In an ongoing dispute between Fujifilm Kyoma and AbbVie, the English Court of Appeal has ruled that “Arrow declarations” are, in principle, a permissible remedy that can be granted by the Patents Courts to parties seeking to establish freedom to operate (see Fujifilm Kyoma and AbbVie [2017] EWCA Civ 1). This is an interesting decision for companies in the biotechnology and pharmaceutical sectors, who may be looking to achieve commercial certainty upon launch of a generic product. More generally, Arrow declarations may be the relief needed to protect against infringement claims from innovator companies who own large secondary patent portfolios and who attempt to shield their patents from challenges before the national courts.

Arrow declarations originate from the 2007 case Arrow Generics Limited and Merck & Co. Inc (EWHC 1900 (Pat), [2007] FSR 39), and concern products rather than patents. A party requesting an Arrow declaration is essentially seeking a declaration that the specific product they are looking to manufacture, sell, use etc would have lacked novelty or been obvious at a particular date. The purpose of such a declaration would be to provide the party with a Gillette defence to any subsequent claim for infringement of a patent with that date as the priority date.

Arrow declarations become particularly relevant where a patentee seeks to protect their patents from third party attack. For example, a patentee who is faced with opposition proceedings before the EPO or revocation proceedings before a national court can withdraw their approval of the text for grant, such that their patent is revoked before issues of validity have been decided. Provided the patentee has a divisional application pending, they can continue to pursue claims which could pose a problem to third parties.

In the dispute between Fujifilm Kyoma and AbbVie, Fujifilm is trying to clear the way for launch of its biosimilar Humira product. Humira (or adalimumab) is a monoclonal antibody that binds to human TNFα. It can be used to treat a variety of inflammatory disorders including arthritis, psoriasis, Crohn’s disease and ulcerative colitis, and is the largest selling prescription drug in the world. AbbVie are the owners of a large international patent portfolio protecting this blockbuster drug. However the UK SPC based on the basic compound patent is set to expire on 15 October 2018 meaning that AbbVie will be reliant on secondary patents (such as formulation and second medical use patents) to retain their monopoly after this date.

Fujifilm has brought two claims against AbbVie before the UK Patents Court, the first (FKB1) seeking revocation of two dosage regime patents (EP(UK)1406656 and EP(UK)1944322). AbbVie has withdrawn its approval of the text for both of these patents such that they have been revoked by the EPO. There are however, a number of divisional applications pending, divided from both of these patents. Fujifilm is seeking to establish commercial certainty in the face of these pending divisional cases by obtaining an Arrow declaration: namely, that their adalimumab biosimilar used subcutaneously at a specific dose for the treatment of rheumatoid arthritis, psoriatic arthritis and/or psoriasis would have been obvious at the priority date of the patent family. Fujifilm’s second claim (FKB2) includes a request for a similar Arrow declaration, to provide legal certainty in the face of divisional applications divided from EP(UK)1,737,491 (which was granted but promptly revoked by AbbVie before third parties could challenge validity).

In two challenges before the High Court, AbbVie have sought to strike out FKB’s claims for Arrow declarations. In particular, it has been argued that these declarations, if granted, would be in conflict with section 74 of the UK Patents Act, for the reason that there is no right to challenge validity of a pending application. In both cases, AbbVie were unsuccessful and the two cases have now been heard by the Court of Appeal. Although the court considered carefully any potential conflict between Arrow declarations, the UK statute and proceedings before the EPO, it was concluded that the Patents Courts could exercise their discretion in granting Arrow declarations. It was noted that in exercising discretion, the courts should bear in mind the existence of the statutory proceedings for revocation, and that these should be the normal vehicle for obtaining any desired findings of invalidity. However, it was stated at paragraph 93 of the judgment:

“Where, for example, it appears that the statutory remedy is being frustrated by shielding subject matter from scrutiny in the national court, it should be open to the court to intervene.”

And at paragraph 100:

“Because of the way AbbVie have appeared to act, there is a case for the court to intervene by way of declaration to provide FKB with a measure of useful commercial certainty.”

Following the Court of Appeal’s ruling, it is now up to the Patents Court judges to implement this decision, following the full trials of FKB1 and FKB2 due to take place in the first half of 2017.