Patent invalidation is the process of declaring a patent null and void. A patent can be invalidated on the grounds of lack of novelty, lack of inventive step, obviousness, insufficiency, or bad faith. A patent can also be invalidated if the subject matter is not patentable, if it does not meet the requirements of the applicable patent law.
In Amgen Inc. v. Sanofi (2023)[1], the US Supreme Court unanimously affirmed that a “patent's specification must describe the invention ‘in such full, clear, concise, and exact terms as to enable a skilled person in the art’ to ‘make and use’ the invention”.
Citing earlier judgments, it reiterated that: “The definiteness of a specification must vary with the nature of its subject. Addressed as it is to those skilled in the art, it may leave something to their skill in applying the invention.”
The petitioners, Amgen, had been granted two patents. With these patents, Amgen claimed a monopoly over all antibodies that specifically: (a) bind to amino acids on a naturally occurring protein known as PCSK9, which raises Low-Density Lipoprotein (LDL); and,(b) block PCSK9 from impairing the body’s ability and mechanism for removing LDLs (commonly referred to as “bad cholesterol”) from the bloodstream.
Soon after receiving these patents, Amgen sued respondents (Sanofi) for infringement. In response, Sanofi argued that the patents were invalid for lack of enablement, because Amgen, the applicant, had failed to describe its invention “in such full, clear, concise, and exact terms as to enable any person skilled in the art…to make and use the [invention].”
Thus, Sanofi contended that Amgen’s patents failed to meet this standard under §112(a),US Code, Title 35 — Patents. The district court and Federal Circuit ruled in favour of Sanofi.
Hence, Amgen filed its appeal before the US Supreme Court.
The core legal question for the court to adjudicate fell on a narrow compass. It was whether a specification that describes a broad functional claim must enable a person of ordinary skill in the art (PHOSITA) to make and use every embodiment within that claimed class. Or, whether it is acceptable for reasonable experimentation to enable discovery of remaining embodiments.
The Court held that if a patent claims an entire class (a broad genus), the specification must enable the full scope of that class without requiring undue experimentation. The longstanding jurisprudential tenet of “the more one claims, the more one must enable” was reiterated. It ruled that the claims were not enabled, because Amgen’s disclosure (26 exemplars) did not teach how to make and use the vast number of antibodies captured by the claims and left investigators to “hunt” for the remainder.
The court further observed that Amgen’s patents claimed a broad "genus" of antibodies on the basis of function, not structure. However, the patent specifications only described a small number of particular antibodies. The Court emphasized that enablement is a function of claim scope, and broader claims demand commensurately greater disclosure.
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Amgen argued that its patent provided a "roadmap" for scientists to create other antibodies, which the court opined was insufficient. It concluded that this merely amounted to a "research assignment" and would require extensive, undue experimentation.
Importantly, the Court clarified that it was not creating a new rule or test standard for the enablement doctrine. Rather, it applied existing principles (including the classic Wands factors) to conclude Amgen’s claims were overbroad relative to its disclosure. Hence, the existing precedent that a patent must enable the full scope of what it claims was reaffirmed.
The Supreme Court's decision upheld the lower courts' rulings that Amgen's patents were invalidated for lack of enablement.
The Supreme Court unanimously affirmed the Federal Circuit’s judgment. The court ruled that Amgen's patents were invalid for failing to meet the "enablement" requirement of patent law and that Amgen's patent claims were too broad because they covered millions of antibodies but only described a few.
The decision confirmed that a patent holder must enable every species covered by the claim, and broad claims require a correspondingly broad enablement disclosure. The ruling provides greater clarity for patent holders and the pharmaceutical industry by reinforcing the requirement for detailed, specific enablement for broad claims. Practitioners view the ruling as a significant tightening of protection for functional-genus claims, especially in biologics.
The decision forced patenting professionals to advise inventors and applicants in bio-tech to either narrow claim scope, provide richer disclosure (more sequences/structural data), or file narrower, multiple applications. The USPTO too issued examiner guidance referencing the decision and the Wands Analysis.
At Blaze Ventures, we have qualified professionals and elaborate processes for assisting enterprises and inventors ensure biotechnology and pharmaceuticals claims, particularly in the biologics space, meet the ‘enablement requirement’ and are held ‘patentable’.
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[1] 598 U.S.594, 143 S. Ct. 1243
