Patent disclosure requirements for therapeutic antibody patents

ABSTRACT

Introduction: 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.

KEYWORDS:

• Therapeutic antibodies
• disclosure requirements
• patent protection
• support requirements
• sufficiency
• Canada
• United States and United Kingdom

Article highlights

• 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.

• Jurisdictional differences exist in the framing and application of disclosure requirements.

• In the Canadian trial AbbVie v. Janssen [17], use claims of functionally claimed antibodies were found valid. This decision suggests that a single antibody class can, in at least some cases, be sufficient to meet the disclosure requirements of claims directed to the use of functionally claimed antibodies.

• In contrast, in the corresponding US litigation of AbbVie v. Janssen [19], antibody claims functionally claimed were ultimately found invalid, for among other reasons, lacking ‘written description support’, suggesting that a single antibody class may not be sufficient for broad product claims.

• The UK may provide an intermediate position — patent claims that include embodiments that are clearly not supported by the data in the application will not meet the disclosure requirements. However, claims may properly encompass embodiments which may be provided or invented in the future, if such embodiments demonstrate the technical contribution made by the invention.

This box summarizes key points contained in the article.

Declaration of interest

The authors have no 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. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Additional information

Funding

This paper was not funded.