Patent Law

Biotech Claims Need to be Tied to a ?Particular Machine or Apparatus?

By Stephen Albainy-Jenei

In a nonprecedential opinion today, Classen Immunotherapies, Inc. v. Biogen IDEC (06-1634, -1649), Circuit Judge Moore affirmed the denial of patent-eligibility of a medical treatment method under 35 USC § 101, that is, a question of whether the claimed invention meet the requirements for patentable subject matter.

The entire opinion is as follows:

?In light of our decision in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc), we affirm the district court?s grant of summary judgment that these claims are invalid under 35 U.S.C. § 101. Dr. Classen?s claims are neither ?tied to a particular machine or apparatus? nor do they ?transform[] a particular article into a different state or thing.? Bilski, 545 F.3d at 954. Therefore we affirm.?

The claims in Classen are directed to methods of selecting vaccine regimens by comparing two regimens and identifying the regimen less likely to cause chronic autoimmune disorders.  The patent was killed by District Court Judge Quarles as directed to patent ineligible processes under Section 101 under the belief that the immunization step was an ?insignificant post-solution activity? and the claims were merely an indirect attempt to patent the idea that there is a relationship between vaccine schedules and chronic immune mediated disorders and “an attempt to patent an unpatentable natural phenomenon.?

The Court reasoned:

Although articulated as a process, the ‘283 patent does not claim a specific technique or technical process of testing vaccine safety. Instead, the ‘283 patent describes only a general inquiry of whether the proposed correlation between an immunization schedule and the incidence exists. As such, the process is indistinguishable from the idea itself. Accordingly, the ‘283 patent seeks to patent an unpatentable natural phenomenon.

The question here is whether the claims meet the machine-or-transformation test in the application of the natural phenomena identified by the inventors.  Note that the Federal Circuit in Bilski left open the possibility that the requirements could change depending upon future developments in technology and the sciences, which could alter the machine-or-transformation test noting that “we recognize that the Supreme Court may ultimately decide to alter or perhaps even set aside this test to accommodate emerging technologies.”

It looks like the Federal Circuit decided to just knock this one down and wait for a better case to analyze deeply.

See also: How Did We Get to Bilski and What Can We Do About It?

Full post as published by Patent Baristas on December 19, 2008 (boomark / email).