Posts Tagged: "medical diagnostics"

On July 18, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in CareDx, Inc. v. Natera, Inc. affirming a summary judgment ruling of the District of Delaware, which invalidated claims from three Stanford University patents licensed by CareDx as patent  ineligible. The decision marks yet another blow to medical diagnostic testing, this time in the context of organ transplants, and the prospects of their developers for obtaining enforceable patent rights.

The latest ruling involving patent eligibility of medical diagnostics comes from Chief Judge Connolly of the United States District Court for the District of Delaware in a consolidated case brought by CareDx, Inc. and the Board of Trustees of the Leland Stanford Junior University against Natera, Inc. (Civil Action No. 19-0567-CFC-CJB) and Eurofins Viracor, Inc. (Civil Action No. 19-1804-CFC-CJB). After initially denying the Defendants’ motions for summary judgment of invalidity of the asserted patents under 35 U.S.C. §101 in December 2020, the Court then later denied certification motions for interlocutory appeal and instead ruled sua sponte to reconsider its own denial of summary judgment. Following an evidentiary hearing during which expert testimony was heard, the Court reversed its previous ruling to find all claims of the asserted patents invalid as a matter of law under §101.

“The COVID-19 crisis has once more highlighted the need for incentivizing investment and innovation—and thus, for patent laws that duly “promote” and protect such “progress,” precisely as our Founders envisioned,” writes Chief Judge Paul Michel, now retired from the Federal Circuit. As he so often is, Judge Michel is absolutely correct. Many are asking why testing for the coronavirus that causes COVID-19 has been slow to roll out, and why tests in many countries are inaccurate. Those familiar with U.S. patent laws understand the problem. There has been a deemphasis on medical diagnostics in America as the result of a series of Supreme Court and Federal Circuit rulings, coupled with Congressional inaction.

Today, like so much of the rest of the world, the United States is faced with many shortages due to the coronavirus pandemic, including personal protective equipment, basic medical supplies, and qualified medical staff. Of course, the lack of treatments or vaccine is a huge problem. Another secular problem is the lack of a quick, inexpensive, reliable test for the virus. But a test for the virus is a diagnostic method, and that is a big problem for U.S. patent laws because diagnostic methods are simply not patent eligible in the United States. This is also a big problem for the world because ever since the veil of patent eligibility was lifted for the life sciences sector in 1981 by the U.S. Supreme Court in Diamond v. Chakrabarty, the U.S. has dominated the biotechnology sector, specifically, and life science sectors more generally speaking. In 1981, the Supreme Court opened the floodgates saying that what was created by man could be patented, and if it could be owned it could be invested in, and investors rushed in and the biotechnology industry that we know today was born. But what the Supreme Court gave they can, and ultimately did, take away.

Is Unified a war profiteer?  Of course, they are. But they are only one cog in the larger worldwide scheme of the most powerful multinational corporations whose goal is to monopolize technologies by destroying patents and innovation. This recklessness to preserve their monopolies has brought utter destruction to our nation’s innovation engine – startups.  

The United States Office of the Solicitor General has filed its brief in response to the Supreme Court’s March request for views in Hikma Pharmaceuticals v. Vanda Pharmaceuticals. The December 6 brief says that the Federal Circuit correctly held the relevant claims of Vanda’s patent-in-suit eligible, and that the case “is not an optimal vehicle for bringing greater clarity” on the topic of Section 101 law since the CAFC arrived at the correct result. Instead, the High Court should grant certiorari in a case like Athena Diagnostics v. Mayo Collaborative Services, in which the order denying en banc rehearing “was accompanied by multiple separate opinions articulating different understandings of Mayo and seeking clarification from this Court.”

Mayo Collaborative Services has filed its brief in opposition to Athena Diagnostics’ petition to the Supreme Court in early October asking the justices to weigh in on whether its patent claims for a method of making a medical diagnosis are patent eligible under Section 101. Eleven amici have weighed in on the case, and the patent community is waiting to see if the High Court will grant the petition and help to solve the Section 101 problem, which has been particularly problematic for the field of medical diagnostics. Mayo states its argument quite simply in the opening sentence of its brief, relying on the Court’s 2012 precedent in Mayo v. Prometheus: “Patent claims directed to a natural law that employ only conventional and routine activities to detect that law are not patent eligible. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 73 (2012). That rule disposes of this case, as the district court, appellate panel, and en banc Federal Circuit each concluded.”

November 1 was the deadline for filing amicus briefs to the U.S. Supreme Court, which is considering whether to grant a petition for writ of certiorari to take up Athena Diagnostics v. Mayo Collaborative Services on appeal from the U.S. Court of Appeals for the Federal Circuit. Almost every amicus filing to the Supreme Court in this case supported granting the petition or backed up the position of petitioner Athena, who is asking the Supreme Court to clarify its patent-eligibility doctrine under the Alice/Mayo framework on the subject of medical diagnostic patent claims. The appeal to the Supreme Court follows a hotly contested denial of an en banc rehearing of the Federal Circuit’s original panel decision in Athena, which produced eight opinions, including four dissents, with many judges agreeing that Athena’s invention should be patent eligible even while they disagreed over whether Supreme Court precedent allowed for patent protection of diagnostic methods.

I don’t really know why we need the Federal Circuit anymore. Witness the denial of en banc rehearing in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC on July 3. This denial of rehearing provoked eight separate opinions, with no single opinion achieving more than four judges in support. With 12 judges deciding whether to rehear the case en banc that means no single opinion gained support from more than one-third of the Court. And that opinion that gained the most support was a dissenting opinion, meaning those judges wanted to rehear the case and specifically said that the claims “should be held eligible”.  In fact, as Retired Chief Judge of the Federal Circuit, Paul Michel, noted yesterday, “all 12 active judges agreed that the Athena patent should be deemed eligible, even though seven judges apparently felt helpless in view of Mayo.”  The truth is the Federal Circuit is not helpless. The Federal Circuit is choosing to interpret Mayo—on the life science side—and Alice—on the software side—expansively. The Federal Circuit has one primary job, which is to bring stability and certainty to U.S. patent laws. It would be easy to distinguish both Mayo and Alice, but rather than recognize the peculiar facts of these cases as representing the most trivial of innovations, the Federal Circuit has used Mayo to destroy medical diagnostics and Alice to destroy software. More analytical prowess would be expected from a first-year law student.

April 22 was the deadline for filing amicus briefs with the Court of Appeals for the Federal Circuit in Athena Diagnostics’ petition for an en banc rehearing by the court. The petition comes after a 2-1 panel decision in early February affirmed a district court’s ruling that patent claims covering methods of diagnosing myasthenia gravis (MG), an autoimmune disorder that causes weakness in skeletal muscles, were directed toward laws of nature and were thus unpatentable subject matter under 35 U.S.C. § 101. In an invitation to file briefs with the Federal Circuit in this case, Knowles IP Strategies Founder Sherry Knowles and AddyHart Partner Meredith Addy discussed the need for amici to hold the Federal Circuit accountable regarding its duty to apply a strict statutory construction of the literal language of Section 101 to ensure that patent eligibility cases are decided in a way that is consistent with Constitutional statutes. Knowles and Addy filed a brief on behalf of Freenome Holdings and Achillon Pharmaceuticals (discussed below). Theirs and other briefs that have now been filed raise concerns about the inability to patent life-saving diagnostic methods that are found ineligible under Section 101 using the Alice/Mayo framework simply because the invention or discovery involves monitoring natural processes.

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.

Athena Diagnostics filed a petition for en banc rehearing of the United States Court of Appeals for the Federal Circuit’s decision in Athena Diagnostics v. Mayo on April 8, 2019. Amicus briefs are due April 22, 2019. The Athena decision continues to apply U.S. Supreme Court-created common law to the analysis of 35 U.S.C. §101. In its brief requesting rehearing, Athena argues that the decision is “precisely the evisceration of patent law against which the U.S. Supreme Court has long warned” and that the claims at issue were patent eligible, as they are “novel, man-made substances”, “do not preempt natural laws” and “serve a new and useful purpose of diagnosing serious diseases”. Knowles IP Strategies LLC (Sherry M. Knowles) and AddyHart (Meredith Addy) intend to file an amicus brief in support of neither party requesting that the Federal Circuit carry out its constitutional duty to apply strict statutory construction of the literal words of 35 U.S.C. §101 to decide the case (See, Unconstitutional Application of 35 U.S.C. § 101 by the U.S. Supreme Court; 18 J. Marshall Rev. Intell. Prop. L. 144 (2018)).

2018 celebrates the six-year anniversary of one of the most important Supreme Court decisions of the modern era. On March 20, 2012, the Court handed down its ruling in Mayo v. Prometheus Laboratories. The decision was understood immediately to be a break from the immediate past, a product of the Court’s intention to clarify patent eligibility for a new era of biotech, pharma, and life science technologies. The Court hoped it would help clarify eligibility issues raised by new technologies that the drafters of Title 35 § 101, 102, and 103 hadn’t envisioned, but it’s done the opposite. Six years later, eligibility is harder to discern than ever, especially for diagnostic method claims.

Dr. Frances Ligler is a pioneer in biosensor activity and a member of the 2017 class of inductees into the National Inventors Hall of Fame. This New Years’ Eve 2017 marked the 26th anniversary of the issue of a foundational patent in the field of portable optical biosensors, devices which are more adept at providing biological analysis in the field and outside of clinical lab settings.