Walgreen CO v. Novartis Pharmaceuticals Corporation

CourtDistrict Court, S.D. New York
DecidedAugust 15, 2019
Docket1:18-cv-09861
StatusUnknown

This text of Walgreen CO v. Novartis Pharmaceuticals Corporation (Walgreen CO v. Novartis Pharmaceuticals Corporation) is published on Counsel Stack Legal Research, covering District Court, S.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Walgreen CO v. Novartis Pharmaceuticals Corporation, (S.D.N.Y. 2019).

Opinion

DOCUMENT □□□ ELEC] NICAELY: FELED □□ UNITED STATES DISTRICT COURT DOC #:_, op oe SOUTHERN DISTRICT OF NEW YORK DATE FILED □□ (S71 ee rt ee ee er ee ee ee eee x & =. = □□□

: OPINION AND ORDER > GRANTING DEFENDANTS’ : PARTIAL MOTION TO DISMISS : 18 Civ. 4361 (AKH) In Re Novartis and Par Antitrust Litigation : 18 Civ. 5536 > 18 Civ. 5603 : 18 Civ. 5708 : 18 Civ. 5886 : 18 Civ. 6776 : 18 Civ. 9861 >: 18 Civ. 11835 >: 18 Civ. 12293 meme eee enene eeememencneene X

ALVIN K. HELLERSTEIN, U.S.D.J.: Two Novartis companies, Novartis Pharmaceuticals Corporation and Novartis AG, (both, “Novartis”), nearing the end of one patent covering their prescription drug, Exforge, a blood pressure regulator, and facing challenges to two others, made an agreement with Par Pharmaceutical, Inc. (“Par”) to keep Par’s generic equivalent off the market for as much as two years. Par agreed to delay marketing its generic until September 30, 2014; and Novartis agreed not to charge Par with infringement and to delay launching its own authorized generic to compete with Par until March 30, 2015. Plaintiffs, for themselves and a class, sued Novartis and Par for violating federal antitrust laws, alleging “per se” and “rule of reason” violations. Defendants move to dismiss the “per se” count and claims under state laws. I grant the motions.

Background A. Factual History Because defendants’ motion to dismiss is partial and does not challenge the general sufficiency of plaintiffs’ complaints, the discussion contextualizing the motion can be brief. This is a civil antitrust action arising out of allegations that Novartis Pharmaceuticals and Par Pharmaceuticals engaged in anticompetitive conduct that delayed the entry of generic competition for Exforge, a prescription drug developed by Novartis that treats hypertension and has the active ingredients amlodipine and valsartan. Plaintiffs’ core allegation is that Novartis and Par entered into an unlawful settlement agreement in which Par would not compete in the Exforge market by introducing a generic version of Exforge for a period of time, effectively extending the life of Novartis’ patents. Novartis owned U.S. Patent No. 5,399,578 (‘the ’578 patent), which covered valsartan, marketed under the name Diovan. Amended DPP Complaint (“DP Compl.”), 18-cv-4361, ECF 47 1,4, 77. The validity of this patent was not challenged. The patent expired on March 21, 2012, and a regulatory exclusivity attached to the patent expired on September 21, 2012. According to plaintiffs’ theory, this is the earliest possible date that generics would have entered the market, but for the unlawful agreement. DP Compl. § 81. Specifically, the class complaints allege that as Par developed a generic version of Exforge, Par notified Novartis that it planned to launch its generic product prior to the expiration of certain follow-on patents (U.S. Patent Nos. 6,294,197 (“the ?197 Patent”) and 6,395,728 (“the Patent”)), which it claimed were invalid or would not be infringed by Par’s proposed generic equivalents. DP Compl. § 82.

Pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585, known as the Hatch- Waxman Act, generic manufacturers may apply for approval to market a generic version of a previously approved medication. In contrast to the detailed and involved process to market a medication for the first time, in a New Drug Application (“NDA”), pursuant to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301, et seq., an Abbreviated New Drug Application (‘ANDA”) requires a less elaborate showing: roughly stated, that the proposed generic medication is equivalent to an existing medication. In conjunction with its ANDA, a filer may certify that patents disclosed by the brand manufacturer and purporting to cover the existing medication are invalid or will not be infringed by the marketing of the generic (a “Paragraph IV certification”). 21 U.S.C. § 355(j)(2)(A)(vii)(IV). An applicant filing a Paragraph IV certification must give notice to the patent holder, among others, and describe the basis for its position that the patent at issue is invalid or will not be infringed. 21 U.S.C. § 355G)(2)(B). Such an application constitutes an act of patent infringement. 35 U.S.C. § 271(e)(2)(A). “Ifthe generic applicant begins to market its generic product prior to a determination of the patent’s validity or scope, the launch is considered to be ‘at risk’ and the manufacturer can be forced to pay damages.” In re Wellbutrin XL Antitrust Litig., 133 F. Supp. 3d 734, 739 (E.D. Pa. 2015) (citing 35 U.S.C. § 271(e)(4)(C)), aff'd sub nom. Inre Wellbutrin XL Antitrust Litig. Indirect Purchaser Class, 868 F.3d 132 (3d Cir. 2017). If a brand manufacturer files suit within forty-five days of the application, the suit triggers an automatic thirty-month stay on the FDA’s approval of the application, but a brand manufacturer is not required to sue within this period. 21 U.S.C. §§ 355(c)(3)(C), G)(5)(B)Giii). The regulatory framework incentivizes generic manufacturers to file an ANDA and to challenge invalid patents. See In re Nexium (Esomeprazole) Antitrust Litig., 42 F. Supp.

3d 231, 245 (D. Mass. 2014), aff'd, 842 F.3d 34 (1st Cir. 2016). The first applicant to submit a Paragraph IV certification and receive approval for its ANDA gains a 180-day exclusivity period that begins on the date of the generic’s first commercial marketing, during which no other generics may be marketed. 21 U.S.C. § 355(j)(5)(B)(iv). The 180-day period of exclusivity does not apply to any generic marketed by the brand manufacturer (an “authorized generic”), because the brand manufacturer has already received approval for the drug. See King Drug Co. of Florence v. Smithkline Beecham Corp., 791 F.3d 388, 393 (3d Cir. 2015). Following the filing of a Paragraph IV certification, parties to the patent infringement dispute may resolve the dispute through an agreement, in which the brand manufacturer grants a license to the generic manufacturer, along with other consideration, allegedly to forestall a challenge to the patent and the introduction of generic competition. Such agreements are referred to as reverse payment settlement agreements, because in a traditional license arrangement, the patent or rights holder receives consideration from the alleged infringer and subsequent licensee, rather than the reverse. See F.T.C. v. Actavis, Inc., 570 U.S. 136, 140 (2013). When the agreement includes as consideration a promise that the brand manufacturer will not market its own authorized generic, as alleged here, the agreement is referred to as a “no- AG agreement.” The Food and Drug Administration (“FDA”) tentatively approved Par’s ANDA on March 19, 2010. The FDA granted final approval of Par’s ANDA on March 28, 2013, representing, according to plaintiffs’ theory, the latest possible date that the generics would have entered the market, but for the allegedly unlawful agreement. DP Compl. □ 11.

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Walgreen CO v. Novartis Pharmaceuticals Corporation, Counsel Stack Legal Research, https://law.counselstack.com/opinion/walgreen-co-v-novartis-pharmaceuticals-corporation-nysd-2019.