Orange Book Blog

OBB News Briefs

• Earlier this week, FDA released its highly anticipated response concerning granisetron 180-day exclusivity.  This marks the first time that FDA has interpreted the "failure to market" forfeiture provisions of the 2003 MMA.  FDA Law Blog posted a nice summary of FDA's response.
• FDA Law Blog also posted on a very interesting case recently filed by Nu-Pharm against FDA, in which Nu-Pharm seeks to force FDA to grant it final approval to market generic Depakote (divalproex sodium).
• The Wall St. Journal had an interesting article yesterday on health plans that pay doctors $100 each time they switch a patient to a generic drug.  The WSJ Health Blog posted this summary of the article.
• A district court in New York recently held that three Purdue Pharma patents on Oxycontin are not unenforceable for inequitable conduct.
• Cypress Pharmaceutical announced today that it has settled patent litigation with GSK concerning its generic version of Zantac (ranitidine) syrup.

IQPC "Pharmaceutical Patent Litigation Strategies 2008" Conference, London, March 31 - April 1

IQPC will be holding its 3rd annual "Pharmaceutical Patent Litigation Strategies" conference in London, March 31 to April 1.

The conference is split into two days--one focusing on European law, the other focusing on U.S. law--and includes an optional third day, with workshops.  The European Focus Day will emphasize proposals for supranational patent litigation; EPLA; and the community patent and how to push it forward.  The U.S. Focus Day will analyze the trends and developments in the pharmaceutical and biotech law sector; the Patent Reform Act 2007; parallel US and European patent litigation strategies; and key rulings.

Margot Fröhlinger, Director, European Commission, will be speaking during the European Focus Day on "How to Achieve Consistency Across European Courts in the Future."  Dr. Fröhlinger leads an exceptional speaker panel that will discuss successful litigation practices and a changing regulatory framework in order to provide superior practical intelligence.

IQPC's 3rd annual "Pharmaceutical Patent Litigation Strategies" conference is sharply focused on improving in-house patent litigation for pharmaceutical companies.  The event will feature the latest updates from both in-house experts and outside counsel.  Key issues to be covered include the link between regulations and actual litigation practices; international litigation processes; patent life extension; and new industry developments.

For more information or to register, please visit the conference website.

Teva Seeks Relisting of J&J's Risperdal Patent and Asserts Right to 180-Day Exclusivity

A reader recently e-mailed me about an interesting citizen petition that Teva filed last August.  In the petition, Teva requests that FDA:  (1) relist U.S. Patent No. 5,158,952 in the Orange Book for Risperdal (risperidone) tablets; (2) confirm Teva's right to 180-day exclusivity for risperidone tablets; and (3) refrain from approving any other ANDAs for risperidone tablets until Teva's exclusivity expires.  Risperdal is Johnson & Johnson's blockbuster treatment for schizophrenia and other neurological disorders.

Teva filed its ANDA for risperidone tablets on August 28, 2001, with a paragraph III certification to U.S. Patent No. 4,804,663 and a paragraph IV certification to the '952 patent.  At the time, both patents were listed in the Orange Book for Risperdal.  On October 12, 2001, FDA notified Teva that it had delisted the '952 patent from the Orange Book and informed Teva that it would not accept Teva's ANDA for filing unless Teva amended its paragraph IV certification to reflect the fact that the '952 patent had been delisted.  Teva complied by amending its ANDA.

Five years later, in Ranbaxy v. Leavitt, the D.C. Circuit ruled that FDA had improperly delisted two patents on Zocor because the effect of delisting would be to deny the first ANDA filer of 180-day exclusivity on simvastatin tablets.  According to Teva's citizen petition, following that decision "Teva began reviewing its portfolio of pending ANDAs to determine whether FDA's unlawful delisting practices had deprived Teva of its entitlement to 180-day exclusivity for any other generic product."

In its risperidone petition, Teva contends that because the '952 patent was listed in the Orange Book when it filed its ANDA for risperidone tablets, it had no choice but to certify as to the '952 patent.  "Teva thus did precisely what it was obligated to do under the plain text of the governing statute and Agency regulations, and it therefore earned its exclusivity as the first applicant to file a paragraph IV certification to a patent listed as claiming the reference listed drug."  Teva argues that the Ranbaxy decision compels FDA to relist the '952 patent and restore Teva's right to 180-day exclusivity.  Teva further argues that "the fact that FDA never accepted Teva's paragraph IV ANDA for filing has no bearing on the fact that FDA must relist the '952 patent."

The '663 patent (whose validity was affirmed in a Federal Circuit decision last year) expired on December 29, 2007.  Pediatric exclusivity on Risperdal extends to June 29, 2008.  Thus, FDA must decide the issues presented in Teva's citizen petition before then.  FDA will post its decision in the docket established for Teva's petition.

OBB News Briefs

• Teva announced last week that it was granted 180-day exclusivity for its generic Kytril injection product (granisetron HCl, 1 mg/mL in 1 mL vials).  Thus, it appears the FDA decided the 180-day exclusivity issue raised in Teva's citizen petition--namely, whether Teva's failure to market its generic product within 30 months of ANDA submission caused forfeiture of its exclusivity.  FDA is expected to release a formal response to Teva's petition in the near future.
• King Pharma and CorePharma settled their patent litigation over generic Skelaxin (metaxalone).  According to this AP story, however, analysts disagreed over the impact of the settlement.
• Taro Pharma and Breckenridge Pharma announced settlements with Novartis of their patent cases concerning generic Trileptal (oxcarbazepine).  According to their press releases, Taro and Breckenridge are sharing 180-day exclusivity for the product.
• Bloomberg published an interesting article earlier this week about the faltering biotechnology industry in China.
• Both Pharmalot and the WSJ Health Blog had posts this week about a Bloomberg story that reported the FDA approved only 19 new drugs last year, the fewest since 1983.
• Pharmalot also posted this week on a new report from Cutting Edge Information entitled "Combating Generics 2008," which found that 66 percent of brand name drug companies do not begin strategizing against generics until at least two years after product launch.