Roche wins patent appeal over Hemlibra, its hemophilia A drug, against Takeda’s Baxalta

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In a patent dispute revolving around two competing hemophilia medications, Roche’s Genentech unit has achieved its second consecutive victory. Following a previous ruling by a US district court that favored Roche and invalidated a patent held by Takeda’s Baxalta unit, the US Court of Appeals for the Federal Circuit has upheld the decision.

In the recent ruling, US Circuit Judge Timothy B. Dyk emphasised a fundamental principle of patent validity, stating that patents must provide a comprehensive, precise, and clear description of inventions. This description should enable individuals with the requisite expertise to replicate and utilise the invention “without undue experimentation.”

The patent in question, held by Baxalta, pertains to an antibody that binds to a crucial protein responsible for blood clotting. During the appeal process, Baxalta argued that skilled practitioners could employ a screening process that did not constitute undue experimentation.

However, the circuit court rejected this argument and upheld the initial decision to invalidate the patent. In explaining its rationale, the Circuit Court referenced a notable Supreme Court ruling in Amgen v. Sanofi. In this prior case, the Court upheld the invalidation of two of Amgen’s Repatha patents due to a similar lack of “enablement.”

The concept of “enablement” stipulates that patents are valid only when they contain sufficient disclosure to enable an individual with ordinary expertise in the relevant field to create the invention without encountering undue challenges.

It is worth noting that Takeda acquired Baxalta through a series of merger transactions, with Shire initially incorporating Baxalta into its portfolio in 2016, followed by Takeda’s acquisition of Shire in 2019.

Roche’s Genentech unit’s successive wins in this patent dispute underscore the importance of clear and comprehensive patent descriptions in the pharmaceutical industry and their role in protecting intellectual property rights.

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