Mylan announced in a press release today that it has launched its generic Norvasc (amlodipine besylate). Mylan's generic launch follows the Federal Circuit's decision yesterday, invalidating Pfizer's patent on Norvasc. The case presents some very interesting issues involving the interaction between patent rights, pediatric exclusivity, and 180-day exclusivity.
Last month, Mylan lost its patent challenge when Judge Terrence F. McVerry of the U.S. District Court for the Western District of Pennsylvania found that Pfizer's patent is valid, enforceable and infringed by Mylan. At the time, the district court enjoined Mylan from marketing its generic Norvasc "until after the expiration of Pfizer's '303 patent term, as extended by the pediatric exclusivity period." Pfizer's patent expires this Sunday, March 25; Pfizer's pediatric exclusivity expires six months later, on September 25. Since then, Pfizer and Mylan have been busy filing motions to amend the district court's injunction and Mylan has appealed the decision to the Federal Circuit.
On March 8, Pfizer asked the district court to modify its injunction to include a "section 271(e)(4)(A) order" stating that the effective date of approval of Mylan's ANDA shall not be earlier "than the date of expiration of the '303 patent (March 25, 2007, with attached six months of pediatric exclusivity ending on September 25, 2007, to which Pfizer is entitled)." The FDA had already granted final approval to Mylan's ANDA and, according to Pfizer, "in a telephone conversation on March 7, 2007, the FDA advised Pfizer that the FDA will not reset Mylan's effective approval date without a judgment including a section 271(e)(4)(A) order."
Mylan opposed Pfizer's motion and filed its own motion to amend the district court's order, asking the district court to enjoin Mylan only until Pfizer's patent expires on March 25. According to Mylan's motion:
Pediatric exclusivity does not grant a drug maker a six month patent extension, but acts [only] to prohibit FDA from granting final approval. Here Mylan has already received final approval and is the only ANDA filer with final approval. In effect, then, the pediatric exclusivity period applies to all generic competitors except Mylan, thus giving Mylan a six-month head start over generic competitors.
In response, Pfizer filed a combined opposition and reply. Pfizer argued that its proposed amended judgment was "purely formal, incorporating the precise words of the statue. Mylan's proposed amended judgment, on the other hand, seeks to . . . deny Pfizer its right of pediatric exclusivity without any basis whatsoever."
On March 16, the district court reached a sort of compromise, ordering that Mylan's ANDA shall not be approved until Pfizer's patent expires and enjoining Mylan until then. Mylan then filed an emergency motion to stay the court's new order, arguing that "there is a real danger that the Court's order will prompt the FDA to revoke [Mylan's] approval, keeping Mylan off the market even after the patent has expired." Mylan worried that it would lose its 180-day exclusivity rights if the FDA revoked its approval. Three days later, Pfizer opposed the motion. Later that same day, the court denied it.
Yesterday, of course, the big news hit: the Federal Circuit invalidated Pfizer's patent in a separate case against Apotex, who had filed its own ANDA to market generic Norvasc (albeit later than Mylan). Mylan's lawyers immediately picked up the phone, called Judge McVerry, and made "an emergency oral telephonic motion for a stay of the injunctive relief." Recognizing that Mylan's lawyers presented the same emergency motion to the Federal Circuit, Judge McVerry denied Mylan's motion.
At the same time, Mylan filed this complaint against the FDA today in the District of Columbia district court, asking the court to enjoin FDA from taking any action that would "disturb the final approval granted to Mylan's ANDA." Mylan indicated that in a phone call with Mylan's counsel, "FDA counsel stated that FDA would revoke Mylan's final approval and convert it to a tentative approval," if the Federal Circuit did not stay the March 16 order "by mid-day on March 23, 2007." Mylan also filed this emergency TRO motion.
Apparently the Federal Circuit granted Mylan's motion for a stay of the March 16 order--otherwise Mylan could not have launched its generic Norvasc. The Federal Circuit's action seems to moot the lawsuit Mylan filed today in the D.C. district court.
Now that Mylan has launched, the interesting question is whether the FDA will approve any other generics when Pfizer's patent expires on Sunday. In its press release today, Mylan states that its generic launch triggered its 180-day exclusivity period, precluding the FDA from approving any other generics. This AP story published today, however, suggests that Apotex has a different understanding, and expects to launch its own generic Norvasc "in the very near future."
Meanwhile, Pfizer announced late today that in response to Mylan's generic launch, it has launched an authorized generic Norvasc through its Greenstone subsidiary. Pfizer added that it "will continue to pursue all available legal remedies to protect the market for Norvasc through a six-month pediatric exclusivity period that expires in September, 2007."
Stay tuned . . . this story is developing quickly.