A closely watched and hotly debated life sciences patent dispute saw the U.S. Supreme Court affirm a narrow interpretation of patent enablement when filing for patent protection. The Supreme Court’s May 18 decision raised the bar for what information patent applicants may have to provide in order to meet the long-standing requirement that someone reasonably skilled in the art could make or use the invention as claimed without undue experimentation given the information provided in the patent disclosures and common knowledge in the field. In the dispute in question, the Court ruled that functional genus claims are not enabled by the specification disclosing as many as 26 species that belong to the functional genus and general methods for obtaining the genus. 

The long-running dispute involved three makers of cholesterol drugs—Sanofi and Regeneron Pharmaceuticals, who are partners in marketing one brand of drug, versus rival Amgen Inc. At issue are Amgen’s patent claimsi that are directed to the genus of antibodies that bind to specific amino acid residues of PCSK9 and block PCSK9 from binding to LDL receptors, not tied to any specific structures or sequences.

The U.S. Court of Appeals for the Federal Circuit sided with the Sanofi and Regeneron and found two of Amgen’s drug patents invalid because they failed to meet the enablement requirement, which requires applicants to disclose enough specific details in the patent application  so that “one reasonably skilled in the art could make or use the invention from the disclosures in the patent coupled with information known in the art without undue experimentation.” The Federal Circuit denied Sanofi’s motion for lack of written description, which is another hotly contested issue for antibody claims.

In a unanimous decision on May 18, the Supreme Court upheld the Federal Circuit Court of Appeals’ decision that Amgen’s patent applications lacked the specificity to enable the claims at issue, even though Amgen identified the amino acid sequences of 26 antibodies that perform the claimed functions.

Amgen had argued for a broader interpretation of enablement and claimed it provided sufficient information in its patent applications. Amgen said its antibodies in the two cholesterol drugs could be made or used through “well-known screening techniques.” But Justice Neil Gorsuch compared this to “little more than two research assignments” in his written opinion.

Functional genus claims are a common patent protection strategy in biotech, chemical and pharmaceutical related patents. Under this strategy, a patent holder asserts that protections apply not only to a specific composition, but also to related compositions. The effect is a much broader scope of patent protection for patent holders in these fields of technology, for example.

Sanofi and Regeneron argued that patent applicants must clear a higher bar and provide greater detail to meet the enablement requirement.

The Supreme Court also rejected Amgen’s arguments that narrowing the scope of patent enablement would stifle innovation. Amgen controls more than two-thirds of the market share in this particular category of cholesterol drug (PCSK9 inhibitors), and the defendants argued that companies like Amgen should reap the benefits of their inventions.

But the Justices said Congress, not the courts, should draw the line between rewarding inventors and insuring the public benefits from those innovations. “Since 1790, Congress has included an enablement mandate as one feature among many designed to achieve the balance it wishes. Our only duty in this case lies in applying that mandate faithfully,” the Court wrote.

The case was of particular interest to companies in the life sciences and chemical sectors. But the narrower interpretation of enablement also could impact other types of patents. Legal observers in the life sciences community were divided on the case, with industry insiders seeing merits to both arguments.

Moving forward, in some instances, companies may consider offering additional details and examples on various species, applications, categories, and embodiments when preparing patent applications. This likely creates additional work and expense for applicants on the front end, but it may well offer greater protection against future challenges to any granted patents. Importantly, companies should carefully evaluate asserting functional genus claims even if they are supported by multiple species and may meet the written description requirement.

Also, expect more challenges to existing patents on enablement grounds. The Supreme Court has made it clear it takes a narrow view of this test’s scope, so be prepared to see enablement tested more frequently in the future.

i US Patent No. 8,829,165 (Amgen)
1. An isolated monoclonal antibody, wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDLR.

US Patent No. 8,859,741 (Amgen)
1. An isolated monoclonal antibody that binds to PCSK9, wherein the isolated monoclonal antibody binds an epitope on PCSK9 comprising at least one of residues 237 or 238 of SEQ ID NO: 3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDLR.