Posts Tagged: "Athena Diagnostics v. Mayo Collaborative Services"

To the surprise and sorrow of some, but the relief of others, the Supreme Court earlier today denied certiorari in some key cases on patent eligibility law, putting any hope of further clarity in this realm squarely in the hands of Congress. Many see this as a dereliction of the Court’s duty, while others are just thankful the Court will not cause further harm than it already has. Commenting on the development, IPWatchdog CEO and Founder Gene Quinn tweeted out his view that this was a “bad day for patent eligibility” and that the denial of Athena ultimately “means medical diagnostics are NOT patentable in America.”

The Supreme Court this morning released its orders list, in which it denied all pending petitions for certiorari on cases concerning patent eligibility. The Court has now made it fully clear that it does not plan to wade back into the Section 101 debate, leaving it up to Congress to clarify the law. Thus—with an impeachment trial and presidential election looming this year—a quick 101 fix seems increasingly unlikely. The Court considered a number of petitions concerning Section 101 on Friday. Of them, Athena Diagnostics v. Mayo Collaborative Services was thought to have the best chance of being granted. In December, the United States Office of the Solicitor General (SG) weighed in on the petition in Hikma Pharmaceuticals v. Vanda Pharmaceuticals, recommending against granting cert in that case in favor of hearing one like Athena instead.

Athena Diagnostics today filed its reply brief to Mayo Collaborative Services at the Supreme Court in the closely-watched petition asking the High Court to clarify U.S. patent eligibility law. The reply reiterates the points made in Athena’s petition for certiorari and dismisses Mayo’s argument in November that “any further action regarding the patentability of medical diagnostic claims such as Athena’s that employ conventional, known techniques should and does rest with Congress.” The reply comes three days after the United States Solicitor General recommended that SCOTUS grant cert in Athena or “another such case”, rather than in Hikma Pharmaceuticals v. Vanda Pharmaceuticals.

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.

On November 1, Meredith Addy of AddyHart P.C. and I submitted an Amici Curiae brief to the U.S. Supreme Court on behalf of Freenome Holdings and New Cures for Cancers in support of the Petition for Certiorari in Athena Diagnostics v. Mayo Collaborative Services. If the Supreme Court does not take this case, it is unlikely to reconsider its decisions on Section 101 of the U.S. patent law. This may be our last gasp judicial effort. The Supreme Court takes cases raising inconsistencies in the law or a circuit split. We knew parties/amici would focus on the Federal Circuit’s “internal circuit split,” so we took a different approach and urged the Court to resolve five critical inconsistencies in the law, summarized below.

A petition for certiorari was filed on October 1 in the case of Athena Diagnostics v. Mayo Collaborative Services asking the question: “Whether a new and specific method of diagnosing a medical condition is patent-eligible subject matter, where the method detects a molecule never previously linked to the condition using novel man-made molecules and a series of specific chemical steps never previously performed.” The petitioners hinge their argument throughout the brief on the novel beneficial utility of their claimed method…. However, benefit has not always carried the day in recent eligibility analyses….. Patent eligibility, considered to be the most important question facing the patent system, poses insidious problems under current jurisprudence to some of the most beneficial cutting-edge technology available today. What is most curious is that this problem apparently can be solved simply by reaching back to the foundations of modern patent law and the underlying requirement that inventions be “useful,” a term that has been baked into the statutory provisions since the first patent act.

Athena Diagnostics filed its petition for certiorari with the U.S. Supreme Court yesterday in Athena Diagnostics v. Mayo Collaborative Services. There is a strong argument for the Court to grant the petition, and patent stakeholders on all sides are sure to weigh in via amicus briefs over the next month. The petition could represent the best chance for clarifying Section 101 law in the near-term, since patent reform efforts on the topic have been seemingly stalled. Below are a few initial reactions from the patent community to Athena’s arguments.

As expected, Athena Diagnostics last night filed its petition for certiorari to the U.S. Supreme Court, asking it to fix the United States’ patent eligibility law problem. Adam Gahtan and Eric Majchrzak of Fenwick & West and Seth Waxman, Thomas Saunders, Joshua Koppel and Claire Chung of WilmerHale filed the petition for Athena. The specific question Athena is presenting is: “Whether a new and specific method of diagnosing a medical condition is patent-eligible subject matter, where the method detects a molecule never previously linked to the condition using novel man-made molecules and a series of specific chemical steps never previously performed.” Athena urged the Court to take the case considering the Federal Circuit’s eight separate opinions in which the court divided 7-5 on denying en banc review—evidence of “much-needed guidance on the proper application of the judicially-created exceptions to Section 101 of the Patent Act.”

Next week, the Supreme Court will hear the first of six IP cases granted cert last term. On Monday, the Court will hear Peter v. NantKwest, in which the question presented is “Whether the phrase ‘[a]ll the expenses of the proceedings’ in 35 U.S.C. 145 encompasses the personnel expenses the USPTO incurs when its employees, including attorneys, defend the agency in Section 145 litigation.” The Court will heard other IP cases in November and December, while Google v. Oracle, Berkheimer v. HP, and Hikma v. Vanda await a decision on cert, and petitions in Straight Path IP Group, LLC v. Apple Inc., et al. and Athena Diagnostics v. Mayo Collaborative Services have the patent world holding its collective breath.

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.

The Court of Appeals for the Federal Circuit was created to provide much-needed clarity and consistency to the nation’s patent law. In prior decades, the law had become hopelessly confused and incoherent due to disparate decisions of the regional courts of appeals. Two successive presidential commissions called for rectifying the situation because U.S. industrial competitiveness was lagging, and industries were faltering as a result of the weakness that had compromised the effectiveness of the patent system. For the previous century-and-a-half it had helped transform the country from a poor, agrarian land into the most advanced, powerful and wealthy nation on earth. In the 20th Century, nearly every significant scientific invention was created in America. But that was beginning to fade in the 1970s and beyond. Congress responded in 1982 by creating the Federal Circuit to hear all patent appeals…. These welcome developments increased incentives to invest in expensive research and development and the even more costly process of commercializing new inventions, putting new cures, products and services into the public’s hands and onto store shelves. In just the last few years, those incentives have lagged again due to sudden increases in uncertainty in the patent system, particularly regarding eligibility.

On July 3, the Court of Appeals for the Federal Circuit denied en banc rehearing in Athena Diagnostics v. Mayo Collaborative Services. The 86-page order from the Federal Circuit includes eight separate opinions—four concurring with the en banc denial and another four dissenting from the decision. The separate opinions reflect a Federal Circuit that isn’t divided so much on the issue of the importance of Athena’s now invalidated patent claims but, rather, the application of the U.S. Supreme Court’s Section 101 jurisprudence under Mayo Collaborative Services v. Prometheus Laboratories (2012). Throughout the opinions, it seemed clear that the Federal Circuit was eager to have the Supreme Court take this case up on appeal in order to clarify Mayo’s judicial exception to laws of nature and its impact on patent claims covering medical diagnostics.