In March the U.S. Patent and Trademark Office (USPTO) released a guidance memo on patents involving natural processes, natural products, or laws of nature. This is the second such memo USPTO has issued connected to the Myriad and Mayo cases. Those decisions dealt with medical tests (genetic in the case of Myriad and diagnostic in the case of Mayo) and whether or not the work done with various natural products and processes was sufficient to warrant patent protection. The USPTO requested comments on the guidance memo, which were due by July 31.
Reaction to the guidance memo suggests many feel the memo goes much further than the Supreme Court intended with respect to its decisions. To wit, the USPTO guidance would apply to patents involving natural processes, natural products or laws of nature outside of the genetic and medical testing contexts of the Myriad and Mayo cases. This inference is made from the examples cited in the guidance, which include derivatives of natural products. The Supreme Court has not ruled on such patents, and some comments argue that absent Supreme Court rulings on that subject matter, the USPTO should not provide guidance to its examiners that would constrain patent activity.
However, USPTO has recently taken more active measures in terms of evaluating what can be patented. In the amicus brief (highlights by The New York Times) USPTO filed in the Myriad case the agency argued for distinguishing between products that were merely isolated from natural processes, natural products or rules of nature and those products that represented additional work. than mere isolation. It may see this guidance as an extension of that approach in areas outside of genetic tests.
Again, I am not a lawyer. Readers who are should feel free to complain in the comments.
It’s too soon after the close of the comment period to know exactly what USPTO might do in response to the comments. It’s conceivable that parties opposed to the current guidance may take the office to court should any revisions are not to their liking.