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Mayo v. Prometheus: A Retrospective on its Impact on Life Science Innovation
Plus! A safer medical marijuana patent, the "modern Edison," and a secondary characteristics case
In 2012, the Supreme Court handed down a ruling that would reverberate throughout the world of biotechnology: in Mayo v. Prometheus (2012), it ruled that natural phenomena cannot be patented. This was highly contentious at the time, with commentators arguing that this would cripple the biotechnology field and lead to many more dramatic cases. They were not wrong on one thing: Mayo would be followed years later by many major cases, both at the Federal Circuit and the Supreme Court and directly affecting the subject matter eligibility of some of the most contentious patents in the life sciences.
It has now been just over a decade since Mayo was handed down. When it first came down from 1 First Street, NE, it was controversial. Its critics accused the Supreme Court of poor reasoning and undermining the patent system;1 its supporters called it a win that would promote innovation and allow doctors to use medical knowledge without fear. Ten years later, and with a long line of cases, it is worth asking: what, actually, was the impact of Mayo?
Comparison: Two Post-Mayo Cases
To consider the impact of Mayo, it helps to review the impact of subsequent cases that applied the Mayo standard, most of these cases involving patents in the life sciences. Though it is difficult to make claims about a counterfactual, one study found that venture capital investment in diagnostics was nearly $10 billion lower than it would have otherwise been. To see why, look at Ariosa Diagnostics v. Sequenom (2015). Sequenom was a pioneer in non-invasive prenatal testing, and particularly the use of cDNA to detect birth abnormalities without an amniocentesis. This is particularly useful because amniocentesis comes with a risk of miscarriage. Unlike with Myriad, here observers were steadfastly in favor of the patenter. One attorney said that Ariosa “strikes at the very heart of the patent system” while another called it “very bad news for the patenting of diagnostic methods.” Though the non-invasive prenatal testing market has continued to grow, the newer tests are much less reliable and amniocentesis, with a roughly .2% miscarriage rate, has not been replaced. What was feared has come to pass: without the incentive or ability to protect truly novel diagnostic innovations, there has been less investment in the research needed to make those tests great.
As the courts have made clear, it is not enough to have something truly novel or nonobvious.2 To clear the subject matter bar, barring a revision of the Mayo v. Prometheus standard, courts will require what the Apotex v. Sanofi (2008) Court called an “inventive concept” that serves to limit the scope of the claims and demonstrate substantial novelty. While these cases continue to reverberate through the biotech ecosystem, the Supreme Court has shown no interest in changing its holdings, even in the face of truly breakthrough innovations. In fact, it rejected cert on appeal in CareDx and Stanford University v. Eurofins Viracor, Inc (2022), a case invalidating a groundbreaking method for determining if a host will reject an organ transplant. And in any case, patent attorneys are learning to modify their drafting practices. Take Illumina, Inc. v. Ariosa Diagnostics, Inc. (2023), a case involving an Illumina cell-free DNA test. It was similar to the Ariosa fetal test, but drafted to emphasize a change in the composition of the blood plasma after separating long and short fragments, thus adding a sufficiently “inventive concept” to survive a patent eligibility claim despite nearly-identical claims. It would be quite shocking if the ability to patent breakthroughs was hobbled for a decade just to turn into yet another expensive drafting exercise.
That does not mean that all subsequent cases have been harmful for innovation. Take AMP v. Myriad (2013), a blockbuster Supreme Court case that invalidated Myriad Genetics’s patent for its BRCA1/BRCA2 breast cancer screening test. At issue was 14 claims across 7 different patents. The Supreme Court held that genes could not themselves be patented, even if they were new, because they were natural phenomenon under §101. Myriad was formed to monetize the breakthrough discovery of BRCA1/BRCA2, which was the first isolated human gene usable for diagnostic purposes. The 2001 USPTO guidelines clearly permitted the granting of patents in genes, stating that “like other chemical compounds, DNA molecules are eligible for patents when isolated from their natural state and purified or when synthesized in a laboratory from chemical starting materials,” relying on the “purified and isolated” standard that has allowed for drug formulation patents for over a century for drugs like aspirin and B12 vitamins, as well as the holding in Diamond v. Chakrabbaty (1980). By 2012, nearly 20% of the human genome had been patented, according to the ACLU, and Myriad had grown into a publicly traded company with half a billion dollars in annual revenue on the back of its BRCA1/BRCA2 testing monopoly, for which it charged around $4,000 per test.
The immediate effect of Myriad was the effective invalidation of tens of thousands of patents of isolated genes. Myriad itself took a financial hit: revenue growth stalled and it began losing money. There was a particular fear that Myriad would harm the personalized health and digital health spaces and disincentivize research into useful genes. The flip side, of course, is that allowing genes to be open allowed for new testing companies to be created because they could use the knowledge contained in papers without fearing litigation, so some expected Myriad to trigger a boom. Soon after the ruling was handed down, countless companies like Color Genomics and Veritas Genomics were founded, offering tests for mere hundreds of dollars—typically alongside dozens of other hereditary risk factors. These companies could not have produced such tests in a pre-Myriad world. The main limiter for companies like 23andme today in offering diagnostic tests is the FDA, not USPTO, and gene research continues unabated. So overall, it seems like the doomsayers were likely incorrect: Myriad was a net gain for the world. In fact, even Myriad itself now relies on open science for its personalized medicine products.
As life science patents have been slowly chipped away by the Mayo line of cases, they showcase the long-recognized impacts of the patent system. In some cases, it prevented companies from cordoning off essential knowledge to the benefit of all, while in others, it disincentivized the necessary research to create breakthrough innovation. The lesson seems to be that allowing inventors to patent knowledge that is factual and mostly useful in aggregate stifles innovation while forbidding the patenting of a breakthrough method disincentivizes investment in improving that method. As courts continue to hear these cases, they should consider the legacy of Mayo and its impact on the innovation the patent system exists to promote to provide protections for the types of inventions patents actually incentivize.
Gripping Gazette entries
CN 108026505 B: A patent for Renaissance BioScience for a yeast-based RNA platform for producing and delivering bioactive molecules, joining a portfolio that is 50 patents strong
US 11645550 B2: A machine learning based method from SAE for creating interoparable digital standards for use in an API where the machine handles the “translation” between standards
AU 2021206784 B2: A patent for medical marijuana that is safer at lower dosages while maintaining particular therapeutic effects—the original patent was filed in Canada in 2016 by publicly-traded SciSparc, which has been racking up national patents ever since
Intex Recreation Corp. v. Team Worldwide Corporation, No. 20-1141 (Fed. Cir. 2023): Amusing litigation upholding an IPR ruling that rendered self-inflating air mattresses as invalid. Most notably, in nonobviousness cases, patentees can refer to “secondary characteristics” as evidence in favor of nonobviousness so long as the patentee demonstrates that the unique features added value to the product under Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366 (Fed. Cir. 2019), but Team Worldwide only provided evidence that features unrelated to the patent drove sales
WSOU Investments LLC v. Google LLC, Nos. 2022-1063, 2022-1065 (Fed. Cir. Oct. 19, 2023): In software patents, when is a processor “means for processing?” According to the Federal Circuit, district courts shouldn’t be too harsh on patentees
Genentech, Inc. et al v. Biogen Ma Inc. et al., No. 1:23-cv-11573: Roche and its subsidiaries Chugai and Genentech settled with Biogen over a patent suit for Actemra a mere 3 months after filing suit, scuttling what was shaping up to have been a major biosimilar case
US 6634041 B2: A towel that converts to a tote bag, now available to Etsy crafters everywhere
US 6634048 B1: The patent for a system that automatically controls the temperature of a washing machine and limiting the valve cycles, originally by GE and now assigned to Haier. For older patents like this the patent attorney had to specify they used a microprocessor!
US 6634071 B2: A method from the US Navy for making piezoelectric transducers that appears relatively simple and can form complex curves
Notable news items
Martin Goetz, recipient of the first software patent, passed away at age 93 this week. He was a pioneer in the software business generally, not only in IP (The Register)
A profile of Leigh Rothschild, an inventor of over 130 patents who is divisively considered a patent troll by some, and more divisively calls himself a “modern Edison” (Bloomberg Law)
A patent lawsuit over a drug caused Exelixis stock to plunge; a reminder that patent litigation has serious commercial consequences (Seeking Alpha)
This was always at least somewhat exaggerated because prior to Mayo, USPTO considered diagnostic methods patent-ineligible under the machine-or-transformation test under LabCorp v. Metabolite (2006). Mayo created a test for such methods, which made them subject-matter eligible in a “Lord giveth, Lord taketh away” scenario. Today’s MPEP is greatly influenced by Mayo and, subsequently, Alice v. CLS Bank (2014).
Discovering a new law of nature can help prove nonobviousness. After all, how could it be obvious if it required new science?.