Teva Sues FDA After the Agency Refuses to Relist RISPERDAL Patent and Recognize the Company’s 180-Day Exclusivity Eligibility

March 7, 2008

In August 2007, Teva Pharmaceuticals USA submitted a citizen petition to FDA requesting that the Agency relist in the Orange Book U.S. Patent #5,158,952 (“the ‘952 patent”) covering Janssen Phaemaceutica’s RISPERDAL (risperidone) Tablets (approved under NDA #20-272), and to confirm the company’s eligibility for 180-day exclusivity. (See Orange Book Blog post here.)  According to the petition, Teva submitted ANDA #76-228 to FDA on August 28, 2001.  The ANDA contained a Paragraph III certification to U.S. Patent #4,804,663 (which expired in December 2007, but is covered by a period of pediatric exclusivity scheduled to expire in June 2008), and a Paragraph IV certification to the ‘952 patent.  In October 2001, FDA notified Teva that the ‘952 had been delisted from the Orange Book, and required the company to amend its patent certification to reflect that the ‘952 patent was no longer listed in the Orange Book as claiming RISPERDAL Tablets.  Teva complied and submitted the ANDA amendment.

In November 2006, the U.S. Court of Appeals for the District of Columbia 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 states in its petition that following the Ranbaxy decision the company reviewed its ANDA portfolio for any potential unlawful patent delistings that could affect the company’s eligibility for 180-day exclusivity.  This review led to the company’s August 2007 citizen petition.

Teva argues 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 ANDA #76-228, “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 remains eligible for 180-day exclusivity.  Teva also contends that because FDA “failed to provide official notice of the ‘delisting’ for several months following the submission of Teva’s ANDA,” the delisting does not affect Teva’s “entitlement” to 180-day exclusivity. 

On February 26, 2008, FDA denied Teva’s petition.  FDA states that according to the Agency’s records, the ‘952 patent was delisted before Teva submitted ANDA #76-228 to FDA, and that as a result, the delisting was proper and Teva is not eligible for 180-day exclusivity.  Specifically, according to FDA, Janssen requested that the Agency delist the ‘952 patent from the Orange Book in April 2001, and “[i]n accordance with these instructions, FDA modified its patent listing database on June 11, 2001” to remove the patent from its RISPERDAL Orange Book file.  FDA states that the “delisting of the ‘952 patent was reflected in the publicly available, electronic Orange Book shortly after June 29, 2001, and no later than July 20, 2001, the date of the next database update.”  As such, “at the time Teva submitted its ANDA, the electronic Orange Book contained the most current information regarding patents listed for Risperdal tablets . . . [and Teva’s] assertion that the delisting of the ‘952 patent did not become effective until publication of the 2002 annual edition of the Orange Book is without merit.” 

FDA notes that the Agency’s decision is consistent with the Ranbaxy decision.  In Ranbaxy, “[t]he NDA holder’s request to delist the patents for simvastatin came almost 2 years after the Ranbaxy ANDA was submitted and almost 3 years after the Ivax ANDA was submitted.  In contrast, [Janssen] requested that the ‘952 patent for Risperdal be delisted 2 to 4 months before Teva’s ANDA for risperidone was submitted” (emphasis in original). 

Dissatisfied with FDA’s petition response, Teva sued the Agency on March 4, 2008 in the U.S. District Court for the District of Columbia requesting injunctive relief.  Specifically, Teva’s complaint requests that the court enter an injunction compelling FDA to relist the ‘952 patent and restore the company’s paragraph IV patent certification, and declare that Teva is entitled to 180-day exclusivity.  Teva also requests that the court enjoin FDA from granting final approval to other ANDAs for generic RISPERDAL during Teva’s 180-day exclusivity period.  (Both Mylan and Pliva have tentatively approved ANDAs.)  Teva’s memorandum accompanying the company’s motion for expedited preliminary injunctive relief makes similar requests and argues that “FDA’s refusal to relist the ‘952 patent and honor Teva’s right to 180-day exclusivity as the first Paragraph IV filer fundamentally undermines the Hatch-Waxman regime and flatly contradicts the [Ranbaxy decision].”

By Kurt R. Karst    

Categories: Drug Development