UPDATE: Pfizer application denied
on Jun 6, 2007 at 11:39 am
UPDATE 2:40 p.m.
Supreme Court Justice John Paul Stevens on Wednesday denied, without opinion, an application by Pfizer, Inc., to stay and recall the mandate of the Federal Circuit Court’s March 22 decision nullifying patent claims on a Pfizer high blood pressure drug. The order by Stevens allows makers of generic products to continue marketing substitutes for Pfizer’s Norvasc.
A U.S. company that makes and sells cheaper generic versions of brand-name drugs urged a Supreme Court Justice on Tuesday to allow it to continue marketing a generic medicine for easing high blood pressure. Apotex Corp. said it would be hurt far more than Pfizer Inc., the brand-name medicine’s manufacturer, if Justice John Paul Stevens acts to stall a lower court ruling in Apotex’s favor. The Federal Circuit Court on March 22 struck down three claims on Pfizer’s patent for its widely used Norvasc blood pressure drug. Pfizer has asked Stevens to block that ruling temporarily.
Pfizer’s Norvasc patent actually expired on March 25, but it went to Justice Stevens in hopes of protecting its right to be the exclusive source of the medicine during a special six-month extension of its patent monopoly through Sept. 25. Apotex has been marketing its generic version since May 24, relying upon the Federal Circuit ruling that the Pfizer patent claims were invalid because their development was “obvious.” That continued competition is what Pfizer sought to interrupt with its stay application (Pfizer v. Apotex, 06A1131).
Apotex filed its answer (download here) at Stevens’ request. On Wednesday, Pfizer filed this reply. Pfizer also has a motion pending before the full Court to act swiftly on its petition challenging the Federal Circuit decision. Pfizer wants the case sent back to the Circuit Court for another look. The Court is expected to consider that separate request quickly, perhaps at its private Conference this Thursday.
In Apotex’s response, the company contended that Pfizer may lose some profits if Apotex continues in the market, but that Pfizer could later make a claim for damages if its patent should later be upheld. “Absent a showing that the court of appeals could not fashion effective relief should that court ultimately rule in favor of Pfizer, it has no right to a stay because Pfizer’s injury is not irreparable.” In any event, Apotex said, Pfizer’s estimate that it would lose some $600 million in revenue over the next four months was “overstated” because Pfizer would go on facing competition from the marketing of another generic by Mylan Laboratories.
By contrast, Apotex said, a delay in its victory on the patent’s invalidity would result in losses that it would have no way ever of recovering, if that victory should ultimately stand. Its costs, it said, would include what it spent to put its generic medicine on the market, the cost of stopping sales, and the loss of profits from marketing its drug. “The stay could be expected to last for most if not all of the remaining period” of Pfizer’s patent extension, Apotex argued. Come late September, the case would become moot, and Apotex would have no remedy at all, it said.
Pfizer, in seeking a stay and a recall of the Federal Circuit ruling against it and in its petition challenging that decision, wants the Supreme Court to return the case to that appeals court to reconsider in light of the Justices’ ruling in KSR International v. Teleflex on April 30, ordering the Circuit Court to take a more flexible view of when an invention is “obvious.”
Apotex contended on Tuesday that the KSR ruling already has been brought to the attention of the Federal Circuit, so it considered it in the Pfizer case before putting that ruling into effect. Moreover, Apotex contended, KSR would not require a change in the Circuit Court’s ruling against the Pfizer patent.
Apotex argued that “it is unlikely at best that KSR would convince the court of appeals to uphold Pfizer’s patent when it had already invalidated that patent on grounds of obviousness. If anything, it is the dissenting opinions [in the Circuit Court’s denial of rehearing] that appear out of step with KSR.” Moreover, Apotex said, the Circuit Court had already anticipated the more flexible notion of obviousness that the Supreme Court embraced in KSR.
In other arguments against even temporary relief for Pfizer, Apotex asserted that it is unlikely the Supreme Court will agree to hear Pfizer’s petition, that there is no “reasonable likelihood” that the Justices would actually overturn the Circuit Court decision, and that Pfizer should not be given a stay now because it failed to ask the Circuit Court one before going on to Justice Stevens.
(Stevens is handling the stay-and-recall application because Chief Justice John G. Roberts, Jr., normally the Circuit Justice for the Federal Circuit, routinely recuses himself from cases involving Pfizer. It is up to Stevens to decide whether to act on the application alone, or refer it to his colleagues for action.)
In Pfizer’s reply to Apotex on Wednesday, the big drugmaker said it was “false” to suggest it would have “some sort of damages remedy” if it ultimately won on the patent issue. The exclusivity of its post-expiration marketing does not extend the patent itself, Pfizer said. There would be no private right of actiion against generic companies for violating that added period of exclusivity, it argued.
Moreover, Pfizer contended, it is now suffering even more harm, because the Federal Circuit on Tuesday overturned two other District Court cases finding the Pfizer patent valid and enforceable, based upon its ruling in the Apotex case.
The fact that Mylan Laboratories is already marketing a generic competition to Norvasc, Pfizer’s reply said, does not mean that Pfizer would not be able to get “further equitable relief” against Mylan and other generics during the remaining period of exclusivity for Pfizer.
Pfizer’s reply also disputed Apotex on whether the full Court was likely to grant it any relief on its petition, and on whether it should have first sought a stay in the Circuit Court.
