New guidance provides optimism for securing life sciences patents in the US

The US Patent and Trademark Office (USPTO) has released its 2014 Interim Guidance on Patent Subject Matter Eligibility, which will provide some optimism to those pursuing patent protection for life sciences related innovation in the US.

The guidance has been closely anticipated, following landmark rulings in the cases of Mayo Collaborative Serv. v. Prometheus Labs and Inc.Association for Molecular Pathology v. Myriad Genetics, Inc. The Myriad ruling concluded that all naturally-occurring human gene sequences are unpatentable. The earlier Prometheus ruling found that a patent relating to a method for optimising drug treatment was also unpatentable, as claims about its innovative nature merely amount to reciting a law of nature.

This new guidance supersedes initial guidelines released in March 2014 and has been produced following a significant level of feedback, largely critical, of the initial guidelines. The latest version focuses on the Prometheus ruling and provides criteria to be used when establishing patentability:

-         law of nature

-         natural phenomenon

-         or an abstract idea  

If the claim provides additional elements that provide significantly more over and above these elements, it is considered to be patent eligible.

Justin Wilson, senior associate at Withers & Rogers, a leading firm of patent and trade mark attorneys, said: 


“The latest guidance from the USPTO is very welcome as inventions that might not have been eligible for patent protection previously, now appear to be patent eligible. For example, claims that are directed to a combination of two or more naturally-occurring substances might not have been considered eligible under the initial guidelines. However, the new guidance recognises that if the combination of these elements does not itself occur in nature, this type of claim may now be eligible for protection.”



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