In Amgen v. Sanofi,[1] the U. S. Supreme Court unanimously held that Amgen’s asserted patent claims[2] were not enabled by the patent specifications.[3] Consequently, the Court affirmed the Federal Circuit decision of claim invalidity based upon non-enablement.
Amgen’s asserted claims were directed to artificial antibodies which prevent a high concentration of LDL (“bad cholesterol”) by: (i) attaching to a naturally occurring protein which prevents cell receptors from removing LDL from the blood, while (ii) also preventing this same protein from binding to these receptors. These claims exclusively described the antibodies by these two functions, and not by other identifying characteristics. Each patent exclusively disclosed (i) twenty-six linearly aligned amino acid sequences from corresponding artificial antibodies, and (ii) two linearly aligned amino acid sequences folded in three-dimensions. However, there was record evidence of a vast number of indeterminant antibodies which could also potentially fulfill the two claimed simultaneous functions.[4]
The Court concluded that these particular patents only provided trial and error recommendations for creating those antibodies whose biochemical structures were not specifically disclosed. The Court explained that to claim such a vast number of undetermined antibodies, the patent’s enablement information must be correspondingly greater. Here, only two such antibodies were disclosed with a three-dimensional structure among potentially millions.[5] The Court did understand that in some industries initial minimal experimentation, or a disclosed characteristic of all class members, could support enablement. However, neither of these situations were present in this case.
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[1] 143 S. Ct. 1243 (2023).
[2] A claim is a sentence located at a patent’s conclusion which represents one version of subject matter for which the patent owner has obtained legal protection. Claims generally appear in a series which begins with the sentences which provide the broadest protection and conclude with sentences which provide narrower protection.
[3] To comply with the statutory enablement requirement, a patent must sufficiently describe how to create an invention so that a person of ordinary skill in that particular industry could reproduce this invention without undue experimentation. 35 U.S.C. section 112. Otherwise, the claims directed to the invention without sufficient enablement are invalid and not enforceable.
[4] An antibody is a protein of the immune system which “neutralizes” a harmful foreign substance known as an antigen. Disease-causing organisms and insect venom are two examples of subject matter which human antibodies recognize as antigens. BRITANNICA “Antibodies” at https://www.britannica.com/science/antibody on August 30, 2023, most recently updated August 18, 2023. When naturally occurring, human antibodies fail to recognize human cells, organs and tissues, they attack these body components and cause autoimmune disease. Australasian Society of Clinical Immunology and Allergy, “Autoimmune Diseases” at https://www.allergy.or.au/patients/autoimmunity/autoimmune-diseases on August 30, 2023. Artificially modified antibodies address ailments which naturally occurring antibodies do not resolve.
[5] Protein biochemists understand that unless there is (i) a very specific procedure for either producing the three- dimensional structure or (ii) specific conditions for doing so, then even with a specific linear string of protein components (amino acids), there may not be an operative three-dimensional fit of the antibody with either the target protein and/or the receptor site.
Intellectual Property for Businesspeople 