Intellectual property considerations for molecular diagnostic development with emphasis on companion diagnostics

ABSTRACT

Introduction: The development of molecular diagnostics is a complex endeavor, with multiple regulatory pathways to consider and numerous approaches to development and commercialization. Companion diagnostics, devices which are “essential for the safe and effective use of a corresponding drug or diagnostic product” (see U.S. Food & Drug Administration, In Vitro Diagnostics - Companion Diagnostics, U.S. Dept. of Health & Human Services(2016), available at https://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm407297.htm) and complementary diagnostics, which are more broadly associated with a class of drug, are becoming increasingly important as integral components of the implementation of precision medicine.

Areas covered: The following article will highlight the intellectual property (‘IP’) considerations pertinent to molecular diagnostics development with special emphasis on companion diagnostics.

Expert opinion/commentary Summary: For all molecular diagnostics, intellectual property (IP) concerns are of paramount concern, whether the device will be marketed only in the United States or abroad. Taking steps to protect IP at each stage of product development is critical to optimize profitability of a diagnostic product. Also the legal framework around IP protection of diagnostic technologies has been changing over the previous few years and can be expected to continue to change in the foreseeable near future, thus, a comprehensive IP strategy should take into account the fact that changes in the law can be expected.

KEYWORDS:

• Molecular diagnostics
• patent
• patent prosecution
• CDx
• development
• commercialization

Article highlights

• This article summarizes intellectual property (‘IP’) considerations pertinent to molecular diagnostics development with special emphasis on companion diagnostics.

• The article discusses IP considerations and suggestions based on the specific stages of technology and product development for diagnostics.

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. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper has not been funded.