In a decision issued September 20, 2012, in Bristol Meyers Squibb Co. v. Kappos, the U.S. District Court for the District of Columbia denied the USPTO’s motion for reconsideration of the court’s January 27, 2012 decision that found that the statutory deadline for bringing a civil action to challenge the Patent Term Adjustment (PTA) awarded by the USPTO is tolled when the patentee pursues reconsideration of the agency decision. This ruling is significant, because the 180-day statutory period often occurs before the USPTO issues its decision on a request for reconsideration.Continue reading this entry
In a decision issued August 3, 2012 in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., the Federal Circuit held that the safe harbor provisions of 35 USC § 271(e)(1) can shield the defendants from liability for patent infringement arising out of their use of patented methods to satisfy FDA testing requirements for their approved products. Judge Moore wrote the opinion for the court, which was joined by Judge Dyk. Chief Judge Rader wrote a dissenting opinion, explaining his contrary view and asserting that the majority decision is in direct conflict with the court’s August 2011 decision in Classen Immunotherapies, Inc. v. Biogen Idec. Chief Judge Rader was in the majority in that decision, while Judge Moore dissented. A petition for certiorari in Classen is pending at the Supreme Court, and it is likely that the Supreme Court will have to resolve these conflicting views of the safe harbor. Continue reading this entry
I wrote previously about the patentability issues raised in Genetics Institute, LLC v. Novartis Vaccines & Diagnostics, Inc., and Novartis’ ability to rely on unexpected results discovered after the filing date to support non-obviousness. Here, I look at another interesting issue in the case, related to the scope of a patent term extension under 35 USC § 156 and district court jurisdiction under 35 USC § 291.
The Technology At Issue
The technology at issue relates to truncated forms of Factor VIII, an essential blood-clotting protein. As explained in the Federal Circuit opinion, the proper functioning of Factor VIII depends on its ability to bind another protein, von Willedbrand factor (“vWF”), although Factor VIII can exhibit a procoagulant effect without complexing to vWF. Truncated forms of Factor VIII are based on the discovery that certain portions of the protein are not required for its procoagulant activity, and that region a3 is critical to vWF binding.
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.
In a decision that sent The Medicines Company’s stock prices soaring, the District Court for the Eastern District of Virginia determined that the USPTO’s rejection of The Medicines Company’s application for Patent Term Extension was based on an incorrect—and unreasonable and unfair —interpretation of the governing statute. The patent at issue relates to Angiomax®, an anticoagulant that is generating revenue of about $100M per quarter. Unless the USPTO appeals, The Medicines Company patent will be extended to December 2014. (Without the extension, the patent will be expired as of March 23, 2010.) In addition to representing a significant victory for The Medicines Company, the decision strikes a blow against the USPTO’s policy of strictly and rigorously applying the statute, sometimes to the detriment of patent holders who miscalculated the filing deadline and suffered potential losses of millions of dollars.