Published on 12 February 2013
Patenting Human DNA: SCOTUS Pharma and Biotech Case Preview

Patents form the basis of the  pharma and biotech industry, also called the life sciences industry. They give companies an incentive to make large investments in risky drug development and innovations, which have the potential to be ineffective or to fail Food and Drug Administration (FDA) approval. More than 6,000 U.S. businesses spent $22 billion on biotech R&D in 2011, according to the Organization for Economic Cooperation and Development (OECD). If an innovation succeeds, a patent gives the developer a time-limited monopoly to sell the invention, allowing them to recoup their investments and earn profits.

Is Human DNA Patentable?

This year, the U.S. Supreme Court will hear arguments in Association for Molecular Pathology v. Myriad Genetics, Inc., in which the court will address the question of whether human genes are patentable. The answer to that question could have profound implications for not only the biotech industry but health care as a whole.

The U.S. Patent and Trademark Office (PTO) granted the first human DNA patent several decades ago. At least 42,000 genetic patents exist today, representing one fifth of known human genes. That estimate comes from a 2005 study in the journal Science and likely now outdated. Nonetheless, it is the estimate cited in an amicus brief for the Myriad case, and in other research.

Isolated DNA vs. DNA in Nature

Myriad Genetics holds patents on two types of isolated DNA – BRCA 1 and BRCA 2 – that are associated with much higher risks of breast cancer or ovarian cancer. Natural phenomena and laws of nature are not patentable under 35 U.S.C. 101, in the Patent Act. However, Myriad’s patents are based on the notion that by removing BRCA 1 and BRCA 2 from the human body, Myriad has created a patentable product that is different from naturally occurring DNA.

“The patents on the DNA give Myriad the exclusive right to look for variants of BRCA1 and BRCA2, even when using routine, conventional methods for isolating and sequencing,” says the petition for writ of certioari.

The petitioners in this case, mostly geneticists and physicians led by Association for Molecular Pathology (AMP), say that Myriad’s exclusive right to test for BRCA 1 and BRCA 2 hinders research and access to care.

In an amicus brief siding with Myriad, Rosetta Genomics argues that gene patents encourage rather than stifle innovation and research, and that eliminating gene patents “may effectively kill the relatively new diagnostic and personalized medicine industries altogether…”

A district court rule against Myriad, but the Court of Appeals for the Federal Circuit reversed the decision. The Supreme Court last year asked the Court of Appeals to rehear the case. After the appeals court came to the same conclusions, the Supreme Court agreed to take it on. Arguments in the case have yet to be scheduled, but you can keep track of the developments on SCOTUSblog.com.

Mayo v. Prometheus

The Myriad case comes on the heels of another important patent case, Mayo Collaborative Services v. Prometheus Laboratories, Inc. Prometheus Laboratories holds two patents on methods to administer drugs to combat autoimmune diseases, and to measure the level of those drugs in a patient’s blood. The Supreme Court, in a unanimous decision, ruled that the Prometheus methods did not add enough usefulness in applying natural laws to warrant patents.

Read this Congressional Research Service (CRS) report for more information on the Mayo case and its implications.

SCOTUS Case Previews

This post is part of a short series of previews about upcoming Supreme Court cases that affect the pharma and biotech industry. Though Myriad is the most high-profile of the group, other important cases deal with the state tort liability for generic prescription drugs and the legality of pay-for-delay settlements, another patent-related case.

About Author

An expert on Medicaid, Medicare, and health reform, Kip Piper, MA, FACHE, is a consultant, speaker, and author. Kip Piper advises health plans, hospitals and health systems, states, and pharma, biotech, medical device, HIT, and investment firms. With 30 years’ experience, Kip is a senior consultant with Sellers Dorsey, top specialists in Medicaid and health reform. He is also a senior advisor with Fleishman-Hillard and TogoRun. For more, visit KipPiper.com. Follow on Twitter @KipPiper, Google +, Facebook and connect on LinkedIn.

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