Immaculate Conception? Priority and Invention in the CRISPR Patent Dispute

Area of Science:

• Biotechnology
• Genomics
• Intellectual Property Law

Background:

• CRISPR-Cas9 gene editing technology has revolutionized biological research.
• Patent disputes are common in rapidly advancing scientific fields.
• The U.S. Patent Trial and Appeal Board (PTAB) presides over patentability challenges.

Purpose of the Study:

• To explain the patent law "conception" requirement.
• To detail the PTAB's interference decision regarding CRISPR-Cas9.
• To discuss the implications of the PTAB ruling on CRISPR technology and scientific practice.

Main Methods:

• Analysis of the PTAB's February 2022 interference proceeding decision.
• Review of patent law principles concerning "conception" in inventorship.
• Examination of the documented timelines of CRISPR-Cas9 development by competing research groups.

Main Results:

• The PTAB determined Broad Institute researchers "conceived" of CRISPR-Cas9 in eukaryotic cells in 2012.
• This verdict was reached despite University of California, Berkeley researchers documenting the concept 7 months prior.
• The decision hinges on the specific legal definition of "conception" in patent law.

Conclusions:

• The PTAB's interpretation of "conception" significantly influences the attribution of inventorship for CRISPR-Cas9.
• This ruling has practical consequences for the commercialization and application of CRISPR technology.
• Understanding patent law is crucial for navigating scientific innovation and intellectual property.