Puzzled By Prometheus

24 May 2012 PharmaPatents Blog

Last Wednesday I attended an excellent roundtable on Prometheus hosted by The George Washington University Law School and The Biotechnology Industry Organization (BIO). The roundtable was moderated by Hans Sauer of BIO and John M. Whealan of GW Law, and the panelists included The Honorable Paul R. Michel, intellectual property law professors, industry representatives, and practitioners (including my colleagues Hal Wegner and Andrew S. Baluch). While the program offered lots of food for thought, one point in particular (made by Daryl Joseffer of King & Spalding) had people talking during the reception.

If the Prometheus claims included only the administering step, even the Supreme Court would have upheld patent-eligibility.

A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder.

Indeed, the Prometheus decision itself is careful to distinguish its holding from claims directed to “a new way of using an existing drug.”

So, how can adding more words to the claims—the “determining” step and the “wherein” clause—make them less patent-eligible?

A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

Doesn’t adding words to a claim make the claim more specific?

Of course, the shorter claim might not have been patentable over the prior art, but how could language that makes a claim patentable render it patent-ineligible?

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