The Ensuring Innovation Act recently became law after passing in the Senate with unanimous, bipartisan support. According to one Senator, the intent of the legislation was to “close loopholes to prevent awarding market exclusivity to products that do not present true innovation and unduly delay cheaper generic from entering the market.” Is this much ado about nothing, or much to be concerned about?
Continue Reading The Impact of the Ensuring Innovation Act on NCE Exclusivity
Biosimilars
Generic Competition for Withdrawn Drug Products
By Sarah Cork on
When a pharmaceutical company withdraws a product from the market, the basis for the withdrawal can affect whether a competitor can commercialize a generic version of that product. A generic cannot be approved if, in the FDA’s view, the product was withdrawn for “safety and effectiveness” reasons.
But how does the FDA reach that conclusion? A newly filed case may shed some light on the Agency’s decision-making process.…
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CAFC Tightens Enablement Standard for Functional Claiming of Antibodies
By Lawrence Frank & Siegmund Y. Gutman on
In the recent case of Amgen Inc. v. Sanofi, Aventisub LLC, the Federal Circuit affirmed the district court’s invalidation of certain of Amgen’s antibody patent claims, concluding that the claims were not “enable[d]” under 35 U.S.C. § 112. This decision establishes that it is more difficult to satisfy the enablement requirement for antibody claims that use functional language to describe the antibody. (The court granted Amgen’s motion to extend the deadline for filing a petition for panel rehearing and/or rehearing en banc until April 14, 2021. See id., Order (March 8, 2021).)
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Continue Reading CAFC Tightens Enablement Standard for Functional Claiming of Antibodies