Novartis Sues FDA Over Generic FAMVIR; Alleges that FDA Failed to Require a Split Certification

September 23, 2010

By Kurt R. Karst –   

On September 22, 2010, 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.  Unlike many recent lawsuits against FDA challenging ANDA approval based on bioequivalence issues and that involve the first marketing of a generic, the Novartis lawsuit takes issue with patent certification/“section viii” labeling carve-out statement issues and involves a subsequent approval.  (Back in August 2007, FDA approved the first generic version of FAMVIR under ANDA No. 77-487 and granted 180-day exclusivity.)

FDA first approved FAMVIR under NDA No. 20-363 in June 1994.  FAMVIR is listed in the Orange Book with five patents, including U.S. Patent No. 5,246,937 (“the ‘937 patent”).   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 shortly after the approval of NDA No. 20-363, and has since been flagged with only a U-96 patent use code, which is defined in an Orange Book addendum as  “METHOD OF TREATING VARICELLA ZOSTER (SHINGLES) INFECTIONS.”

FDA’s approval letter for ANDA No. 78-278 states that the application contains a “section viii” statement with respect to each of the five Orange Book-listed patents (all five patents are flagged with the same U-96 patent use code).  According to Novartis, however:

The FDA approved Watson’s ANDA improperly in violation of the [FDC Act] and the Administrative Procedure Act ("APA"), 5 U.S.C. § 551, et seq., because (i) Watson's ANDA No. 78-278 did not satisfy a statutory precondition to FDA approval in that it failed to include a certification, pursuant to 21 U.S.C. Section 355(j)(2)(A)(vii), with respect to the compound claims in the '937 patent directed to famciclovir; and (ii) as reflected in the FDA's Orange Book, Novartis is entitled to marketing exclusivity with respect to those tablets until March 21, 2011.

That is, Novartis alleges that the ‘937 patent covered more than a method-of-use claim and required a patent certification in addition to a “section viii” statement – i.e., a split certification.  According to the Complaint:

Watson’s section viii statement was potentially sufficient only with respect to method of use claims in the ‘937 patent, but was insufficient with respect to the drug product claims in the '937 patent.  Where a patent has been submitted for Orange Book listing that claims both the drug product and a method of using the drug, FDA has repeatedly ruled that the ANDA applicant must address all claims for which the patent was submitted. (internal quotation omitted). 

Novartis relies on FDA’s March 15, 2010 citizen petition response to a Sandoz petition involving ACTOS (pioglitazone HCI) Tablets and ACTOPLUS MET (pioglitazone HCl; metformin HCI) Tablets to support its position.  As we previously reported, the Sandoz petition requested that FDA refuse to approve any ANDA for a generic version of ACTOS and/or ACTOPLUS MET if the ANDA includes a “section viii statement” with regard to certain Orange Book-listed patents, but does not also include a Paragraph IV certification to the respective patent (i.e., a split certification). 

As with the ‘937 patent, the patents at issue in the Sandoz petition were submitted to FDA for Orange Book listed prior to August 18, 2003 and were flagged with method-of-use claims.  August 18, 2003 is the date on which FDA’s June 2003 regulations implementing the FDC Act’s patent listing provisions went into effect, and when the Agency made a technological leap in identifying Orange Book-listed patents.  As FDA explained in its March 2010 petition response, prior to 2003, the “Orange Book database lacked the technological capacity to display a single patent as claiming more than one aspect of the drug.”  Patents submitted to FDA after August 18, 2003 may be identified in the Orange Book as covering the drug product, drug substance, and/or an approved method of use. 

FDA granted the Sandoz petition and stated that the Agency would consider ANDAs that do not address the relevant drug product claims in the patents at issue to be ineligible for final approval.  Why? Because according to FDA:

Under the plain language of the statute, the patent certification requirement is not triggered by the publication in the Orange Book of patent information submitted to FDA.  Rather, . . . the statute requires certification where the patent (or patent claim) claims a listed drug, and where the NDA holder is required to submit and has submitted that patent information to FDA.  This obligation to certify attaches regardless of whether that submission is accurately reflected in the Orange Book.  Thus, the pre-2003 technological limitations that prevented our Orange Book listings from reflecting the fact that [the NDA holder] submitted the patents as claiming both a drug product and a method of using that drug product do not limit [the NDA holder’s] rights to receive patent certifications for the drug product claims in the [patents at issue.]

It is unclear whether Novartis notified FDA when the company first submitted the ‘937 patent for Orange Book listing that the patent contains both method-of-use and drug product/drug substance claims.  It will certainly be an interesting case for Hatch-Waxman folks to watch!


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