Hostname: page-component-6bf8c574d5-qdpjg Total loading time: 0 Render date: 2025-02-17T01:08:01.701Z Has data issue: false hasContentIssue false
  • English
  • Français

Amgen v. Sanofi: The U.S. Supreme Court Reviews Patent Enablement

Published online by Cambridge University Press:  13 December 2023

Gregory Curfman Open the ORCID record for Gregory Curfman [Opens in a new window]  and
Marcia M. Boumil
Gregory Curfman
Affiliation:
JAMA, CHICAGO, IL, USA YALE UNIVERSITY, NEW HAVEN, CT, USA
Marcia M. Boumil
Affiliation:
TUFTS UNIVERSITY, BOSTON, MA, USA.
Get access Rights & Permissions [Opens in a new window]

Extract

On June 18, 2023, the U.S. Supreme Court in the matter of Amgen, Inc. et al. v. Sanofi, et al.1 unanimously upheld the 2021 decision of the U.S. Court of Appeals for the Federal Circuit,2 striking down as overbroad Amgen’s patent claim to an entire functional genus of monoclonal antibodies. Amgen’s patent claims were not limited to antibody structure or antibody amino acid sequences. This is significant because Amgen’s patent claims did have amino acid sequences, but they were directed to the epitope.

Keywords

Monoclonal AntibodiesPatent EnablementGenus Patent ClaimsPCSK9 InhibitorsLDL Receptors
Type
Columns: Health Policy Portal
Information
Journal of Law, Medicine & Ethics , Volume 51 , Issue 3: Seeking Reproductive Justice in the Next 50 Years , Fall 2023 , pp. 689 - 693
Copyright
© 2023 The Author(s)

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Footnotes

About This Column

Aaron Kesselheim serves as the editor for Health Policy Portal. Dr. Kesselheim is the JLME editor-in-chief and director of the Program On Regulation, Therapeutics, And Law at Brigham and Women’s Hospital/Harvard Medical School. This column features timely analyses and perspectives on issues at the intersection of medicine, law, and health policy that are directly relevant to patient care. If you would like to submit to this section of JLME, please contact Dr. Kesselheim at [email protected].

References

598 U.S. __ (2023).Google Scholar
987 F.3d 1080 (2021).Google Scholar
See Fala, L., “Repatha (Evolocumab): Second PCSK9 Inhibitor Approved by the FDA for Patients with Familial Hypercholesterolemia,” American Health & Drug Benefits 9 (Spec Feature) (2016): 136–139, PMID: 27668060; PMCID: PMC5013843.Google Scholar
Brenner v. Mason, 383 U.S. 519 (1966).Google Scholar
Id. Google Scholar
D. Holman et al., Case Studies and Trends at the PTAB Involving 35 U.S.C. § 112, available at <https://www.sternekessler.com/sites/default/files/2022-02/ptab_year_in_review_2021_35_usc_section_112_article_final.pdf> (last visited Sept. 12, 2023).+(last+visited+Sept.+12,+2023).>Google Scholar
35 USC section 112(a).Google Scholar
See Mowry v. Whitney, 81 US 620 (1871).Google Scholar
35 USC Section 112(a).Google Scholar
[Oral Argument], Amgen, Inc. et. al. v. Sanofi, et al., No. 21-757, Heritage Rep. Corp., p. 56, U.S. Sup. Ct. March 27, 2023, available at <https://www.supremecourt.gov/oral_arguments/argument_transcripts/2022/21-757_5h26.pdf> (last visited Sept. 12, 2023)+(last+visited+Sept.+12,+2023)>Google Scholar
[Brief of Intellectual Property Professors as Amici Curae In Support of Petitioners], Amgen, Inc. et. al. v. Sanofi, et al., No. 21-757], p.2, available at <https://www.supremecourt.gov/DocketPDF/21/21-757/251201/20230103084920246_Amicus%20Brief.pdf> (last visited Sept. 12, 2023).+(last+visited+Sept.+12,+2023).>Google Scholar
[Brief of Sir Gregory Paul Winter and Interested Scientists as Amici Curae In Support of Respondents], Amgen, Inc. et. al. v. Sanofi, et al., No. 21-757], p.7, available at <https://www.supremecourt.gov/DocketPDF/21/21-757/254497/20230210100916044_WinterSanofi%20Amici%20Main%20E%20FILE%20Feb%2010%2023.pdf> (last visited Sept. 12, 2023).+(last+visited+Sept.+12,+2023).>Google Scholar
566 U.S. 66 (2012).Google Scholar
569 U.S. 576 (2013).Google Scholar
M.M. Boumil and G. Curfman, “Patenting Laws of Nature: Effect on Cardiovascular Innovation,” JAMA Cardiology 3, no. 11 (2018): 1031-1032, doi: 10.1001/jamacardio.2018.3365. PMID: 30347007.CrossRefGoogle Scholar
S.4734 — Patent Eligibility Restoration Act of 2022.Google Scholar
US 8,030,457 (Continuation of 8829165); US 8,030,457 (continuation of 8859741) and US 9,045,547 (a method of use patent)(Continuation of 8859741).Google Scholar
Brief of Arnold Ventures, The National Center for Health Research and Certain Medical Doctors as Amicus Curiae in Support of Respondents, p. 25, Amgen, Inc. et. al v. Sanofi, et. al, 598 U.S. __ (2023).Google Scholar
See [CRS Report, Patent-Eligble Subject Matter Reform: Background and Issues for Congress, No. R-45918, Dec. 1, 2022, available at <https://sgp.fas.org/crs/misc/R45918.pdf> (last visited Sept. 12, 2023).+(last+visited+Sept.+12,+2023).>Google Scholar
S. Tu and C.M. Holman, “Antibody Patents: Use of the Written Description and Enablement Requirements at the Patent & Trademark Office,” Berkeley Technology Law Journal (2022), Forthcoming, WVU College of Law Research Paper No. 2022-005, available at <https://ssrn.com/abstract=4025167> or <http://dx.doi.org/10.2139/ssrn.4025167> (figure 2) (last visited Sept. 12, 2023).CrossRef+or++(figure+2)+(last+visited+Sept.+12,+2023).>Google Scholar