Novartis Pharmaceuticals Corp. v. Actavis, Inc.

January 07, 2013

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Novartis Pharmaceuticals Corp. v. Actavis, Inc., Civ. No. 12-366-RGA-CJB, 2012 U.S. Dist. LEXIS 176445 (D. Del. Dec. 5, 2012) (Burke, M.J.)

Drug Product and Patent(s)-in-Suit: Exjade® (deferasirox); U.S. Pat. Nos. 6,465,504 (“the ‘504 patent”) and 6,596,750 (“the ‘750 patent”)

Nature of the Case and Issue(s) Presented:  Actavis filed an ANDA seeking approval to market a generic version of Exjade, deferasirox in tablet form. Novartis listed the ’504 and ’750 patents as covering Exjade. Actavis certified against the patents and Novartis filed suit against Actavis alleging patent infringement. Actavis answered and asserted a counterclaim requesting an order requiring Novartis to de-list the ‘750 patent on the grounds that the patent does not claim an approved use for the drug. Novartis answered the counterclaim complaint. Actavis filed a motion for judgment on the pleadings that it did not infringe the ‘750 patent. Actavis argued that it could not infringe the ‘750 patent since the claims recite methods limited to “treating diseases which cause an excess of metal in a human or animal body” and it was seeking approval for a different use “chronic iron overload due to blood transfusions.” The court determined that entering judgment on the pleadings was inappropriate because it would require the court to determine the proper construction of the claim term “diseases” which did not have a clear meaning. Therefore, the Magistrate Judge recommended denying the motion.

Why Novartis Prevailed:  Novartis prevailed because the court determined that Rule 12(c) was not the appropriate vehicle to dispose of the claim. Actavis did not argue that Novartis failed to plead sufficient facts, rather Actavis claimed that it could not plausibly infringe the claims of the ‘750 patent. Actavis argued that the patent’s claim to “treating diseases which cause an excess of metal in a human or animal body” cannot amount to the FDA-approved use of treating “chronic iron overload due to blood transfusions.” According to Actavis, the patent relates to the treatment of “diseases” while the FDA- approved use is not for the treatment of “diseases” but instead for an underlying cause or result of such diseases – “chronic overload caused by blood transfusions.” Relying heavily on the recent Federal Circuit decision, Bayer Schering Pharma AG v. Lupin, Ltd., 616 F.3d 1316 (Fed. Cir. 2012), Actavis argued that a Rule 12(c) motion was the appropriate vehicle to dispose of the infringement claim. Actavis argued that under Bayer, a court could dispose of an infringement claim regarding a method of use patent at the pleading stage if the ANDA applicant’s proposed method of use is different from the use protected by the patent in suit. The court did not find the Bayer decision helpful because in Bayer the resolution of the case depended on whether the branded drug label indicated that the FDA approved all three uses claimed in the patent and did not require the court to construe a term in the patent. The court determined that the instant motion requires the court to construe the term “disease” to determine whether “the treatment of chronic iron overload due to blood transfusions” falls within the scope of the patent. In the briefing papers, each party cited some of the same portions of the specification and reached opposite conclusions regarding the breadth of the term “disease.” This underscored the court’s determination that it does not yet have before it other intrinsic and extrinsic evidence that many be important in analyzing the meaning of the claim term.

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

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