Federal Circuit Holds Sequenom Diagnostic Method Patent Invalid Under 101

The Federal Circuit has issued its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., affirming the district court’s finding that Sequenom’s claims are invalid under 35 USC § 101. The court’s decision shows the sweeping impact of the Supreme Court’s decision in Mayo v. Prometheus on the patent eligibility of diagnostic methods, and could have a ripple effect across the diagnostic and personalized medicine industry. Continue reading this entry

Federal Circuit Finds Nunc Pro Tunc Agreement Does Not Confer Standing

The tenuous nature of an exclusive licensee’s standing to enforce a patent was something I learned early in my legal career, when I was a judicial clerk at the Federal Circuit. In Alps South LLC v. Ohio Willow Wood Co., the Federal Circuit issued another painful lesson on this topic, when it reversed, vacated and remanded a jury verdict of willful infringement because the plaintiff-licensee lacked standing to bring suit without joining the patent owner. Continue reading this entry

Federal Circuit Hears Oral Arguments In Neupogen Biosimilar Case

On June 3, 2015, the Federal Circuit heard oral arguments in Amgen v. Sandoz regarding the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). As reflected in Judge Lourie’s comments, this case requires the court to interpret a statue that should win “a Pulitzer Prize for complexity.” Continue reading this entry

Another Sequenom Patent Appeal Heads To The Federal Circuit

While Sequenom’s appeal of the district court’s summary judgment of invalidity of U.S. Patent 6,258,540 under 35 USC § 101 has been pending at the Federal Circuit, the USPTO has been considering the validity of the patent under 35 USC §§ 102 and 103 in an Inter Partes Review proceeding. Now that the decision of the Patent Trial and Appeal Board also is on appeal at the Federal Circuit, will the court wait even longer to decide the patent eligibility issues? Continue reading this entry

Dependent Claims Give Rise To Improper Broadening Reissue

In ArcelorMittal France v. AK Steel Corp., the Federal Circuit found that the addition of a dependent claim to a reissue application improperly broadened the scope of the original independent claims beyond the two-year period for a broadening reissue. While the court invoked the law-of-the-case doctrine, the same result could occur with any patent where the claims have been construed more narrowly. Continue reading this entry