Patent law, intro
As I indicated in my previous entry, the good folks at Bio Careers have asked me to blog about my experiences regarding my transition from scientist to patent law attorney. Before getting into that, I thought I would dedicate this entry to a brief review of Bilski. As you may or may not know, Bilski v. Kappos was the eagerly anticipated decision from Supreme Court of the United States (“SCOTUS”) regarding the patentability of business method patents (http://www.supremecourt.gov/opinions/09pdf/08-964.pdf). Claim 1 was representative of the claims at issue and read in relevant part:
(a) initiating a series of transactions between said commodity provider and consumers of said commodity wherein said consumers purchase said commodity at a fixed rate based upon historical averages, said fixed rate corresponding to a risk position of said consumers; (b) identifying market participants for said commodity having a counter-risk position to said consumers; and (c) initiating a series of transactions between said commodity provider and said market participants at a second fixed rate such that said series of market participant transactions balances the risk position of said series of consumer transactions.
There really was never any question whether the claims in Bilski would be held unpatentable for not being directed to patentable subject matter (all nine justices agreed that they were unpatentable under 35 U.S.C. § 101). The big question was how broadly the SCOTUS would rule regarding the patentability of business method patents in general. A majority of justices held that business methods are patentable in general, as long as they do not merely recite an abstract idea (regarding the claims at issue in Bilski, the Court held that “Allowing petitioners to patent risk hedging would preempt use of this approach in all fields, and would effectively grant a monopoly over an abstract idea.”). The big question left for patent practitioners is obviously “When does a process merely define an abstract idea?” Not much guidance is provided by the SCOTUS.
The interesting thing to me in my practice (and hopefully to readers of the blog) is how the decision in Bilski will affect biotech/pharma patents directed to methods involving treatment, diagnosis, pharmacogenomics, etc. The same day that Bilski was decided, the SCOTUS sent back two cases to the Federal Circuit (the court for patent appeals) for further proceedings in view of its Bilski decision. In the first case, Promethius v. Mayo (http://www.cafc.uscourts.gov/opinions/08-1403.pdf), the court found the following claim patentable:
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.
In the second case, Classen v. Biogen (http://www.cafc.uscourts.gov/opinions/06-1634.pdf), the court summarily found the following claim unpatentable:
A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.
In view of Bilski’s abstract idea test, I’m not sure how the Federal Circuit will re-decide these cases. There is the distinct possibility that the Federal Circuit will conclude that the decisions should come out the same even in view of Bilski. However, I’m not sure either claim should be patentable under Bilski. In fact, I see more of a problem with the claim in Promethius, since the real novelty lies in the last clause regarding the correlation of pmol levels of 6-thioguanine and the need to increase or decrease the drug. This would seem to me nothing more than an abstract idea. Note that once the level of 6-thioguanine is determined (which is not a novel process), nothing further is actually required.
No definitive answers here, just food for thought.
More to come in two weeks, where I begin the story of my path from science to the law.