Posts Tagged: "Ariosa v. Sequenom"

On August 3, the United States Court of Appeals for the Federal Circuit (CAFC) denied a petition for rehearing en banc and issued a modified opinion, following a petition for rehearing filed by Ariosa in Illumina, Inc. v. Ariosa Diagnostics, Inc. Sticking closely to the reasoning of its March opinion, the CAFC reversed a decision by the United States District Court for the Northern District of California that claims of U.S. Patent Nos. 9,580,751 (the ’751 patent) and 9,738,931 (the ’931 patent) belonging to Sequenom and Illumina (Illumina) were invalid under 35 U.S.C. § 101 as being directed to an ineligible natural phenomenon.

The Federal Circuit recently found that a method for preparing an extracellular DNA fraction from a pregnant human female and using it for analyzing a genetic locus involved in a fetal chromosomal aberration was not directed to a natural phenomenon, and thus eligible for patenting. Illumina, Inc. v. Ariosa Diagnostics, Inc., No. 2019-1419 (Fed. Cir. March 17, 2020) (“Illumina v. Ariosa”). The decision includes a dissent. Appreciation of the reasoning of both the Majority and the Dissent is essential to understanding the current state of the debate on subject matter eligibility of processes involving natural phenomenon. The all-important question in such cases centers on how to determine whether such an invention is directed to a judicial exception. Stated differently, when does an invention that uses a natural phenomenon turn into a patent-eligible process rather than being directed merely to the natural phenomenon?

The U.S. Court of Appeals for the Federal Circuit (CAFC) has reversed a district court decision finding certain claims of two patents covering prenatal DNA testing patent ineligible. The CAFC held that “the claimed methods utilize the natural phenomenon that the inventors discovered by employing physical process steps” and thus were patent-eligible. The patents at issue in the case acknowledge but are not related to the patented invention held invalid in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1373 (Fed. Cir. 2015). The opinion was authored by Judge Lourie, with Judge Reyna dissenting.

With more dissents than any other Federal Circuit Judge in history,  Judge Pauline Newman is driven by a need to safeguard our national system of innovation. Judge Newman has argued throughout the years that the Federal Circuit was created to rebuild and renew the patent system to encourage and incentivize industry, which is precisely the purpose both the Carter and Reagan Administrations had in mind when advocating for the creation of the Federal Circuit, which ultimately took form in 1982. Judge Newman has no qualms about speaking out in dissents when the objective of the Federal Circuit to bring certainty to U.S. patent laws is being hindered, in her view, by the majority, regardless of the complexities or dollar-values at stake in the case. In fact, in one interview she declared, “I have not hesitated to comment when I think that a panel isn’t going in quite [the] appropriate direction. Others have felt that perhaps I haven’t gone in quite the appropriate direction . . . . [A]ll in all it seems to me that it’s quite healthy to present a certain amount of turmoil to practitioners in the short run. But in the long-run I think the law is better for it.” George C. Beighley, Jr., “The Court of Appeals for the Federal Circuit: Has It Fulfilled Congressional Expectations?,” 21 FORDHAM INTELL. PROP. MEDIA & ENT. L.J. 671, 675–76 (2011). Clearly, she is interested in getting the law right for the greater good as she sees it, regardless of the impact her dissent may have on relationships or status quo.

Today is Alice’s fifth birthday; some may not be celebrating, but as a birthday gift, John Vandenberg argues the decision was not new law and should not be abrogated. – On the third day of the U.S. Senate Judiciary Committee – IP Subcommittee’s hearings this month on whether to radically revise the standards for patent eligibility, I testified on behalf of our patent system’s under-appreciated second engine of innovation. Below are some of the key arguments I made in my oral and written testimony and my thoughts on why the Alice Corp. v. CLS Bank decision was good law that should not be abrogated. Much of the anti-Alice commentary touts our patent system’s first engine of innovation, which uses the lure of monopoly profits or royalties to incentivize innovation and the public disclosure of those innovations. Today’s Sec. 101 jurisprudence is said to harm that first engine of innovation, particularly in life sciences where it is easier to get a patent in Europe and China than in the U.S., causing investment in personalized therapy and medicine R&D in the U.S. to suffer. While some question those factual premises, the “101 status quo” camp primarily responds that Alice (along with IPRs) has curtailed abusive patent troll litigation, cutting patent litigation costs by 40% or more. But, another important point has received little attention: expanding what can be patented, and how claimed, risks harming our patent system’s second engine of innovation.

In Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1376 (Fed. Cir. 2015) the Federal Circuit belittled pioneering work at Oxford University, indisputably one of the world’s leading research institutions. In the Athena Diagnostics v. Mayo Collaborative Services decision handed down early in 2019, the Federal Circuit surpassed itself by belittling pioneering work representing the combined efforts of Oxford University and the Max-Plank Gesellschaft, two of the world’s leading research institutions. A petition for en banc review has been filed and is supported by amicus briefs. This article further supports the need for review, emphasizing inadequate attention paid to the positive eligibility provisions of 35 USC 101, conflict with Diamond v Diehr, an inadmissible extension of admissions within the patent description regarding a genus of techniques to cover a previously undisclosed species of techniques within the genus, and the need to give equal treatment to those who make pioneering inventions or discoveries and those whose inventions or discoveries are incremental.

In each of the recent Federal Circuit decisions on medical diagnostics inventions, Athena Diagnostics v. Mayo Collaborative Services, 2017-2508, (Fed. Cir. Feb. 6, 2019) (“Athena”) and Cleveland Clinic Found. v. True Health Diagnostics LLC, 2018-1218 (Fed. Cir. April 1, 2019; non-precedential) (“Cleveland Clinic II”), the court affirmed a district court ruling that found a medical diagnostic or a related patent invalid for being directed to ineligible subject matter. Athena and Cleveland Clinic II follow the hard stance taken by the Federal Circuit against medical diagnostics inventions, first in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1376 (Fed. Cir. 2015) (“Ariosa”) and next in Cleveland Clinic Found. v. True Health Diagnostics LLC, 859 F.3d 1352, 1361 (Fed. Cir. 2017) (“Cleveland Clinic I”). In Athena, the patent covered a method for diagnosing a disease in a subpopulation of affected individuals based on the discovery of a correlation between the disease and certain autoantibodies found only in that subpopulation. In Cleveland Clinic I, the patent claims were directed to diagnosing the risk of atherosclerotic cardiovascular disease (CVD) based on the correlation between elevated levels of a protein found in the blood and occurrence of atherosclerotic CVD. In Cleveland Clinic II, the claims were directed to methods of identifying elevated levels of the protein but did not include any recitation of the correlation…. The requirement for an improvement to the technology involved in carrying out the claimed method is a steep hurdle for the eligibility of most medical diagnosis inventions, since the essence of such inventions is applying a newly discovered correlation to deliver a practical benefit—not improving the technology used to provide the diagnosis. In this regard, medical diagnostic inventions are unique. This point was highlighted by the Athena dissent through reference to the amici curiae Five Life Sciences Patent Practitioners’ brief, which stated, “[medical] diagnostic methods . . . are so tightly bound to underlying natural laws and phenomen[a], they are especially susceptible to undue expansion of the eligibility standards…” Athena Dissenting opinion at 13.

In Exergen Corporation v. Kaz USA, No. 16-2315 (March 8, 2018), the Federal Circuit, in a split non-precedential opinion, affirmed a holding that Exergen’s claims directed to methods and apparatuses for detecting core body temperature were directed to patentable subject matter under 35 U.S.C. § 101… The majority held that the district court did not clearly err in finding that it was unconventional to use temperature scanning technology to measure arterial temperature beneath the skin… Judge Hughes dissented, arguing that the majority erred by relying on the natural law in determining inventiveness at step two… Judge Hughes seems to suggest that the correct step-two inquiry should be whether, assuming the natural phenomenon were known, it would have been conventional to combine that phenomenon with existing technology to practice the asserted claims.

Earlier today the United States Supreme Court denied certiorari to Sequenom, Inc., which will let stand a decision of the United States Court of Appeals for the Federal Circuit that ruled a truly revolutionary medical test to be patent ineligible. If the Supreme Court were to have taken the case they would have been required to reconsider the overwhelming breadth and scope of their prior ruling in Mayo Collaborative Servs. v. Prometheus Labs. Obviously, the Supreme Court is not ready to reconsider Mayo.

Rather than use the word ‘conflate’ to describe the mongrel mixture of patentability requirements the Supreme Court undertook in Mayo, the Eli Lilly brief characterizes the analysis employed by the Supreme Court as including a separate, implicit ‘threshold test’ for patentability that is applied even before consideration of the statutory patentability requirements. Eli Lilly hypothesizes that this ‘implicit exception was imposed to assure that patents cannot validly protect—or preempt access to—laws of nature, natural phenomena, or abstract ideas.’

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.” 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. 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.

It is that time once again when we look back on the previous year in preparation to close the final chapter in order move fresh into the year ahead. 2015 was a busy year in the patent world, although change was not as cataclysmic as it was in 2013 when the United States became a first to file country or in 2014 when the Supreme Court issued the Alice v. CLS Bank decision. It was still an interesting year nevertheless. As I close out 2015, I’ve reviewed my patent articles and have come up with my own top 10 patent moments for 2015. They appear in chronological order as they happened throughout the year.

The law of patent eligibility is created by the nine least qualified people to make such a determination; the Justices of Supreme Court of the United States. The Supreme Court arbitrarily chooses which of its own prior decisions to follow and ignore, refuses to read and enforce the laws passed by Congress even when the statue is but a single sentence (as is 101), and they openly legislates from the bench by creating judicial exceptions to patent eligibility where no such statutory prerogative exists. If the Federal Circuit will not step up and do the right thing and limit the lawless Mayo decision, which instructs lower courts to ignore the patent statute and drive 100% of the analysis into 101, the U.S. will forfeit our lead in the biotechnology and medical device industries. That will be bad for the economy, but far worse for public health.

The panel decision in this case reads recent Supreme Court precedent to create an existential threat to patent protection for an array of meritorious inventions. It avowedly holds that “groundbreaking” new diagnostic methods that make a significant contribution to the medical field” are ineligible for a patent whenever they (1) incorporate the discovery of a natural phenomenon, and (2) the techniques involved in putting that discovery to its first practical use were individually known beforehand. In other words, the person who first discovers a natural phenomenon can never obtain a patent on any practical application of that new knowledge, however surprising or revolutionary the results, unless the steps she teaches to use it are independently novel. As the example of this case vividly shows, that cannot be correct.