The U.S. Patent and Trademark Office has re-issued interim guidelines that provide its interpretation of the Supreme Court decisions in Mayo Collaborative Services v Prometheus Laboratories, Inc. (2012) and in the Ass’n for Molecular Pathology v Myriad Genetics, Inc. (2013), as well as the recent Supreme Court decision in Alice Corp. Pty. Ltd. v. CLS Bank Int’l. This guidance supersedes the March 4, 2014, eligibility guidance for claims involving laws. The guidelines provide a framework for patent examiners to identify subject matter that is or is not patent eligible under § 101 of the U.S. Patent Statute.
In Mayo, the court held that a method for dosing a medication based on a patient’s metabolite levels after drug administration involves an application of a “law of nature.” In Myriad, the court held that an isolated genomic DNA molecule is not patent eligible; whereas cDNA, a copy of the encoded RNA, is patentable subject matter. These holdings have been viewed by many patent practitioners as narrow and limited to their facts. Nowhere in either decision did the court state that a purified product has to be substantially different in structure from its natural state to be patent eligible. The court in Myriad only held that genes and the information they encode are not patent eligible “simply because they have been isolated from the surrounding genetic material,” and stated that its holding is limited.
In March, 2014, guidelines were issued that went well beyond the holdings in Mayo and Myriad as well as precedential case law. The analysis by the USPTO in the guidelines concluded, for example, that products isolated from nature as well as mixtures thereof, were no longer patent eligible. This view jeopardized the validity of thousands of issued patents, and has resulted rejection of subject matter of many patent applications that heretofore would have issued. The guidelines threatened the foundation upon which the biotechnology industry, and, the long-established pharmaceutical industry are based. The guidelines were soundly criticized by the patent bar and other industry groups. Hearings were held in June, 2014, and a period for comments was provided.
In response the USPTO issued new guidelines on Dec. 15, 2014, the new guidelines are significantly revised, and have far fewer limits on patent eligibility. Included is a framework for assessing whether a claim is directed to non-patent eligible product. A purified natural product, an antibiotic and mixtures of natural products now may be patent eligible. If the purified natural product has different structure, function and resulting properties from its natural state, it likely will be patent eligible. According to the guidelines:
“A product that is purified or isolated, for example, will be eligible when there is a resultant change in characteristics sufficient to show a marked difference from the product’s naturally occurring counterpart."
In public statements accompanying release of the guidelines, the USPTO indicates that the law is still evolving and that they are committed to improving the guidance. The USPTO will open a 90-day comment period and will hold a public forum in January.
-Submitted by Stephanie Seidman, McKenna Long & Aldridge LLP.