Federal Circuit Report

• Publication year: 2023
• Author: Naveed Hasan

FEDERAL CIRCUIT REPORT

Naveed Hasan

Reichman Jorgensen Lehman & Feldberg LLP

[With contributions by Philip Eklem, Reichman Jorgensen Lehman & Feldberg LLP.]

This article discusses the Supreme Court's decision in Amgen Inc. v. Sanofi¹ as to the issues related to the enablement requirement of 35 U.S.C. § 112(a).² In Amgen, the Court affirmed the Federal Circuit's decision that Amgen's patent claims did not satisfy the enablement requirement.³While the case primarily related to the enablement requirement of 35 U.S.C. § 112(a), it also relates to the public policy surrounding claim scope. This article addresses the Court's analysis and its impact on claim scope.

THE COURT'S ANALYSIS

Background

In 2014, Amgen obtained U.S. Patent Nos: 8,829,165 ('165 patent) and 8,859,741 ('741 patent),⁴ directed to antibodies that (1) "bind to specific amino acid residues on PCSK9," and (2) "block PCSK9 from binding to LDL receptors."⁵ Claims 19 and 29 of the '165 patent and claim 7 of the '741 patent claimed an entire genus of antibodies to perform the two functions.⁶ After Amgen sued Sanofi for patent infringement, Sanofi responded in the district court that claims 19 and 29 of the '165 patent and claim 7 of the '741 patent were invalid for failing to satisfy the enablement requirement under 35 U.S.C. § 112(a).⁷ Sanofi argued that the claims at issue covered potentially millions of undisclosed antibodies.⁸ Amgen disagreed and argued that the claims were enabled because "scientists can make and use every undisclosed but functional antibody if they simply follow the company's 'roadmap' or its proposal for 'conservative substitution.'"⁹ The district court agreed with Sanofi and granted Sanofi judgment as a matter of law, holding that claims were not enabled.¹⁰ The Federal Circuit affirmed.¹¹

The Court's Analysis

The Patent Bargain

The Court began its analysis by discussing the "patent-bargain."¹²The Court explained that patent law offered a "quid-pro-quo" to patent owners: the government provides a monopoly over an invention for a given time period because a patent owner fully discloses their invention to enable a person of skill in the art to carry out the invention.¹³ This concept allows for the patent owner to benefit from the monopoly of their invention

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and the public to benefit from the full disclosure of the invention.¹⁴ Congress's intention was to promote innovation by providing a fully disclosed invention to the public.¹⁵ The Court stated "today, just as in 1790, the law secures for the public its benefit of the patent bargain by ensuring that, 'upon the expiration of [the patent], the knowledge of the invention [i]nures to the people, who are thus enabled without restriction to practice it.'"¹⁶ The Court further noted that if a patent disclosure fails to enable the invention, "the public does not receive its benefit of the bargain."¹⁷ In its current form, the enablement requirement is rooted in 35 U.S.C. § 112(a), which states:

The 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.¹⁸

The Court's Reliance on Previously Decided Supreme Court Cases

The Court relied on previously decided cases that centered around the enablement requirement for its analysis, including O'Reilly v. Morse;¹⁹ The Incandescent Lamp Patent;²⁰ and Holland Furniture Co. v. Perkins Glue Co.²¹ Each of these cases dealt with patents that claimed more than they enabled.²²

Morse involved a patent directed to a telegraphic system.²³ The patent included eight claims, seven of which were limited to telegraphic structures and systems.²⁴ The Court held that the eighth claim of the patent was not enabled by the specification because the claim covered all means of achieving telegraphic communication, but the specification did not describe how to make and use them all.²⁵ The Court indicated that the claim covered the "essence" of the invention, and therefore, the enablement requirement was not satisfied.²⁶

Incandescent Lamp involved a patent that claimed an electric lamp with an "incandescing conductor" made of "carbonized fibrous or textile material."²⁷The patent owners, William Sawyer and Albon Man, alleged that Thomas Edison infringed their patent because Edison's lamp used bamboo (i.e., a fibrous or textile material).²⁸ The Court held that the patent claim at issue was too broad and the specification did not describe "'a quality common' to fibrous and textile substances that made them 'peculiarly' adapted to incandescent lighting."²⁹ The Court further noted that Edison discovered using bamboo for the lamp only through "painstaking experimentation."³⁰

Holland Furniture involved a patent for starch glue for wood veneering.³¹ The patent claimed, "starch glue which, [when] combined with about three parts or less by weight of water, will have substantially the same properties as animal glue."³² The Court held that "[o]ne attempting to use or avoid the use of Perkins' discovery as so claimed and described functionally could do so only after...