Pfizer seeks swift patent protection
on Jun 1, 2007 at 11:05 am
UPDATE Friday a.m.
Pfizer’s petition filed Wednesday, now docketed as 06-1582, poses these questions: “(1) Whether the Federal Circuit’s failure to reconsider its judgment under the KSR standard merits summarily granting the petition, vacating the judgment, and remanding for further consideration in view of KSR? (2) Whether, if the petition is not granted prior to September 25, 2007 — when Pfizer’s pediatric exclusivity for Norvasc comes to an end — the Court should instead grant the petition and order the Court of Appeals’ judgment vacated under United States v. Munsingwear, Inc., 340 U.S. 36 (1950), and U.S. Bancorp Mortgage Co. v. Bonner Maill Partnership, 513 U.S. 18 (1994).” The motion for expedition asks the Court to decide during the current Term whether to grant and vacate the Circuit Court ruling, suggesting a briefing schedule that would be completed by June 16. “The relief that Pfizer seeks in its petition, a summary GVR order rather than a full review on the merits, is particularly susceptible to treatment in an expedited fashion,” the motion argues. Pfizer told the Court that about $500 million in revenue would be at stake over the coming months if the Circuit Court ruling is vacated.
Pfizer filed its motion to stay the Circuit Court with Chief Justice John G. Roberts, Jr., who normally is the Circuit Justice for the Federal Circuit. Roberts, however, has routinely recused himself from cases involving Pfizer. This application thus will be considered initially by the senior Associate Justice, John Paul Stevens; it is up to him whether to act alone or refer it to his colleagues.
(NOTE; Links to all of the filed documents are at the end of this post.)
The major drug maker, Pfizer Inc., in an emergency plea Wednesday, asked Chief Justice John G. Roberts, Jr., to block a Federal Circuit Court ruling that scuttled the company’s patent rights on the main ingredient in its widely used Norvasc medicine for easing high blood pressure. The application (Pfizer v. Apotex, 06A1131) contends that the Circuit Court failed to apply the Justices’ unanimous April 30 ruling overturning the appeals court’s method of judging patentability. Besides asking for an immediate order to delay the Circuit Court ruling, Pfizer also filed a petition for review, and asked for expedited consideration of that, too.
The Federal Circuit, Pfizer argued, has already put into effect its March 22 ruling that three claims on Pfizer’s amlodipine besylate were invalid because their creation would have been obvious to specialists in the field. The patent claims cover the active ingredient in the most-prescribed anti-hypertension drug, one that Pfizer said earns it more than $150 million every month. The March 22 ruling, Pfizer said, applied the Circuit’s prior formula for weighing whether a patent is valid because its invention was “obvious.” Under patent law, an invention that is an outgrowth of earlier technology cannot be patented.
Pfizer had asked the Federal Circuit to reconsider its March 22 ruling. While that plea was pending, the Supreme Court at the end of April decided KSR International v. Teleflex, mandating a new way of examining the obviousness of an invention. Pfizer told the Federal Circuit about that ruling, but on May 21, over three judges’ dissents, the Circuit Court refused to rehear the case. At the same time, at the request of Apotex, a generic drug maker, the Federal Circuit issued its mandate — thus cutting off Pfizer’s remaining monopoly under its patent claims.
Pfizer told the Chief Justice that Apotex, three days after the lower court denied reconsideration, launched a generic version of a drug with the same active ingredient as in Norvasc. Pfizer’s own patent actually expired on March 25, it noted, but the company has gained an extension through Sept. 25 because it has undertaken tests to decide whether the active ingredient will be medically useful for children, too — a pediatric extension allowed by federal law. That extended period, however, ended when the Federal Circuit put its ruling into effect, the company said.
“Issuance of the mandate essentially opens the door for Pfizer’s competitors to begin releasing competing products, thereby depriving Pfizer of its remaining statutorily-guaranteed exclusively period,” the application asserted.
The company’s separate appeal asked the Supreme Court to grant review of the Federal Circuit’s March 22 ruling, to vacate it, and then send the case back to the lower court to apply the KSR decision regarding obviousness to the Pfizer patents at issue.
Here are the cert. petition, motion to expedite, and motion to recall the mandate and stay proceedings.
