Patenting Health: You Cannot Own the Laws of Nature

Patenting Health: You Cannot Own the Laws of Nature

On March 20, 2012, the United States Supreme Court decided Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (U.S. 2012). The case was unanimous and emphatically reaffirmed that United States patent law does not allow ownership of "laws of nature." The context was a pair of patents owned by Prometheus which claimed a method for administering a drug. The drugs involved are thiopurines which are used used to treat autoimmune diseases. They are particularly subject to metabolic changes in individuals. This can result in either underdosing or overdosing, with sometimes disastrous side effects. The patent claims recited a three step process to minimize the prospects of improper dosages. The trial court ruled that Mayo had violated the claims of the patent, but granted summary judgment in Mayo's favor because the process was not patentable. The Supreme Court agreed, stating that these "simply tell doctors to gather data from which they may draw an inference in light of the correlations."

The justification for patent incentives reaches a high point when it solves a ravaging health problem, such as proving a cure for malaria, AIDS, or Lyme disease. It dips to its nadir when it interferes with research or interferes with professional judgment or practice. However, patent owners want profit from patents. If they can, they would like to control competitors. Professor Colleen Chien of Santa Clara University summarizes the situation:

While each patent dispute is unique, most fit the profile of one of a limited number of patent litigation stories. When an independent inventor sues a large company, for instance, a David v. Goliath match-up results. In contrast, if the parties are more evenly matched, comprising two large private or publicly traded corporations, the result can be patent warfare, potentially of global dimensions.…the strategic use of patent litigation by well-established large companies against their smaller, less-established rivals has been called predatory. Colleen V. Chien, Of Trolls, Davids, Goliaths, and Kings: Narratives and Evidence in the Litigation of High-Tech Patents, 87 N.C. L. Rev. 1571, 1577 (2009).

Congress has power to enlarge patent law to “include anything under the sun that is made by man.” However, it is extremely unlikely to contradict the Supreme Court's "bright-line prohibition against patenting laws of nature, mathematical formulas and the like.” Applying this principle, the Court rejected the United States government's amicus argument that the case ought these claims ought to be judged on the basis of novelty (35 U.S.C. § 102), obviousness (35 U.S.C. § 103), or specificity (35 U.S.C. § 112), rather than on the fundamental uestion of patentability per se. Congress  has always acquiesced in the Supreme Court interpretation of permissible scope. See also, Bilski v. Kappos, 130 S. Ct. 3218 (2010).

The world patent picture

United States patent laws and practices cast a long shadow in world intellectual property. Entities that seek to promote high capital value for patent rights have been able to draw on United States patent policy as an example of strong proprietary rights. The Bilski and Mayo cases provide a basis to push the other direction, in favor of access rights.

The great mass of humanity needs access to medical advances now more than even. However, in the international patent regime created by the current World Trade Organization (WTO) and the TRIPS Agreement (“Trade Related aspects of Intellectual Property”) loads the dice against such access. Professor Rochelle Dreyfuss states that this treaty structure does little, however, "to explicitly safeguard the interests of those who seek to use protected works. In some ways, this structure is not surprising. Because the free traders who negotiated the GATT worked in an environment in which the core concern, reducing market barriers, was viewed as producing (at least in the long term) unmitigated welfare gains." Rochelle Cooper Dreyfuss, Trips-Round II: Should Users Strike Back?, 71 U. Chi. L. Rev. 21 (2004).

Scope for medical advance

The Court patent laws must not interfere with research and practice. It stated:

The patent claims at issue implicate this concern. In telling a doctor to measure metabolite levels and to consider the resulting measurements in light of the correlations they describe, they tie up his subsequent treatment decision regardless of whether he changes his dosage in the light of the inference he draws using the correlations. And they threaten to inhibit the development of more refined treatment recommendations that combine Prometheus' correlations with later discoveries.

Doctors and small companies now have a better chance to move ahead with constructive practices and innovations.

All in all, March 20 was a good day for the public.

Howard C. Anawalt is a United States attorney, law professor, and writer. He has previously written for the IPilogue here and here.