In June 2015, the Federal Circuit decided that Sequenom's patent (US Patent No. 6,258,540) is not patent eligible for the reasons that the claims recite cell-free fetal DNA (“cffDNA”) which is a natural phenomenon, and that the remaining part of the claims such as using methods like PCR to amplify and detect cffDNA was well-understood, routine, and conventional activity at the time of the invention. In December 2015, the Federal Circuit denied Sequenom's petition for en banc rehearing.
On March 21, 2016, Sequenom filed a petition for a writ of certiorari with Supreme Court to review the Federal Circuit's decision. The Question Presented provided in the petition is as follows.
Whether a novel method is patent-eligible where: (1) a researcher is the first to discover a natural phenomenon;(2) that unique knowledge motivates him to apply a new combination of known techniques to that discovery; and (3) he thereby achieves a previously impossible result without preempting other uses of the discovery?
In the petition, Sequenom has presented the following three points as the reasons for granting the petition.
- The Federal Circuit's decision has dangerously overextended Mayo;
- The presented issue is vitally important; and
- The case is an ideal vehicle.
First, with regard to point (I), the petition firstly indicated that the two-part test used in the Supreme Court's earlier decisions, Mayo and Alice, was not intended to serve as a fully developed legal rule that could be easily or mechanistically applied to all future cases as acknowledged by Mayo's author. Thus, the petition requested that the Supreme Court clarify that its precedents permit patenting meritorious invention like the Sequenom patent.
Specifically, the petition discussed that the Supreme Court found that Diehr's method is patent eligible since the combination of recited technique was not known while each separate technique was already known. The petition indicated that Sequenom's patent is like Diehr's method since the phenomenon the inventors discovered motivated them to teach a new method that no one was practicing, and whose combined steps were in fact the opposite of a conventional approach that had previously treated the key materials as waste.
In addition, the petition stressed that Section 101 forecloses claims that preempt essentially all uses of a natural phenomenon-not claims foreclosing only particular methods of using them that the inventor has disclosed. The petition criticized the Federal Circuit's rationale that once a formalistic application of Mayo's two-part test suggests that the claims combine an unpatentable discovery with conventional techniques, preemption concerns are fully addressed and made moot, and requested the Supreme Court to clarify Mayo's breadth.
Then, the petition argued that the Federal Circuit broadens the breadth of Mayo as it interpreted Mayo to require invalidating patents whenever they incorporate a natural law or phenomenon and recite techniques that are separately well-known, conventional, or routine. In particular, it criticized the Federal Circuit's interpretation of Mayo by presenting three examples (i.e., Diehr's invention, etc.), which were treated as patent eligible, but would be patent ineligible under the Federal Circuit's interpretation. Moreover, the petition argued that the Federal Circuit's reading of Mayo leads to ironic and unacceptable results since such an interpretation would invalidate inventions which recombine only well understood and readily available techniques to achieve breakthrough results.
Second, with regard to point (II), the petition stressed the importance of the presented issue based on the following points.
- Support of trustworthy amici (e.g., twelve different briefs supported rehearing);
- Necessity of addressing the question on whether or not patents will ever be available in biomedical field; and
- Necessity of addressing the discordance with foreign jurisdictions.
Third, with regard to point (III), the petition stressed that this case is an ideal vehicle for clarifying the Supreme Court's position on patent eligibility of the patent that combined and utilized man-made tools in a new way that revolutionized a field.
Now, the ball is back to the Supreme Court. And soon, the Supreme Court will decide whether or not the Court grants the petition and hears this case.