Pharma-Related Patent Enablement Reaches the Highest Court
Pharma-Related Patent Enablement Reaches the Highest Court
The U.S. Supreme Court has agreed to hear a case that is extremely significant for companies that operate in the biotechnology, pharmaceutical, and chemical sectors. At issue in Amgen v. Sanofi[1] is a determination of the appropriate legal standard to be applied between whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. §112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “‘time and effort.’” The patents at issue, which are owned by Amgen, cover the cholesterol medication, Repatha®. In a February 2021 decision,[2] the Federal Circuit invalidated Amgen’s asserted patent claims for failing to satisfy the statutory enablement requirement.
Of note, Amgen’s relevant patent claims cover a genus of antibodies that bind to particular amino acid residues on a target PCSK9 protein. The salient technical issue is that these patent claims have the potential to include an expansive number (e.g., 1,000,000+) of currently unknown antibodies that have the claimed amino acid binding profile. The relevant patent specification does not contain all of the details of these unknown antibodies. This type of situation, wherein the production of each embodiment (i.e., antibody) within the full scope of a broad genus claim is not disclosed in the patent specification, is arguably the current state of affairs in the biotechnology, pharmaceutical, and chemical sectors, irrespective of how much capital and human resources any company may have.
The potential death of the genus claim, as Professors Karshtedt, Lemley, and Seymore have coined it[3], is, in a word, troubling. Antibodies – as just one example – constitute a ~$145 billion annual market[4], and much of that market is built on the strength of patents that routinely cover a genus of antibodies. To require patent applicants to limit their claim scope to a small number of species of antibodies arguably creates an almost impossible burden for obtaining sufficient patent protection to secure the financing necessary to bring these remarkable therapeutics to patients.
Innovative companies, particularly those with reduced research budgets for carrying out the necessary experimental data to more fully support genus claims, should be on high alert with respect to how this case is decided. In the interim and going forward, working with experienced and sophisticated legal advisors is an absolute must as the industry adapts to the constantly evolving patent laws.
[1] Case number: 21-757.
[2] Amgen Inc. v. Sanofi, 987 D.3d 1080 (Fed. Cir. 2021).
[3] Karshtedt et al. (2021) “The Death of the Genus Claim”, Harvard Journal of Law & Technology, 35(1).
[4] Lemley & Sherkow (2022) “The Antibody Patent Paradox”, Yale Law Journal, forthcoming.
About the Authors
Raph Y. Kim
Raph focuses on the strategic management of patent prosecution and patent portfolio development in a variety of life science technologies including pharmaceutical compounds, chemicals, and biomaterials. A chemical engineer, Raph has conducted advanced biological experiments for human stem cell research and tissue engineering, e.g., by designing and fabricating microfluidic chips and nano/micro-scale surface patterns, and has experience in molecular biology, genetic modification, biochemical assays, advanced imaging, and nano/micro technology for biological uses. He once clerked for the largest law firm in South Korea.
Raph focuses on the strategic management of patent prosecution and patent portfolio development in a variety of life science technologies including pharmaceutical compounds, chemicals, and biomaterials. A chemical engineer, Raph has conducted advanced biological experiments for human stem cell research and tissue engineering, e.g., by designing and fabricating microfluidic chips and nano/micro-scale surface patterns, and has experience in molecular biology, genetic modification, biochemical assays, advanced imaging, and nano/micro technology for biological uses. He once clerked for the largest law firm in South Korea.
Jeffrey D. Morton, PhD
Jeff provides strategic intellectual property advice, including patent prosecution, and related transactional support for emerging and mature companies in a wide variety of industries, with a particular focus on life sciences and medical technologies. A PhD immunologist, he has extensive patent experience in technologies including genomics, immunology, and gene editing technologies, and advises on complex freedom-to-operate life sciences issues. Jeff also maintains an active trademark practice and provides cross-border legal advice with Canadian clients, being admitted in both the U.S. and Canada. He leads Procopio’s Life Sciences practice and co-leads its Licensing and Technology Transactions practice.
Jeff has been recognized by the World Intellectual Property Review as a U.S. Patent Leader and Trademark Leader and as an IAM Strategy 300 world-leading IP strategist.
Jeff provides strategic intellectual property advice, including patent prosecution, and related transactional support for emerging and mature companies in a wide variety of industries, with a particular focus on life sciences and medical technologies. A PhD immunologist, he has extensive patent experience in technologies including genomics, immunology, and gene editing technologies, and advises on complex freedom-to-operate life sciences issues. Jeff also maintains an active trademark practice and provides cross-border legal advice with Canadian clients, being admitted in both the U.S. and Canada. He leads Procopio’s Life Sciences practice and co-leads its Licensing and Technology Transactions practice.
Jeff has been recognized by the World Intellectual Property Review as a U.S. Patent Leader and Trademark Leader and as an IAM Strategy 300 world-leading IP strategist.
Robert “Bob” Ramos
Bob assists venture-backed startups, mid-sized companies, basic research institutes, as well as large biopharmaceutical companies related to worldwide patent and trademark acquisition and strategic counseling in the biotechnology arts, including molecular biology, antibodies/peptibodies, protein therapeutics, cancer therapies, gene therapy, cellular immunotherapy, and nucleic acids; as well as next generation sequencing and modern genomics, including microfluidics, microarrays, bioinformatic and pharmacogenomic analysis for personalized medicine and companion diagnostics. Bob’s practice includes preparing and prosecuting U.S. and foreign patent applications, patent landscape analysis, opinion work, including patentability, non-infringement, invalidity and freedom-to-operate opinions. He also provides due diligence analysis in connection with venture capital, public and private financing, mergers & acquisitions; as well as litigation support, post-Grant Oppositions, and worldwide Trademark procurement and enforcement strategy.
Bob has extensive Biopharma industry experience where he participated in hundreds of detailed global patent strategy decisions for high value IP assets. As part of an extensive patent strategy, Bob co-managed the expedited generation of a lead recombinant protein and its accelerated pre-clinical development to acceptance for First-In-Human clinical trials. Bob practiced at Amgen for over 10 years, where he was the lead IP Attorney for 2 commercial and 2 Phase I biologics. Bob also managed the worldwide procurement and enforcement strategy for a trademark portfolio comprising hundreds of registered trademarks protecting numerous pharmaceutical products.
Bob assists venture-backed startups, mid-sized companies, basic research institutes, as well as large biopharmaceutical companies related to worldwide patent and trademark acquisition and strategic counseling in the biotechnology arts, including molecular biology, antibodies/peptibodies, protein therapeutics, cancer therapies, gene therapy, cellular immunotherapy, and nucleic acids; as well as next generation sequencing and modern genomics, including microfluidics, microarrays, bioinformatic and pharmacogenomic analysis for personalized medicine and companion diagnostics. Bob’s practice includes preparing and prosecuting U.S. and foreign patent applications, patent landscape analysis, opinion work, including patentability, non-infringement, invalidity and freedom-to-operate opinions. He also provides due diligence analysis in connection with venture capital, public and private financing, mergers & acquisitions; as well as litigation support, post-Grant Oppositions, and worldwide Trademark procurement and enforcement strategy.
Bob has extensive Biopharma industry experience where he participated in hundreds of detailed global patent strategy decisions for high value IP assets. As part of an extensive patent strategy, Bob co-managed the expedited generation of a lead recombinant protein and its accelerated pre-clinical development to acceptance for First-In-Human clinical trials. Bob practiced at Amgen for over 10 years, where he was the lead IP Attorney for 2 commercial and 2 Phase I biologics. Bob also managed the worldwide procurement and enforcement strategy for a trademark portfolio comprising hundreds of registered trademarks protecting numerous pharmaceutical products.
Xiaofan “Frank” Yang, PhD
Dr. Yang provides comprehensive IP strategic counseling to public and private biotechnology, pharmaceutical, digital health and medical device companies. His patent counseling and prosecution experience creates and protects IP assets as primary value propositions for growth enterprises in all stages of business, from proof of concept to clinical development, regulatory approval and product launch. Dr. Yang is also experienced in conducting due diligence in complex venture financings, public offerings, partnering/licensing transactions, and mergers and acquisitions. Dr. Yang has a global client base, including companies and investors in U.S., Europe, and Asia. After obtaining his B.S. in polymer chemistry and Ph.D. in organic synthesis, Dr. Yang worked as a medicinal chemist in the pharmaceutical industry for more than four years before becoming a patent practitioner in 2006. He is a member of the firm’s Management Committee.
Dr. Yang provides comprehensive IP strategic counseling to public and private biotechnology, pharmaceutical, digital health and medical device companies. His patent counseling and prosecution experience creates and protects IP assets as primary value propositions for growth enterprises in all stages of business, from proof of concept to clinical development, regulatory approval and product launch. Dr. Yang is also experienced in conducting due diligence in complex venture financings, public offerings, partnering/licensing transactions, and mergers and acquisitions. Dr. Yang has a global client base, including companies and investors in U.S., Europe, and Asia. After obtaining his B.S. in polymer chemistry and Ph.D. in organic synthesis, Dr. Yang worked as a medicinal chemist in the pharmaceutical industry for more than four years before becoming a patent practitioner in 2006. He is a member of the firm’s Management Committee.
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