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Teva Pharma BV & Anor v Amgen, Inc & Anor [2013] EWHC 3711 (Pat)

The High Court has refused to remove from patent proceedings the original owner of the patent in suit (which had assigned the UK designation of the patent, but no other European equivalent patent).

European Patent No. 1 482 046 ("046") and European Patent No. 2 345 724 (“724”) are both part of a complicated family of European patents and patent applications, all of which claim the same priority from a US Patent Application. The claims of 046 are similar, albeit not identical, to those of 724.
Prior to 13 August 2013, all of the patents and applications in this family, and their counterparts worldwide, were owned by Amgen, Inc. (“AI”).

The UK designation of 046 ("046 (UK)") lapsed on 31 July 2013 because the renewal fee had not been paid by AI. On 13 August 2013 AI assigned 724 to Amgen Manufacturing Ltd ("AML"), a company incorporated in Bermuda wholly-owned by AI. On 14 August 2013 AI applied for a preliminary injunction against Teva in Germany for threatened infringement of the German designation of 046 ("046 (DE)").
On 19 September 2013 Teva brought a claim against AI for revocation of the UK designation of 724 (“724 (UK)”) ("the Revocation Claim").

On 7 October 2013 Teva brought a claim against AI for a declaration that any Supplementary Protection Certificate based on 724 (UK) would not be valid, either because 724 (UK) was itself invalid, or because lipegfilgrastim does not fall within the scope of 724 (UK) or because the grant of a SPC would be contrary to Articles 3(a) or 3(b) of European Parliament and Council Regulation 469/2009/EC of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) ("the SPC Regulation") ("the SPC Claim").

On 16 October 2013 Amgen's solicitors wrote to Teva's solicitors informing them about the assignment of 724. On 6 November 2013 Teva brought a claim against AI and AML for a declaration that Teva would not infringe 724 (UK) by dealings in a product called Lonquex, the active ingredient in which is lipegfilgrastim ("the DNI Claim").

When the three abovementioned claims were brought, AI was the registered proprietor of 724 (UK), although AI had assigned 724 to AML. At the time of Mr Justice Arnold’s judgment, AML had become the registered proprietor of 724 (UK).

On 4 November 2013 Amgen applied for orders that AML be substituted for AI in both the Revocation Claim and the SPC Claim. It was later agreed that the fate of AI in the DNI Claim would follow the court’s decision in relation to the other two claims.

Mr Justice Arnold noted that all three claims had been properly brought against AI at the dates on which they were commenced, since at those dates AI was the registered proprietor of 724 (UK) even though it had assigned 724 (UK) to AML.

Mr Justice Arnold had to decide whether it was "desirable" within the meaning of the Civil Procedural Rules (“CPR”) rule 19.2(3) for AI to cease to be a party to the three claims.

Mr Justice Arnold agreed with Teva’s contention that it should be inferred that AI's motive to assign 724 to AML was to avoid having to give disclosure of documents in the event that Teva brought a claim to revoke 724. AI had been prepared to assert 046 against Teva in Germany, but not even to defend 724 in the UK, and for this “there could be only one explanation, because there is only one material difference between revocation claims in Germany and the UK: disclosure”. Teva contended that it may be inferred that AI had damaging documents which it would have had to disclose in the UK.

However, Mr Justice Arnold did not accept that this in itself made it “desirable” for AI to remain a party, noting that a “group of companies is entitled to structure its patent holdings in whatever manner it considers most advantageous”, and that “there is nothing improper about choosing an ownership structure which avoids or minimises the risk of disclosure”. He also noted that there would be other ways for Teva to obtain disclosure from AI even if it were not a party.

Teva argued that their real adversary was AI and therefore AI should be a party so that the court’s rulings would be binding on it. The key question was whether Teva had a legitimate interest in ensuring that AI was bound by the court’s decision on the merits. In answering this question, Mr Justice Arnold considered the principles concerning the grant of declaratory relief. He then explained that, in deciding whether it was “desirable” for AI to remain a party, it was sufficient to decide whether Teva had a real prospect of successfully claiming declaratory relief against AI: if Teva had a real prospect of success, then it must follow that it was desirable for AI to remain a party.

In addressing this Mr Justice Arnold identified four ways in which AI may be affected by the court’s determination of the issues concerning 724(UK):

First, AML could assign 724 back to AI at any time.

Secondly, keeping AI as a party removed an obstacle in the way of Teva relying on the principle in Henderson v Henderson as an answer to a future claim by AI of infringement of 046 (UK) (if AI was able to obtain an order for restoration of 046 (UK) to the register) or other patents in the family.

Thirdly, if Teva was successful in the UK, it may then wish to contend that the findings of fact made by the UK court were res judicata, giving rise to issue estoppels binding on Amgen in other proceedings, such as the proceedings against AI in Germany for revocation of 046 (DE). Whilst national courts would decide the effect of such finding, Arnold J considered that Teva was more likely to prevail if AI was a party.

Fourthly, Arnold J noted that Amgen could file an application for a SPC in respect of 724 (UK) based on Teva's marketing authorisation for Lonquex and, whilst the natural interpretation of the SPC Regulation lead to the conclusion that only AML could be granted the SPC, Arnold J’s experience of “many references to the Court of Justice of the European Union concerning the interpretation of the SPC Regulation shows that it is difficult to be confident as to the answers to such questions”. Therefore it was at least arguable that if a SPC could validly be granted, it could be granted either to AI (as original holder of the patent) or to AML (as AI's successor in title).

Accordingly, Arnold J considered it desirable for AI to remain a party and Amgen’s application was dismissed.

Read the decision (in English) here.

Head note: Scott Parker and Ben Hall