PTAB Finds Personalized Treatment Claims Unpatentable under Mayo
On August 14, 2017, the USPTO Patent Trial and Appeal Board (PTAB) issued a decision in Ex parte Ramsey, an unfavorable decision to applicants seeking to obtain claims directed to personalized medicine inventions. Specifically, the PTAB held that a method claiming “optimizing therapeutic efficacy for treatment of a psychotic disorder by choosing the antipsychotic medication to administer based on the presence of the OPRP genetic signature” is directed to a law of nature or a natural phenomenon and, therefore, is patent-ineligible under Mayo Collaborative Services v. Prometheus Labs., 566 U.S. 66 (2012).
The patent application at issue discloses a method of treating psychotic disorders such as schizophrenia. The claimed method provides solutions to a problem that “[t]here are currently no proven ways to identify which antipsychotic drug is optimal for a given patient.” Claim 1 is illustrative:
1. A method for treating a human subject having or suspected of having a psychotic disorder, comprising:
a) selecting a subject having or suspected of having a psychotic disorder and who has been determined to have the OPRP genetic signature, wherein the OPRP genetic signature is defined as a genotype comprising a homozygous genotype for the T allele at rs11960832 and either a homozygous or heterozygous genotype for the T allele at rs7975477; and
b) treating the subject that was determined to have the OPRP signature with an antipsychotic treatment other than clozapine or quetiapine.
The Examiner rejected claims 1-10 as being directed to patent-ineligible subject matter. The Examiner found that “the claims inform a relevant audience about certain laws of nature. The additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community. The additional steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.” Specifically, the Examiner reasoned that “[t]he correlation between whether particular OPRP genetic signature is present and response to clozapine or quetiapine treatment is considered a ‘law of nature’ in accordance with Mayo.”
On appeal by Applicant to the PTAB, the Board began its analysis by comparing the claims on appeal with the claims in Mayo. According to the PTAB, “claim 1 [on appeal] falls squarely into the category of inventions that were held ineligible for patenting by the Mayo court.” The PTAB characterized claim 1 as “directed to a method of optimizing therapeutic efficacy for treatment of a psychotic disorder by choosing the antipsychotic medication to administer based on the presence of the OPRP genetic signature.” The PTAB noted that, like claim 1 at issue in Mayo, claim 1 on appeal “sets forth a law of nature—namely, a relationship between the OPRP genetic signature and the likelihood that particular antipsychotic drugs will prove ineffective.”
The PTAB then analogized the “selecting” step of claim 1 on appeal to the “administering” step of the method claimed in Mayo. According to the PTAB, the “selecting” step “simply directs the audience of doctors who treat patients having psychotic disorders to a particular subset of those patients.” The PTAB concluded that “claim 1 amounts to nothing significantly more than an instruction to apply the applicable law when treating their patients.”
The PTAB rejected several arguments raised by Appellants. According to the PTAB, the claimed method is not “a new use for an old drug,” which is patent-eligible under the USPTO’s Subject Matter Eligibility Guidelines (the “Guidelines”). The PTAB also rejected the argument that the claim should be eligible just like the USPTO’s amazonic acid example, reasoning that “the cited exemplary claims address analysis of a different class of inventions that have been held to be patent-ineligible,” i.e., natural products that are analyzed under Myriad. The PTAB further stated that “[i]n any event, the Supreme Court’s decision in Mayo is controlling based on the facts of this appeal.” Apparently, PTAB asserted that it is not bound by the Guidelines.
Patent-Eligibility for Biotechnology Inventions
This decision is an example of the disturbing trend for biotechnology and medicine invention patents after the Supreme Court’s Mayo and Myriad decisions.
In biotechnology and medicine, especially the diagnostic methods and personalized medicine area, patent application processes are becoming less predictable. First, there are not many helpful fact patterns that applicants and patentees can rely on to support the patentability of claims. In 2015, the Federal Circuit held that methods of genetic testing by detecting and amplifying paternally inherited fetal cell-free DNA (cffDNA) from maternal blood and plasma unpatentable under Mayo in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015). Several circuit judges expressed their concerns about the sweeping implication of the Mayo decision in the denial of rehearing en banc while agreeing that Mayo compelled the unpatentability of the claims in Ariosa. Ramsey is another troubling example of the application of Mayo.
Second, the PTAB’s refusal to be bound by the Guidelines is also disturbing. It not only makes the patent application examination process even less predictable but also may signal the PTAB’s willingness to affirm the decision of an Examiner who has not followed the Guidelines. Or, perhaps, being fully aware of the impact Mayo has had on the biotech industry, the PTAB decided this way so that this case will go all the way up the appeal ladder in the hope that, ultimately, some more realistic limitations will be placed on Mayo. Only time will tell.
In conclusion, the Ramsey decision is another unfavorable example under Mayo that may impede innovation in the biotechnology industry. The biotechnology industry needs clarity, consistency and predictability as to the scope of patent protection for inventions in the area. This may only be achieved through legislation, especially given that the Supreme Court has denied the petition to review the Ariosa decision.
What can patent applicants do in the meantime? First, remember that Mayo is not the law in the rest of the world, so be sure to continue to draft patent applications as if Mayo is not the law. Second, for purposes of the U.S. patent, draft “an application within the application” by including, to the extent possible, as many active steps as possible relating to the method of detecting or selecting that one skilled in the art would not appreciate as being “well-understood, routine and conventional.”
Saul Ewing Arnstein & Lehr attorneys regularly assist clients with drafting and prosecuting patent applications in life sciences/biotech fields. If you have any questions about this client alert or would like more information, please contact the authors or the attorney at the firm with whom you are regularly in contact.