woman-in-labTo the surprise of many, including myself, the Supreme Court denied Sequenom’s petition for writ of certiorari (“Petition”). Sequenom asked the Court whether the inventive concept required under the Mayo/Myriad framework can come from the discovery of the natural phenomenon itself. This distinction would allow the Court to differentiate a meritorious invention like Sequenom’s from the method that was held patent-ineligible in Mayo. In Mayo, the natural phenomenon was well known- those of skill in the art were aware of the differential metabolism of thiopurine drugs and how this differential metabolism impacted dosing considerations and patient care. In other words, the natural phenomenon was well known. In contrast, the discovery of a natural phenomenon—the presence of paternally inherited cffDNA in maternal plasma—was what made Sequenom’s invention groundbreaking. After all, no one was using paternally inherited cffDNA from maternal blood plasma for prenatal diagnosis prior to Sequenom’s discovery. In both cases, absent the natural phenomenon implicated in the claims, it is fair to say the remaining elements of the claim were routine.

Furthermore, the denial of the Sequenom’s petition was all the more surprising based on the dicta in Myriad. The Myriad Court explained what was not implicated in that decision—diagnostic method claims. Myriad did not involve new applications to knowledge about the BRCA1 and BRCA2 genes, but to composition claims of BRCA1 and BRCA2.

However, the Myriad Court seemed to endorse Judge Bryson’s statement:

“[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications to that knowledge.”

Sequenom tried to do just that, by claiming their pioneering application for the non-invasive diagnostic testing of genetic abnormalities of a fetus, spending $70 million on development of their test prior to 2011 (named “MaterniT21”). Sequenom’s competitor, Ariosa, launched a competing test. Because Sequenom’s claims were invalidated under the Mayo/Myriad framework, Ariosa did not have to pay a dime in royalties.

As Sequenom noted in their Petition:

“[i]f combining a new insight about the natural world with ‘available elements’ to achieve  extraordinary new results is unpatentable subject matter—as is now U.S. law absent [the U.S. Supreme Court’s] intervention—no such breakthroughs are patent-eligible. That means anyone who would invest in making, validating, or commercializing inventions like these for human medical use must invite others along for the free ride, with predictably unfortunate results.”

Sequenom remarked that application of the current Mayo/Myriad test “undermines just about any biomedical breakthrough you can conceive. Vaccines? They combine the natural fact of immune response with known methods of drug administration. Even for previously unstudied diseases like Zika? Yes. Aspirin—perhaps the world’s most successful patented medicine? It combined a natural plant product with basic chemistry techniques.” While Sequenom’s remarks regarding the scope of § 101 may be a bit overreaching (for example, Example 28 of the Subject Matter Eligibility Examples released in May of this year indicate that at least the USPTO will still provide a relatively broad scope of protection for vaccines), the specter that many groundbreaking diagnostic inventions are now likely unpatentable is real. Regrettably, the Court was unmoved by these policy arguments made by Sequenom and several amici of the effect of continuing uncertainty on the biotechnology industry if Sequenom’s Petition was denied.

Indeed, the Federal Circuit’s interpretation of the Mayo/Myriad framework is expansive, making it difficult to know what will be eligible for patenting. Of the four cases that have come before the Federal Circuit since Mayo and Myriad that involve molecular diagnostics, the court invalidated all challenged claims. That trend is likely to continue with the Court’s denial of Sequenom’s Petition. Judge Dyk confirms this idea in the en banc opinion: “I think that we are bound by the language of Mayo, and any further guidance must come from the Supreme Court, not this court.”

By refusing Sequenom’s Petition, the Court has decided that the bounds for the Mayo/Myriad framework need no further clarification, refusing to make bright line distinctions between newly discovered natural phenomena and what is already known and lending certainty to patent practice in the biotechnology field. The natural phenomenon remains divorced from the additional steps of the method. Under § 101, methods are supposed to be generally patent-eligible subject matter. The judicial exceptions to patent-eligible subject matter (laws of nature, natural phenomena, and abstract ideas) should be just that—exceptions to the rule. Unfortunately, as applied to biotechnology inventions, the exception has become the rule, and § 101 lacks any discernable limits.