Biotech Patent Rejected Under Section 101 of US Patents Law in View of BILSKI

The US Court of Appeals for the Federal Circuit (CAFC) issued on Friday, December, 19 2008,  a decision rejecting a biotech patent under Section 101 of the US Patent Law in view of the CAFC’s earlier decision in In re Bilski (“the Bilski case”). 

The case involved a patent of Classen Immunotherapies, Inc. that sued a series of defendants including Biogen Idec, GlaxoSmithKline, and Merck & Co., as well as several others on the charge of patent infringement (“the Classen case”). The case was an appeal from the Maryland District Court which issued a Summary Judgment of patent invalidity.

The patent in question in the Classen case was US 5,723,283, directed to a method of determining the effect of immunization schedule on mammals. The relevance of this patent is primarily for determining an immunization schedule in laboratory animals¹.

In the Classen case the CAFC affirmed the District Court’s Summary Judgment citing the CAFC earlier en banc Decision in the Bilski case.

The patent at issue in the Bilski case concerned a business method. In the Bilski case, the CAFC changed the test for determining eligible subject matter in the US by adopting the “machine or transformation test” instead of the previously applicable “useful, concrete and tangible result” test of patentability under Section 101 of the US Patents Law². The “machine or transformation” test means that for an invention to be patentable under Section 101, it must be tied in some way to a machine or involve a “transformation into a different state or thing”.

The CAFC is the appeal court for all intellectual property cases, including appeals from district courts and from the Board of Appeals and Patent Interference of the USPTO. Thus the court’s opinion on patentability plays a major role in the US patent system.

Accordingly, the Bilski case, albeit highly controversial, was considered by many to be one of the most important decisions in a long time and one that may have far-reaching consequences. Others, however, considered the decision far less significant – as applying narrowly to business methods and possibly more to software inventions. However, the recent decision in the Classen case may suggest that the Bilski decision may have broad implications.

The Court’s decision in the Classen case was very brief and quoted below in full:

“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.

Although the CAFC decision is of no precedent-setting significance and should be viewed as directed to the specifics of the Classen case, one cannot but wonder as to how far the CAFC will take the “machine-or-transformation test” in the future and the extent to which it will be applicable in a variety of technological fields.  

The direction which the CAFC will yield in the future is of high significance to applicants and patent holders.

1 Section 101 of the US Patents Law reads:

“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.”

2 Claim 1 of the patent reads as follows:

“1. 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.”