6 Years Later: The Effects of the Mayo Decision on Diagnostic Methods

https://depositphotos.com/51325933/stock-illustration-6-years-of-service-6.html2018 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 after the Mayo decision, eligibility is harder to discern than ever, especially for claims to diagnostic methods.

Section 101

The Mayo ruling was primarily concerned with Section 101 – the basic premise of U.S. patent law. It states: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”

The Mayo decision

The plaintiff in the Mayo case was Prometheus Laboratories, a specialty pharmaceutical and diagnostics company that had patented a suite of tests for assessing the correct dosages of certain Crohn’s disease medications. When Mayo Clinic developed its own similar tests and began using them, Prometheus sued Mayo for infringement.

The Supreme Court ultimately invalidated Prometheus’ methods patent, saying, “The steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity.” Importantly, the Court also added that “upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.”

A split framework

What’s most important about Mayo is that the ruling split the framework for determining patent eligibility into two parts:

  1. The Supreme Court reaffirmed the long-held position that Section 101 has three categories of unstated exceptions: laws of nature, natural phenomena, and abstract ideas. These exceptions are not patentable because they belong to everyone. The Court noted, by way of example, that this means Einstein could not have patented relativity, nor Newton any of his laws.
  2. At the same time, the Supreme Court, also said that if an invention is based on an exception, it still might be patentable as long as it doesn’t restrict others’ use of that exception. The Court warned that judges should carefully examine such claims to avoid “interpreting patent statutes in ways that make patent eligibility “depend simply on the draftsman’s [the attorney’s] art.”

Directional change from 1981 to 2012

This two-step process represented a significant change, as it refuted a guiding principle established in the 1981 ruling for Diamond v. Diehr. According to the Diehr ruling: “In determining the eligibility of respondents’ claimed process for patent protection under § 101, their claims must be considered as a whole. It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis.”

The Mayo ruling instead asked courts to “dissect” claims into the two-part framework outline above. This is an especially tricky proposition for assessing diagnostic method claims that often involve both laws of nature and genuinely inventive steps and procedures.

In the 6 years since Mayo, the life sciences have been hit hard, with the validity of method patents being frequently – and successfully – challenged. This trend can be attributed to Mayo, not least because its logic led to other similarly disruptive rulings.

Myriad Genetics

The Supreme Court returned to Section 101 in Molecular Pathology v. Myriad Genetics in 2013, about a year after Mayo. This case allowed the Court to attempt to draw a Mayo-based separator between naturally-occurring discoveries and new applications of those discoveries. Here’s what happened:

Myriad Genetics had obtained a set of patents for isolating the BRCA1 and BRCA2 genes and identifying an important mutation that acted as a reliable predictor of women’s risk for breast cancer. Myriad then built diagnostic methods involving synthesized complementary DNA, or “cDNA.” When Myriad claimed others were infringing their patents if they used BRCA1 and BRCA2, a cohort of doctors, patients, and advocacy groups banded together to challenge Myriad’s patents.

At the District Court level, all of the BRCA 1 and 2 patents, including the cDNA, were invalidated as being naturally-occurring discoveries, citing Mayo. The Federal Court then went the other way, deciding all of the patents were valid since isolating a gene produces something not found in nature.

Ultimately, the Supreme Court ruled the BRCA1 and BCRA2 genes to be unpatentable, since “Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.” On the other hand, the cDNA that Myriad created from the genes was patentable because “the lab technician unquestionably creates something new when cDNA is made,” and thus, that “cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments.”

The Court took pains to note that this case wasn’t about a method claimed by Myriad, writing: “It is important to note what is not implicated by this decision. First, there are no method claims before this Court. Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. But the processes used by Myriad to isolate DNA were well understood by geneticists at the time of Myriad’s patents.”

Alice arrives

In 2014, just one year after the Myriad case was decided, the Supreme Court attempted to clarify Mayo once again in Alice Corp. v. CLS Bank International. This time, it said that in determining patent eligibility, a court must:

  1. Determine whether the claims at issue are directed to one of those three patent-ineligible concepts – e.g. laws of nature, natural phenomena, and abstract ideas.
  2. Conduct a “search for an inventive concept” that ensures that “the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.’”

As a refinement of Mayo, this guidance isn’t especially profound, but unfortunately, the Court got more — and somehow simultaneously less — specific about the third exception: abstract ideas. It said that in order to not be considered an abstract idea, an invention had to offer “something more” – but the Court did not state what that might be, to the frustration of many. It’s an ambiguity that remains unresolved six years later.

Since Mayo, Myriad, and Alice

There are lots of examples of diagnostic-method patent holders caught in the wake of Mayo:

  • 2014: Myriad Genetics went back to court and lost patents for BRCA diagnostic methods (ruled invalid) because they were based on the abstract idea of comparing a patient’s genes to baseline genes – a well-understood, routine and conventional method.
  • 2015: A Federal Circuit panel invalidated Sequenom’s patent for prenatal gender tests based on fetal DNA screening – because DNA’s is considered natural phenomena and can’t be patented.
  • 2016: Genetic Technologies sued Merial L.L.C for infringing its patent for a method of analyzing genomic DNA sequences. The district court invalidated Genetic Tech’s patent, asserting that is was “directed to a natural law.”
  • 2017: Four patents owned by the Cleveland Clinic Foundation were invalidated because were found to be based on natural laws (methods of diagnosing the presence of myeloperoxidase as a signifier of cardiovascular disease).

Happy anniversary?

The Supreme Court’s efforts at redefining patent eligibility for the modern age and biotech really began in earnest back in 1980 with the controversial bacteria of Diamond v. Chakrabarty. The Court’s ongoing struggles show the inadequacy of our patent laws when it comes to biotech especially, and technology in general. The Court is essentially attempting to build the car while they’re driving it, and that’s bound to result in a bumpy ride.

In addition, it could be argued that discarding Diehr’s admonition to consider each patent as a whole rather than its constituent parts was a mistake – placing current courts in the position of dissecting complicated patent claims beyond their capabilities.

For now, we can only hope new cases emerge that result in sufficient clarity to tip the balance back from excessive patent denials and invalidations and more effectively protect the innovations so regularly emanating from the biotech, pharma, and life science industries.


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Join the Discussion

3 comments so far.

  • [Avatar for Anon]
    July 20, 2018 01:01 pm

    Mr. Cole,

    Once again, your post while sounding good defends the indefensible.

    “Claims of defendable scope” is simply not the panacea that you advance.

  • [Avatar for Paul Cole]
    Paul Cole
    July 20, 2018 11:58 am

    This is typical of many articles on this subject, which emphasize a generalist and woolly interpretation of Mayo and its successors without detailed consideration of the Supreme Court and Federal Circuit decisions to determine the lessons that should be learned, whether there are good ways forward, and what they are.

    For example, in Cleveland Clinic, the method of treatment patent was not challenged under Section 101 and rightly so.

    It astonishes me that the discussion is entirely on the judicial exceptions without proper consideration of the requirements for compliance with one of the positive eligible categories of Section 101. If more attention were paid to this positive compliance, and the drafting of claims of defendable scope, them much trouble would be avoided.

  • [Avatar for Steve]
    July 19, 2018 04:17 pm

    … recently observed at the entrance to the PTO:

    An obviously disheartened, discouraged inventor holding up a sign for all to see which said:

    Will work for a 101 traversal.