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Potential Crisis in Patent Law? Patent Eligibility of Medical Advances

"A potential crisis of patent law and medical innovation" – that is how two concurring judges described the decision that found a groundbreaking non-invasive prenatal diagnostic test ineligible for a patent in Ariosa Diagnostics, Inc. v. Sequenom, Inc.1 The Federal Circuit there had applied criteria set forth in two earlier Supreme Court cases about two other diagnostic tests – for calibrating the proper drug dosage for treating autoimmune diseases and for the BRCA genes limited to breast cancer.2 Those two diagnostic tests were similarly held to be patent ineligible, each because it was directed to a "law of nature." While some of the public cheered these rulings saying, "no patents on DNA," others worried whether this would quell medical innovation.

Laws of nature are patent ineligible to avoid “disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.”3 The decision in Mayo was based on the reasoning that awarding exclusive rights to “the basic tools of scientific and technological work” such as the natural response of the human body to disease and treatment would prevent further innovation based upon them which is necessary for the continued improvement of medical care.4 Similarly, the Supreme Court in Myriad expressed the concern that “Myriad’s patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes [genes related to breast cancer] by breaking the covalent bonds that connect the DNA to the rest of the individual’s genome.”5

Yet, patent protection spurs innovation, industry and the economy. As Abraham Lincoln explained, without patent protection, advances slow and industry stagnates:

Before [the patent system] any man might instantly use what another man had invented, so that the inventor had no special advantage from his own invention. The patent system changed this, secured to the inventor for a limited time exclusive use of his inventions, and thereby added the fuel of interest to the fire of genius in the discovery and production of new and useful things.6

In fact, the petition asking the Supreme Court to consider the Ariosa (prenatal diagnostic) case argued that if the patent eligibility rule was not changed "the bottom may well fall out of life-science innovation." Over 20 amicus briefs were filed in support, citing the need for patent protection to recoup the millions of dollars necessary to research and develop new medical and life science inventions.

Since the Mayo, Myriad, and Ariosa decisions, more diagnostic test patents have fallen as “not patent eligible” under the “Mayo test”7 which evaluates (1) “whether the claims at issue are directed to a patent-ineligible concept”; and (2) if so, “whether the remaining elements, either in isolation or combination with the other non-patent-ineligible elements, are sufficient to transform the nature of the claim into a patent-eligible application.”8

The concurring and dissenting opinions in the Ariosa case expressed worry that application of the Mayo test could impede patent-eligibility of praiseworthy advances in the life sciences and risk stifling innovation in diagnostics and therapeutics. Justice Linn noted that “[b]ut for the sweeping language in the Supreme Court’s Mayo opinion, I see no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible. . . . It is hard to deny that Sequenom’s invention is truly meritorious.”9 Justices Laurie and Moore’s concurrence acknowledged that “[i]t is said that the whole category of diagnostic claims is at risk” and “a crisis of patent law and medical innovation may be upon us, and there seems to be some truth in that concern.”10 Justice Dyk said he shared “the concerns of some of my colleagues that a too restrictive test for patent eligibility . . . may discourage development and disclosure of new diagnostic and therapeutic methods in the life sciences, which are often driven by discovery of new natural laws and phenomena.”11 Justice Newman in her dissent argued that, as the panel recognized, “[t]he new diagnostic method here is novel and unforeseen, and is of profound public benefit—’a significant contribution to the medical field’—a ‘breakthrough,’” and reasoned that patenting would not “preempt further study of this science, nor the development of additional applications” but patenting would “facilitate the public benefit of provision of this method through medical diagnostic commerce, rather than remaining a laboratory curiosity.”12

The courts’ search for balance between these competing concerns appears now to have come to rest on a basic concept of patent law, that an invention is defined by the claims. Indeed, application of the Mayo test in more recent cases reveals it not as a sweeping denunciation of the patent eligibility of medical breakthroughs but as a requirement for claims anchored in specific practical application of new scientific knowledge. One such decision is Rapid Litigation Management Ltd. v. CellzDirect Inc.,13 where the claimed invention related to an improved process of preserving hepatocytes, “a type of liver cell that have a number of attributes useful for testing, diagnostic, and treatment purposes”14 The inventors learned that some hepatocytes could be refrozen, contrary to previous wisdom, and created a process for using that newly-discovered scientific principle to collect and refreeze those cells.15 These claims were found patent eligible under the Mayo test. Critical to the analysis was that the claims did not simply claim a law of nature: “hepatocytes’ ability to survive multiple freeze-thaw cycles.” Instead, the claims were to a “new and improved technique” with very specific steps that began with hepatocytes that have been frozen and subjected to fractionation and ended with a multi-cryopreserved hepatocyte preparation having a higher percentage of viable cells.

The direction to patent practitioners appears to be to draft narrow claims rooted in the practical application of the newly discovered natural law. Justice Dyk suggested in his Ariosa concurrence that the breadth of the claim should be “sufficiently limited to a specific application of the new law of nature discovered by the patent applicant and reduced to practice” in order “to supply the necessary inventive concept.”16 Justice Dyk hoped that “[t]hese patents [will] provide the world with disclosure and useful applications of previously unknown natural laws, and the opportunity to obtain such patents [will] help to restore the incentive to make those discoveries that the patent system has historically provided.”17

  1. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282 (Fed. Cir. 2015) (denying petition for rehearing en banc).
  2. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012); Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013).
  3. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1294 (2012).
  4. Id. at 1301, 1305.
  5. Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2113 (2013).
  6. Abraham Lincoln, Second Lecture on Discoveries and Inventions (Feb. 11, 1859).
  7. See, e.g., PerkinElmer v. Intema, 496 F. App'x 65 (Fed. Cir. 2012) (finding that a method of measuring levels of certain biomarkers from pregnancy to determine whether there was an increased risk of Down's syndrome was patent ineligible); In re BRCA1, 774 F.3d 755 (Fed. Cir. 2014) (finding that isolated DNA claims were patent ineligible); Genetic Techs. Ltd. v. Merial, LLC, 2016 WL 1393573, at *10 (Fed. Cir. Apr. 8, 2016) (finding that the "simple mental process step of 'detect[ing] the allele' in claim 1, either alone or in combination with the physical steps described above, does not supply sufficient inventive concept to make the claim patent-eligible under § 101"); Genetic Techs. Ltd. v. Lab. Corp. of Am. Holdings, 2014 WL 4379587 (D. Del. Sept. 3, 2014) (finding that a method of analyzing a human sample to detect the presence of certain genetic variations, and linking that variation with a resulting physical condition was patent ineligible); Esoterix Genetic Labs. LLC v. Qiagen Inc., 133 F. Supp. 3d 349, 349 (D. Mass. Sept. 25, 2015) (finding "method for determining whether particular types of pharmaceutical drugs are likely to be effective in treating non-small cell lung cancer in a patient based on presence or absence of certain nucleotide variances in patient's gene" was patent ineligible); Endo Pharms. Inc. v. Actavis Inc., 2015 WL 7253674, at *1 (D. Del. Nov. 17, 2015) (finding discovery that "the bioavailability of controlled released oxymorphone is affected by renal function or that renally impaired patients could or should be treated safely and effectively by administering to them a reduced [ ] dosage of controlled release oxymorphone" was patent ineligible); The Cleveland Clinic Found. v. True Health Diagnostics, LLC, 2016 WL 705244 (N.D. Ohio Feb. 23, 2016) (finding that correlation between myeloperoxidase in the blood and the risk of cardiovascular disease was patent ineligible).
  8. In re BRCA1, 774 F.3d 755, 763 (Fed. Cir. 2014) (quoting Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1296-97 (2012)).
  9. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1380-81 (Fed. Cir. 2015) (Linn. J., concurring).
  10. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282, 1285 (Fed. Cir. 2015) (Laurie & Moore, J., concurring).
  11. Id. at 1287 (Dyk, J., concurring).
  12. Id. at 1294 (Newman, J., dissenting).
  13. No. 2015-1570, 2016 WL 3606624 (Fed. Cir. July 5, 2016).
  14. Rapid Litig., 2016 WL 3606624, at *1.
  15. Id. at *2.
  16. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282, 1291 (Fed. Cir. 2015) (Dyk, J., concurring).
  17. Id. at 1292 (Dyk, J., concurring).