Biogen International GMBH v. Mylan Pharmaceuticals Inc., U.S. Supreme Court, No. 21-1567

Urging the Supreme Court To Reaffirm The Distinctions Between The Different Disclosure Requirements Needed to Obtain A Patent

This case presents a question that has divided the Federal Circuit and created justifiable confusion and anxiety among biotech companies, as well as among innovators in other fields.  The question is what is required to satisfy 35 U.S.C. §112’s requirement that an inventor provide a “written description of the invention” in order to secure a patent?

Biogen received a patent for a drug, dimethyl fumarate (“DMF”), to be used to treat multiple sclerosis.  In applying for the patent, Biogen disclosed all elements of the claimed invention and stated that “an effective dose of DMF . . . to be administered to a subject orally can be from . . . about 480 mg to about 720 mg per day.”  Nonetheless, a divided panel of the Federal Circuit held Biogen’s patent to be invalid because the company, supposedly, did not satisfy written description requirement.  In what is part of a worrying trend in patent law, the Federal Circuit departed from the text of the statute and created additional requirements that crowd out the simple statutory command to provide a “written description of the invention.”  The Federal Circuit reasoned that the patent’s §112 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.

Knowing that the Supreme Court alone can correct errors made in patent law by the Federal Circuit, NELF has filed an amicus brief supporting Biogen’s petition for certiorari.

NELF argues that the Federal Circuit’s decision confounds the three separate disclosure requirements set forth in 35 U.S.C. §112(a): the written disclosure requirement, the enablement requirement, and arguably the best mode requirement.  Although long-standing Federal Circuit precedent holds that those requirements are to be considered separate and distinct, the Federal Circuit decision conflates them.  The decision also conflates the written description with the requirement of nonobviousness.  As NELF illustrates, the decision departs from the Supreme Court’s own teachings on this issue and is inconsistent even with the circuit’s own earlier §112 jurisprudenence.

If allowed to remain uncorrected, NELF warns, these conflations will stifle innovation by creating uncertainty for innovators, particularly for biotechnology companies, emerging or new technologies, and their investors, as well as for the Patent Office in patent examination, and the courts in patent enforcement litigation.

The urgency of review is all the greater, NELF notes, because the erroneous decision in this case is not an isolated one.  Its conflation of the separate patentability requirements continues a trend found in other recent decisions of the FederalCircuit and the lower courts.  Such decisions have caused uncertainty, lack of predictability, confusion and undue expense in this highly important area of property law.  The trend includes the conflation of the patentable subject matter requirement (35 U.S.C. §101) and nonobviousness (35 U.S.C. §103).  To arrest this ominous trend, NELF urges the Court to grant certiorari to address and clarify the law on the patentability requirements at issue here.


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