Bristol-Myers Squibb Company v. Nanocopoeia, LLC

CourtDistrict Court, D. Minnesota
DecidedApril 10, 2023
Docket0:22-cv-01283
StatusUnknown

This text of Bristol-Myers Squibb Company v. Nanocopoeia, LLC (Bristol-Myers Squibb Company v. Nanocopoeia, LLC) is published on Counsel Stack Legal Research, covering District Court, D. Minnesota primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Bristol-Myers Squibb Company v. Nanocopoeia, LLC, (mnd 2023).

Opinion

UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA Bristol-Myers Squibb Company, Case No. 22-cv-1283 (KMM/JFD) Plaintiff,

v. ORDER Nanocopoeia, LLC, Defendant. Since 2006, Plaintiff Bristol-Myers Squibb Company has manufactured Sprycel, a drug that is used to treat certain types of leukemia. Sprycel contains the active ingredient

dasatinib in the crystalline monohydrate form. Bristol-Myers has two patents that claim the crystalline form of dasatinib: the ‘725 patent and ‘103 patent.1 Defendant Nanocopoeia, a specialty pharmaceutical company based in Minneapolis, . Bristol-Myers filed this patent infringement action, asserting that if Nanocopoeia’s drug is approved, it would infringe Bristol-Myers’ patents. By filing this case, Bristol-Myers triggered an automatic thirty-month

stay on FDA approval of Nanocopoeia’s drug. Nanocopoeia now moves for judgment on the pleadings, seeking dismissal of Bristol-Myers’ infringement claims regarding the two patents covering the crystalline form of dasatinib, and a judgment of non-infringement on

1 The full title of the patents at issue are United States Patent No. 7,491,725 and United States Patent No. 8,680,103. Bristol-Myers also alleges infringement of United States Patent No. 8,242,270, but that patent is not at issue in this motion. the corresponding counterclaims that Nanocopoeia asserted against Bristol-Myers. For the reasons discussed below, the motion is DENIED. BACKGROUND

Drug manufacturers obtain FDA approval through one of three types of applications: (1) a full New Drug Application (“NDA”) if the drug has not yet been approved; (2) an Abbreviated New Drug Application (“ANDA”) for a generic version of an already approved drug; and (3) a “505(b)(2) NDA” for a new formulation of an already approved drug. See generally 21 U.S.C. § 355. [Nanocopoeia Mem. 8, Dkt. No. 73.]

Nanocopoeia’s drug is not yet on the market, so this case involves allegations of hypothetical infringement under the Hatch-Waxman Act. Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”), codified at 21 U.S.C. §§ 355, 360cc and 35 U.S.C. §§ 156, 271, 282, to provide a framework for the introduction of generic versions of previously approved drugs. Ethypharm S.A. France v. Abbott Lab’ys, 707 F.3d 223, 227 (3d Cir. 2013). The Act sought to strike a balance between

incentivizing the development of new drugs by protecting patent holders who took on the risk of developing those drugs, and allowing competitors to bring low-cost alternatives to the market by making it easier, and faster, for them to secure FDA approval. See Janssen Pharmaceutica, N.V. v. Apotex, Inc., 540 F.3d 1353, 1355 (Fed. Cir. 2008). Addressing those competing interests required compromises. The Act authorized patent term extensions for patent holders who lost time waiting for initial FDA approval of

their drugs, see 35 U.S.C. § 156, but it allowed manufacturers seeking approval for a generic version or new formulation of an already approved drug to start the FDA approval process before the initial patent expires, see id. at § 271(e)(1), and to rely on certain data provided in the NDA for the approved drug to make the application process a little less onerous, see 21

U.S.C. § 355(b)(2). When an applicant files an ANDA or 505(b)(2) NDA, it must certify that its proposed drug will not infringe a current drug patent. It can do so by certifying that the listed drug is not patented, the patent has expired, or that the patent itself is invalid or won’t be infringed by the new drug. See Bayer AG v. Elan Pharm. Rsch. Corp., 212 F.3d 1241, 1244 (Fed. Cir. 2000) (“Elan Pharm.”) (describing types of certifications); see also 21 U.S.C.

§ 355(j)(2)(A)(vii)(I)–(IV) (for ANDAs) and id. at § 355(b)(2)(A)(i)–(iv) (for 505(b)(2) NDAs). If the applicant certifies that the patent for the listed drug is invalid or won’t be infringed by the proposed drug, but the owner of that patent disagrees and files an infringement suit within 45 days, the Hatch-Waxman Act triggers an automatic thirty-month stay on FDA approval of the new drug.2 21 U.S.C. §§ 355(c)(3)(C), (j)(5)(B)(iii). In this way, the Hatch-Waxman Act makes the very act of filing an ANDA or

505(b)(2) NDA a technical or “artificial” act of infringement for purposes of vesting jurisdiction with the district court, so that the court can engage in the infringement analysis before the drug is approved and enters the market. See Ferring B.V. v. Watson Lab’ys, Inc.-Fla., 764 F.3d 1401, 1408 (Fed. Cir. 2014) (explaining that this artificial infringement theory is

2 More specifically, the filing of an infringement action suspends FDA approval of the proposed drug “until the earliest of the expiration of the patent, judicial resolution of [the question of infringement,] or thirty months from the receipt of notice.” Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1569 (Fed. Cir. 1997). meant to create “case or controversy jurisdiction”). But once jurisdiction is established by the “artificial” act of infringement, the inquiry of whether the patent will actually be infringed by the proposed drug “1s determined by traditional patent infringement analysis.” See Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1365-66 (Fed. Cir. 2003). The plaintiff patent owner “still carries the burden” to show that the defendant’s product would infringe its patents. Id. And because the drug is not yet on the market, the infringement inquiry under the Hatch-Waxman Act involves a “hypothetical case that asks the factfinder to determine whether the drug that will be sold upon approval of the [application] will infringe the asserted patent.” In re Brimonidine Pat. Litig., 643 F.3d 1366, 1377 (Fed. Cir. 2011). The court must determine whether, if the proposed drug was approved and manufactured based on the specifications provided in the defendant’s ANDA or 505(b)(2) NDA, it would infringe the plaintiff's patents. E/an Pharm., 212 F.3d at 1248-49. In this case, Nanocopoeia filed ee ee ee ee ::<3 «23-0: controversy jurisdiction with the Court, and now this Court’s task 1s to determine whether the drug envisioned by Nanocopoeia’s NDA will infringe Bristol-Myers’ patents.

ee

DISCUSSION Nanocopoeia moved for judgment on the pleadings under Federal Rule of Civil Procedure 12(c). In a patent case, the law of the regional circuit dictates the standard of

review. Nat. Alts. Int’l, Inc. v. Creative Compounds, LLC,

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Bristol-Myers Squibb Company v. Nanocopoeia, LLC, Counsel Stack Legal Research, https://law.counselstack.com/opinion/bristol-myers-squibb-company-v-nanocopoeia-llc-mnd-2023.