Posted: March 4th, 2013
Regeneron Pharmaceuticals Inc. and Bayer Pharma AG v. Genentech Inc., Court of Appeal, London, UK, 21 February 2013,  EWCA Civ 93
The Court of Appeal upheld the decision of the Patents Court that Genentech’s patent was valid and infringed.
Regeneron and Bayer applied to revoke Genentech’s patent, EP (UK) 1 238 986, regarding the use of human vascular endothelial growth factor (hVEGF) antagonists for the treatment of non-cancerous (non-neoplastic) diseases which are characterised by excessive blood vessel growth (neovascularisation or angiogenesis). Regeneron and Bayer attacked the patent on the grounds of lack of novelty, obviousness and insufficiency.
Regeneron and Bayer also sought a declaration of non-infringement in respect of a product called VEGF-Trap which had been developed by Regeneron and licensed to Bayer. Bayer intended to sell VEGF-Trap in the UK for the treatment of neovascular age-related macular degeneration (ARMD), a leading cause of premature blindness. Genentech counterclaimed for infringement.
In the Patents Court, Mr Justice Floyd held the patent to be valid and infringed. Regeneron and Bayer appealed this decision.
On appeal, Regeneron and Bayer argued that the Judge had misconstrued the claims of the patent as not requiring any therapeutic effect on the disease or disorder in question and that he was inconsistent in applying his construction when considering validity. They also argued that the Judge had wrongly held that the claims encompassed any variant of a naturally receptor which retained the ability to bind VEGF and inhibit its activity. The Court of Appeal rejected the appellants’ arguments on construction. The specification clearly showed that Genentech intended variants to be included within the scope of the monopoly and VEGF-Trap fell within the scope of the patent.
The appellants’ novelty attack was based on a Genentech article that was co-authored by the two named inventors of the patent which they said disclosed VEGF antagonists in the form of antibodies and their use for treating relevant diseases and disorders. The Court of Appeal rejected the novelty attack as the article did not provide the same teaching as the patent and noted that the Judge had construed the claims of the patent correctly and had applied this construction when considering novelty.
The appellants argued that the Judge had applied the wrong test in assessing whether it was obvious to take the step from the prior art to the invention and that he should have held the patent to be obvious because it was not plausible that all VEGF antagonists would be useful in the treatment of non-neoplastic neovascular diseases. The Court of Appeal rejected all of the criticisms of the Judge’s approach and held that he had applied the correct test when making his assessment.
The appellants argued that the Judge should have found the patent to be insufficient because the monopoly claimed was far too broad and encompassed the use of a vast number of antagonists in the treatment of a wide range of conditions which it fell far short of enabling. The Court of Appeal rejected all of the appellants’ insufficiency attacks and noted that it was plausible that VEGF antagonism could be used to treat any non-neoplastic neovascular disease and that it was not necessary to establish efficacy by carrying out clinical trials. The Court of Appeal also commenced that a claim for an invention of broad application may properly encompass embodiments which may be provided or invented in the future and which have particularly advantageous properties, provided such embodiments embody the technical contribution made by the invention.
Read the judgment in English here.
Head note: Rob Fitt