title: Patent disclosure requirements for therapeutic antibody patents.
abstract: Therapeutic antibodies have grown to become an important product class within the biopharmaceutical market. A prerequisite to their commercialization is adequate patent protection. Disclosure requirements and the types of claims available in different jurisdictions can impact the scope of protection available for antibodies. Areas covered: A comparative review of statutory bases, patent office practices and selected decisions in Canada, the United States and the United Kingdom related to disclosure requirements is provided. Expert opinion: Differences in disclosure requirements exist in different jurisdictions which can impact the type of claims obtained and their survival when attacked in litigation. Including a wide variety of claim types is a key strategy to ensuring therapeutic antibodies are adequately protected. Method of use claims may provide advantages and broader protection in some circumstances and should also be considered.
authors.affiliation: a Bereskin & Parr LLP, Life Sciences Group/Montreal and Toronto , Canada.
authors.forename: Carmela
authors.initials: C
authors.lastname: De Luca
authors.affiliation: a Bereskin & Parr LLP, Life Sciences Group/Montreal and Toronto , Canada.
authors.forename: Anastassia
authors.initials: A
authors.lastname: Trifonova
mesh_terms: D000818:Animals; D000906:Antibodies / Q000627:therapeutic use*; D002170:Canada; D030881:Disclosure; D006801:Humans; D007880:Legislation, Drug; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D006113:United Kingdom; D014481:United States
chemical_list: D000906:Antibodies
keywords: Canada; Therapeutic antibodies; United States and United Kingdom; disclosure requirements; patent protection; sufficiency; support requirements