Diagnostic Patents Suffer Another Setback In US As Supreme Court Refuses To Hear Sequenom Appeal

In recent years, there have been a couple of really important US Supreme Court decisions in the biotech field. One is the 2013 judgment striking down gene patents. The other is a ruling from 2012 that rejected the patenting of basic medical diagnostics, in a case involving Mayo Collaborative Services and Prometheus Labs. The resultant loss for biotech companies in terms of devalued patent portfolios, and their reduced ability to control the market using intellectual monopolies, has been so serious that it is no surprise that there are periodic attempts to get these decisions mitigated through subsequent court rulings.

For this reason, the industry has been watching with great interest a case involving Sequenom, and its patent on a non-invasive pre-natal diagnosis test using the fact that fetal DNA is present in the blood plasma of expectant mothers. A lower court invalidated that patent on the basis of the Mayo decision, and Sequenom appealed to the Supreme Court to review the ruling. But a statement from the company has now dashed the biotech industry's hopes:

The Supreme Court of the United States denied [Sequenom's] petition to review decisions by lower Federal courts that the claims of Sequenom's U.S. Patent No. 6,258,540 ("'540 Patent") are not patent eligible under the patent eligibility criteria established by the Supreme Court's Mayo Collaborative Services v. Prometheus Laboratories decision. In the petition, Sequenom urged the Court to hear the case because the Court is uniquely suited to reconcile and interpret the patent eligibility criteria established in its Mayo decision. Sequenom will pursue no further appeal opportunities for review of the '540 Patent.

Although the industry will doubtless whine about how there is no incentive to produce new diagnostic tests, there's no evidence that research and development in this area has ground to a halt in the US since the Supreme Court ruling on Mayo. All that has happened is that obvious applications of natural biological phenomena have been removed from patentability. Given the inherent reasonableness of that, we can probably hope that further challenges to Mayo will also fail.

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