Despite NELF’s Urging, the Supreme Court Declines to Reaffirm the Distinctions between the Different Disclosure Requirements Needed to Obtain a Patent
Biogen International GMBH v. Mylan Pharmaceuticals Inc., U.S. Supreme Court, No. 21-1567
This case presented a question that continues to divide the Federal Circuit and create justifiable confusion among biotech companies, as well as among innovators in other fields. The question is what level of description 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 the 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 disclosure requirements that crowd out the simple statutory command to provide a “written description of the invention.” The Federal Circuit reasoned that Biogen’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.
Because the Supreme Court alone can correct errors made in patent law by the Federal Circuit, NELF filed an amicus brief supporting Biogen’s petition for certiorari.
NELF argued 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 separate and distinct, the Federal Circuit decision conflated them. The decision also conflated the written description with the requirement of nonobviousness. As NELF illustrated, the decision departed from the Supreme Court’s own teachings on this issue and was inconsistent even with the circuit’s own earlier §112 jurisprudence.
If allowed to remain uncorrected, NELF warned, these conflations will stifle innovation. They will create uncertainty for innovators, particularly for biotechnology companies, emerging or new technologies, and their investors, as well as for the Patent Office and the courts. The urgency of review is all the greater because the erroneous decision in this case was not an isolated one; it continues a trend found in other recent decisions of the Federal Circuit and the lower courts. To arrest this ominous trend, NELF urged the Court to grant certiorari to address and clarify the law on the patentability requirements at issue here.
On October 3, 2022, the Court denied the petition.