Biotechnology: Recent History
PATENTS
US Supreme Court and Federal Circuit- products of nature and natural phenomenon
A focus of my practice is Biotechnology and Life Sciences. If you operate in this field it is important that you understand the changes to patent eligible subject matter that have resulted from Supreme Court and Federal Circuit decisions in the last few years.
In 2018, the Federal Circuit decided the patentability of treating a patient based on the patient's metabolism. Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117. In 2012, the US Supreme Court held that a patient's metabolism was a law of nature and not patentable. Mayo v. Prometheus (see below). Here as in Mayo, the claims included a determination of a patient's metabolism of a particular compound. In this case the compound was iloperidone and the treatment is for schizophrenia. Unlike Mayo, these claims also required a treating physician to administer specific amounts of iloperidone based on the results of the metabolic assay. The Federal Circuit found that unlike Mayo, the claims were directed to an application of a natural relationship, as they were directed to a specific treatment for specific patients using a specific compound at specific doses. Therefore the claims were not directed to a judicial exception and were patent eligible. Also see the USPTO Memorandum of June 7, 2018
In 2013, the US Supreme Court decided the patentability of naturally occurring DNA sequences. The USPTO had previously allowed claims to naturally occurring biological materials if they were claimed in an isolated form. Myriad Genetics had discovered and patented the DNA sequences corresponding to the BRCA1 and BRCA2 gene mutations, as useful markers for breast and ovarian cancer. The Supreme Court found that these genes were sequences of DNA that occurred in nature and that producing them in an isolated form did not make them patent eligible. Association for Molecular Pathology vs. Myriad Genetics, Inc., No. 12-398. By extension of this logic, other natural compounds such as proteins, antibiotics, etc., even if claimed in isolated form, are also not patent eligible as products of nature. An exception being if their isolated form conveys new properties.
In 2012, the US Supreme Court decided the patentability of optimizing the treatment of a gastrointestinal disorder with 6-thioguanine. Researchers had discovered the optimum limits of the drug, although treating with 6-thioguanine was not new. The Court found that administering and measuring levels of 6-thioguanine was not patentable as it amounted to nothing more than observing a law of nature, in this case the metabolism of the drug. Mayo v. Prometheus, 132 S. Ct. 1289 (2012).
These 2012-2013 decisions had a negative effect on thousands of issued patents and pending applications and left many applicants with a sense of confusion about patentable material. The types of claims that have been hit hardest are diagnostic claims and treatment claims. In an attempt at clarity, the USPTO has released Subject Matter Eligibility Guidance and the courts have continued to decide cases to define patentable subject matter.
