Flare-Up Over Generic Herpes Drug Could be Short-Lived

September 27, 2010

By Kurt R. Karst –   

Just two days after Novartis Pharmaceuticals Corporation (“Novartis”) filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s September 14th approval of Watson Laboratories, Inc.’s ANDA No. 78-278 for a generic version of the herpes drug FAMVIR (famciclovir) Tablets, FDA, on September 24th, updated the Agency’s drug approval database (Drugs@FDA) to show that ANDA No. 78-278 is tentatively approved.  FDA’s move could signal an end to the litigation. 

As we reported last Thurdsay, Novartis’s Complaint alleges that FDA failed to require a split certification (Paragraph IV certification and “section viii” statement) with respect to  U.S. Patent No. 5,246,937 (“the ‘937 patent”), one of five patents listed in the Orange Book for FAMVIR, and requests that the court enter an order requiring FDA to withdraw approval of ANDA No. 78-278 until March 21, 2011.  The ‘937 patent expired on September 21, 2010, but is subject to a period of pediatric exclusivity that expires on March 21, 2011.  The ‘937 patent was listed in the Orange Book in 1994 and has since been flagged with only a method-of-use; however, Novartis alleges that the ‘937 patent also includes compound claims that cannot be carved out with a “section viii” statement. 

Prior to August 2003, technological limitations prevented FDA’s Orange Book listings from reflecting the fact that an NDA sponder submitted a patent as claiming both a drug product or drug substance claim and a method-of-use claim.  ANDA No. 78-278 contained a “section viii” statement to the ‘937 patent (and to the other four Orange Book-listed patents, which are flagged with the same patent use code as the ‘937 patent), but not a certification to the patent.

Novartis followed up its Complaint with a Motion for a Temporary Restraining Order and Preliminary Injunction (“TRO/PI”).  As with the company’s Complaint, Novartis argues in its TRO/PI motion that FDA’s decision to approve ANDA No. 78-278 is inconsistent with a March 15, 2010 FDA citizen petition decision.  In that case, FDA said that the Agency would not consider ANDAs eligible for final approval unless such application contained an appropriate certification (i.e., a split certification) to patents listed in the Orange Book for ACTOS (pioglitazone HCI) Tablets and ACTOPLUS MET (pioglitazone HCl; metformin HCI) Tablets.

Last Friday, Judge John D. Bates issued a Minute Order in the FAMVIR case for a September 30, 2010 scheduling conference.  Provided FDA maintains the tentative approval for ANDA No. 78-278 there might not be much to discuss at that conference.

REMINDER: Register for HPM's free webinar "The Evolution of the Park Doctrine" on October 8th. (link to registration: http://hpmwebinar.eventbrite.com/)


Categories: Hatch-Waxman