Federal Circuit Considers Whether Justiciable Case or Controversy Exists in Hatch-Waxman Case

Posted on July 26, 2008 by Brian Wm. Higgins
  • Merck & Co. Inc. v. Apotex Inc., No. 2007-1362 (Fed. Cir. July 16, 2008) (non-precedential)

     In this appeal, the Federal Circuit affirmed and vacated a decision by the U.S. District Court for the District of Delaware (J. Sleet) in favor of Plaintiff-Appellee Merck & Co., Inc. (“Merck”). 

     Merck obtained approval from the FDA to market the drug FOSOMAX®. It sued Apotex for patent infringement when Apotex filed an Abbreviated New Drug Application (“ANDA”) seeking FDA approval to commercialize a generic version of FOSOMAX®.  Apotex counterclaimed for a declaratory judgment of patent invalidity and noninfringement.

     Following discovery, Merck granted Apotex a covenant not to sue for infringement of all patents-in-suit, and moved to dismiss all claims and counterclaims on the grounds that the case no longer presented an Article III case or controversy. Apotex then moved to amend its counterclaims to add a claim for a violation of the Sherman Antitrust Act, 15 U.S.C. § 2. The district court denied Apotex’s motion to amend its counterclaims, and granted Merck’s motion to dismiss all claims and counterclaims for lack of Article III jurisdiction.

     On appeal, the Federal Circuit affirmed the district court’s denial of Apotex’s motion to add an antitrust counterclaim, and vacated the district court’s decision regarding infringement and invalidity as moot and remanded with instructions to dismiss the claims as moot. In reaching those decisions, the Federal Circuit stated that a justiciable Article III controversy may continue to exist between a patentee drug company and an ANDA filer in the context of the Hatch-Waxman Act even after the patentee drug company has granted the Paragraph IV ANDA filer a covenant not to sue. Caraco Pharm. Labs., Ltd. v. Forest Labs., Inc., 527 F.3d 1278, 1296-97 (Fed. Cir. 2008).  However, in this case, two events after oral argument on appeal rendered the infringement and validity claims moot:

  1. The FDA decided to treat the statutory automatic 30-month stay on Apotex’s ANDA as dissolved once the district court dismissed the case; thus Apotex's ANDA could be approved; and 

  2. Teva, which filed the first ANDA against FOSOMAX®, began marketing its generic FOSOMAX® on or about February 6, 2008, so Apotex no longer suffered a delay in entering the market that is traceable to Merck and redressible by a court judgment.

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Maryland IP Litigation 2008: Lawsuit Summary No. 7

Posted on February 13, 2008 by Brian Wm. Higgins

     The following lawsuit filed in the U.S. District Court for the District of Maryland pits brand and generic drug makers (source: Justia).

  • #7: Forest Laboratories, Inc. v. Lupin Pharmaceuticals, Inc., No. 1:2008cv00239, filed January 28, 2008; assigned to J. Legg

     This Hatch-Waxman lawsuit involves Namenda® (memantine HCl). According to the complaint, plaintiff Forest Labs., Inc., a Delaware corporation based in New York, is the exclusive licensee of Orange Book-listed U.S. Patent No. 5,061,703. Plaintiff Forest Labs. Holdings, Ltd., is an Irish company based in Bermuda; plaintiffs Merz Pharma GmbH & Co. KGaA and Merz Pharma GmbH are German companies.

     Also according to the complaint, defendant Lupin Pharmaceuticals, Inc., a Virginia company based in Baltimore, MD, is the wholly-owned subsidiary and agent of Lupin Ltd., an Indian company based in Mumbai. Lupin Ltd. allegedly submitted, through its agent Lupin Pharma, an Abbreviated New Drug Application No. 90-051 to the FDA for approval to market generic Namenda®. It sent Forest the required notice of its ANDA submission on December 14, 2007.

     Plaintiff is asserting infringement of the ‘703 patent, and is seeking to enjoin Lupin from marketing its generic formulation before expiration of the '703 patent.

     Interestingly, plaintiffs also filed a concurrent lawsuit in the District Court for the District of Columbia because they claim not to be able to determine with certainty which one of Lupin, Inc., or Lupin Ltd. was the actual filer of the ANDA. This move was in anticipation of a jurisdictional challenge by Lupin (see related post here).

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Foreign Drug Manufacturer's Future Commercial Activity Contributorily Infringes U.S. Patent, Federal Circuit Says

Posted on September 5, 2007 by Brian Wm. Higgins

Summary:  Foreign supplier of active pharmaceutical drug to U.S. applicant seeking FDA approval to market generic Lexapro® was enjoined along with the U.S. applicant based on supplier's commercial partnership with the U.S. applicant.  Case:  Forest Laboratories, Inc. v. Ivax Pharmaceuticals, Inc., 07civ1059 (Fed. Cir. 2007) (Schall, J., dissenting-in-part).

 

     Ivax Pharmaceuticals, Inc., submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market generic tablets containing escitalopram oxalate (“EO”), the active ingredient in Lexapro®.  Forest Laboratories, Inc., which owns the patent for Lexapro®, sued Ivax under the Hatch-Waxman Act, which provides that the mere filing of an ANDA is an act of infringement.  During discovery, Forest learned that part of Ivax's ANDA submission included information provided by Mumbai-based Cipla, Ltd., Ivax's alleged EO drug supplier. Cipla was joined in the lawsuit. After the parties stipulated to infringement and the district court found the patent-at-issue not invalid nor unenforceable, it included Cipla in the injunction against Ivax.

     On appeal, the Federal Circuit agreed with the district court's decision to include Cipla:

"Here, we do not know if Cipla first approached Ivax or vice versa, but the plan to manufacture, import, market, and sell the EO products described in the ANDA was undoubtedly a cooperative venture, and Cipla was to manufacture and sell infringing EO products to Ivax for resale in the United States. Under the standards for inducement which we apply to 35 U.S.C. § 271(b), Cipla has therefore actively induced the acts of Ivax that will constitute direct infringement upon approval of the ANDA, and it was thus not inappropriate for the district court to include Cipla within the scope of the injunction."

     The Federal Circuit cited Allergan, Inc. v. Alcon Labs, Inc., 324 F.3d 1322 (Fed. Cir. 2003) for the notion that merely filing an ANDA is a constructive act of infringement, and may support a cause of action for induced infringement.

     The dissent asserted that the safe harbor provision of § 271(e)(1) exempted Cipla from being enjoined with Ivax; however, the majority disagreed with that conclusion, saying:

"Cipla is providing information, and will provide material, that Ivax will use to obtain FDA approval. Up to that point, there is indeed no infringement. And, in fact, Ivax is not currently liable for infringement, as long as it is only pursuing FDA approval, not commercially manufacturing or selling the infringing product. However, just as Ivax will be liable for, and hence is being enjoined from, the commercial exploitation of [EO] when it is approved by the FDA and during the life of the patent, so should Cipla be enjoined. They are partners. Cipla would be contributing to the infringement by Ivax, so the injunction should cover both partners. It is true that, as the dissent states, § 271(e)(2) defines Ivax's filing of its ANDA as an infringement, and Cipla did not file the ANDA; however, when the question of an injunction against commercial activity arises, Cipla is as culpable, and hence entitled to be enjoined, as Ivax."

Result:  Ivax and Cipla are enjoined from infringing the patent-in-suit. 

Comments:

  • The claims that the parties stipulated to infringing included claims directed to the drug EO, a pharmaceutical formulation containing EO as an active ingredient, and methods of making the EO

  • Links to Teva Pharmaceuticals (reportedly owns Ivax), Cipla Ltd., and Forest Laboratories

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Federal Circuit Considers Pharmaceutical Research Exception, Finds No Case or Controversy

Posted on July 24, 2007 by Brian Wm. Higgins

In Benitec Australia, Ltd. v. Nucleonics, Inc., the Federal Circuit affirmed a district court’s judgment dismissing Nucleonic’s declaratory judgment counterclaims against Benitec for lack of subject matter jurisdiction after the district court granted Benitec’s motion to dismiss its infringement claims without prejudice. In reaching its decision, the Federal Circuit evaluated the standard for declaratory judgment at two time periods: (1) at the time the declaratory judgment counterclaims were initially filed, and (2) at a later time after intervening events had affected the parties’ relationship.

With regard to the first time period, the Federal Circuit noted that at the time Nucleonics filed its counterclaims for declarations of invalidity and unenforceability, Benitec’s patent infringement claims were pending. Thus, because Nucleonics had been charged with infringement of Benitec’s U.S. Patent No. 6,573,099 (which is directed to RNA-based disease therapy), there existed a case or controversy adequate to support jurisdiction at that time.

With regard to the second time period, the Federal Circuit noted that it had previously rejected the argument that subsequent events cannot divest a trial court of jurisdiction. In this case, the district court and Federal Circuit considered a number of intervening events, including:  (1) Benitec had withdrawn its infringement claims, (2) Benitec had given Nucleonics a covenant not to sue, and (3) Nucleonics was not close to filing a New Drug Application (NDA) for its RNA drug products. 

Considering point (3), the Federal Circuit commented that the Supreme Court’s Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005) “read[] expansively the pharmaceutical research exception of § 271(e)(1)”: 

“It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention…solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.” 35 U.S.C. § 271(e)(1).

In view of the Supreme Court’s decision in MedImmune, Inc. v. Genentech, Inc., 127 S. Ct. 764 (2007) (which was decided after oral arguments in this case), the Federal Circuit stated that a party seeking to base jurisdiction on the Declaratory Judgment Act bears the burden of proving that the facts alleged, "‘under all the circumstances, show that there is a substantial controversy, between the parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.'"  Applying that standard to the case at hand, there was no case or controversy adequate to support declaratory judgment, because:

“The parties have now both taken the position that Nucleonics’s present activities related to the human medical application of RNAi are, in light of § 271 and the Supreme Court’s decision in Merck, not infringing and cannot become infringing until after Nucleonics files a new drug application (“NDA”) with the U.S. Food and Drug Administration (“FDA”). Nucleonics does not even anticipate filing an NDA before ‘at least 2010-2012, if ever.’ Therefore, Nucleonics’s activities of developing and submitting information to the FDA related to human application of RNAi does not present a case or controversy of sufficient immediacy and reality to warrant declaratory judgment jurisdiction over the enforceability of the ’099 patent. The fact that Nucleonics may file an NDA in a few years does not provide the immediacy and reality required for a declaratory judgment.”

Comments: 

  • This case should have considerable interest to the many Maryland pharmaceutical companies that are involved in developing new drugs and that anticipate filing NDAs in the future, as well as to patent holders seeking a dialog with those companies about licensing and infringement issues. 


  • Other recent cases in which the Federal Circuit has considered the application of the standards set forth in MedImmune for determining declaratory judgment jurisdiction: Teva Pharmaceuticals USA, Inc. v. Novartis Pharmaceuticals Corp., 482 F.3d 1330 (Fed. Cir. 2007), and Sandisk Corp. v. STMicroelectronics NV, 480 F.3d 1372 (Fed. Cir. 2007).


  • Cite to slip opinion:  Benitec Australia, Ltd. v. Nucleonics, Inc., No. 06 Civ 1122 (Fed. Cir. July 20, 2007) (Dyk, J., dissenting)


  • Others commenting on this case:  Patently-O and 271 Blog
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