Patents Court Grants Arrow-Style Declarations Aimed At Piercing Secondary Patent Shields

Mr Justice Carr has granted an "Arrow" declaration to Fujifilm Kyowa Kirin Biologics Company Limited ("FKB"), Samsung Bioepsis UK Limited and Biogen Idec Limited (SB/Biogen) that their biosimilar adalimumab product for the treatment of rheumatoid arthritis, psoriatic arthritis and/or psoriasis administered at 40mg every other week by subcutaneous injection was anticipated and/or obvious at the claimed priority dates of AbbVie's patents [2017] EWHC 395 (Pat).

Although Mr Justice Carr was keen to stress the unusual nature of this case, the grant of the declaration is of interest as it provides an effective tool for parties seeking to clear the path for a product launch where the patentee has created multiple layers of secondary patent protection. The focus on the product being obvious or anticipated as at a certain date provides powerful protection and commercial certainty without conflicting with a patentee's ability to obtain patent protection. In granting the declaration, Carr J held that the declaration sought would still serve a useful purpose despite the fact that after revocation proceeding had been issued AbbVie had disapproved of the text of two of the patents (EP (UK) 1,406,656 and EP (UK) 1,944,322) with the effect of revoking them centrally and de-designating a further patent (EP (UK) 2,940,044).

Carr J rejected AbbVie's submissions that the undertakings it offered gave at least as much protection to the relief sought in the declaration finding that there was no coherent explanation why AbbVie had refused to submit to judgment, or alternatively gave an acknowledgement in the same form as the declarations. The Judge considered that the intention and objective effect of AbbVie's conduct was to shield AbbVie's Humira patent portfolio from examination of validity whilst continuing to file further divisionals and threatening infringement proceedings in respect of biosimilar products wherever launched. The declaration therefore provided clarity and was useful in that they dispelled commercial uncertainty, particularly in relation to the supply chain in the UK (and European) market.

The Judgment also dealt with a number of issues of the formal assignment of priority of EP'656, with Carr J finding that the patent applicant had the right to claim priority as the beneficial owner of that right through a complex chain of title relying on the US and German law pertaining to employee inventions, the requirements for effective nominations and construction of contracts.

Background

AbbVie was the proprietor of a number of patents relating to its antibody product Humira (adalimumab), which was the highest selling prescription drug in the world by global sales, achieving net sales of over US$12.5 billion in 2014. Adalimumab is a fully human antibody that binds and neutralises the activity of TNFα and is used in the treatment of rheumatoid arthritis ("RA"), psoriatic arthritis and psoriasis. The basic patent and associated SPC expires on 15 October 2018. AbbVie owned and has applied for a number of patents and divisionals relating to the dosage regime for the treatment of the licensed indications.

FKB and SB/Biogen were seeking to "clear the path" in relation to these secondary patents in order to launch their biosimilar adalimumab products in Europe, including the UK after the SPC expired. Due to regulatory requirements, the biosimilar products must utilise the same dosing regimens authorised for Humira. FKB and SB/Biogen initially started revocation proceedings and also sought...