Bird & Bird’s London patent team has secured a win before the UK High Court for their client Gilead, a global pharmaceutical company known for its work in the medical fields of virology, oncology and inflammation.
On 21 March 2023, Mr Justice Meade held that two patents owned by the Defendant NuCana were invalid for added matter, lack of plausibility and insufficiency including on the basis of the undue burden involved in making the class of “2-methyl up 2-fluorine down” compounds, such as sofosbuvir, falling within the claims. Sofosbuvir is the key component of Gilead’s new class of anti-viral drugs (Solvaldi, Harvoni, Vosevi and Epclusa) that act as inhibitors of an essential enzyme of the Hepatitis C virus. The compound has achieved blockbuster status, with the capability to effectively cure Hepatitis C on a global scale.
In this judgment, the Judge not only considered plausibility, but also “implausibility”, in view of the upcoming decision of the EPO Enlarged Board of Appeal (G2/21, Sumitomo), which has the potential to change the way patentability is assessed in all areas of technology, and particularly the Life Sciences industry.
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