Athena Diagnostics Amici Warn of Harms to Biotech Revolution Under Current Alice/Mayo Framework

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.

Brief of BIO, PhRMA, CLI and WARF

In a brief  filed by a collection of organizations, including trade associations representing a wide swath of biotechnology developers, the amici argue that Athena Diagnostics is a proper vehicle to clarify the U.S. Supreme Court’s Mayo standard, which has caused great uncertainty in the biotech industry. Athena’s patent claims, which involve the use of man-made reagents used to diagnose a subset of MG patients that had never before been diagnosed, would satisfy Mayo’s patentability framework when properly applied. The claims struck down in Mayo involved no new diagnostic technology nor newly created molecules, whereas Athena’s claims covered a novel muscle-specific kinase (MuSK) protein labelling not disclosed by the prior art.

Other case law precedent from the Supreme Court and Federal Circuit conflicts with the finding that Athena’s patent claims were ineligible, says the brief. In Association for Molecular Pathology v. Myriad Genetics (2013), the Supreme Court assumed that patent protection would be available for new applications of knowledge about particular genes. In Vanda Pharmaceuticals v. West-Ward Pharmaceuticals International (2018), the Federal Circuit upheld claims reflecting the inventors’ recognition of a natural relationship between a drug, genetic variations and side effects.

The brief also argues that Section 101 jurisprudence is being applied by the Federal Circuit in a way that affects biotech patents to a greater degree than software patents. In Federal Circuit cases such as McRo Inc. v. Bandai Namco Games America (2016) and Enfish v. Microsoft (2016), software claims were upheld because the appellate court found that the claims were directed to improvements in computer functions. However, in Athena and other life sciences cases, judges and judicial panels have failed to assess whether the claims cover technological improvements, such as the improvement in diagnosing 20% of MG patients that had never before been diagnosed by other methods. The brief adds:

“[I]f software inventors can patent new processes that use conventional computers, why is it effectively impossible to patent diagnostic inventions that use conventional laboratory processes?… Without serious consideration and intervention by the entire court, investment in the U.S. diagnostic industry may disappear, and the harm could spread to other biotech sectors.”

Brief of Seven Law Professors

The amici in this brief  include seven professors of law who, while they may differ in their views on certain aspects of patent law, have concerns that the law isn’t properly promoting and protecting inventions in today’s innovation economy. The professors include: Richard A. Epstein, Laurence A. Tisch Professor of Law, New York University School of Law; Chris Holman, Professor of Law, University of Missouri-Kansas City School of Law; Adam Mossoff, Professor of Law, Antonin Scalia Law School, George Mason University; Kristen Osenga, Professor of Law, University of Richmond School of Law; Michael Risch, Professor of Law, Villanova University School of Law; Ted Sichelman, Professor of Law, University of San Diego School of Law; and Brenda M. Simon, Associate Professor of Law, Thomas Jefferson School of Law.

The professors argue that en banc rehearing is warranted because the majority panel misapplied the two-step Alice/Mayo framework for determining Section 101 patent eligibility. The way that the Federal Circuit and district courts have been applying Alice/Mayo would have invalidated claims of famous 19th century patents that were expressly upheld by the U.S. Supreme Court. One example is Samuel F.B. Morse’s patent covering the electro-magnetic telegraph, which was upheld as valid and infringed in the 1853 case, O’Reilly v. Morse. Claim 1 of the patent in that case, covering a method of operating an electro-magnetic telegraph, would be invalidated under today’s application of Alice/Mayo.

Similarly, the Federal Circuit panel’s approach would have invalidated certain claims of Alexander Graham Bell’s telephone patent, upheld as patentable in the 1888 case, Dolbear v. American Bell Telephone Company, as well as the first ever U.S. patent, issued in 1790 to Samuel Hopkins, for a method of making potash. Hopkins’ method involved conventional steps such as burning and dissolving ash, but he improved the timing and the order of the steps. Significantly, Hopkins’ patent was reviewed and approved by none other than Thomas Jefferson, then the Secretary of State and well-known for his view that patents “should be granted rarely and for only truly innovative inventions.” It was also issued under the 1790 Patent Act, the first patent statute and one drafted by the original Framers of the Constitution. The brief continues:

“[W]hen a panel decision’s interpretation of patent eligibility doctrine calls into question the validity of a patent issued under the 1790 Patent Act and signed by Jefferson, it is cause to question whether the panel has correctly interpreted and applied the law.”

Further, an overly restrictive application of Alice/Mayo undermines the Supreme Court’s ruling in Bilski v. Kappos, where the Court held that Section 101 is a “dynamic provision designed to encompass new and unforeseen inventions.” The value of diagnostic tools has grown dramatically since the biotech revolution was kickstarted by the Supreme Court’s 1980 decision in Diamond v. Chakrabarty, and, while the cost of making a diagnostic test is low, research and development costs for creating those tests are sometimes in excess of $100 million. The Federal Circuit’s Alice/Mayo application would have invalidated patents important to the Industrial Revolution and it is similarly harming innovation during today’s biotech revolution, amici argue. An en banc reversal of the panel’s decision would rebalance the patent system and provide necessary guidance on the proper application of Alice/Mayo to innovative diagnostics tests.

Brief of Freenome Holdings and Achillion Pharmaceuticals

This brief  was filed by a pair of amici that have an interest both in ensuring that the balance of powers in government under the Constitution is properly honored, and that the scope of patent eligibility under Section 101 and the Constitution’s Patent Clause (Article I, Section 8, Clause 8) are strictly applied. Freenome Holdings develops non-invasive blood tests for early cancer detection with the use of artificial intelligence. Achillion Pharmaceuticals has three drugs in clinical trials for orphan diseases treatments that may benefit from personal diagnostic assays.

The amici argue that the proper statutory construction of Section 101 requires a recognition that discoveries are patent eligible subject matter. The language of the statute says that “whoever invents or discovers” a new and useful process, machine, manufacture or composition of matter may obtain a patent. Supreme Court cases such as Connecticut National Bank v. Germain (1992) have held that courts have to presume that statutory language enacted by Congress means what it says. The Supreme Court has even gone so far as to analyze grammar in determining Congressional intent in decisions such as District of Columbia v. Heller (2008). To leave “or discovers” out of a patent eligibility analysis runs counter to this case law.

Further, the legislative history of the Patent Act shows that Congress clearly intended for discoveries to be patentable. While the word “discovers” was removed from Section 101 between 1793 and 1836, there were references to discoveries that remained in other parts of the patent statute. In the 1952 Patent Act, a definition of the word “invention” was included, which established that it meant “invention or discovery” and this definition was retained through recodifications of the patent statute, including the 2011 America Invents Act. The courts cannot remove language from the statute when performing patent eligibility analyses and to do so is unconstitutional, says the brief.

Amici also argue that the courts are not authorized to create patent law and that a review of case law shows that there has never been a proper statutory construction of the literal terms of Section 101 referring to “invents or discovers.” While the Court in Bilski noted that judicial exceptions to Section 101 for laws of nature, physical phenomena or abstract ideas have defined the reach of the statute for 150 years, Congress alone is authorized to create patent law, and even SCOTUS acknowledged that its judicial exemptions aren’t a part of the statutory text. The Supreme Court also overstepped its boundaries in Myriad when it found that “groundbreaking… discovery does not by itself satisfy the [Section] 101 inquiry.” Says the brief:

“It is hard to imagine a more Constitutionally contradictory statement than the Supreme Court ruling that ‘discoveries’ cannot be patented when the very statute the Court is applying requires that any ‘invention or discovery’ can be patented. The Court says ‘A not B’ while the statute says ‘A or B.’ And, Myriad’s inconsistent statement that a discovery is not an invention, is all the more inconsistent with the definition of invention added in the 1952 Patent Act: ‘an invention can be a discovery.’”