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New Guidelines a Shot in the Arm for Life Science Patents?

On May 5, the U.S. Patent and Trademark Office issued updated guidelines to its examiners regarding patent eligibility under Section 35 U.S.C. § 101. The guidance reinforces that examiners must carefully consider all of an applicant’s arguments and evidence. Furthermore, examiners must now communicate a more detailed rationale on why they rejected an application, as well as use best practices in evaluating an applicant’s response to the rejection. 

This is welcome news to the life sciences community that many said was severely hampered after the landmark 2012 Supreme Court decision in Mayo v. Prometheus. In that case, the Supreme Court ruled that a process invented by Prometheus to administer drugs based on a person’s level of metabolites was not eligible for patent protection because it covered a law of nature, not an innovative new process.

The new guidance also gives examiners some broader flexibility with regard to interpreting the merits of a patent application. Examiners will also receive an extensive list of new life science eligibility examples, along with additional training. According to the U.S. Patent Office, of the 629,647 patent applications in 2015, a total of 325,979 (or 52%) were granted. This is up 1% from 2014. 

While it’s too early to tell what the impact will be on life science patents, there are those who believe  the U.S. Patent Office is attempting to soften what many experts felt was a rigid Supreme Court interpretation of what is considered patentable. Stay tuned….

John Pennett has public accounting experience with a strong emphasis on life sciences companies. Member New Jersey Society of Certified Public Accountants and New Jersey Technology Council and advisory board of eLabs.

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