Novartis Pharmaceuticals Corporation v. Becerra

District Court, District of Columbia·Decided October 15, 2024·No. Civil Action No. 2024-2234·Published

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

NOVARTIS PHARMACEUTICALS CORPORATION,

Plaintiff,

XAVIER BECERRA, et al., No. 24-cv-02234 (DLF) Defendants.

and

MSN PHARMACEUTICALS INC., et al.,

Intervenor-Defendants.

MEMORANDUM OPINION

Novartis Pharmaceuticals Corporation brings this action against the Secretary of Health

and Human Services and the Commissioner of the Food and Drug Administration (“FDA”) for

injunctive relief. Novartis alleges that FDA violated the Administrative Procedure Act, the Federal

Food, Drug, and Cosmetic Act, and the agency’s implementing regulations by approving an

application by intervenor-defendants MSN Pharmaceuticals Inc. and MSN Laboratories Private

Ltd. (collectively, “MSN”) to market a generic version of Novartis’s heart failure drug Entresto.

Before the Court is the plaintiff’s Motion for Summary Judgment, Dkt. 38, and the federal and

intervenor-defendants’ Cross Motions for Summary Judgment, Dkts. 43, 46. For the reasons that

follow, the Court will deny the plaintiff’s motion and grant the defendants’ motions. I. BACKGROUND

A. Statutory Background

The Federal Food, Drug, and Cosmetic Act provides the statutory framework for FDA’s

oversight of drug products. Manufacturers must obtain FDA approval to market a new drug by

submitting a New Drug Application containing clinical data from studies demonstrating the drug

is safe and effective. 21 U.S.C. § 355(b)(1). The original manufacturer often holds multiple

patents covering the drug product as well as patented methods-of-use of the drug. FDA maintains

a publication, the Approved Drug Products with Therapeutic Equivalence Evaluations

(colloquially, the “Orange Book”), listing active drug patents including method patents. After the

exclusivity period expires for a patented drug product, generic manufacturers may submit an

Abbreviated New Drug Application (“ANDA”) to obtain FDA approval to market a generic

version of the drug. 21 U.S.C. § 355(j). ANDAs need not include independent clinical data of the

drug’s safety or effectiveness; the applicant need only establish its generic is “the same as” a

previously approved reference drug. See id. § 355(j)(2).

To demonstrate “same”-ness, an ANDA applicant must show its generic drug has the same

labeling and the same active ingredients as the reference drug, among other requirements. Id.

§ 355(j)(2)(A)(ii), (v). If the applicant seeks approval for a drug with uses protected by patents

listed in the Orange Book, the applicant may file a “Section viii statement” certifying it will not

market or label the generic for patented-protected uses. Id. § 355(j)(2)(A)(viii). Section viii

permits applicants to carve out protected uses—resulting in a so-called “skinny-label”—subject to

statutory and regulatory constraints. See Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S.

399, 405–06 (2012) (noting that Section viii skinny-label carveouts were intended to “speed the

introduction of low-cost generic drugs to market”). To accommodate Section viii applicants, the

Federal Food, Drug, and Cosmetic Act provides an exception to same-labeling requirements for 2 “changes required . . . because the [generic] drug and the [reference] drug are produced or

distributed by different manufacturers.” 21 U.S.C. § 355(j)(2)(A)(v).

FDA regulations further define same-labeling requirements. 21 C.F.R. § 314.94(a)(8)(iv).

Regulations reiterate that a generic may differ from the reference label if the drug is produced by

a “different manufacturer[],” to account for differences in marketing exclusivity or patent rights:

[D]ifferences between the applicant’s proposed labeling and labeling approved for the reference listed drug may include differences in expiration date, formulation, bioavailability, or pharmacokinetics, labeling revisions made to comply with current FDA labeling guidelines or other guidance, or omission of an indication or other aspect of labeling protected by patent or accorded exclusivity under section 505(j)(5)(F) of the Federal Food, Drug, and Cosmetic Act.

Id. (emphasis added); see also id. § 314.127(a)(7) (permitting approval of “changes required

because . . . aspects of the [reference] drug’s labeling are protected by patent”). However, the

labeling differences may “not render the proposed drug product less safe or effective than the listed

drug for all remaining, nonprotected conditions of use.” Id.

FDA regulations also provide that a generic must be “identical in active ingredient(s)” to

the reference drug. 21 C.F.R. § 314.92(a)(1); see 21 U.S.C. § 355(j)(2)(A)(ii). An active

ingredient is “any component that is intended to furnish pharmacological activity or other direct

effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the

structure or any function of the body of man or other animals.” 21 C.F.R. § 314.3(b) (definition

of “Active ingredient”). Regulations further define an “identical active drug ingredient” as being

“the same salt 1 . . . of the same therapeutic moiety.” Id. (definition of “Pharmaceutical

1 A salt is a chemical compound comprised of an anion (a negatively-charged atom or group of atoms) and a cation (a positively-charged atom or group), linked by an ionic bond. See FDA Opp’n at 30–31, Dkt. 44; FDA, Guidance for Industry: Regulatory Classification of Pharmaceutical Co- Crystals at 4 (Feb. 2018) (“Salts: Any of numerous compounds that result from replacement of part or all of the acid hydrogen of an acid by a metal or a radical acting like a metal”).

3 equivalents”). An “[a]ctive moiety” is “the molecule or ion, excluding those appended portions of

the molecule that cause the drug to be . . . [a] salt (including a salt with hydrogen or coordination

bonds), or other noncovalent derivative (such as a complex . . . ) . . . responsible for the

physiological or pharmacological action of the drug substance.” Id. (definition of “Active

moiety”). Active ingredient sameness is evaluated based on the chemical structure of the drug’s

finished dosage form, prior to administration. 54 Fed. Reg. 28,872, 28,881 (July 10, 1989); see

also FDA, Sameness Evaluations in an ANDA – Active Ingredients, Guidance for Industry at 4

(Nov. 2022) (“[W]e generally consider the chemical form of an active ingredient to be the entire

molecule, including those portions of the molecule that cause the drug to be an ester or salt.”). But

drug ingredients need not have the same solid state physical form to have the same chemical

identity. See Final Rule: Abbreviated New Drug Application Regulations, 57 Fed. Reg. 17,950,

17,958–59 (Apr. 28, 1992) (active ingredient sameness does not require finding that “solid state

forms of the drug have not been altered”).

B. Factual Background

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