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Conflation of dosing regimen with efficacy at issue in Bayer appeal in US

By Melissa Ritti ( May 5, 2025, 20:55 GMT | Insight) -- Germany’s Bayer Pharma Aktiengesellschaft and Mylan Pharmaceuticals are set to square off at the US Court of Appeals for the Federal Circuit tomorrow morning over findings by the Patent Trial and Appeal Board that a patent linked to the blood thinning drug “Xarelto” was inherently anticipated by a published discussion of its dosing regimen. The regimen was disclosed in a clinical trial which studied Xarelto's active ingredient, rivaroxaban, when combined with aspirin. The patent's invalidation was an “illogical” result, Bayer says, for a “clinically proven effective regimen is novel, nonobvious, and merits patent protection” so long as proof of efficacy is not disclosed by — or reasonably expected from — prior art.Amid plummeting sales of Xarelto in a market now crowded with generic competition in the US and abroad, Bayer Pharma Aktiengesellschaft is taking its dispute with one of those generic manufacturers back to court....

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