PharmaTech v. Eisai

Pharmaceutical Technologies (“PharmaTech”) filed a false marking complaint under 35 U.S.C. 292 against Eisai on Tuesday, April 5 in the U.S. District Court for the District of Arizona. Notably, the complaint cites the Orange Book listing for its Aricept® drug as a primary basis for its allegations that Eisai advertises patent protection for the drug.

Eisai, the complaint alleges, included four patents in the Orange Book listing for its Aricept® product. The complaint includes a hyperlink tohttp://www.accessdata.fda.gov/scripts/cder/ob/default.cfm with instructions as to how to search for Aricept® by its proprietary name. As of this writing, the Orange Book lists the patents as described in the complaint, along with a fifth patent that expired in November 2010. As the complaint stated, the NDA holder, not the FDA, determines which patents are included in Orange Book listings. The complaint therefore characterized the listings as “advertisements,” which the statute prohibits from falsely listing patent protection. The complaint disputes the listing of two of the allegedly problematic patents based at least on earlier expiration dates due to terminal disclaimers. The other two allegedly problematic patent listings involve arguments that Aricept® does not fall within their claimed scope.

In its complaint, PharmaTech also alleges that Eisai falsely marked Aricept® packaging material with the four patent numbers. However, only one sentence in the complaint mentioned packaging-based false marking.

PharmaTech further alleged that Eisai intended to deceive the public through its use of the patent markings. Because Eisai filed terminal disclaimers and because it is a sophisticated party with in-house counsel and regularly-retained outside counsel, the complaint alleged that Eisai had actual knowledge that its patents had earlier expired or did not cover Aricept®. Submitting an ANDA against an Orange Book listed patent can be an act of patent infringement under 35 U.S.C. § 271(e)(2), so PharmaTech argues that false Orange Book listings are the same as false advertisements of patent protection.

The complaint also discusses the earlier Federal Circuit case between Eisai and Teva (on which we previously reported). In Teva v. Eisai, the Federal Circuit ruled that once an original filer files an ANDA, a subsequent ANDA filer has standing to bring suit against the NDA holder as the party who listed its product and the related patent(s) in the Orange Book. The drug at issue in that case was Aricept®, the same drug at the center of the PharmaTech complaint. PharmaTech offers the Tevacase in support of its allegations that Eisai has set out to quell competition in the Aricept® market and has succeeded in doing so.

If PharmaTech prevails in its suit, NDA holders should exercise even greater care in their Orange Book listings. While any inapplicable Orange Book listings could bring about costly litigation between the NDA holder and ANDA filers, the risks of improper Orange Book listings would only increase if any third party could bring a qui tamaction for large fees for false marking under § 292. However, because NDA holders would have greater incentive to ensure accurate Orange Book listings, potential ANDA filers would also have more reliable notice of drugs’ patent coverage or lack thereof. If PharmaTech’s case fails, NDA holders may not have to face qui tamactions from third parties for improper Orange Book listings and ANDA filers alone may be able to challenge relevant Orange Book listings.

Additionally, as discussed in an earlier update on the Senate’s patent reform bill, some versions of patent reform would eliminate the qui tam route of enforcement from the false marking statute in § 292. If these measures become law, a ruling for PharmaTech in this case would essentially only be useful to parties who could show injury from false marking, who in most cases would be ANDA filers who could already bring suit under other causes of action.