The challenges of joint performance to method patents

ABSTRACT

Introduction: Biotech patents are facing increasingly stern challenges. The patent statue holds that a multi-step method patent is not directly infringed unless all steps are carried out and attributed to a single entity. When separate steps are performed jointly by two or more parties, those parties are liable for divided infringement if there exists a direct infringement. Possibilities thus exist for unauthorized but non-infringing joint performance, i.e. enforcing a method patent will be difficult if joint performance stands as a valid defense against direct infringement.

Areas covered: This analysis covers issues on patent infringement, specifically on divided infringement of diagnostic and method patents.

Expert opinion: A retrospective analysis indicates that a large number of cancer diagnostic patents issued during 2005-2014 are potentially vulnerable to read on unauthorized use in the manner of joint performance. Inventors should draft patent claims appropriately to reduce the risk to assert their patents in this regard.

KEYWORDS:

• Cancer
• method patents
• diagnostic patents
• divided infringement
• patent infringement

Article highlights

• Would-be infringers may avoid being responsible for patent infringement by dividing patent components between two or more parties for performance.

• Multi-step method patents are especially vulnerable to such unauthorized joint performance.

• A retrospective analysis on cancer diagnostic patents issued 2005-2014 reveals that more than half of the patents include claims potentially vulnerable to unauthorized joint performance.

• Proper claim drafting can remedy this vulnerability.

This box summarizes the key points contained in the article.

Declaration of interest

The author has 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.

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Additional information

Funding

This study was supported by the intramural funding of National Health Research Institutes (105-IPHS-PP06).