Gene Patent Questions Remain: USPTO Issues Examiner Guidelines

Gene Patent Questions Remain: USPTO Issues Examiner Guidelines

The new Patent Office guidance, issued March 4, extends the Supreme Court’s legal logic into areas that were neither mentioned nor decided in the Myriad case itself. Myriad went to the Supreme Court exclusively on the question whether human genes are patentable. And human genetic diagnostic testing was the only context in which the Supreme Court thought about this question. The Supreme Court also acknowledged that it is not a scientific expert, and perhaps recognized that its opinion could be interpreted and extended in unexpected ways by others who have a more complete understanding of the science and of the greater context of patent law. That’s why the Court’s opinion contains multiple explicit statements about how it is meant to be understood narrowly, and that it decides nothing more than a narrow question having to do with natural DNA molecules that were removed from their natural environment.

The Patent Office, on the other hand, now has to implement an opinion that – while it may have made sense to the Justices – doesn’t necessarily make sense to patent examiners. While the guidance acknowledges that the holding in Myriad itself was limited to nucleic acids, the PTO decided that the Supreme Court’s legal reasoning should also extend much more broadly to the examination of claims to (without limitation):

“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.” This will be done regardless of whether limitations such as “isolated,” “recombinant,” or “synthetic” are part of the claim.

No such industrial, agricultural or medical products were discussed or even mentioned in the Supreme Court opinion. Did the Supreme Court really intend to abolish patents on naturally-sourced “antibiotics,” “petroleum derivatives,” “resins” or “proteins” having nothing to do with genes or genetic testing, regardless of whether they are “isolated,” “recombinant,” or “synthetic?” The Patent Office must have concluded that the only way to make sense of the Supreme Court opinion is to extend it in this way. The implications of this new guidance are really unclear at this time. As of last month, the USPTO was still issuing claims to isolated proteins, purified botanical molecules, fermentation products and other naturally-derived substances. Many such claims would not have been issued under the new guidance – so what does that mean for the enforceability of these existing patents? We know that, for nucleic acids alone, approximately 8,700 current U.S. patents contain at least one claim of this kind. We can safely assume that tens of thousands of other current patents contain claims to “isolated,” “recombinant” or “synthetic” substances found in or derived from natural sources. Readers are left to draw their own conclusions about how many of those would now be rejected, if they were examined today.

How this all plays out and its impact on biotechnology research and development will have to be assessed over the coming months.


Hans Sauer is BIO’s Deputy General Counsel, Intellectual Property, Legal & Intellectual Property