January 20, 2020 | The past few years have been hard on diagnostics companies wanting to patent their work. In several cases, courts have ruled that discovering or measuring biomarkers and associating those biomarkers with a particular disease, diagnostic tests both start and end with naturally occurring phenomena. Unless there are novel technical steps in between—in how those biomarkers are collected, measured, or interpreted, for example—nothing was invented, and the diagnostic test isn’t patentable. Companies cannot patent natural laws.
Last week the Supreme Court again chose not to reconsider a decision.
“The requirement for an improvement to the technology involved in carrying out the claimed method is a steep hurdle for the eligibility of most medical diagnosis inventions,” wrote Sanjeev Mahanta in IPWatchdog in April, “since the essence of such inventions is applying a newly discovered correlation to deliver a practical benefit—not improving the technology used to provide the diagnosis. In this regard, medical diagnostic inventions are unique.”
Bryan Wheelock, a principal in the St. Louis office of Harness, Dickey & Pierce, spoke with Diagnostics World News about how the current climate around diagnostic patentability is impacting the market and what to watch for next.
Diagnostics World News: Do you believe diagnostics companies are holding off on development of diagnostics products until patent eligibility legislation passes and they can be patent-protected?
Bryan Wheelock: I do believe that at least some companies are deferring development of some diagnostic products until the protectability of diagnostic products is clarified. It is only reasonable to expect companies to react to an increased risk to their investments. While some companies continue development—perhaps adjusting how they exploit their diagnostic developments—some certainly will divert their resources to other, less risky endeavors.
Has the inability to protect diagnostics with patents led to reductions in investment in diagnostic products?
Common sense indicates that the lack of protection affects investment. As Senators Tillis and Coons observed in their June 2019 statement after their patent reform hearings, anyone who watches Shark Tank knows that “the ability to secure patent protection plays a vital role in securing funding for new ideas.”
Relying on government funding, the kind of basic scientific research that discovers the science behind new diagnostic technologies will continue, even if private investment is reduced. However, what is harder to replace is the investment in developing commercial diagnostic products, shepherding these new products through the regulatory process, and promoting acceptance and adoption of the products. Some estimates of the cost of developing a new diagnostic product are as high as $75 – 100 million. Rational investors need some comfort that these costs can be recouped and restoring patent protection for diagnostic products provides that comport and is a way to speed both the discovery and delivery of new diagnostic products.
How will the passage of patent eligibility legislation change how diagnostics companies develop their tests?
If patent eligibility legislation restores protection for diagnostic inventions, companies that reduced their investment in diagnostic products will increase their investments; companies that continued to invest in diagnostic tests will reallocate their resources to riskier, but potentially more profitable tests; and companies that relied on secrecy to protect their developments can rely upon more public methods of exploitation.
How will patent eligibility legislation help or hurt U.S. companies’ competitiveness in the global marketplace?
Anything that improves investment and profitability of U.S. diagnostic product companies will improve their competitiveness in the global marketplace, and the restoration of protection in the U.S. will improve their competitiveness in the U.S., as well.
What comes next? For what developments should diagnostics makers watch?
The Supreme Court recently (January 13) denied certiorari to review the Federal Circuit’s decision in Athena Diagnostics v. Mayo Collaborative Services, a poster child for the protection of diagnostic methods. Until [Athena’s] invention disclosed in U.S. Patent No. 7,267,820, one fifth of patients suffering from Myasthenia Gravis, [a chronic autoimmune neuromuscular disease that causes weakness in the skeletal muscles,] could not be correctly diagnosed. While agreeing that the public interest is poorly served by adding disincentives to the development of new diagnostic methods, and expressing the personal view that providing patent protection to novel and non-obvious diagnostic methods would promote the progress of science and the useful arts, the Court of Appeals, bound by Supreme Court precedent, affirmed the district court’s holding that the claimed diagnostic test was not patentable subject matter. Now that the Supreme Court has denied review, the protection of new diagnostic products—at least those that relate to new discovered correlations between physiology and disease—will be non-existent. The Constitution gives Congress the power to protect inventions and discoveries, and if Congress does not exercise this power to restore the incentive to develop and disseminate new diagnostic technologies, everyone will suffer.