Earlier today Sequenom, Inc. filed a Petition for Writ of Certiorari in the Supreme Court of the United States, challenging the decision of the United States Court of Appeals for the Federal Circuit in Ariosa Diagnostics, Inc. v. Sequenom, Inc. If the Supreme Court takes this case, which they absolutely should, they will be required to reconsider the overwhelming breadth and scope of their prior ruling in Mayo Collaborative Servs. v. Prometheus Labs.
The single question presented by Sequenom in the petition for certiorari 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?
“We think that there is a compelling case for the Supreme Court to step in,” said Sequenom’s counsel Thomas Goldstein, the founder of the widely popular SCOTUS Blog. “The issue turns entirely on how to read the Court’s cases. The stakes could not be higher for the life sciences. And this is undoubtedly a breakthrough invention that illustrates the harm from the Federal Circuit’s ruling.”
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Reasons for Granting Cert.
Before launching into a detailed analysis of why the Supreme Court should grant certiorari in this particular case, Sequenom makes the following general argument in the brief, which basically makes the point that the sweeping language of Mayo simply cannot mean what it says because when applied as written even groundbreaking, novel, non-obvious and highly useful innovations are no longer patent eligible. The brief explains (at pages 11-12):
This is as straightforward a certiorari candidate as any patent case can be. It is manifestly important: A host of judges and amici have stressed that the result below is untenable— invalidating previously irreproachable inventions and precipitating what Judge Lourie called “a crisis of patent law and medial innovation.” Pet.App. 78a. Those judges have likewise emphasized that the only clarifications that can avoid such results “must come from the Supreme Court.” Pet.App. 84a (Dyk, J.); Pet.App. 20a-21a (Linn, J.). And this is the vehicle this Court needs to provide that clarification: Every opinion below agrees that this case tests Mayo’s uncertain limits by invalidating an otherwise plainly meritorious invention. As Mayo’s author has acknowledged, that case could only “sketch an outer shell” of its test, Arg. Tr. 28, Alice v. CLS Bank Int’l, 134 S. Ct. 2347 (2014) (No. 13-298) (Breyer, J.), partly because it was hard to “figure out much … to go beyond … an obvious case.” Id. 10-11. Here, unlike Mayo, every intuition points towards patent-eligibility. And yet the Federal Circuit felt compelled by Mayo to condemn this meritorious patent—and, a fortiori, the patents underlying an entire, vital field of American healthcare innovation. If, as several judges below observed, that cannot be what Mayo intended, this is precisely the case in which this Court needs to say so.
The case itself shows why. Sequenom invested enormously in developing and validating a recognized “breakthrough” for clinical use, only to see that investment radically undermined by fast-following competitors trading on an uncertain legal doctrine. As several judges below explained, even they find it hard to reconcile Mayo’s test with other language in the opinion, Pet.App. 23a-24a (Linn, J.), let alone other language in other opinions, Pet.App. 90a-91a (Dyk, J.). It is infinitely harder for businesses to decipher where the doctrine now stands, especially because it (now) seems divorced from intuitions about patent-eligibility for “revolutionary” inventions like this one. Right now, Section 101 doctrine lacks any discernable limits, and so no company can trust in the patent system when deciding whether to invest in bringing an invention to market. This issue has become particularly life-threatening to life-science innovators. Pet.App. 77a-78a (Lourie, J.); Pet.App. 90a (Dyk, J.). And so unless this Court clarifies some limits on Section 101, a doctrine that was meant to be a narrow exception will become the rule by default in at least this industry, and likely beyond.
This wayward patent tale begins back in 1996, when two doctors discovered cell-free fetal DNA (cffDNA) circulating in maternal plasma. They used that discovery to invent a test for detecting fetal genetic conditions in early pregnancy that avoided dangerous, invasive techniques that are potentially harmful to both the mother and the fetus. They filed a patent application, which matured into U.S. Patent No. 6,258,540, which claims certain methods of using cffDNA. The patent teaches technicians to take a maternal blood sample, keep the non-cellular portion (which was “previously discarded as medical waste”), amplify the genetic material that only they had discovered was present, and identify paternally inherited sequences as a means of distinguishing fetal and maternal DNA. The claimed method does not preempt other demonstrated uses of cffDNA.
In response to letters threatening claims of infringement from Sequenom, Ariosa Diagnostics, Inc., Natera, Inc. and Diagnostics Center, Inc. each filed separate declaratory judgment actions from December 2011 through early 2012 against Sequenom alleging that they did not infringe the ‘540 patent.
The district court determined that the claims of the ’540 patent in question were directed to the natural phenomenon of paternally inherited cffDNA and that the claims did not add enough to the natural phenomenon to make the claims patent eligible under § 101. The district court determined that the steps of amplifying and detecting were well-understood, routine, or conventional activity in 1997 (the critical date), when the application for the ’540 patent was filed. The district court concluded that the ’540 patent was not directed to patentable subject matter because the only inventive component of the processes of the ’540 patent is to apply those well-understood, routine processes to paternally inherited cffDNA, a natural phenomenon.
On Appeal to the Federal Circuit
Ultimately, the Federal Circuit concluded that the discovery in question was “a significant contribution to the medical field,” but that did not matter insofar are patent eligibility is concerned.
The Federal Circuit, in the original panel opinion authored by Judge Reyna, explained that it was undisputed that the existence of cffDNA in maternal blood is a natural phenomenon. It was further clear that the inventors did not create or alter any of the genetic information encoded in the cffDNA. The method covered in the patent claims ends with paternally inherited cffDNA, which is also a natural phenomenon. The method, therefore, begins and ends with a natural phenomenon. Thus, the claims were found to be directed to matter that is naturally occurring.
The inquiry did not end here, however, because the claims at issue are drawn to naturally occurring phenomena, it was necessary under the Supreme Court’s so-called Mayo framework to ask a second question – whether the elements of the claim contain sufficient inventive conception to transform the claimed naturally occurring phenomenon into a patent eligible invention. The Federal Circuit concluded that the claims did not satisfy this second prong of Mayo.
Judge Reyna wrote:
The method at issue here amounts to a general instruction to doctors to apply routine, conventional techniques when seeking to detect cffDNA. Because the method steps were well-understood, conventional and routine, the method of detecting paternally inherited cffDNA is not new and useful.
Judge Linn wrote a separate concurring opinion concluding that given the unnecessarily sweeping language of the Supreme Court’s decision in Mayo he was constrained to agree that the patent claims at issue were ineligible. Judge Linn explained that the Supreme Court lumped all post-solution conventional activity together as if it necessarily had to be qualitatively the same.
Judge Linn wrote:
The Supreme Court’s blanket dismissal of conventional post-solution steps leaves no room to distinguish Mayo from this case, even though here no one was amplifying and detecting paternally-inherited cffDNA using the plasma or serum of pregnant mothers. Indeed, the maternal plasma used to be “routinely discarded,” because, as Dr. Evans testified, “nobody thought that fetal cell-free DNA would be present.”
Judge Linn concluded “Sequenom’s invention is truly meritorious.”
It is unfortunate that the Federal Circuit did not recognize that a discovery as significant as the one embodied in the ‘540 patent is patent eligible. Of course, it is hard to argue with Judge Linn’s analysis. It should not be that way, but because of the extraordinary breadth of the decision in Mayo it has to be that way.
It seems clear that the Supreme Court did not intend to destroy medical research or make it impossible to patent groundbreaking medical advances, but that is what Mayo has done when the language of the Supreme Court is faithfully applied, at least to the extent it can be applied. The Supreme Court has arbitrarily chosen which of its own prior decisions to follow and which decisions ignore, while simultaneously refusing to read and enforce the laws passed by Congress even when the statue is but a single sentence (as is 35 U.S.C. 101, which clearly says discoveries are patent eligible).
It is time for the Supreme Court to stand up and face the music. If they did not intent to render groundbreaking medical innovations patent ineligible they must take this case and they must place real, consequential limits on Mayo.