Redefining Enablement: The Impact of Amgen v. Sanofi on Patent Law and Biotechnology

Lana El-Etr, Contributing Member 2024-2025

Intellectual Property and Computer Law Journal

I. Introduction

The Patent Act’s enablement clause states that a patent’s specification must contain a “written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person in the skilled art to which it pertains or with which it is most nearly connected, to make and use the same.”[1] This clause requires that a patent teach a person of “ordinary skill in the art” to be able to make and use the full scope of the claimed invention without undue experimentation.[2] Courts have interpreted this standard over time, a major example being the recent United States Supreme Court decision Amgen v. Sanofi. In this case, the Court clarified that a patent’s disclosure must be specific enough so that a skilled person can make and use the invention for all the embodiments claimed, not just select claims.[3] This clarification prevents “genus” claims that cover large groups of related compounds or inventions without detailed, enabling descriptions for each.[4]

This article explains the impact and importance of Amgen v. Sanofi in the world of patent law, specifically in the field of biotechnology patents. Part II summarizes the procedural history and analyzes the reasoning behind the Supreme Court’s decision. Parts III evaluates the impact of Amgen on the enablement clause on the biotechnology and pharmaceutical industries, and the potential challenges regarding broad patent claims post-Amgen. Part IV concludes by examining the broader implications of Amgen v. Sanofi on future patent litigation, innovation strategies in the biotechnology sector, and the evolving balance between patent rights and public access to technological advancements.

II. Background

The dispute in Amgen centered around Amgen’s patent claims over a class of antibodies that lower LDL cholesterol that targets the PCSK9 protein.[5] The body produces LDL receptors that function to extract LDL cholesterol from the bloodstream.[6] When PCSK9 binds to these receptors, they are degraded, resulting in increased cholesterol.[7] Because of this phenomenon, several pharmaceutical companies began researching possible antibodies to target PCSK9, specifically to bind to a specific region of PCSK9, called the “sweet spot.” [8] When an antibody binds to the sweet spot, it prevents PSCK9 from binding and subsequently degrading LDL receptors.[9] The structure of an antibody is essential to its function as it dictates where it will bind to the antigen, which in this case is the PCSK9 protein.[10]

Amgen developed a PCSK9-inhibiting drug as treatment for lowering cholesterol under the name Repatha, whereas Sanofi–another pharmaceutical healthcare company–competed with their own antibody-based drug called Praluent.[11] Each drug used a distinct antibody with its own amino acid-based sequence.[12] Amgen obtained additional patents in 2014, called the ‘165 and ‘741 patents, which included a claim for “the entire genus” of antibodies that (1) “bind to specific amino acid residues on PCSK9,” and (2) “block PCSK9 from binding to [LDL receptors].”[13] Amgen supported this claim by identifying amino acid sequences of 26 antibodies that perform these functions, as well as three-dimensional structures for two of these antibodies.[14] In addition to this, Amgen provided two methods of making these antibodies: the “roadmap” and the “conservative substitution.”[15]

The “roadmap” method instructs scientists to generate antibodies in a lab, test them to see which ones bind to PCSK9, and then test those antibodies to see which ones bind to the “sweet spot.”[16] The “conservative substitution” method involves starting with an antibody with a known function, altering certain amino acids that have comparable properties, and seeing if the resulting antibody has similar functions to the original antibody.[17]

Procedural History

Not long after receiving these two patents, Amgen sued Sanofi for infringement.[18] Sanofi argued that they were not liable to Amgen because the relevant claims were invalid as a matter of law.[19] Sanofi reasoned that while Amgen had identified 26 known amino acid sequences to bind to PCSK9, its claims covered potentially millions of undisclosed antibodies that perform the same functions.[20] Furthermore, Sanofi argued that neither of Amgen’s outlined methods of generating additional antibodies enabled a person skilled in the ordinary art to do so reliably under Section 112 and instead prompted a “trial-and-error” process of discovery.[21]

The District Court granted Sanofi judgement as a matter of law, holding that the claim at issue did not satisfy the enablement standard.[22] The Third Circuit affirmed, holding that no reasonable person could find that Amgen provided sufficient instructions to create and use antibodies beyond the identified 26 amino acid sequences.[23] The United States Supreme Court granted Amgen’s petition for certiorari in 2022.[24]

United States Supreme Court Decision

The United States Supreme Court began by outlining the purpose of the patent “bargain,” a system where inventors receive limited protection from competition for their invention, while the public benefits from their invention.[25] This “quid pro quo” concept is foundational to U.S. patent law by requiring inventors to provide detailed specifications of their inventions, ensuring that someone skilled in the field can reproduce and utilize the invention once it becomes public.[26]

The Court began to examine the requirement of detailed disclosures, which over time has reflected the same principles of enablement, through cases such as O’Reilly v. Morse, Incandescent Lamp Patent, and Holland Furniture Co. v. Perkins Glue Co.[27] These cases clarified that when broad claims are made, patent applications are obligated to provide comprehensive guidance.[28] A broad claim must enable all possible embodiments within its scope; thus, the broader the claim, the more detailed information is required to satisfy enablement standards.[29] In cases where general qualities or adaptable methods suffice, inventors may fulfill the requirement through examples or adaptable descriptions.[30]

However, the Court reasoned those overly vague descriptions, like those in Amgen’s patent, fell short of the enablement standard because they would require others to undertake excessive trial and error.[31] Such descriptions risk granting Amgen monopolistic control beyond the scope of the invention disclosed.[32] While Amgen’s specification adequately described 26 antibody structures, the Court found that the claims attempted to cover a much broader array—an entire “kingdom” of antibodies that Amgen did not specifically describe.[33]

The Court noted that Amgen’s broad claims, which cover all antibodies that bind to PCSK9 and prevent it from binding to LDL receptors, resemble earlier cases where inventors attempted to claim entire classes of materials or technologies. For instance, in Incandescent Lamp, the inventors sought to claim all fibrous materials for light filaments, and in Morse, the inventor tried to monopolize all telegraphic communication.[34]

Amgen argued that its broad claims were justified, suggesting that scientists could replicate undisclosed antibodies by following a “roadmap” or using a method of “conservative substitution.”[35] However, the Court found that these methods were insufficient, effectively turning scientists into research assistants who would need to undertake time-consuming trial-and-error experiments.[36] Analogized to a lock with countless possible combinations, Amgen’s roadmap resembles instructions to randomly try combinations rather than an actual enabling disclosure. [37] The Court emphasized that in cases where a patent claim encompasses an entire genus of embodiments, the specification must provide more than mere general guidance—requiring instead a detailed disclosure that prevents leaving the identification of the appropriate embodiment to only trial and error.[38]

Despite Amgen’s contention that the Court of Appeals misapplied the enablement test, the Supreme Court disagreed, finding that the core issue was Amgen’s failure to provide a sufficiently detailed disclosure to enable the full scope of its claimed embodiments.[39] It further elaborated that specification may require a “reasonable amount of experimentation” in order to make and use the claimed invention, and the level of reasonableness hinges on the nature of the invention and its underlying art.[40]  Writing for the unanimous Court, Justice Gorsuch stated that enablement is not assessed based on the total time and effort required to create every possible variation covered by a claim, discloses to the public. [41] In short, the Court affirmed the Federal Circuit’s holding that the patent is invalid due to lack of sufficient enablement.[42]

III. Discussion

Impact of Amgen v. Sanofi on Patent Enablement

Although the Supreme Court declined to consider policy implications in its conclusion, the regulatory threshold it drew in Amgen fundamentally alters the foundational balance in patent law between stimulating promoting innovation without hindering competition or capitalizing upon preexisting innovation.

Supporters of the Court’s decision find the ruling accurately aligned with the purpose of the enablement clause, while critics were not so sure. Irena Royzman, from Kramer Kevin Naftalis and Frankel LLP, stated that the decision rejects the notion that a patent can broadly outline an invention and rely on the public to develop it, as this does not align with the intended quid pro quo.[43] John Masur, a professor at the University of Chicago Law School, noted that this decision will make it more difficult for companies to pioneer scientific breakthroughs.[44] If a company gets a patent that is limited to the embodiments of the invention is discovered, it will have created an opportunity for others to discover an alternative version.[45] In other words, the narrower the claims of a patent, the less the patent protects, which can be detrimental to patent owners.[46] Narrower patent claims make it easier for other inventors to construct new inventions and carefully worded claims in order to strategically work around already claimed patent subject matter.[47]

Anne Li of Crowell and Moring LLP countered that this holding was correct because it limits a company to claim what it actually did, not what someone else could do, and has the effect of restoring the enablement requirement for biotech patents to be consistent with other technological fields.[48] In other words, this ruling illustrates the Court’s ongoing efforts to promote innovation by limiting the scope of patent monopolies. For example, in biotechnology, overly broad patents on genes and biological materials have sparked controversy, as they can hinder research advancements and restrict patient access to medical treatments.[49] The Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics (2013) struck down patents on naturally occurring DNA sequences, ensuring that researchers could study and develop genetic tests without infringement concerns.[50] Similarly, in Mayo Collaborative Services v. Prometheus Laboratories (2012), the Court invalidated patents on a diagnostic method, preventing monopolies that could have stifled medical innovation.[51] By reinforcing reasonable limits on patent scope, this ruling helps prevent such barriers and fosters further scientific progress.

Others have noted that this decision will push inventors to claim less broadly, narrowly tailor descriptions, and provide more experimental examples.[52] Moreover, Moreover, the decision is expected to lead to an increase in dispositive motion practice, with accused infringers attempting to resolve enablement issues as matters of law rather than allowing them to reach a jury.[53] Additionally, litigants may advance creative arguments about the scope of Amgen’s applicability, the interplay between enablement and written description requirements, and how closely particular cases resemble historical precedents cited by the Court. Lower courts will now grapple with how to apply Amgen’s broad pronouncements to real-world disputes, particularly in life sciences and potentially beyond.[54]

Impact of Amgen v. Sanofi on Biotechnology and Pharmaceutical Companies

This case heightened the standard for establishing enablement, making it more difficult to patent genus claims that rely on functional descriptions, especially in the field of biotechnology and pharmaceuticals. This narrower standard is likely to encourage more precisely worded and defined patents, which will affect the way biotechnology and pharmaceutical companies approach innovation and developing new biologic treatments. Companies have already started invoking Amgen in litigation.[55] Within a day of the Supreme Court issuing its opinion, two pharmaceutical companies had already cited it as a defense in hopes of turning infringement suits around.[56] Some attorneys find that the decision has “provided fresh language for people to use.”[57]

Prior to the decision, there was significant support from biopharma companies.[58] For instance, GlaxoSmithKline (GSK) expressed concerns that the Amgen decision could “threaten incentives to invest in future discoveries.”[59] Other biopharma companies including AbbVie and Bristol Myers Squibb, as well organizations like the National Association of Patent Practitioners and the Intellectual Property Professors have broadcasted their support behind Amgen’s appeal in separate briefs filed to the U.S. high court.[60] Even the law division of the American Chemical Society petitioned to participate in oral arguments on behalf of Amgen.[61] These actions reflect the industry’s view that the decision could restrict patent claims, potentially hindering companies’ ability to obtain exclusive rights to their innovations and, consequently, reducing the incentives for sustained investment in the biotech and pharmaceutical sectors.

Impact on Patent Examiners

Since the Amgen decision, patent examiners face an increased workload, as they will need to review a broader range of patents with more specific technical disclosures.[62] The ruling requires them to interpret claims more narrowly, particularly for genus claims, which can be challenging given the complexity of molecular-level inventions.[63] This shift in the enablement standard demands that patent examiners pay closer attention to the sufficiency of disclosures, ensuring they meet the new, stricter requirements for clarity and specificity.

Impact on Patent Prosecutors

As a result of the Amgen decision, patent prosecutors will experience increased pressure and risk of rejection as they will need to assist in the reissuing process and provide more detailed technical disclosures to encompass all aspects of the claims. This includes describing inventions at the molecular level, which can be particularly difficult due to the inherent complexity and precision required for biotech patents.[64] Prosecutors will need to ensure that patent applications meet the Court’s heightened standards for enablement, offering a clear roadmap for replicating the invention regardless of its scope.[65]

Challenges for Broad Patent Claims

The Amgen decision highlights the fact that while broad claims face higher scrutiny, they are not completely barred from being valid. That decision rests on the subject matter’s level of predictability.[66] This is difficult to implement in the context of biotechnology and pharmacology, specifically with antibody research, as even the most minuscule alteration in the structure of an antibody will drastically change its function and performance.[67] Based on this unpredictability, it is difficult to distinguish what exactly is patentable. Antibody patents may become more predictable in the future with the help of artificial intelligence, but science has yet to advance to that point.

IV. Conclusion

In sum, the Supreme Court’s ruling in Amgen v. Sanofi marks a significant shift in patent law, particularly within the biotechnology and pharmaceutical sectors. By emphasizing the requirement for specific, enabling disclosures, the Court has tightened the standards for patent claims that attempt to cover broad categories of inventions, known as genus claims. This decision not only reinforces the foundational “bargain” principle of patent law—where inventors are rewarded for their innovations while ensuring the public can access and build upon them—but also imposes new challenges for patent applicants. Companies will now be compelled to craft more precise and detailed specifications, ensuring they provide adequate guidance for others to replicate their inventions without excessive experimentation.

As the field of patent law continues to evolve, biotechnology firms may need to adapt their strategies by focusing on refining their claims and disclosures to align with the Court’s expectations. The implications of this ruling are already being felt, as it has prompted a reevaluation of existing patent portfolios and a renewed emphasis on the importance of specificity in patent applications. Moving forward, the tension between fostering innovation and maintaining competitive markets will be at the forefront of patent law. As companies navigate this new legal environment, the ongoing development of technologies, including artificial intelligence, may eventually provide additional tools to enhance the predictability of patentable inventions, although the scientific community acknowledges that the necessary advancements are still forthcoming. Thus, Amgen v. Sanofi serves as a pivotal case that will both positively and negatively shape the future of patent law, innovation, and competition in the biopharmaceutical industry.

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[1] 35 U.S.C. § 112(a) (2018).

[2] Key Takeaways from the USPTO’s New Guidance on Written Description and Enablement, Dentons, (Jan. 12, 2024), https://www.dentons.com/en/insights/alerts/2024/january/12/key-takeaways-from-the-usptos-new-guidance-on-written-description-and-enablement [https://perma.cc/SL7A-EKHJ].

[3] Amgen Inc. v. Sanofi, 598 U.S. 594, 613 (2023).

[4] Id.

[5] Id. at 598.

[6] Id. at 599.

[7] Amgen, 598 U.S. at 598.

[8] Id. at 602.

[9] Id.

[10] Id. at 601.

[11] Amgen, 598 U.S. at 602-603.

[12] Id. at 598.

[13] Id. at 603.

[14] Id.

[15] Amgen, 598 U.S. at 603-604.

[16] Id. at 603.

[17] Id at 600.

[18] Id. at 603.

[19] Id. 

[20] Amgen, 598 U.S. at 603.

[21] Id. at 604.

[22] Id.

[23] Id.

[24] Amgen, 598 U.S. at 604.

[25] Id.

[26] Id. at 604-605.

[27] Id. at 605-606.

[28] Amgen, 598 U.S. at 604.

[29] Id. at 613.

[30] Id. at 611.

[31] Id. at 614.

[32] Amgen, 598 U.S. at 613.

[33] Id.

[34] Id. at 610.

[35] Id. at 603.

[36] Amgen, 598 U.S. at 614.

[37] Id. at 614-615.

[38] Id. at 616.

[39]  Id. at 599.

[40] Id. at 612.

[41] Amgen, 598 U.S. at 608.

[42] Id. at 616.

[43] Ryan Davis, Justices Clamp Down On Broad Patents In Amgen Decision, Law360 (May 18, 2023, 10:15 PM EDT), https://www.law360.com/articles/1679257/ [https://perma.cc/C5ZT-6NRQ].

[44] Id.

[45] Id.

[46] Manual of Patent Examining Procedure (MPEP) § 2173.05(c) (9th ed., rev. 10.2019).

[47] Id.

[48] Davis, supra note 43.  

[49] Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 590 (2013).

[50] Id.

[51] Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 92 (2012).

[52] Jeremy Edwards & Robert Sloss, 5 Takeaways from the U.S. Supreme Court Decision in Amgen v. Sanofi, Procopio, Cory, Hargreaves & Savitch LLP (May 23, 2023), https://www.procopio.com/5-takeaways-scotus-amgen-sanofi/ [https://perma.cc/Q35V-CS7F].

[53] Id.

[54] Id.

[55] Dani Kass, What IP Attys Should Know About Enablement After Amgen, Law360 (May 22, 2023, 9:49 PM EDT), https://www.law360.com/articles/1679839 [https://perma.cc/AZ7F-D39Y].

[56] Id.

[57] Id.

[58] Amid Supreme Court Patent Fight, Sanofi-Amgen Garners Wide Support from Pharma Peers and IP Groups, Fierce Pharma (May 18, 2023), https://www.fiercepharma.com/pharma/amid-supreme-court-patent-fight-sanofi-amgen-garners-wide-support-pharma-peers-and-ip-groups [https://perma.cc/2SN2-P5LM].

[59] Alex Baldwin, GSK Claims Amgen v. Sanofi Decision Threatens Innovation, LIFE SCIENCES IP REVIEW (May 25, 2023), https://www.lifesciencesipreview.com/americas/gsk-claims-amgen-v-sanofi-decision-threatens-innovation-4442 [https://perma.cc/9KLU-ETT8].

[60] Id.

[61] Id.

[62] Ryan Davis, What Innovators Can Expect in the Patent World After Amgen, LAW360 (July 11, 2023, 6:43 PM EDT), https://www.law360.com/articles/1688115/what-innovators-can-expect-in-the-patent-world-after-amgen [https://perma.cc/XE33-RNCZ].

[63] Id.

[64] Id.

[65] Id.

[66]Amgen Inc. v. Sanofi: Implications for Broad Patent Claims, THE NATIONAL LAW REVIEW (July 17, 2023), https://natlawreview.com/article/watch-post-amgen-enablement-case-law-united-states-patent-and-trademark-office  [https://perma.cc/NZ4R-4NKM].

[67] Mark L. Chiu et al., Antibody Structure and Function: The Basis for Engineering Therapeutics, 8 Antibodies 55 (2019).