ANGIOMAX – The Other Patent Battle

By Kurt R. Karst –      

With all of the hullabaloo that has been going on in court and on Capitol Hill in the continuing battle over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 Patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) Injection  (see, e.g., here and here), it has been easy to overlook the other ANGIOMAX patent battle that has been brewing in the U.S. District Court for the District of Delaware over the two other Orange Book-listed patents for the drug – U.S. Patent Nos. 7,582,727 (“the ‘727 Patent”) and 7,598,343 (“the ‘343 Patent”) – both of which expire on July 27, 2028, but are subject to periods of pediatric exclusivity that expire on January 27, 2029.  Those patents, issued on September 1, 2009 (the ‘727 Patent) and October 6, 2009 (the ‘343 Patent), were timely submitted to FDA for Orange Book listing, and served as flypaper for Paragraph IV patent certifications from several ANDA sponsors, including APP Pharmaceuticals, LLC (“APP”), the company embroiled in a battle with MDCO in the Federal Circuit over a PTE for the ‘404 Patent. 

The ‘727 Patent and ‘343 Patent infringement actions have taken an interesting turn.  In court papers filed earlier this year, but only recently made available (with redactions), APP, in its Opening Brief in Support of Motion for Leave to File First Amended Answers and Counterclaims Under FRCP 15(A), seeks leave to assert unenforceability defenses and declaratory judgment counterclaims based on MDCO’s alleged inequitable conduct before the U.S. Patent and Trademark Office, and, more interesting to us, unenforceability defenses and declaratory judgment counterclaims based on MDCO’s alleged unclean hands before FDA and in filing the patent infringement lawsuits.  According to APP, MDCO “comes to these lawsuits with unclean hands that preclude MedCo’s requested relief,” because the company “knowingly submitted false certifications to FDA under penalty of perjury to have the patents-in-suit listed in the Orange Book.  MedCo then initiated this lawsuit because of those improper listings.” 

In APP’s First Amended Answers and Counterclaims to The Medicines Company’s Complaint for each patent (here and here), APP seeks declaratory and injunctive relief pursuant to FDC Act §505(j)(5)(C), among other statutory provisions.  FDC Act §505(j)(5)(C), applicable to ANDA sponsors, is the patent delisting counterclaim provision added to the statute by the 2003 Medicare Modernization Act (“MMA”), and states:

(I) In general.  If an owner of the patent or the holder of the approved application under subsection (b) for the drug that is claimed by the patent or a use of which is claimed by the patent brings a patent infringement action against the applicant, the applicant may assert a counterclaim seeking an order requiring the holder to correct or delete the patent information submitted by the holder under subsection (b) or (c) on the ground that the patent does not claim either –

(aa) the drug for which the application was approved; or

(bb) an approved method of using the drug.

(II) No independent cause of action.  Subclause (I) does not authorize the assertion of a claim described in subclause (I) in any civil action or proceeding other than a counterclaim described in subclause (I).

The MMA also added an almost identical counterclaim provision at FDC Act §505(c)(3)(D)(ii) applicable to 505(b)(2) applications.  As we previously reported, the statutory counterclaims provisions were recently asserted in the context of a 505(b)(2) application for Intelliject, Inc.’s epinephrine auto-injector, e-cue, which FDA recently tentatively approved.  At the time we posted on the Intelliject case in March, we thought that case was the only instance in which the MMA patent delisting counterclaim provisions had been asserted (outside of a patent use code challenge that is), but APP appears to have asserted the provision in late February. 

Count Three of each of APP’s counterclaims for the ‘727 and ‘343 Patents are almost identical and state that the patents “[do] not meet the requirements of 21 U.S.C. § 355(b)(1), (b)(2), and the regulations thereunder, including, without limitation, 21 C.F.R. § 314.53(b), § 314(c)(2)(ii), § 314.3(b).  It therefore was improper for MedCo to list the [patents] in the Orange Book.”  APP requests that the court “adjudge and declare that the [patents are] not properly listed in the Orange Book and enter a mandatory injunction ordering MedCo immediately to request the FDA to delist the [patents] from the Orange Book.”

MDCO, in its Opposition Brief, shoots back, stating that APP’s proposed amendments regarding unclean hands are futile and fail to state a claim for relief.  “There is no nexus between the alleged false listing and whether or not APP's ANDA infringes the patents-in-suit.  APP’s allegations of unclean hands based on Orange Book listing certifications are an improper attempt to enforce FDA regulations.  The Court should preclude APP from asserting such allegations here in this patent litigation” (emphasis in original; citation omitted).  APP, in its Reply Brief, however, says otherwise: “The nexus here could not be stronger.  But for MedCo’s unconscionable acts of submitting false listing certifications to FDA for the patents-in-suit and then suing APP because of those improper listings, these lawsuits would not exist.”  In other words, says APP, “this Court would not have subject matter jurisdiction over these Hatch-Waxman actions against APP because activities reasonably related to securing FDA approval cannot constitute patent infringement as matter of law.”