By Bettina Lengsfeld

Personalized medicine treatment plans have become more difficult to protect through patents because of the recent USPTO Patent Trial and Appeal Board (PTAB) decision. The PTAB affirmed the Examiner’s rejections of SureGene’s claims that are directed to methods of treatment based on a subject’s genetic makeup.

SureGene claims 1-10 were rejected. Independent claim 1 reads as follows:

  1. A method for treating a human subject having or suspected of having a psychotic disorder, comprising:
    1. 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
    2. Treating the subject that was determined to have the OPRP signature with an antipsychotic treatment other than clozapine or quetiapine.

During the prosecution of the patent, the Examiner rejected these claims as being directed to ineligible subject matter and used the standard set out in Mayo Collaborative Services v. Prometheus Labs., Inc., 566 U.S. 66 (2012).

Subject matter eligibility is determined first if a claim falls within the enumerated categories in 35 U.S.C. § 101 (i.e. process, machine, manufacture, or composition of matter). Judicial exceptions such as, natural phenomena, laws of nature, and abstract ideas, are patent ineligible. Although, if a claim may be patent eligible if it uses a law of nature, natural phenomenon, or abstract idea to perform a real-world function. In Mayo, the Court found that if a claim is directed to the mere application of a judicial exception does not rise to the level of significantly more that the natural phenomenon and therefore is not patentable.

In ex parte Timothy, the natural phenomenon was the link between a subject having a specific genetic makeup and the lack of effectiveness of specific drugs. The PTAB agreed with the Examiner and found that the “selection” step does not add significantly more to the natural phenomenon and is patent ineligible.

Where does this leave personalized medicine?

In 2003 the human genome was fully sequenced. Along with next generation sequencing capabilities, researchers began sequencing individual patients, determining the specific disease, treating the specific disease for that individual. This method of treatment promises to be more accurate and effective treating cancers and other diseases.

With the decision in ex parte Timothy, biotech companies and investors are left wondering if their latest medical advance will be patent protected. Without patent protection there will be less incentive to invest in biotech companies, large or small, because they may not enjoy the statutory monopoly granted to them through a patent for a period of time. Without this protection companies stand to lose significant profit and may be unable to continue groundbreaking research.

Student Bio: Bettina is the Web Administrator on the Journal of High Technology Law. She is currently a 3L at Suffolk University Law School. Bettina received her doctorate in Microbiology from the University of Texas at Austin and her Bachelor of Science in Molecular Biology from the University of California, San Diego.

Disclaimer: The views expressed in this blog are the views of the author alone and do not represent the views of JHTL or Suffolk University Law School.

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