On August 31, 2011, the Federal Circuit issued its second decision in Classen Immunotherapies, Inc. v. Biogen Idec, which was on remand from the Supreme Court after Bilski v. Kappos. Judge Newman wrote the opinion for the court, which was joined by Chief Judge Rader, and holds that two of the three asserted patents recite patent-eligible subject matter under 35 USC § 101. The court also finds that the “safe harbor” of 35 USC § 271(e)(1) only applies in the context of obtaining pre-marketing regulatory approval, and so did not prevent some of Classen’s infringement claims relating to studies of already-approved vaccines. While this decision raises some questions as it answers others, the Federal Circuit provides useful guidance for evaluating the patent-eligibility of method claims that involve some type of information gathering.
There is much in the Classen opinions that warrants further analysis and commentary, but for now I provide this synopsis of the main points.