels for shops. Birss J held the patent to be valid, and infringed by Design & Display. The claimants elected for an account of profits, rather than damages, and the account was heard in the Intellectual Property Enterprise Court (IPEC). Two points arose on appeal to the Court of Appeal from IPEC:

  • are Design & Display liable for the whole of the profits made on the sale of panels sold together with the infringing inserts as incorporated parts (given that it is the inserts that are the patented invention and not the panels)?
  • are Design & Display entitled to set off any part of their general overheads against the gross profit for which they are accountable?

On issue 1, on the facts, customers specified panels, and were indifferent about the inserts (provided that some form of insert was included). The Court of Appeal held that the profits made on the panels would therefore have to be apportioned for the element contributed by the inserts. This was to be contrasted with a case in which the patented item was an essential ingredient in the creation of the defendant's whole product, in which circumstances account would be made of the whole profit (panels incorporated with inserts).

On issue 2, the Court of Appeal said the question to ask is: if the defendant had not infringed the patent would he have anyway carried on a non-infringing business which would have been sustained by the overheads in fact used to sustain the infringement? In other words, a defendant may not simply allocate a proportion of its general overheads to an infringing activity in order to reduce the profit payment to the claimant. The bottom, the court said, is line whether (a) the overheads would have been incurred anyway even if the infringement had not occurred and (b) the sale of infringing products would not have been replaced by sale of non-infringing products.

The Court of Appeal held, in this case, that a deduction is permissible. The case has been remitted to IPEC for the apportionment of profits.

The decision

Stay of English proceedings refused pending EPO Appeal

Mrs Justice Rose has refused to stay validity and infringement proceedings between Eli Lilly and Janssen. The judge said that it may be that the EPO proceedings do produce a clear determination in Eli Lilly's favour (revoking the claims of Janssen's patent EP 2 305 282, which relates to Solanezumab) rendering the English proceedings redundant. This carries the risk that some costs in pursuing the English proceedings will be wasted until then. However the judge reasoned that there is a chance that even though the EPO proceedings are resolved before the English proceedings, they will not be determinative of all the issues between the parties. In particular, the infringement issues are important and it is better that the English proceedings, which are the only forum in which the infringement issue can be decided, continue and neither party was attracted by the idea of the English proceedings splitting out infringement from invalidity.

The decision

Double-patenting of Unitary Patents and German national patents proposed

The German Ministry of Justice and Consumer Protection (BMJV) has published a draft Unified Patent Court ratification instrument and draft amendments. According to the draft instrument, in its current form, it would be possible to double patent in Germany in the new system – that is, hold a duplicate German national patent and a Unitary Patent for the same invention. The draft amendments recognise the burden on a defendant caused by the possibility of double patenting by providing the possibility to raise an "objection of dual claim". This means that, if an action regarding a Unitary Patent is pending before the UPC, has been finally adjudicated by the UPC, or is lodged during infringement proceedings concerning the national patent for the same invention, the German court will dismiss as inadmissible the action based on the national patent. This provision does not apply to interim proceedings.

However, there is no similar dual claim provision which deals with nullity proceedings. The effect therefore appears to be that revocation of a Unitary Patent in the UPC would not prevent the need to additionally revoke the national patent in the German Federal Patent Court.

The UK Government's position on implementation of the UPC Agreement into UK law is that double-patenting of Unitary Patents and GB national patents should be prohibited. This was on the basis that it would place an unfair burden on third parties.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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