At the recent Biotechnology/Chemical/Pharmaceutical Customer Partnership the US Patent and Trademark Office (USPTO) discussed its Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Law of Nature, Natural Phenomena and Natural Products and announced that it will hold a forum on May 9 2014 to receive public feedback on the guidance. Its presentation, along with the USPTO’s March 19 2014 slide presentation introducing the guidance, provides an insight into how the guidelines will be applied. However, as illustrated below, despite the guidance and the Supreme Court cases on patent-eligible subject matter, there is still much uncertainty as to what constitutes patent-eligible subject matter. 

On March 10 2014 a federal judge of the US District Court in the District of Utah denied Myriad’s request for a preliminary injunction to stop competitor Ambry Genetics from providing screening tests for the BRCA1 and BRCA2 genes. This decision follows the US Supreme Court’s unanimous decision holding that “genes and the information they encode are not patent-eligible simply because they have been isolated from the surrounding genetic material” (Association for Molecular Pathology v Myriad Genetics Corp, 133 S Ct 2107, 2120 (2013)).

In its June 13 2013 decision the Supreme Court invalidated Myriad’s claims to the DNA sequences that encode the BRCA1 and BRCA2 genes. However, the court upheld claims to cDNA sequences, noting that cDNA “differs from natural DNA in that the noncoding regions have been removed” and “[a]s a result, cDNA is not a ‘product of nature’ and is patent-eligible under § 101”. The Supreme Court did not consider any method claims. After the Supreme Court decision, Ambry announced plans to sell screening tests for the BRCA1 and BRCA2 genes. Myriad sued Ambry and requested a preliminary injunction, arguing that while the Supreme Court invalidated claims to DNA sequences that encode the BRCA1 and BRCA2 genes, claims to DNA primers (short strands of DNA used to amplify larger DNA segments, such as those encoding BRCA1 and BRCA2 genes) and method claims for analysing BRCA1 and BRCA2 sequences using primers and probes remain valid. In particular, Myriad argued that because primers and probes do not occur in nature, the claims at issue were directed towards patent-eligible subject matter. Ambry disagreed, arguing that primers and probes were nothing more than short segments of DNA and were not patent eligible. The judge sided with Ambry finding that it had “raised substantial questions concerning whether any of the patent claims at issue in Plaintiffs’ Motion are directed toward patent-eligible subject matter under 35 U.S.C. § 101” and denied the injunction.

On March 4 2014, shortly before the Utah decision, the USPTO issued its Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Law of Nature, Natural Phenomena and Natural Products for use in assisting patent examiners to assess whether claims cover subject matter that is eligible for patentability. Interestingly, this guidance contains examples almost identical to the facts in the Utah case. In particular, Example E analyses the patentability of DNA primers and their use in amplifying a target DNA sequence. With regard to the primers themselves, the guidance agrees with the Utah decision and concludes that the primers are not significantly different from naturally occurring DNA and are thus not patent eligible. However, with regard to the use of DNA primers in amplifying a target DNA sequence, the guidance disagrees with the Utah decision and concludes that it is patentable subject matter. In reaching their conclusions both the USPTO guidance and the Utah decision consider whether the claimed process contains an inventive step aside from the patent-ineligible subject matter. Both answer that it does not. However, whereas in the USPTO guidance this is but one of many factors to consider and is outweighed by other factors, in the Utah case an inventive step aside from the patent-ineligible subject matter is considered an essential requirement for patentability. This disagreement highlights the uncertainty created by the Supreme Court’s recent attempts to define eligible subject matter. The Utah decision is now on appeal at the Court of Appeals for the Federal Circuit.