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Protecting the unpatentable: Arrow declarations

2 August 2018

A recent decision of the Court of Appeal to overturn the High Court ruling in an ongoing dispute between GSK and Vectura Limited has once again brought the validity of Arrow declarations to the forefront of UK patent law.

An Arrow declaration provides commercial certainty or freedom to operate surrounding the marketing of a product or process, by ruling that the product or process was known or obvious at the priority date of a patent application. This provides the declaration holder with a “Gillette defence” against a potential claim of infringement in the future, i.e. after the patent has been granted.  A Gillette defence is a type of “squeeze” argument, deployed by an alleged patent infringer, which states that if the product or process falls within a patent claim, and that product or process would have been known or obvious at the priority date, that claim must be invalid for lack of novelty or inventive step.

An Arrow declaration was first considered in Arrow Generics Limited v Merck & Co. Inc. “the Arrow case”, (see here) concerning Merck’s patent relating to the use of alendronate in the treatment of osteoporosis. After the original patent was revoked, Arrow and other generic drug companies had established markets in Europe; however, Merck revived four divisional applications after opposition proceedings had concluded. With one application proceeding to grant and the possibility of further applications granting, Arrow required commercial certainty for its UK market. At the High Court hearing, whilst the judgement fell short of granting a declaration, it was not ruled out as a possibility at trial.

Fast forward ten years and Arrow declarations were revisited in a landmark ruling in the case of Fujifilm Kyowa Kirin Biologics Co., LTD. (FKB) v AbbVie Biotechnology Limited, (see here). This case related to AbbVie’s extensive patent portfolio concerning the use of adalimumab and FKB’s biosimilar products. AbbVie’s filing strategy and deletion of subject matter from pending applications was considered to constitute an attempt to prevent scrutiny by the court. Therefore, at the Court of Appeal, it was suggested that a declaration and/or injunction might be a possibility at trial.

Turning back to the present case, in June 2018 at the Court of Appeal it was decided that GSK’s claim for an Arrow declaration could proceed to trial, see here. This relates to five Vectura patent applications, which have yet to proceed to grant, concerning the delivery of drugs by inhalation. GSK markets such drugs for the treatment of asthma and chronic obstructive pulmonary disease. Vectura was pursuing a strategy where multiple applications were filed claiming a single technical concept, but using different language, which created a degree of uncertainty as to the scope of the subject-matter claimed.

This latest judgement confirms that, whilst the normal vehicle for challenging patent validity is revocation proceedings, further options of Arrow declarations and/or injunctions exist for establishing commercial certainty for products and processes. These declarations are not available as of right, but are at the discretion of the court, and whether such a declaration is allowable must be decided at trial. The trial of GSK v Vectura will commence in November.

 

Dr Abbie Fisher
Life Sciences & Chemistry group

If you require further information on anything covered in this briefing, please contact Abbie Fisher (afisher@withersrogers.com; +44 1926 310 700) or your usual contact at the firm. This publication is a general summary of the law. It should not replace legal advice tailored to your specific circumstances.

© Withers & Rogers LLP, August 2018