title: Are biosimilars patentable?
abstract: BACKGROUND
  This paper explores whether, and under what circumstances, a biosimilar approved in the United States under the Biologics Price Competition and Innovation Act (hereafter 'BPCIA') can be patented. The possibility that a biosimilar product could have meaningful patent protection arises from specific requirements for biosimilarity under the BPCIA, which account for the fact that manufacturing processes of biologics are inherently imprecise. The requirements for biosimilar approval may provide sufficient leeway to a biosimilar applicant to patent structural or formulation differences that provide non-clinical but business-relevant advantages over the reference molecule, such as improved shelf-life or ease of manufacture, without compromising clinical biosimilarity.
  
  
  METHODS
  Examination of the BPCIA and related Acts, Food and Drug Administration (FDA) guidance papers, case law, patent database searching, and relevant scholarly articles.
  
  
  CONCLUSIONS
  Legislative and regulatory requirements for the approval of a biosimilar under the BPCIA are focused on clinical results and allow a degree of leeway for differences to exist between a biosimilar's structure and non-clinical components and those of the biosimilar's reference molecule. This leeway can be exploited to provide the biosimilar with potentially patentable business-relevant advantages over its reference product while maintaining clinical biosimilarity to the reference product.
authors.affiliation: a Perry + Currier Inc. & Currier + Kao LLP , Toronto , Ontario , Canada.
authors.forename: Damian
authors.initials: D
authors.lastname: Rolfe
authors.affiliation: b Department of Biology , University of Toronto , Mississauga , Canada.
authors.forename: Jayson
authors.initials: J
authors.lastname: Parker
authors.affiliation: c Grand Challenges Canada , Toronto , Canada.
authors.forename: Max
authors.initials: M
authors.lastname: Morgan
mesh_terms: D000818:Animals; D001688:Biological Products / Q000008:administration & dosage* / Q000737:chemistry / Q000191:economics; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage* / Q000737:chemistry / Q000191:economics; D017277:Drug Approval / Q000331:legislation & jurisprudence; D006801:Humans; D007880:Legislation, Drug; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D014481:United States
chemical_list: D001688:Biological Products; D059451:Biosimilar Pharmaceuticals
keywords: Biologics; FDA; biosimilars; law; patent; pharmaceuticals