Share This

Biotech Patent Holders, I Hate to Say I Told You So, But …

On March 4, 2014, the U.S. Patent and Trademark Office ("USPTO") issued new guidelines to its Patent Examiners to assist them in determining which patent claims are not eligible for patenting.  While the guidelines are not law and not binding on federal courts, they nevertheless create hurdles that patent applicants must overcome in their quest for patentable claims.  The guidance memorandum ("Guidance") is in response to recent court decisions such as Ass'n for Molecular Pathology v. Myriad Genetics ("Myriad") and Mayo Collaborative Servs. v. Prometheus Labs., Inc. ("Mayo").  In those decisions, the United States Supreme Court held that naturally-occurring DNA and certain diagnostic methods are not patentable because they are directed to natural products and/or natural phenomena.

In an earlier special article to WRAL TechWire published on October 1, 2013, I noted that while the driving force behind Myriad arose from concerns about greater patient access to certain types of diagnostic tests, potential losers following Myriad actually had nothing to do with genetic testing.  That's because while Myriad was ostensibly directed to the question of the patent eligibility of isolated naturally-occurring DNA, the test applied by the Supreme Court could potentially render patents to other isolated naturally‑occurring biomolecules, such as proteins and peptides, invalid as well.  The Guidance supports this assessment, and goes even further.

The Guidance contains a non-exclusive list of a wide range of subject matter requiring closer scrutiny to determine whether they possess something "significantly different" from natural products or natural phenomena.  To put this in perspective, according to the Guidance, gunpowder would be considered a natural product because it is "a mixture of naturally occurring saltpeter, sulfur and charcoal."  Examples of subject matter that trigger such scrutiny include "chemicals derived from natural sources (e.g., antibiotics, fats, oils, petroleum derivatives, resins, toxins, etc.); foods (e.g., fruits, grains, meats, and vegetables); metals and metallic compounds that exist in nature; minerals; natural materials (e.g., rocks, sands, soils); nucleic acids; organisms (e.g., bacteria, plants, and multicellular animals); proteins and peptides; and other substances found in or derived from nature").  

Navigating Patent Subject Matter Eligibility Under the Guidelines

The Guidance lays out a three-part test for Examiners to follow when determining patent eligibility of claimed subject matter.

Step One:  Is the claim directed to one of the four statutory categories of patent eligible subject matter (i.e., a process, machine, manufacture, or composition of matter)?  If no, the subject matter is not eligible for patenting.  If yes, the Examiner is to go to Step Two.

Step Two:  Is the claim directed to a "judicial exception" to the four statutory categories (i.e., is it directed to subject matter the courts have carved out of the statutory categories and deemed patent ineligible for public policy reasons, such as an abstract idea, a law of nature/natural phenomenon, or a natural product)?  If no, the subject matter is eligible for patenting.  If yes/maybe, the Examiner is to go to Step Three.

Step Three:  Is the claim as a whole directed to something "significantly different" than a judicial exception (i.e., significantly different than a natural product or law of nature)?  If no, the subject matter is not eligible for patenting.  If yes, the claim is directed to patent eligible subject matter.

As noted above, the Guidance lists a wide array of subject matter that is now considered by the USPTO to fall under a judicial exception to patent eligibility and that is, therefore, subject to closer scrutiny to determine if the claim recites something significantly different than a natural product or law of nature.  And, as noted above, the list is considered non-exclusive, so there could be more such examples.

What constitutes a significant difference is addressed in the Guidance via discussion of a balancing act of factors and the presentation of various examples.

What Is "Significantly Different" From a Natural Product or Law of Nature?

Nearly 15 pages of the Guidance are dedicated to instructing Patent Examiners on how to determine if subject matter is significantly different than a natural product or law of nature.  In general, elements or steps that demonstrate that the subject matter is markedly different from what exists in nature or elements or steps that practically apply the natural product or law of nature in a significant way qualify as significantly different.

To determine whether these criteria have been met, the Guidance advises Examiners to compare six factors that tip the scales in favor of patent eligibility with six factors that tip the scales against patent eligibility.  These factors generally fall into two groups:

  • Factors applicable only to natural products (or things that appear to be natural products) that concern structural similarities and differences; and,
  • Factors applicable to any claim that concern whether the claim recites elements or steps that add significantly more to a natural product or law of nature. 

A number of examples are provided that are valuable to biotech patent seekers and their counsel, including:

  • Claims drawn to plasmids;
  • Bacteria harboring plasmids;
  • Purified and altered natural products;
  • Methods of treatment using a natural product or natural principle;
  • Compositions comprising multiple natural products; and,
  • Nucleic acid sequences and methods of use.

For example, a claim directed to an inoculant comprising a number of naturally‑occurring bacteria would not be considered to be markedly different from what occurs in nature because the aggregation of the naturally-occurring bacteria does not change the structure of the bacteria.  By contrast, a bacterium that naturally comprises a plasmid that enables degradation of a type of hydrocarbon but that has been genetically modified to include multiple plasmids enabling degradation of multiple types of hydrocarbons would be markedly different in structure from what occurs in nature.


The impact of the Guidance's application of Myriad and Mayo is far-reaching.  What started as a pothole underneath naturally-occurring DNA and certain diagnostic methods has now grown into a sinkhole swallowing up chemicals derived from natural sources and compositions comprising aggregations of naturally-occurring biological and chemical products.

It is important to note that the Guidance is not law and is not binding on federal courts.  One needs only look to Myriad for an example in which almost 30 years of USPTO policy (in that case, granting patent claims to isolated naturally-occurring DNA) was reversed by the United States Supreme Court.  For now, though, patent applicants face a new gauntlet in their quest for patentable claims.

© 2016 Ward and Smith, P.A.

This article is not intended to give, and should not be relied upon for, legal advice in any particular circumstance or fact situation. No action should be taken in reliance upon the information contained in this article without obtaining the advice of an attorney.

We are your established legal network with offices in Asheville, Greenville, New Bern, Raleigh, and Wilmington, NC.