By Kevin E. Noonan --
Sequenom filed its anticipated petition for certiorari today for Supreme Court review of the Federal Circuit's decision in Ariosa v. Sequenom. The petition advises the Court that it "should take this opportunity to provide the guidance the Federal Circuit is openly seeking, and avoid a result neither it nor Congress could have intended."
The "Question Presented" reads as follows:
In 1996, 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. Their 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 within (which they alone knew about), and identify paternally inherited sequences as a means of distinguishing fetal and maternal DNA. Notably, this method does not preempt other demonstrated uses of cffDNA.
The Federal Circuit "agree[d]" that this invention "combined and utilized man-made tools of biotechnology in a new way that revolutionized prenatal care." Pet.App. 18a. But it still held that Mayo Collaborative Servs. v. Prometheus Labs., 132 S. Ct. 1289 (2012), makes all such inventions patent-ineligible as a matter of law if their new combination involves only a "natural phenomenon" and techniques that were "routine" or "conventional" on their own. Multiple judges wrote separately below to explain that while this result was probably not intended by Mayo, it controlled, and only this Court could now "clarify" Mayo's reach to prevent a "crisis" in life-science innovation.
The Question Presented is: 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?
The Petition asserts three grounds: that:
• The Decision Below Has Dangerously Overextended Mayo, and the Court needs to clarify that its precedents permit patenting meritorious inventions like this one.
• This Issue is Vitally Important.
• This Case Is An Ideal Vehicle.
The Statement of the Case recites the inventiveness of the claimed invention, including that the fraction of maternal blood from which the cffDNA was detected was routinely discarded. It recounts the surprise and acclaim with which the invention was greeted in the art, and the application of human ingenuity required to make a practical genetic test from their discovery that cffDNA could be found in maternal blood, i.e., specifically targeting paternally derived portion of the cffDNA. Specifically recited in this regard are the utilities of detecting Downs syndrome, fetal gender and Rh disease using a simple blood test instead of invasive conventional methods (amniocentesis, e.g.). The Petition also mentions the parsimoniousness of the claimed invention, being limited to the test and not including the cffDNA itself or having claims that would preempt all uses of cffDNA by others, citing peer-reviewed journal articles describing alternative methods that would not infringe the claims invalidated by the inferior courts. Tellingly, the Petition asserts that what is inventive is the combination, not the individual steps which were all well known.
The Petition also recites the procedural history of the case and the decisions of the courts below, making special mention of Judge Linn's "remarkable" concurrence. It characterizes the panel decision as being based on "evident rationale was that, because the discovery of cffDNA in maternal plasma directly motivated the '540 patent's new combination of known techniques, that invention merely reflected that patent-ineligible discovery itself. According to the majority, that rendered the patent ineligible under Section 101 as a matter of law, even though it 'agree[d]' that the patent 'combined and utilized man-made tools of biotechnology in a new way that revolutionized prenatal care.' Id. (emphasis added)." It further characterizes (as error) the panel's treatment of the preemption issue as "a one-way ratchet: It 'may signal patent ineligible subject matter,' but 'the absence of complete preemption does not demonstrate patent eligibility.'" Finally the Petition notes that Judge Linn's concurrence, as well as the concurrences to the Federal Circuit's decision denying rehearing en banc, evince the conclusion that "despite this patent's inventive merit, the case would have to be resolved in this Court because Mayo tied the Federal Circuit's hands."
The Petitioner then boldly states that "[t]his is as straightforward a certiorari candidate as any patent case can be," because the judges below clearly stated that only correction by the Court would remedy the situation. The practical effect is clear: "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." How to do so is simple, according to Petitioners: "this case allows the Court to emphasize that a new combination of otherwise conventional techniques is patent-eligible even if it is straightforwardly motivated by a patentee's unique discovery of a natural law or phenomenon." In this regard, the Petition cites Justice Breyer's dicta in Mayo that "a new use for a known drug" should remain patent eligible, and Justice Thomas's citation in Myriad with approval Judge Bryson's view that the party who discovers a natural phenomenon would be in the best position to claim applications of that knowledge." -- which is just the case here.
This portion of the Petition recites a litany of horrors if the Court does not review (and reverse) the decision below -- from preventing patenting (and development) of vaccines against, for example, the Zika virus, to the conclusion that prior inventions would be patent-ineligible on drugs like aspirin, and even PCR itself, which in Kary Mullis's own words was "a simple idea that 'lay unrecognized for more than 15 years after all the elements for its implementation were available.'" As a consequence, "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."
Worse, according to petitioners, the Federal Circuit's decision "jettison[ed]" the one objective basis for making a Section 101 determination: preemption. "An approach to Section 101 that reduces such a critical fact to a 'moot' afterthought is too badly broken to let lie."
The Petitioners further note that that Justice Breyer himself did not intend the Mayo decision to be the end of the development in the law, but to merely "sketch the outer shell of the content" of Sec 101.
The Petition cites Diehr, Mayo, and Myriad for the proposition that a new combination of old steps should be enough to pass Section 101 muster, illustrating the principle with the statements from Mayo regarding new uses of an old drug:
[T]he Court intimated that "a new way of using an existing drug" would be patent eligible. But that can be true only if patent eligibility extends to new combinations of routine steps that would be self-evident to researchers who knew about a new discovery: After all, the drug is known, the means of administering it are known, and the only new insight is the natural law that the drug treats a disease no one previously knew it treated. So, unless the "inventive concept" that Mayo requires can be found in combining existing techniques in a new way to capitalize on a newly discovered natural phenomenon, Mayo itself is wrong about the patent eligibility of new uses for existing drugs. Conversely, if Mayo (like Diehr) is better understood to permit patenting unconventional combinations of known techniques and materials to accomplish new results that capitalize on newly discovered natural phenomena, the invention at issue here is patent-eligible, because that description fits it to a T.
And regarding preemption:
[T]he preemption concern is not that the patent covers all the immediately useful ways in which an insight known only to the inventor can be harnessed right now. . . . Instead, the concern is that a patent covers all the ways a natural discovery might ever be put to use, including highly innovative ones the patentee does not know and cannot teach.
Finally in this section Petitioner outlines the dangers to innovation that the decisions below create, including invalidation of almost all prior patents including the first one ever granted, on a method for making potash, and otherwise comprising an exhaustive list of suddenly and retrospectively patent ineligible inventions.
With regard to the importance of the issue the Petition cites the twelve "trustworthy amici" who participated at the en banc rehearing stage, as well as the Solicitor General's similar warnings in Mayo. The "suddenly muddled" state of Section 101 law discourages innovation in the life sciences according to the Petition and, ironically, "now affirmatively encourages researchers to keep as secret as possible those very 'basic tools of scientific and technological work' that Section 101 doctrine is designed to render into a public good for the benefit of scientific progress." Repeating a meme developed below:
After the decision below, those seeking new vaccines, new uses for existing drugs, and even holy grail insights like early, non-invasive cancer screens, may conclude that the game isn't worth the candle. And who could blame them: They could revolutionize their field, teach their colleagues a method that is the diametric opposite of conventional wisdom, create a practical, non-invasive test that confers enormous medical benefits on society, have their research cited a thousand times, and yet still lose their patent (after incurring a huge expense in reliance on its protection) because their previously unknown method relies on too fundamental an insight they alone had into the natural world. If this is the permanent reality, neither aspiring scientists nor venture capitalists may see much to gain in developing or commercializing biomedical research.
And then there are the international obligations (ironic in light of Justice Breyer's recent exposition on how the laws of other nations can inform the interpretation of American law, albeit to be fair not patent law; see, The World and the Court: American law and the New Global Realities) that are contravened by the suddenly limited view of patent eligibility that distinguishes what it eligible in the U.S. from what is eligible in the rest of the world.
The section arguing why this case as an ideal vehicle for review repeats the mantra that even the Federal Circuit recognized that it rendered the "wrong" decision but felt hamstrung by Mayo. Accordingly only the Court can correct this error. The Petition ends on three final points:
• The record below, which includes a preliminary injunction motion, claim construction and inter partes review is better developed than most Section 101 cases;
• The claims at issue include independent and dependent claims, down to the scope of individual tests, which imposes particular granularity for the Court to consider in deciding what should be patent eligible; and
• Finally, this may be the last chance for the Court to correct the situation, because left intact this decision will turn genetic diagnostic inventions into trade secrets and other forms of protection when available, and will preclude certain innovations entirely.
Amicus briefs are due in 30 days, and as stated in the Petition are expected to encourage the Court to grant certiorari.