Mayo, Myriad, America Invents Act and BPCIA: how has the United States biopharmaceutical market been affected?
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.
['Finston|Susan K|SK|', 'Davey|Neil S|NS|', 'Davé|Elina|E|', 'Ravichandran|Varsha|V|', 'Davey|Sonya R|SR|', 'Davé|Raj S|RS|']
D001688:Biological Products D003955:Diagnostic Tests, Routine D023281:Genomics D006801:Humans D010330:Patents as Topic D035521:Supreme Court Decisions D014481:United States
biopharmaceutical patent eligibility law of nature and natural phenomenon BPCIA and AIA DNA and cDNA Mayo and Myriad biologic and biosimilar protein and peptide