Lawsuit Alleges False Marking Based on Orange Book “Advertising”

By Kurt R. Karst –      

Since the U.S. Court of Appeals for the Federal Circuit issued its December 2009 decision in Forest Group, Inc. v. Bon Tool Co. concerning the maximum $500 per violation penalty for intentionally falsely marking a product (in that case, spring-loaded parallelogram stilts) with a patent in violation of 35 U.S.C. § 292, setting off a barrage of hundreds of false patent marking qui tam lawsuits (including challenges to the Constitutionality of the statute), we have followed with some passing interest the various legal (and legislative) twists and turns of the issue, because scores of lawsuits involve FDA-regulated products – see our previous posts here and here.  Although the Gray On Claims Blog recently reported that the number of false marking qui tam lawsuits appears to have slowed since the Federal Circuit’s March 15, 2011 decision in In re BP Lubricants USA Inc., in which the Court held that the particularity requirement of Fed. R. Civ. P. 9(b) applies to false marking cases, that did not stop Pharmaceutical Technologies, LLC (“PharmaTech”) from lodging a Complaint last week in the U.S. District Court for the District of Arizona (Phoenix Division) against Eisai, Inc. and Eisai Medical Research, Inc. (collectively “Eisai”) for allegedly falsely marking ARICEPT (donepezil HCl) Tablets.

What makes the Eisai/ARICEPT case of particular interest to us is PharmaTech’s use of FDA’s Orange Book and the allegation of false Orange Book “advertising.”  Although the Orange Book has be raised in some false marking cases (see, e.g., Hollander v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., No. 2-10-cv-00836 (E.D. Pa.), it has not, to our knowledge, previously been used as the primary basis for filing a false marking complaint. 

ARICEPT Tablets is listed in the Orange Book with four unexpired patents – U.S. Patent Nos. 5,985,864 (“the ‘864 patent”), 6,140,321 (“the ‘321 patent”), 6,245,911 (“the ‘911 patent”), and 6,372,760 (“the ‘760 patent”) – and one expired patent – U.S. Patent No. 4,895,841.  The ‘760 patent is listed with a “delist requested” flag, indicating that the NDA sponsor requested that FDA remove the patent from the Orange Book, but that the Agency would not do so because of a Paragraph IV certification to that patent.  On November 26, 2010, FDA approved Ranbaxy’s ANDA No. 76-786 with a period of 180-day exclusivity that expires on May 28, 2011 based on Ranbaxy's Paragraph IV certifications to the ‘864, ‘321, ‘911, and ‘841 patents.  Waiting in the wings for the expiration of Ranbaxy’s 180-day exclusivity is Teva’s tentatively approved ANDA No. 77-344.

PharmaTech alleges in its false marking Complaint that Eisai has violated 35 U.S.C. § 292 by falsely advertising ARICEPT in the Orange Book as patented by the ‘864, ‘321, ‘911, and ‘760 patents with the purpose of deceiving the public, and that such alleged false marking has been a part of the reason for the delay in FDA’s approval of ANDA No. 77-344.  Specifically, PharmaTech states that Eisai statutorily disclaimed the ‘864 and ‘321 patents, but that they continue to be “advertised” in the Orange Book, and that “not one claim in either of the ‘911 patent or the ‘760 patent reads on Aricept® tablets.”  Thus, according to PharmaTech:

By maintaining its false Orange Book advertisings/listings for each of the ‘864 patent, the ‘321 patent, the ‘911 patent, and the ‘760 patent for Aricept® tablets – despite actual knowledge that none of those patents cover Aricept® tablets – Defendant(s) have, in the past and present, engaged in conduct that violates the false marking statute.  By way of that unlawful conduct, Defendants are also quelling competition in the United States market for Aricept® tablets, at least by manipulating the Hatch-Waxman Act in a manner that effectively and substantially delays the generic drug manufacturer, Teva Pharmaceuticals USA, Inc., from bringing its generic version of Aricept® tablets, which has been tentatively approved by the FDA, to market in the United States.

If PharmaTech is successful in its false marking lawsuit, it’s possible that other potential plaintiffs will be scouring the Orange Book for allegedly false Orange Book patent “advertisements” on which to hang a complaint.  Watch out!

Thanks to Sean Mahoney for bringing the PharmaTech Complaint to our attention.