title: Mayo, Myriad, America Invents Act and BPCIA: how has the United States biopharmaceutical market been affected?
abstract: This paper discusses how the United States biopharmaceutical market has been affected by recent changes in patent law resulting from United States legislations (Biologics Price Competition and Innovation Act and the Leahy-Smith America Invents Act) and Supreme Court precedents (Mayo Collaborative Services v. Prometheus Laboratories, Inc. and Molecular Pathology v. Myriad Genetics). The authors interviewed eight key opinion leaders from the United States knowledgeable in biopharmaceuticals, including industry veterans, patent counsel, senior scientists and jurists. This paper summarizes the opinions of the key opinion leaders. This paper explains the impact of these Supreme Court decisions - i.e., broadening the exceptions to patent eligibility for law of nature and natural phenomenon - on biopharmaceutical innovations and provides future perspectives.
authors.affiliation: Finston Consulting, LLC, 3414 30th Street, NW, Washington, DC 20008-3250, USA.
authors.forename: Susan K
authors.initials: SK
authors.lastname: Finston
authors.affiliation: Harvard College, 60 Linnaean Street, 144 Cabot, Cambridge, MA 02138, USA.
authors.forename: Neil S
authors.initials: NS
authors.lastname: Davey
authors.affiliation: Union College, Box 521, 807 Union Street, Schenectady, NY 12308, USA.
authors.forename: Elina
authors.initials: E
authors.lastname: Davé
authors.affiliation: Virginia Tech, 300 Turner Street NW, Blacksburg, VA 24061, USA.
authors.forename: Varsha
authors.initials: V
authors.lastname: Ravichandran
authors.affiliation: Perelman School of Medicine, University of Pennsylvania, 576 South 27 Street, Philadelphia, PA 19146, USA.
authors.forename: Sonya R
authors.initials: SR
authors.lastname: Davey
authors.affiliation: Global Pharma, Pillsbury Winthrop Shaw Pittman LLP, 1650 Tysons Boulevard, McLean, VA 22102, USA.
authors.forename: Raj S
authors.initials: RS
authors.lastname: Davé
mesh_terms: D001688:Biological Products; D003955:Diagnostic Tests, Routine; D023281:Genomics; D006801:Humans; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D035521:Supreme Court Decisions; D014481:United States
chemical_list: D001688:Biological Products
keywords: BPCIA and AIA; DNA and cDNA; Mayo and Myriad; biologic and biosimilar; biopharmaceutical; law of nature and natural phenomenon; patent eligibility; protein and peptide