DNA In the issue that will not die, the Supreme Court again considered what can or cannot be patented.  This time the question was whether human genes can be the subject of a patent.

The U.S. Constitution at Article One, Section 8 gives Congress the power “to promote science and the useful arts, by securing for limited times…to inventors the exclusive right to their…discoveries.”  Congress exercised that authority in Section 101 of the patent statute, which authorizes patent protection to “[w]hoever invents or discovers any new and useful… composition of matter.” In the past, the Supreme Court has created exceptions preventing patenting of laws of nature, natural phenomena and abstract ideas.

Myriad Genetics discovered the precise locations of certain genes, the mutation of which increased the risk of certain cancers.  The U.S. Patent and Trademark Office issued patents to Myriad for the genes.  The Federal Circuit Court of Appeals agreed that Myriad’s discovery of the genes was patentable.

The Supreme Court decided that the naturally occurring genes that Myriad located and isolated are a ‘product of nature,’ fall within the ‘law of nature’ exception and are not patentable; however, genes that were modified by Myriad are patentable.

Naturally-occurring materials are staples of biotechnology patenting. Because of the complex questions involved, the transactional costs for the industry to identify and investigate the effects of the Myriad decision will be very high. We can anticipate that the value of companies holding patents to naturally occurring biological materials may be affected.

— Robert Yarbrough, Esq.