Supreme Court Impacts Personalized Medicine

Date: March 22, 2012
Author: Anton Hopen

Author’s Summary:  The value of personalized medicine technologies was negatively impacted this week.  The Supreme Court constrained patent protection for discoveries of how drugs interact between different individuals finding such claims directed to unpatentable laws of nature.  Although this holding may limit intellectual property restraints on practicing personalized medicine, it will likewise diminish investment into the field as well.   Patent attorneys must reevaluate the validity of existing patents in personalized medicine and draft future patent claims to specific application of a drug interaction discovery.

Full Analysis:  In its decision two days ago (March 20, 2012), the Supreme Court reversed the Federal Court’s holding and unanimously held that a test that suggests an optimized drug dosage based on an individual patient’s reaction is unpatentable as a law of nature.  Mayo Collaborative Services v. Prometheus Laboratories, Inc., U.S., No. 10-1150, 3/20/2012.  Paraphrasing the claim at issue:

A method of treatment comprising:

a)      Administering a drug to a patient;

b)      Determining the level of the drug in the patient; and

c)       Increasing or decreasing subsequent drug dosages based on the observed levels.

The Federal Circuit initially found this type of claim patent eligible as administering the drug and determining the drug’s metabolite level involved the “transformation of the human body.”  581 F.3d 1336, 1345 (2009).  Upon a post-Bilksi review, the Federal Circuit came to the “clear and compelling conclusion…that the…claims…do not encompass laws of nature or preempt natural correlations.” 628 F.3d 1347, 1355 (2010).

In its findings this week, the Supreme Court may have coined a new type of (invalid) patent claim for medical discoveries that has three parts: (1) measure; (2) use; and (3) reconsider (aka, "a Prometheus Claim").

1)      Measure the current level of a condition;

2)      Use a particular law of nature to calculate toxicity/inefficacy limits; and

3)      Reconsider the drug dosage in light of the results.

Public Policy was an important consideration for the Court which agreed with medical organizations that asserted if “claims to exclusive rights over the body’s natural responses to illness and medical treatment are permitted to stand, the result will be a vast thicket of exclusive rights over the use of critical scientific data that must remain widely available if physicians are to provide sound medical care.”  Brief for American College of Medical Genetics et al. as Amici Curiae 7.  The Court even noted that Samuel Morse’s general claim for telegraph technology was found unpatentable based partly on a concern that patent law not inhibit further discovery by improperly tying up the future use of laws of nature.

Conclusion:  There remains a substantial disconnect between the Federal Circuit and the Supreme Court with the Federal Circuit trending toward expansive patent rights while the Supreme Court is more conservative.  Patent attorneys are subject to constant pressure from litigators to seek broad, general protection on inventions...sometimes pushing the envelope of statutory subject matter.  A wise strategy should always include asking the rhetorical question (also noted by the Court), "how much future innovation is foreclosed relative to the contribution of the inventor?"  If the patent claims will likely restrain innovation far beyond what the inventor has provided, then the claims should be reconsidered for their statutory validity.