RISPERDAL Orange Book Litigation Update: Initial Briefs Filed and Mylan Enters the Fray

March 24, 2008

Earlier this month, we reported on a lawsuit filed by Teva Pharmaceuticals USA against FDA in the U.S. District Court for the District of Columbia concerning the relisting of U.S. Patent #5,158,952 (“the ‘952 patent”) in the Orange Book covering Janssen Phaemaceutica’s RISPERDAL (risperidone) Tablets.  The lawsuit was filed after FDA denied Teva’s citizen petition requesting that FDA relist the ‘952 patent and confirm the company’s eligibility for 180-day exclusivity based on its Paragraph IV certification to the patent. 

FDA states in its petition response that according to the Agency’s records, the ‘952 patent was delisted before Teva submitted ANDA #76-228 to FDA in August 2001, and that as a result, the delisting was proper and Teva is not eligible for 180-day exclusivity.  Teva had argued in its petition 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 to FDA, “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.”  Teva’s complaint and motion for preliminary injunction requests that the court enter an injunction compelling FDA to relist the ‘952 patent and restore the company’s Paragraph IV certification, declare that Teva is entitled to 180-day exclusivity, and enjoin FDA from granting final approval to other ANDAs for generic RISPERDAL during Teva’s 180-day exclusivity period.  The Orange Book currently lists one patent covering RISPERDAL, U.S. Patent #4,804,663, which expired on December 29, 2007, but that is covered by a period of pediatric exclusivity expiring on June 29, 2008. 

On March 14, 2008, FDA submitted its memorandum opposing Teva’s motion for a preliminary injunction.  According to FDA, “[t]here are numerous reasons to deny Teva’s request.”  In response to Teva’s argument that the printed version of the Orange Book is the official version of the publication and that the delisting of the ‘952 patent did not become effective until the official Orange Book reflected the delisting of the ‘952 patent in January 2002, FDA argues that “Teva’s contention is meritless.  Contrary to Teva’s arguments, neither the FDCA nor FDA regulation limit FDA’s publication of patent information to a paper version or preclude FDA from listing that information on its web site.”  FDA’s brief also opposes Teva’s request based on arguments that the company cannot show irreparable harm in the event Teva is denied injunctive relief, and that Teva has not shown that an injunction would serve the public interest.  FDA also takes issue with Teva’s “years-long delay” in raising the issue with FDA and states that “Teva’s lengthy delay . . . severely undermines its request for equitable relief, especially its allegations of irreparable harm.” 

On March 11, 2008, Mylan Pharmaceuticals Inc., which has a pending ANDA for Risperidone Tablets, submitted a motion to enter the case as an intervenor-defendant and a proposed answer.  According to Mylan’s motion, the company’s “final approval and market entry are at risk of being substantially delayed” because of Teva’s lawsuit, and as such, the court should permit Mylan to intervene “to ensure that its interests are protected.”  On March 20, 2008, the court granted Mylan’s motion to intervene.  Mylan is expected to file its brief in intervention later this week (by March 26th).  Teva’s reply brief is due by April 1, 2008.  Oral argument is scheduled for April 4, 2008. 

We will continue to update you on this interesting case as we learn more information. 

By Kurt R. Karst    

Categories: Hatch-Waxman