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
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.
Collaborative Services v. Prometheus Laboratories, Inc., U.S., No. 10-1150,
3/20/2012. Paraphrasing the claim at
A method of treatment comprising:
Administering a drug to a patient;
Determining the level of the drug in the patient;
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").
the current level of a condition;
particular law of nature to calculate toxicity/inefficacy limits; and
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
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