The eagerly awaited revised guidance on the assessment of subject matter eligibility of claims reciting or involving laws of nature or natural products finally issued from the USPTO on 15 December 2014.  This guidance is significantly less draconian than the guidance that issued in March 2014, and is supplemented with a helpful set of Examples.  Both can be accessed here. It is important to bear in mind, however, that the guidance is only interim and therefore subject to further change.

Background

The past few years have seen US patent practice being shaken up by several key decision of the U.S. Supreme Court concerning the issue as to what subject matter is or is not excluded from patentability (“patent eligibility”). In Mayo v. Prometheus1the Court held that a correlation between the concentration of a biomarker in a patient and the efficacy of a drug treatment was a law of nature.  The Court essentially concluded that while an application of such a law of nature may be patent eligible, a claim directed to the correlation itself is not patent eligible.

Subsequently, in Myriad2, the Court held that claims directed to isolated genomic DNAs were not patent eligible, because the claimed sequences were the same as the naturally occurring gene sequences.  However, claims drawn to cDNAs were considered to be patent eligible, because the claimed cDNA sequences lack introns and therefore differ from the naturally occurring gene sequences.

These decisions prompted the USPTO to publish in March 2014 new guidance for examination of the subject matter eligibility of product and process claims. Controversially, while the Myriad decision concerned certain isolated DNA segments, the March 2014 guidance as much broader, relating to claims that recite or involve a variety of natural products, including inter alia “chemicals derived from natural sources” such as certain antibiotics; nucleic acids; organisms (e.g., bacteria, plants and multicellular animals); proteins and peptides.

Revised guidance

In response to detailed feedback, the USPTO issued a revised interim guidance on 15 December 2014. 

According to the new guidance, a “markedly different characteristics” analysis should be used to determine whether a claim relating to a nature-based product is patent eligible. Markedly different characteristics can reside in the structure or function of the products compared to their naturally occurring counterparts.

Some helpful Examples are provided to illustrate what may constitute “markedly different characteristics”.  The Examples should be read in the context provided by the USPTO, but they seem to illustrate the following principles:

  1. Compositions which have functional characteristics that differ from the characteristics of the individual (naturally occurring) components should be patent eligible.

This seems to apply even if the new characteristic is arguably obvious: An example related to a combination of a fruit juice with a preservative, which has the new characteristic of having a longer shelf life than the preservative-free juice.

  1. A purified product of nature that is structurally and functionally identical to the naturally occurring counterpart is not patent eligible.  However, even a minor structural modification may result in patent eligibility, even in the absence of an associated functional difference.

The structural modification may, for example, be at least one amino acid change in a protein or at least one nucleotide change in a nucleic acid sequence.

  1. A purified product of nature that is structurally and functionally identical to the naturally occurring counterpart may be rendered patent eligible by attaching it to a further component.

For example, an isolated nucleic acid attached to a fluorescent label or incorporated into a vector may be patent eligible.

  1. A method of treating a specific disease with a product of nature which does not tie up all practical uses of the product of nature should be patent eligible.

Outlook

Further comments are invited and can be submitted to 2014_interim_guidance@uspto.gov and a public forum will take place in January 2015.  It is therefore likely that the guidance will be revised again in due course.

It is important to note that the USPTO guidance reflects the USPTO’s interpretation of the case law and is not binding on U.S. courts. Indeed, the guidance stresses that it does not have the force and effect of the law. It remains to be seen whether the courts will agree with the USPTO’s position.