Are biosimilars patentable?

ABSTRACT

Introduction: 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.

Areas covered: Examination of the BPCIA and related Acts, Food and Drug Administration (FDA) guidance papers, case law, patent database searching, and relevant scholarly articles.

Expert opinion: 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.

KEYWORDS:

• Biologics
• biosimilars
• FDA
• law
• patent
• pharmaceuticals

Article highlights

• Biosimilar legislation accounts for the fact that manufacturing processes in the context of biologics are inherently imprecise.

• Unlike traditional generics, which must exhibit sameness, biosimilars may differ from their reference molecules through minor structural variations or formulation differences.

• A biosimilar can possess potentially patentable business-relevant advantages over its reference molecule without impacting the required clinical similarity for biosimilar approval.

• Examples of patentable advantages include improved methods of manufacture, stability, and formulations.

This box summarizes key points contained in the article.

Declaration of interest

J Parker worked for the pharmaceutical companies Schering AG and Novo Nordisk. He is a medical advisor the hedge fund Burlington Capital, which may or may not have investments in any of the companies mentioned in this article. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.