Wednesday, 03 July 2013 15:31

ISOLATED DNA SEQUENCES ARE NOT PATENTABLE

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Those of us who have been waiting with bated breath for the U.S. Supreme Court’s decision on gene patents in the case of Myriad can now exhale.  The Court issued its opinion this morning, in which, as we predicted, they held that cDNA is patentable subject matter, but “isolated DNA” derived from genomic DNA is not patentable.

The Court unanimously agreed that a naturally occurring sequence of DNA, even if isolated, is still a product of nature and therefore is not patentable.  Myriad, they said, did not create or alter any of the genetic information for the BRCA1 or BRCA2 genes, but rather discovered these genes are implicated in breast cancer if mutated.  According to the Supreme Court, a “groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the section 101 inquiry” of patentable subject matter.  Put another way, discovery is not the same as invention, and patent protection is not appropriate for all things.  On the other hand, cDNA was clearly considered to be different and patentable since it does not occur naturally but only synthetically.

 
The biotech industry and universities have been particularly concerned about the effect this opinion would have on the industry, investment, and incentives to continue research and development.  The Court acknowledged the importance of striking the right balance between these interests and the opposing interests of not tying up foundational knowledge and preventing further innovation.  While some may be tempted to start hyperventilating from this opinion, take a deep breath.  There are many ways to reward innovation, and patents are only one such way.  Discoveries may not be patentable, but inventions still are.   According to this Myriad case and the earlier Prometheus decision, applications or uses of laws of nature are still patentable.  Therefore, kits, devices, treatments, and other uses or transformations of naturally occurring things may still be patentable.  The Myriad court specifically stated that method claims, new applications of knowledge of particular genes, and even DNA which has been manipulated or altered are still patentable. 
Read 2484 times Last modified on Monday, 05 August 2013 15:34
Jessica Hauth

Ms. Hauth earned her bachelor's degree in Chemistry and her master's degree in Biochemistry, Cell and Developmental Biology from Emory University, and her law degree from the University of Miami School of Law. She has published her research in the areas of developmental biology, genetics, heterochromatin assembly and maintenance, and RNAi use and characterization. She is a member of the American Chemical Society, American Intellectual Property Law Association, Dade County Bar Association, and Phi Alpha Delta. She is admitted to practice law in Florida state courts, as well as in the United States District Court for the Southern District of Florida. As a Registered Patent Attorney, she concentrates her practice on Patent Prosecution and Intellectual Property Litigation.