In Regeneron Pharmaceuticals Inc. and Bayer Pharma AG v Genentech Inc  EWCA Civ 93 the Court of Appeal of England and Wales found that a patent for therapeutic agents for the treatment of non-cancerous diseases associated with blood vessel growth was valid and infringed.
In March 2012, a first instance trial was held to determine the validity and infringement of European Patent (UK) 1,238,986 (the patent), owned by Genentech Inc (Genentech). The patent concerns therapeutic agents, called VEGF antagonists, for the treatment of non-neoplastic diseases characterised by neovascularisation or angiogenesis. The Claimants alleged that the patent was invalid on the basis of lack of novelty, obviousness and insufficiency.
The Claimants also sought a declaration of non-infringement of the patent in relation to a product they were planning to market called VEGF Trap Eye (VTE) for the treatment of age-related macular degeneration. Genentech counterclaimed, asserting that the patent was infringed by VTE. Floyd J rejected all the validity attacks and held that VTE was infringing at first instance. The Claimants appealed this decision.
The Court of Appeal, with the lead judgment given by Kitchin LJ, upheld the entirety of Floyd J’s decision.
The Claimants maintained that Floyd J had misconstrued the claims of the patent as not requiring any therapeutic effect on the condition in question, and was inconsistent in applying his construction when considering validity. They also argued that he had wrongly held that the claims encompassed any variant of a natural receptor that retained the ability to bind VEGF and inhibit its activity.
The novelty attack was based on a Genentech article authored by the named inventors of the patent which, the Claimants asserted, disclosed VEGF antagonists in the form of antibodies and their use for treating relevant conditions. The Claimants also argued that Floyd J had applied the wrong test in assessing whether the invention was obvious in relation to the prior art and that it was not plausible that all VEGF antagonists would be useful in the treatment of non-neoplastic diseases. The Court of Appeal rejected all these criticisms of Floyd J’s approach and held that he had applied the correct tests and conclusions when making his assessment.
Some of the most interesting commentary pertained to the consideration of the insufficiency arguments put forward. The Claimants argued that Floyd J should have found the patent to be insufficient because the protection claimed was far too wide. It included large numbers of antagonists in the treatment of an extensive range of conditions which, they claimed, it could not deliver in relation to certain specific diseases and it would require undue effort to determine which antagonists were therapeutically effective against any particular neovascular disease. The Court of Appeal rejected all the insufficiency attacks offered, determining that it was credible that VEGF antagonism could be used to treat any non-neoplastic neovascular condition, and that it was not necessary to evidence this through clinical trials.
The Court of Appeal clearly stated that a claim for an invention of broad application may validly cover products identified at a future date, provided such embodiments exemplify the principles and technical contribution made by the invention.
Insufficiency issues are a concern when drafting a patent application for therapeutic treatments, owing to the fact that the basic patents usually have to be applied for long before the clinical testing is completed and marketing authorisation is achieved. As such, patent drafters cannot predict which of the array of disorders the claimed invention may treat will be the ones in relation to which a product will be brought to market. In this case, because the claimed invention disclosed a principle of general application, focussing on a mechanism for treating one physical aspect of an overall condition (angiogenesis), it was able to prevail over insufficiency challenges.