Skip to content

UK – Eli Lilly v. Genentech / referral to CJEU

11 Mar 2019

Eli Lilly And Company & Ors v Genentech, Inc [2019] EWHC 387 and 388 (Pat) (01 March 2019)

This was a claim brought by Eli Lilly and Company (“Lilly”) for revocation of Genentech’s patent EP (UK) No. 1,641,822 (the “Patent”) entitled “IL-17A/F heterologous peptides and therapeutic uses thereof”.

Genentech does not have a marketed product covered by its Patent, and Lilly already markets its product, ixekizumab, under the trade name Taltz, which is an antibody to interleukin-17 indicated for the treatment of psoriasis and psoriatic arthritis. As well as a typical patent revocation/infringement action, this case involved a separate claim (and judgment) in respect of Genentech’s application for a supplementary protection certificate (“SPC”) based on its Patent and Lilly’s marketing authorisation (“MA”) for Taltz.

In the main action, Lilly sought to revoke the Patent on the grounds of lack of novelty, obviousness and insufficiency. It also sought a declaration of non-infringement for its Taltz product. Genentech counterclaimed for infringement, and also sought conditional and unconditional amendments to the Patent, which were allowed (and Lilly’s arguments that the amendments added matter, extended protection and lacked clarity were rejected).

Due to the number and complexity of the issues covered in this case, Mr Justice Arnold’s judgment reached a hefty 618 paragraphs, with the Judge himself noting that he felt it “pertinent to observe at the outset that this is one of the most complex cases I have ever tried”.

Considering obviousness, Lilly argued that the prior art contained an enabling disclosure of the recombinant production of IL-17A/F. On that basis, Lilly argued that it was obvious to the skilled team to make antibodies to IL-17A/F, and to aim for humanised antibodies with the highest possible affinity for the purpose of therapeutic use (in particular the treatment of rheumatoid arthritis). Arnold J found in Lilly’s favour on all counts, in particular finding that Genentech were squeezed between obviousness and insufficiency as to the medical use claims (as either the claims were obvious to try or the Patent would be insufficient for lack of plausibility in such respects).

As well as running a case on IL-17A/F prior art, Lilly had performed experiments on prior art anti-IL-17A/A antibodies (i.e. which bound a different species of IL-17) to support its novelty attack, that it was inevitable that such anti-IL-17A/A antibodies would also bind to IL-17A/F. As a secondary position, Lilly claimed that if it was inevitable, it was nonetheless obvious.

Arnold J dismissed the novelty argument, finding that it was not shown to be inevitable that working the prior art would produce such antibodies. However, Arnold J concluded that it was instead “highly probable” that the skilled team implementing the IL-17A/A prior art using obvious methods would produce an antibody that also bound to IL-17A/F. On that basis, he held that the Patent relevant claims were obvious (noting that the therapeutic use claims were again squeezed versus insufficiency).

Turning to insufficiency, Arnold J considered the issue of plausibility in relation to the medical use claims directed to psoriasis. Arnold J summarised the law as set out in Warner-Lambert Co LLC v Generics (UK) Ltd [2018] UKSC 56, noting that the application of plausibility was highly context-specific and so consideration should be taken of the fact that the present case concerned a new member of a known family.

Applying those principles in this case, Arnold J determined that the correct question to ask was whether it was plausible that an IL-17A/F antibody would have a discernible therapeutic effect against psoriasis. On that basis, and particularly due to the lack of relevant data in the Patent, Arnold J held that the claim of therapeutic efficacy against psoriasis was speculative and that plausibility was not established.

Lilly’s other arguments that the Patent was insufficient on grounds of ambiguity and undue burden were rejected.
Having found the Patent obvious and insufficient for lack of plausibility, Arnold J turned to the issue of infringement, finding in Genentech’s favour, in particular based on construction.

Although the issue did not arise given his conclusion on the normal interpretation of the claims, Arnold J also considered infringement of an integer of claim 1 under the doctrine of equivalents. Applying the questions identified by Lord Neuberger in Actavis v Lilly [2017] UKSC 48, Arnold J found that all three questions were satisfied and that the integer would be infringed.

The second judgment regarding SPCs concerned Genentech’s SPC application for an SPC based on the Patent and the MA for Lilly’s product Taltz. Lilly sought a declaration that the SPC was invalid: first, because Lilly’s Taltz product was not protected by the basic patent in force for the purposes of Article 3(a) of the SPC Regulation; and secondly that Lilly’s MA for Taltz was not a relevant authorisation for the purposes of Article 2, 3(b) and/or 3(d) of the SPC Regulation, on the basis that it is a third party MA relied on without Lilly’s consent.

Notwithstanding that the finding on the invalidity of the Patent meant that Genentech’s SPC application must fail, Arnold J considered the law to be unclear so considered it necessary to refer a question to the CJEU on this issue, in particular taking into account the UK’s imminent departure from the EU and the real risk that, should Genentech appeal the decision, the Court of Appeal may not have jurisdiction to refer the question post-Brexit.

The question referred was: “Does the SPC Regulation preclude the grant of an SPC to the proprietor of a basic patent in respect of a product which is the subject of a marketing authorisation held by a third party without that party’s consent?”

A copy of the judgment can be found here, and the SPC judgment here.

Headnote: Scott Parker, Simmons & Simmons