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The Intellectual Property StrategistFeaturesIntellectual PropertyLitigationPatent Licensing and TransactionsPatent Litigation

As Section 101 and the Progeny of Mayo and Myriad Continue to Wreak Havoc on Portfolios, How Is The Life Sciences Industry Fighting Back?

By Wesley Overson, Otis Littlefield, Mat Swiderski, and Stephanie Blij
June 01, 2019

For years, the United States Patent and Trademark Office (Patent Office or USPTO) allowed claims to biological discoveries including DNA or protein sequences as long as the claims did not encompass the sequences in their natural setting. In Mayo and Myriad, the U.S. Supreme Court wiped out most of those patents for improperly claiming a "law of nature" and "product of nature," respectively. Since that time, the Federal Circuit has expanded the holdings and invalidated more patents directed to biological discoveries. If the newly discovered correlations and properties of what is found in nature cannot be patented, what strategies for protection are left for companies doing biological research?

Diagnostic Patents

Imagine an industry where a company invests decades of time and tens of thousands of lab hours to create billions of dollars on its balance sheet, only to have all of that investment depleted by a governmental entity over which it has no control. This is not some imagined corporate nightmare. It is exactly what has happened to important sub-sectors of the life sciences industry as a result of the Supreme Court decisions in Mayo, Myriad, and their progeny: Mayo Collaborative Services v. Prometheus Labs., Inc., 566 U.S. 66 (2012); Assoc. of Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2012). This article discusses the continued impact of Mayo and Myriad and some of the measures companies are taking to re-build patent portfolios that have been adversely impacted.

Diagnostic patents — particularly those involving cutting-edge genetic discoveries — present an interesting dilemma for patent law: it often takes several years and tens or hundreds of millions of dollars in research and development to discover and then prove what diagnostic information can reliably be gleaned from a particular DNA sequence. But once that information is known — i.e., that a particular DNA sequence is a genetic marker for some aspect of an individual's health — companies often rely on well-established diagnostic tools to identify that genetic marker in a patient. In other words, in diagnostics, the key innovation often is not how a patient is diagnosed, but rather discovering what genetic marker to look for in order to make a diagnosis. We all know that "natural phenomena" are not patentable under 35 U.S.C. §101. So what happens when a company spends several years and millions of dollars identifying new genetic markers and developing corresponding diagnostic tests that meet rigorous standards required of regulatory authorities and medical professionals? Can they protect their investment in research and development under U.S. patent law?

Although courts had found that 35 U.S.C. §101 prohibits patenting laws of nature, natural phenomenon and abstract ideas, throughout the 1980s, '90s, and '00s, the Patent Office encouraged inventors to apply for diagnostic patents in order to encourage innovation. Until the Supreme Court's decision in Myriad, the Patent Office's policy had been that "[a]n insulated and purified DNA molecule that has the same sequence as a naturally occurring gene is eligible for a patent" because the DNA molecule — in its isolated form — is not naturally occurring. 66 Fed. R. 1092-02 (Jan. 5, 2001).

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