By Nicholas L. Lush and Thomas R. Knight
Last month, the Supreme Court affirmed a case that is likely to have lasting repercussions for the future of patent litigation, especially within the field of life sciences. This case, Amgen Inc. et al. v. Sanofi et al. (decided May 18, 2023), follows the efforts of two pharmaceutical companies – Amgen and Sanofi – to secure exclusive rights to antibodies engineered to lower low-density lipoprotein (LDL) cholesterol.
LDL cholesterol is sometimes known as the “bad” cholesterol due to its association with negative health effects such as cardiovascular disease, heart attacks, and strokes. Both companies have created antibodies designed to reduce LDL cholesterol levels in patients by (1) binding to particular, naturally-occurring proteins in the body and (2) preventing the proteins from binding to LDL receptors. To protect their respective antibodies, both companies filed patents that specify the specific amino acid sequences of the developed antibodies.
The issue of this case originates from a second set of patents filed by Amgen, which included claims directed to every antibody that binds to the same proteins in the same way as their developed antibody. These types of claims are known as “genus” claims and are designed to protect an entire class of antibodies that operate in the same way as the claimed antibody. In this manner, genus claims can be very broad and are often filed by early-stage companies trying to secure expansive rights to incentivize external investment and/or to prevent being blocked by competitors innovating in the same technical area.
When a company or inventor files a patent application, the patent represents an exchange with the federal government. Pending approval of the patent application, the applicant receives the right to exclude others from making, using, selling, or importing into the U.S. the patented invention for a predetermined period of time (typically about 20 years after the filing date). In exchange for this limited term “monopoly,” the applicant must disclose the conceived invention to the degree that anyone skilled in the relevant field of art could make and use the disclosed invention after the applicant’s exclusive rights have ended. In particular, the disclosure must be sufficient for this skilled person to be able to practice the claimed invention without undue experimentation. This is called the “enablement” requirement. A patent application that lacks a sufficiently enabling description of the invention cannot result in a valid patent claiming that invention.
In this case, the Supreme Court unanimously agreed that Amgen had not disclosed enough information for someone skilled in the art of engineering antibodies to successfully recreate every type of antibody in the claimed class of antibodies. Amgen identified the amino acid sequences of 26 antibodies that perform the two LDL-reducing functions outlined above. To extend their enablement to all potential antibodies in the same class and function, Amgen provided two forms of trial-and-error approaches in an attempt to also describe all potential future antibodies. Even Sanofi agreed that Amgen had likely disclosed sufficient information to enable the 26 exemplary antibodies. However, because the claims covered more than these 26 enabled antibodies, the claims were not sufficiently enabled to satisfy the patent requirements.
The Court stated that “Amgen’s patents failed to meet [the enablement] standard because they sought to claim for Amgen’s exclusive use potentially millions more antibodies than the company had taught scientists to make . . . [i]n the field of antibodies, some scientists estimate that there may be as many unique antibodies as there are stars in the galaxy”. Rather than providing a means of enabling these countless millions of antibodies through a reasonable amount of experimentation, the Court described Amgen’s efforts at enablement more as a “hunting license” that would lead those endeavoring to replicate this invention to “random trial-and-error discovery”.
The ramifications of the Court’s finding may be far-reaching, especially in the field of life sciences. For those who pursue patents with genus claims, there may now be pressure to narrow the claims of the invention or to include more experimental examples to demonstrate and support enablement. This finding may also affect those who have conducted patent searches and risk assessments of patents with genus claims. Likewise, patents with genus claims may now be more susceptible to invalidity challenges by competitors, similar to Sanofi's challenge to the Amgen patent.
For assistance with navigating the enablement requirements and determining how this latest decision may affect your company’s portfolio and IP strategy, please contact your attorney at Andrus Intellectual Property Law.
Attorneys Joseph D. Kuborn, Aaron T. Olejniczak, Peter T. Holsen and Thomas R. Knight were selected for inclusion in Managing IP's 2023 edition of the IP Stars list as Patent Stars. Managing IP’s World IP Survey covers over 80 jurisdictions, and the rankings are based on extensive research among IP practitioners carried out over six months. A team of researchers seeks responses from thousands of firms and clients. IP Stars highlights attorneys with a strong understanding of products and industry areas, as well as the requisite legal experience.
Andrus was once again included in the guide entitled IAM Patent 1000, which is a standalone publication that identifies individual and firm expertise in all major areas of patent law and practice. Through an extensive research process by a team of highly qualified analysts, the publication identifies the top patent practitioners and law firms in 40 of the world’s most important jurisdictions and 20 U.S. states. In addition to firm-wide recognition, Edward R. Williams, Joseph D. Kuborn, Aaron T. Olejniczak, Peter T. Holsen, Christopher R. Liro, Benjamin R. Imhoff, Ryann H. Beck and Emily M. Chilson were featured individually, based on positive feedback from clients and associates.
Andrus was selected as a ranked law firm in Chambers USA 2023, identifying our firm as one of the best firms in Wisconsin in the field of intellectual property law. In addition to the firm-wide ranking, Joseph D. Kuborn was included as a Ranked Lawyer in IP and Aaron T. Olejniczak was included as a Ranked Lawyer in IP and IP Litigation. Chambers ranks lawyers and law firms based on the research of over 170 full-time editors and researchers at their head office in London. Researchers talk to lawyers and clients, conduct in-depth telephone interviews, and review submission forms provided by law firms.
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