Shaping the Future of Patent Law: The Amgen v. Sanofi Decision and Bite-Sized Monopolies

Shaping the Future of Patent Law: The Amgen v. Sanofi Decision and Bite-Sized Monopolies

by Dennis Crouch

“The more one claims, the more one must enable.”

In a unanimous opinion delivered by Justice Gorsuch, the Supreme Court has affirmed the Federal Circuit’s decision invalidating Amgen’s functionally claimed genus of monoclonal antibodies. The Court held that Amgen’s patent claims were invalid due to a lack of enablement, as they failed to provide adequate guidance for making and using the claimed antibodies.

The case in question is Amgen Inc. v. Sanofi, 22-157, — U.S. — (2023) (21-757_k5g1).

Amgen’s patents cover monoclonal antibodies created by Amgen researchers which aid in reducing blood levels of low-density lipoprotein (LDL), also known as “bad cholesterol.” These antibodies inhibit the operation of a naturally occurring protein known as PCSK9, which degrades LDL receptors and contributes to high cholesterol levels. Amgen’s original patent covered antibodies having particular amino acid sequences, but later its competitor Sanofi patented another antibody with a different sequence from those disclosed and began competing.   Amgen was then able to obtain the broader patents at issue here that are not tied to any particular antibody structure or amino acid sequence. Rather, the claims cover an “entire genus” of antibodies capable of binding to specific amino acid residues on PCSK9 and consequently inhibit PCSK9 activity. Amgen subsequently sued Sanofi for infringement, prompting a defense from Sanofi challenging whether these broader claims were sufficiently enabled.

The Patent Act requires that patent applicant describes the invention in explicit terms to enable any person skilled in the art to make and use the invention. 35 U.S.C. 112. Sanofi characterized the methods Amgen provided for generating additional antibodies as merely a trial-and-error process, claiming that Amgen’s patents failed the enablement requirement as they sought exclusive use over potentially millions more antibodies than the company had taught how to produce. Although a jury sided with the patentee Amgen, the district court and the Federal Circuit agreed with Sanofi’s contention, ruling that Amgen did not meet the enablement requirement as a matter of law.

The enablement requirement is a crucial aspect of the patent “bargain”: an inventor is granted limited protection from competition in exchange for publicly disclosing their new technology. The Supreme Court, in its decision, referenced previous cases such as Morse, Incandescent Lamp, and Holland Furniture, as establishing the requirement that if a patent claims an entire class or genus of processes, machines, or compositions of matter, the specification must enable a person skilled in the field to make and use the entire class. In simpler terms, it follows the elementary school principle: If you bring cookies to share, bring enough for everyone.

If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class. In other words, the specification must enable the full scope of the invention as defined by its claims.

The more one claims, the more one must enable. See §112(a); see also Continental Paper Bag Co. v. Eastern Paper Bag Co., 210 U. S. 405 (1908) (“[T]he claims measure the invention.”).

Amgen v. Sanofi.

In this case, Amgen sought exclusivity for the entire class of functional antibodies, not just the 26 antibodies expressly disclosed.  Although Amgen also provided a “roadmap” for discovering more antibodies, the court found that those approaches were insufficient “research assignments” rather than a clear process for creating the additional antibodies. The Supreme Court ruled that these disclosures did not fulfill the enablement requirement as per the Patent Act, as they simply described Amgen’s trial-and-error method without providing sufficient information for skilled scientists to make the entire class of claimed antibodies.

The Supreme Court did agree with Amgen that functional/genus claims should not be held to a stricter standard of enablement. In other words, there is “one statutory enablement standard.” Nonetheless, the general principle remains that broader claims necessitate more enablement, and all claims must be enabled to their “full scope.”

The outcome of the Amgen v. Sanofi case, while significant, may not come as a surprise to those familiar with the evolution of patent law. In recent years, there has been a growing emphasis on promoting innovation and competition by limiting the scope of patent monopolies. This approach recognizes that patents should strike a balance between incentivizing inventors to disclose their inventions and ensuring that the public can freely build upon existing knowledge. Rather than granting broad and far-reaching patent rights, the trend has been towards encouraging more focused and narrowly tailored claims. This shift reflects a recognition that patents are more palatable when they offer bite-sized protection rather than providing a singular and overpowering monopoly. The ruling in the Amgen v. Sanofi case aligns with this approach, reinforcing the notion that patents should enable the creation and use of the claimed inventions while still allowing for competition and further advancements in the field.