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LSIPR Newsletter 02:13

UK appeals court upholds Genentech patent



London, UK

Gilead and Teva settle over Viread

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 Pharmaceuticals’ drug Eylea.

Gilead Sciences and Teva Pharmaceuticals have settled patent litigation over Gilead’s Viread treatment for HIV and chronic hepatitis B.

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 VEGF Trap-Eye (later named Eylea)—a treatment that uses VEGFs to target non-neoplastic neovascular disease agerelated 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 March 22, 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 February 21, the Court of Appeal upheld Floyd’s findings.

The settlement was reached the day before a trial on the matter was due to start in the US District Court for the Southern District of New York. Under the terms of the settlement, Teva will be permitted to market a generic version of Viread from December 15, 2017. John Milligan, president of Gilead, said that while the company believes strongly in the validity of its patent, the settlement “removes some uncertainty and minimizes further distraction”.

Genetech won at the Court of Appeal.

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-Eye does indeed embody the technical contribution made by the patent; it has a therapeutic effect in patients suffering from age-related macular degeneration 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. n

Life Sciences IP Review

Medicines Patent Pool and ViiV Healthcare tackle paediatric HIV The Medicines Patent Pool (MPP), a UN-backed organisation founded to lower the cost of HIV medicines through licensing patents, has announced a collaboration with leading pharmaceutical companies to increase the availability of life-saving paediatric HIV drugs. The MPP launched the collaboration with ViiV, itself a joint venture between GlaxoSmithKliine, Pfizer and Shionogi after the companies agreed that abacavir, a key drug in the fight against HIV, can now be supplied to the countries that need it most under a patent licence, ViiV and the MPP have also agreed to negotiate licences in the future for paediatric HIV drugs that are currently in development.

Eastern Biotech & Life Sciences expands into Oman Dubai-based genetic testing and diagnostics company Eastern Biotech and Life Sciences has opened its first foreign office in Muscat, Oman. Headquartered in the Dubai Biotechnology and Research Park, the company won the The Gulf Capital SME Info Small Business of the year Award in 2012.

LSIPR Newsletter - February  
LSIPR Newsletter - February  

Life Sciences Intellectual Property Review newsletter for February 2013.