25 February 2013Big Pharma

UK appeals court upholds Genentech patent

England’s Court of Appeal has affirmed a 2012 High Court ruling that pharmaceutical company Genentech’s patent covering human vascular endothelial growth factor (hVEGF) antagonists is valid and has been infringed by Regeneron and Bayer Pharmaceutical’s drug Eylea.

Genentech filed a patent covering the use of (hVEGF) antagonists to treat “non-neoplastic diseases characterised by excessive neovascularisation [diseases characterised by the excessive growth of blood cells or tissue, excluding the growth of tumours] wherein the hVEGF antagonist is: (a) an anti-VEGF antibody or antibody fragment; (b) an anti-VEGF receptor antibody or antibody fragment; or (c) an isolated hVEGF receptor,” in 1992.

But pharmaceutical companies Regeneron and Bayer challenged the patent and sought a declaration of non-infringement to allow them to launch Trap Eye (later named Eylea) – a treatment that uses VEGFs to target non-neoplastic neovascular disease age-related macular degeneration, which causes leaking blood vessels in the eye and is a leading cause of premature blindness.

Regeneron and Bayer argued that the patent lacks novelty and inventive step and is insufficient in its description, because “it merely provides information about the known use of VEGF antagonists and their use for treating disorders” and because its claims are speculative, covering “a huge range of non-neoplastic diseases and disorders without the experimental work needed to support them”. Genentech counterclaimed for infringement.

On 22 March, 2012, High Court judge Justice Floyd found in favour of Genentech and concluded that the patent “is not invalid on any ground alleged” and has been infringed by VEGF Trap Eye.

Regeneron and Bayer appealed against Floyd’s ruling and challenged his decision to construe the meaning of "a medicament for the treatment of a non-neoplastic disease or disorder characterised by undesirable excessive neovascularisation" differently from the definitions put forward by Regeneron and Bayer and Genentech.

But on Thursday, February 21, the Court of Appeal upheld Floyd’s findings.

Lord Justice Kitchin said: “I have some difficulty…in identifying precisely where it is said that the judge has fallen into error”.

Supporting Floyd’s decision to dismiss Regeneron and Bayer’s argument that patent is insufficient, he added:

“A claim for an invention of broad application may properly encompass embodiments which may be provided or invented in the future and have particularly advantageous properties… provided such embodiments embody the technical contribution made by the invention.

“VEGF-Trap does indeed embody the technical contribution made by the patent; it has a therapeutic effect in patients suffering from ARMD by treating the angiogenesis associated with that condition, and it does so by binding to VEGF and inhibiting its biological activity.”

Genentech and Regeneron did not respond to requests for comment. A spokesperson for Bayer said the company “is disappointed with the judicial decision and intends to appeal to the Supreme Court to reconsider” but added that as Genentech’s patent expired in October 2012, the ruling does not prevent it from marketing Eylea.

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