Fujifilm Kyowa Kirin Biologics Company Ltd v Abbvie Biotechnology Ltd (Rev 1)

Entitlement to claim priority must be assessed when the later application is filed. Substantive beneficial ownership and an enforceable right to compel transfer can suffice; formal legal title is not decisive.

Information which the skilled person would routinely obtain when addressing a particular problem may be considered in assessing obviousness, even if it is not common general knowledge. Fixed-dose 40 mg subcutaneous administration every two weeks was obvious for rheumatoid arthritis, with or without methotrexate, and was anticipated or obvious for psoriasis and psoriatic arthritis by 18 July 2003.

Declarations may provide useful UK commercial certainty where patent withdrawal and continuing infringement threats have prevented ordinary validity scrutiny.

Fujifilm Kyowa Kirin Biologics, Samsung Bioepis UK and Biogen Idec sought declarations concerning the proposed marketing of biosimilar adalimumab products. The declarations addressed fixed-dose 40 mg subcutaneous administration every other week, and related weekly regimens, for rheumatoid arthritis, psoriasis and psoriatic arthritis.

The proceedings began as revocation claims concerning AbbVie patents, with declaratory relief also sought. AbbVie subsequently revoked or de-designated relevant UK patent protection and offered undertakings, but resisted the declarations. The trial concerned entitlement to priority, obviousness and anticipation, and whether declaratory relief would serve a useful purpose in the United Kingdom.

The court granted the declarations sought.

1. Priority. Under the Patents Act 1977 and Article 4A of the Paris Convention, entitlement had to exist when the later application and priority claim were filed. An original applicant could not retain a substantive priority right after assigning it. For a PCT application leading to European or UK protection, the relevant part was the part designating the European region or relevant national phase; the inventors’ status as applicants for the United States did not establish entitlement for the non-US designations. The court followed the reasoning in Edwards Lifesciences v Cook Biotech [2009] EWHC 1304 (Pat) and applied KCI Licensing v Smith & Nephew [2010] EWHC 1487 (Pat).
2. Chain of title. The US inventors had transferred their equitable interests to KPC under their employment agreements. Knoll AG was KPC’s nominee and beneficial owner of the relevant clinical-development rights. Although Dr Kempeni retained legal title, Knoll GmbH had a continuing statutory right under the German Act on Employee Inventions to require an invention report and claim the invention. Substantive ownership, rather than formal title, therefore established successor-in-title status. Under German contract law, the parties’ concordant subjective intention prevailed over the incomplete schedules in the asset purchase agreement. Abbott Bermuda was consequently successor in title when the PCT application was filed, and the 656 patent was entitled to its priority date.
3. Obviousness and anticipation. The skilled team comprised the necessary skill-set, whether pharmacological expertise was held by the rheumatologist or a separate pharmacologist. Additional prior art could be considered where the skilled person would obtain it routinely. Reading Kempeni 1999 and Kempeni 2000 with the available abstracts and common general knowledge, the skilled team would have pursued subcutaneous treatment, a two-week interval and a fixed 40 mg dose, with a high expectation of efficacy. The combination with methotrexate was also obvious. The psoriasis and psoriatic arthritis regimen was anticipated or obvious by 18 July 2003 through established prior use.
4. Declarations. The discretion to grant declarations was pragmatic and included justice to each party, useful purpose and special reasons. The declarations would provide commercial certainty in the UK, protect supply chains and assist settlement. The undertakings did not provide equivalent clarity, particularly in light of AbbVie’s withdrawal of patent protection, continuing divisional filings and threats of worldwide enforcement.

This was a first-instance trial judgment. The judgment records earlier interlocutory decisions in the same proceedings, including [2016] EWHC 425 (Pat), [2016] EWHC 2204 (Pat) and [2016] EWHC 3383 (Pat). Appeals from the first two decisions were dismissed by the Court of Appeal in [2017] EWCA Civ 1.