Biogen Asks the Supreme Court to Review Patents’ Written Description Requirement

Biotechnology company Biogen International GmbH filed a petition for a writ of certiorari to the Supreme Court on Tuesday requesting the Court overturn the Federal Circuit’s decision invalidating Biogen’s patent in its suit against Mylan Pharmaceuticals Inc.

According to the petition, Biogen obtained a patent for a multiple sclerosis treatment comprising orally administering a therapeutically effective amount of dimethyl fumarate (DMF) at 480 mg/day. 

After obtaining the patent, Biogen filed a lawsuit against Mylan Pharmaceuticals, Inc. alleging patent infringement, and Mylan responded by arguing that the multiple sclerosis treatment patent was invalid. The district court ruled in favor of Mylan stating that the patent failed to include proof of the efficacy of the 480 mg/day dose and only mentioned the dosage once in three separate examples. 

Biogen timely appealed and a divided panel of the Federal Circuit affirmed the district court’s decision. The Federal Circuit held that the patent did not meet the written description requirements of 35 U.S.C. § 112 because the patent specification did not include data proving the efficacy of the claimed dose, the claimed dose was “listed only once” in the specification, and the claimed dose was not singled out from the other inventions described in the patent. 

Biogen states that it timely petitioned for a rehearing en banc which was denied over the dissent of three judges leading to the present petition for a writ of certiorari. In the present petition, Biogen argues that the Federal Circuit failed to apply the statute’s plain text requiring a “written description of the invention” and its own precedent. Specifically, Biogen asserts that the statutes language clearly does not not require proof of efficacy nor does it require that the patent applicant repeatedly describe or single out the claimed invention from other unclaimed disclosures.

Further, Biogen entices the Court to accept the petition arguing that the Federal Circuit’s decision has fractured the court, caused considerable confusion and resulted in drastic consequences. Biogen argues that the additional requirements imposed by the Federal Circuit will chill investment in innovative technologies due to the extra burden put on inventors. 

Biogen further argues that the Court should grant the petition due to the division within the Federal Circuit over the interpretation of the written description requirement which will result in an “unacceptable risk of inconsistent, panel-dependent decisions that will undermine the stability and certainty on which the patent system depends.”

Biogen is represented by WilmerHale.