On May 18, 2023, the United States Supreme Court unanimously affirmed a U.S. Court of Appeals for the Federal Circuit decision regarding the enablement requirement of the U.S. Patent Law (35 U.S.C. 112(a)). In Amgen Inc. v. Sanofi, the Court held that Amgen’s antibody claims were invalid for lack of enablement.
The case has particular significance for the biotechnology and pharmaceutical industries in the U.S. where applicants often file applications where not all compositions are disclosed and the underlying science can be considered “unpredictable.”
Amgen’s Antibody Claims and the Lower Courts
Both Amgen and Sanofi each developed antibodies that help reduce levels of low-density lipoprotein (LDL) cholesterol. LDL is also known as “bad cholesterol” because it can lead to heart attacks, strokes and cardiovascular disease. The inventive antibodies were developed to inhibit a naturally occurring protein, PCSK9, that binds to and degrades LDL receptors responsible for extracting LDL from the bloodstream.
In 2011, Amgen and Sanofi each obtained patents for their respective antibodies. Amgen then obtained two additional patents in 2014 that claimed priority back to the earlier filed patent application.
Rather than claiming a specific antibody, the additional patents claimed the entire genus of antibodies that: 1) bind to specific amino acid residues on PCSK9; and 2) block PCSK9 from binding to LDL receptors.
Amgen identified the amino acid sequences of 26 antibodies that exhibit both of those functions, and also described two methods that could be used to make other antibodies that exhibit those functions.
Amgen sued Sanofi for infringement, and in response, Sanofi asserted as an affirmative defense that the relevant patent claims were invalid for lack of enablement. The enablement requirement under 35 U.S.C. §112(a) requires that a patent applicant describe their invention “in such full, clear, concise, and exact terms as to enable any person skilled in the art . . . to make and use the [invention].”
The Manual of Patent Examination Procedure further acknowledges that the test of enablement is whether, based on the sufficiency of the disclosure, one of skill in the art could make or use the invention “without undue experimentation.” (see MPEP 2164.01, citing, inter alia, In re Wands, 858 F.2d 731 (Fed. Cir. 1988) at 737).
Sanofi contended that the methods for generating additional antibodies outlined in Amgen’s disclosure were little more than a trial-and-error process of discovery, and as such the enablement requirement was not met.
Sanofi argued that because Amgen sought to claim the exclusive use of millions more antibodies than the company had taught persons skilled in the art to make, the enablement requirement was not met.
A district court jury initially found that Praluent infringed Amgen’s claims. The case was remanded back to the district court on the issue of written description/enablement and the jury again found for Amgen.
Sanofi moved for a judgement notwithstanding the jury verdict and prevailed. Amgen appealed and the Federal Circuit sided with Sanofi.
The Supreme Court Decision
The Supreme Court affirmed the lower court rulings, holding that Amgen failed to enable one skilled in the art to make and use the invention as defined by the claims due in part to the “unpredictability” of the underlying science.
From the Patent Act’s beginnings, the Court stated that the quid pro quo of obtaining a patent is that patent applicants must describe their invention in enough detail that the invention is dedicated to the public upon expiration of the patent.
Citing its own precedent in O’Reilly v. Morse, The Incandescent Lamp Patent, and Holland Furniture Co. v. Perkins Glue Co., the Court stated that 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.
However, a specification does not always have to describe with particularity how to make and use every single embodiment within a claimed class. An example in the specification may suffice if it discloses some quality running through the entire class that can define the class.
Furthermore, a specification is not necessarily inadequate if one of skill in the art must engage in some measure of adaptation or testing as long as the amount of experimentation required is reasonable.
In the present case, the Court reasoned that Amgen’s claims were much broader than the 26 antibodies and corresponding amino acid sequences provided as examples.
Amgen sought to monopolize an entire class of antibodies defined by their function (i.e., every antibody that binds to particular areas of PCSK9 and blocks PCSK9 from binding to LDL receptors).
However, this class of antibodies includes a vast number of antibodies beyond just the 26 that were disclosed.
In addition, the two methods that were described for making antibodies that exhibit the desired functions were determined to amount to little more than two trial-and-error research assignments. Even allowing for a reasonable degree of experimentation, the Court stated that Amgen failed to enable all that was claimed.
Concluding Thoughts
In Amgen v. Sanofi, the Court has affirmed an approach to enablement that has led relevant stakeholders to opine that broad genus claims are no longer possible in the life sciences.
Perhaps most impacted by the decision are small biotechnology start-ups and university technology transfer offices, which have less time and fewer resources to conduct extensive experiments before filing patent applications.
Contact the Intellectual Property Law Attorneys at METROLEX IP Law Group
Whether you are a biotechnology company that needs help patenting an antibody-based invention, or you have other intellectual property needs of any kind, the attorneys at METROLEX IP can provide you with high-quality counseling, advice and work product. Contact METROLEX IP online or over the phone at 202.979.9784.
