D.C. Circuit Issues Opinion in Generic RISPERDAL 180-Day Exclusivity Litigation Reversing District Court Decision

By Kurt R. Karst –      

Earlier today, the U.S. Court of Appeals for the District of Columbia Circuit issued its opinion in Teva Pharmaceuticals USA, Inc. v. Leavitt.  The case concerns the availability of 180-day exclusivity for a generic version of Janssen Pharmaceutica’s schizophrenia drug RISPERDAL (risperidone) Tablets based on Teva’s Paragraph IV certification to U.S. Patent #5,158,952 (“the ‘952 patent”).  Teva argued that the ‘952 patent was incorrectly removed from the Orange Book after the company submitted an ANDA with a Paragraph IV certification to the patent, because the annual paper version of the Orange Book listed the ‘952 patent while FDA’s electronic version did not.  In November 2006, U.S. Court of Appeals for the District of Columbia Circuit decided in Ranbaxy Laboratories Ltd. v. Leavitt that FDA may not delist a patent from the Orange Book following the submission of an ANDA with a Paragraph IV certification to that patent.

Teva sued FDA in March 2008 after the Agency denied a citizen petition Teva submitted in August 2007 requesting that FDA relist the ‘952 patent in the Orange Book and confirm Teva’s eligibility for 180-day exclusivity.  Teva argued in its petition (and in court) that because the “official Orange Book” (that is, the printed edition of the Orange Book) listed the ‘952 patent when the company submitted its ANDA, “FDA’s putative delisting of the ‘952 patent did not become effective until January 2002, when the official Orange Book reflected the delisting of that patent.”  As such, according to Teva, given the decision in Ranbaxy, FDA could not have lawfully delisted the ‘952 patent because of the company’s Paragraph IV certification to that patent, and the company remained eligible for 180-day exclusivity.

On April 11, 2008, Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia issued a 2-page order siding with Teva.  The order declared that the delisting of the ‘952 patent was unlawful, ordered FDA to relist the patent in the Orange Book and to restore Teva’s Paragraph IV patent certification, and enjoined FDA from approving any generic RISPERDAL Tablets ANDAs until Teva’s 180-day exclusivity expires.  FDA appealed the decision.

As we previously reported, on September 12, 2008 (the same day that oral argument was heard), a 3-judge panel of Circuit Judges Brown, Kavanaugh, and Senior Circuit Judge Williams filed a per curiam judgment vacating the district court’s April 11, 2008 injunction and reversing the district court’s order.  The Court also issued its mandate on September 12, 2008.

The Circuit Court’s November 7, 2008 decision, in conformity with the Court’s September 12, 2008 mandate and per curiam judgment, reverses the district court’s decision, vacates the district court’s injunction, and directs for the entry in judgment for FDA.  In reaching its decision, the Court states:

Teva’s ANDA did not meet the clear and unambiguous requirements of the statute because it did not and could not include a certification to a patent that claimed Risperdal . . . .  [(emphasis added)]

Unfortunately for Teva, an ANDA applicant’s right to a period of marketing exclusivity does not vest merely because a paragraph IV certification is filed. Only compliance with paragraph IV triggers exclusivity, and compliance presupposes the existence of a claiming patent.  The claim is a prerequisite; without it, there can be no valid certification.  Inadvertent failure by the agency to meet its separate publication requirement cannot defeat facts. Indeed, for this Court to accept Teva’s position, we would have to accept the proposition that even partial inadvertence is sufficient.  The electronic version of the Orange Book reflected the withdrawal of the ‘952 patent at least a month before Teva submitted its certification. Teva’s argument goes beyond punishing Agency inadvertence; it would reward willful blindness on the part of manufacturers – a position clearly at odds with Hatch-Waxman’s focus on fostering competition and lowering drug prices.

In a concurring opinion, Senior Judge Williams wrote “to clarify an ambiguity in the majority decision:”

The panel opinion says on the one hand that “a ‘claim’ is simply a description of the subject a patent purports to cover as established by the NDA holder.”  Maj. Op. at 6 (emphasis added).  This seems to imply that the statute requires the FDA to accept the NDA holder’s listing and delisting decisions, imposing on it the ministerial role that it has chosen for itself.  On the other hand, the majority opinion describes the FDA’s choice to adopt a ministerial role as a “common-sense policy choice” that is merely “consistent with the statute.”  Id. at 7.  I have seen no reasoning either in this opinion or in those of other courts that would support the idea that the statute mandates a ministerial role; for this case, all that is needed is a conclusion that the FDA’s adoption of that role is reasonable.

Senior Judge Williams repeatedly refers to the Fourth Circuit's 2002 decision in aaiPharma Inc. v. Thompson, in which FDA argued that its role with respect to patent issues is purely ministerial, while the plaintiff argued that FDA has to make its own determination about Orange Book patent listing.  The Fourth Circuit adopted FDA’s interpretation of the FDC Act as reasonable; however, Senior Judge Williams notes that “had the FDA adopted the plaintiff’s position and sought to protect third-party patent holders, the aaiPharma court would have viewed that construction of the statute as reasonable too.”  He concludes that “to read the majority opinion as implying that the statute locks the FDA into a ministerial role would be inappropriate.  Such a reading would prevent the FDA from taking a more active role in the listing process, thereby better protecting third parties’ rights, and finds no support in the cases cited by the majority opinion . . . .”