Getting Anxious – Apotex Files Motion to Intervene in Generic RISPERDAL Litigation; Teva Quickly Files Opposition

On April 11, 2008, we reported that Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia issued a 2-page order in Teva Pharmaceuticals USA, Inc. v. Leavitt siding with Teva over the reslisting of U.S. Patent #5,158,952 (“the ‘952 patent”) in the Orange Book covering Janssen Phaemaceutica’s RISPERDAL (risperidone) Tablets.  Teva sued FDA in March 2008 after the Agency denied a citizen petition Teva submitted to FDA in August 2007 requesting that the Agency relist the ‘952 patent in the Orange Book and confirm Teva’s eligibility for 180-day exclusivity. Judge Lamberth’s order declared that the delisting of the ‘952 patent was unlawful, ordered FDA to relist the patent in the Orange Book and restore Teva’s Paragraph IV patent certification, and enjoined FDA from approving any generic RISPERDAL Tablets ANDAs until Teva’s 180-day exclusivity expires. 

Absent the relisting of the ‘952 patent in the Orange Book and any 180-day exclusivity available to Teva, the only obstacle for generic applicants to obtain full approval of their ANDAs is U.S. Patent #4,804,663 (“the ‘663 patent”).  This patent expired in December 2007, but is covered by a period of pediatric exclusivity scheduled to expire on June 29, 2008.  Since the April 11, 2008 order, companies with a stake in the outcome of this litigation have been patiently waiting to learn whether FDA or Mylan Pharmaceuticals, Inc., which entered the case as an intervenor-defendant, would appeal the decision to the U.S. Court of Appeals for the District of Columbia Circuit.  At least one company does not want to wait any longer.

On April 22, 2008, Apotex, Inc. filed a motion to intervene in the case “to safeguard its substantial interests in the outcome of this litigation.”  According to Apotex’s motion, the company “expected to receive approval of its ANDA in time to launch its generic risperidone tablets by June 29, 2008 and to begin commercial marketing immediately.”  Apotex’s ANDA is not yet tentatively approved.  (Only Mylan and Pliva have tentative ANDA approvals.)  If Judge Lamberth grants Apotex’s motion, then the company “intends to file a notice of appeal and immediately pursue the appropriate appellate remedies to obtain a stay of the District Court’s ruling pending appeal, and/or review of the ruling on an emergency or expedited basis prior to the June 29, 2008 launch date.” 

So why has Apotex only now decided to attempt to intervene in the litigation?  According to the company’s motion, “Apotex’s grounds to intervene arose post-judgment, when it became apparent that neither the Federal Defendants nor Mylan would immediately appeal this Court’s decision, and that even if they appeal, may not prosecute the appeal timely so as to try to dissolve or stay the injunction prior to June 29, 2008” when the period of pediatric exclusivity applicable to the ‘663 patent expires.

Teva quickly filed its opposition to Apotex’s motion to intervene.  According to Teva’s filing, “Litigants who wait to intervene until an adverse judgment has been entered face an especially heavy burden – and Apotex has not come close [to] discharging that burden here . . . .  No court has ever granted a post-judgment motion to intervene on such a thin demonstration of need, and this Court should not wield its substantial discretion to become the first.”  Teva’s opposition also goes on to argue that any speculative risks to Apotex were well known at the outset of the case when Apotex decided not to intervene, and cites industry periodicals and “widely read blogs,” including FDA Law Blog.

By Kurt R. Karst