medical diagnostic patent

Medical Diagnostic Patent

The U.S. Supreme Court decided not to consider a case (LabCorp v.

Metabolite Laboratories) involving a medical diagnostic test patent.

The decision not to hear the case effectively upholds the patent. This

case involved "a patent that claims a process for helping to diagnose

deficiencies of two vitamins, folate and cobalamin. The process

consists of using any test (whether patented or unpatented) to measure

the level in a body fluid of an amino acid called homocysteine and

then noticing whether its level is elevated above the norm; if so, a

vitamin deficiency is likely".

A brief report on the decision (in the NY Times) is here and the

dissenting opinion is available here.

In the dissenting opinion, Justice Breyer argued that "those who

engage in medical research, who practice medicine, and who as patients

depend upon proper health care, might well benefit from this Court's

authoritative answer" (to these questions). Here are a few of the sage

insights in Breyer's dissenting opinion:

If I am correct in my conclusion in Part III that the patent is

invalid, then special public interest considerations reinforce my view

that we should decide this case. To fail to do so threatens to leave

the medical profession subject to the restrictions imposed by this

individual patent and others of its kind. Those restrictions may

inhibit doctors from using their best medical judgment; they may force

doctors to spend unnecessary time and energy to enter into license

agreements; they may divert resources from the medical task of health

care to the legal task of searching patent files for similar simple

correlations; they may raise the cost of healthcare while inhibiting

its effective delivery.

....Even if Part III is wrong, however, it still would be valuable to

decide this case. Our doing so would help diminish legal uncertainty

in the area, affecting a "substantial number of patent claims." See

Brief for United States as Amicus Curiae 12-14 (filed Aug. 26, 2005).

It would permit those in the medical profession better to understand

the nature of their legal obligations. It would help Congress

determine whether legislation is needed.

In either event, a decision from this generalist Court could

contribute to the important ongoing debate, among both specialists and

generalists, as to whether the patent system, as currently

administered and enforced, adequately reflects the "careful balance"

that "the federal patent laws. . . embod[y]."

Breyer's opinion captures a number of important insights about the

impact patents have on innovation and the role the Courts should play

in trying to enhance our deliberation on important societal concerns.

The topic of genomic intellectual property is immensely important for

to the issue of genetic justice. I hope to spend a good deal of this

coming academic year working on the topic of gene patents, so I will

have more to say about this in future blogs.