The Supreme Court Fails to Reconcile 35 U.s.c. § 112

• Jurisdiction: United States,Federal
• Citation: Vol. 48 No. 1
• Publication year: 2023
• Author: D. Benjamin Borson
• topic: Patent law,Intellectual Property,Federal,Civil Procedure

THE SUPREME COURT FAILS TO RECONCILE 35 U.S.C. § 112

D. Benjamin Borson

Borson Law Group P.C.

Biogen v. Mylan, Case 20-1933 (Fed. Cir. 2021: Biogen I); 21-1567 (Sup. Ct. 2022: Biogen II).

Amgen v. Sanofi, Case No. 2020-1074 (Fed. Cir. 2021: Amgen I); 21-757 (Sup. Ct. 4 November 2022: Amgen II).

SUMMARY

These two cases illustrate the difficult issues relating to the two "prongs" of 35 U.S.C. § 112. The "written description" (prong 1) addresses whether the inventors invented something, and the "enablement" (prong 2) addresses whether the specification provides sufficient details to permit persons of skill in the art to practice the invention for the "full" scope of the claims.

Two cases address different aspects of § 112, and there appears to be some significant differences between the two cases.

INTRODUCTION

Biogen v. Mylan

Biogen International GmBH and Biogen MA Inc. are the owners of U.S. Patent No. 8,399,514 (the '514 patent). The '514 patent disclosed and claimed:

A method for treating a subject in need of treatment for multiple sclerosis comprising orally administering a pharmaceutical composition consisting essentially of (a) a therapeutically effective amount of dimethyl fumarate ("DMF"), monomethyl fumarate ("MMF"), or a combination thereof; and (b) one or more pharmaceutically acceptable excipients, wherein the therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof is about 480 mg per day.

Under the Hatch Waxman act, Mylan filed a request for an Abbreviated New Drug Application (ANDA) to manufacture and sell a generic version of dimethyl fumarate (Biogen's Tecfidera®). In the ANDA, Mylan asserted that the '514 patent lacked written description, and therefore the '514 patent was invalid and could not be infringed.

Biogen sued Mylan for patent infringement in the Northern District of West Virginia. The district court

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held that Mylan met its burden in showing that the '514 patent was invalid for lack of written description. Biogen appealed to the Federal Circuit Court of Appeals (Fed. Cir.) challenging the district court's holding.

PANEL OPINION

The matter was on appeal before Judges O'Malley, Reyna and Hughes. In his opinion, Judge Reyna noted that the specification of the '514 patent included that the original title of the priority application was changed to "treatment of multiple sclerosis" based on Biogen's successful Phase III trials. Biogen I, slip op. at 7. However, Judge O'Malley noted "the disclosure does not teach potential dosage levels for DMF." In the priority application, Biogen's Phase II trials showed that DMF in does of 720 mg/day was efficacious in treating MS, and the FDA recommended that Biogen add a dose of DMF of 480 mg/day (to increase patient compliance and reduction in undesirable side effects). The Phase III results showed that both the 480 and 720 mg/day doses were effective. Id. at 9.

Judge Reyna noted that the specification's only recitation of dose levels was:

"... For example, an effective dose of DMF or MM[F] to be administered to a subject orally can be from about 0.1 g to 1 g per pay, 200 mg to about 800 mg per day (e.g., from about 240 mg to about 720 mg per day; or from about 480 mg to about 720 mg per day; or about 720 mg per day). For example, the 720 mg per day may be administered in separate administrations of 2, 3, 4, or 6 equal doses. Id. at 8; emphasis in original.

Judge Reyna reasoned:

Importantly for this appeal, the specification reveals two crucial aspects of the invention. First, the above paragraph features the one and only reference to DMF480 in the entire specification, which puts the DMF480 dose that the '514 Patent claims at the bottom end of the spectrum of a DMF 480-720 mg/day range. Second, the specification defines the term "effective" within a therapeutic, rather than drug-discovery, context. Thus, according to the specification, the terms "'therapeutically effective dose' and 'therapeutically effective amount' refer to that amount of a compound which results in at least one of prevention or delay of onset or amelioration of symptoms of a neurological disorder in a subject or an attainment of a desired biological outcome, such as reduced neurodegeneration (e.g., demyelination, axonal loss, and neuronal death) or reduced inflammation of the cells of the CNS." '514 col. 5 ll. 52-59 (emphases added) (Slip Op. Id.

Further, Judge Reyna reasoned:

the district court found that the specification did not reasonably convey to a person of ordinary skill in the art that the '514 Patent inventors had "actually invented" a method of treating MS with a therapeutically effective dose of DMF480 as of February 8, 2007 (the priority date).

Judge Reyna reviewed the standard for written description:

The [patent] specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.

Judge Reyna reviewed the history of the written description standard:

The Supreme Court recognized, as far back as 1822, that the purpose of requiring a written description under the Patent Act of 1793 was to "put the public in possession of what the party claims as his own

...