Teva Pharm. USA, Inc. v. U.S. Food & Drug Admin., Civil Action No. 20-808 (BAH)

• Court: United States District Courts. United States District Court (Columbia)
• Writing for the Court: Chief Judge Beryl A. Howell
• Parties: TEVA PHARMACEUTICALS USA, INC., et al., Plaintiffs, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Defendants, and SANDOZ INC., et al., Intervenor-Defendants.
• Docket Number: Civil Action No. 20-808 (BAH)
• Decision Date: 31 December 2020

TEVA PHARMACEUTICALS USA, INC., et al., Plaintiffs,
v.
UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Defendants,
and
SANDOZ INC., et al., Intervenor-Defendants.

Civil Action No. 20-808 (BAH)

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

December 31, 2020

Chief Judge Beryl A. Howell

MEMORANDUM OPINION

Plaintiffs Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. (together, "Teva") and intervenor-defendants Sandoz Inc. ("Sandoz") and Mylan Pharmaceuticals Inc. ("Mylan") are pharmaceutical companies that manufacture therapeutic products using glatiramer acetate to treat relapsing-remitting forms of multiple sclerosis. Almost 25 years ago, in 1996, the Food and Drug Administration ("FDA") approved Teva's glatiramer acetate product, Copaxone, as a drug under the Food, Drug, and Cosmetics Act ("FDCA"), 21 U.S.C. § 301 et seq. Years later, and in the face of concerted resistance by Teva, the agency approved generic glatiramer acetate products, including those manufactured by Sandoz and Mylan. Now, in yet another effort to stifle Copaxone competitors, Teva brings this lawsuit, seeking an order compelling FDA to regulate Copaxone as a "biological product" under the Public Health Service Act ("PHSA"), 42 U.S.C. § 201 et seq., rather than as a "drug" under the

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FDCA. According to Teva, such a change was mandated by the Biologics Price Competition and Innovation Act of 2009 ("BPCIA"), Pub. L. No. 111-148, tit. VII, subtit. A, 124 Stat. 119, 804-21 (2010), and subsequent amendments, which expanded the definition of "biological product" to include "proteins" and therapeutic products "analogous" to proteins and required FDA to transition qualifying drugs to biological product status by March 23, 2020.

Teva instituted this action on March 24, 2020 against FDA and the Department of Health and Human Services, as well as the heads of those agencies in their official capacities (together, the "federal defendants"), challenging FDA's determination that Copaxone is neither a protein nor a product analogous to a protein and therefore cannot be transitioned from the FDCA to the PHSA. See generally Compl., ECF No. 1. Shortly after, Mylan and Sandoz intervened as defendants. Mot. Intervene by Sandoz Inc., ECF No. 9; Mot. Intervene as Def., ECF No. 19; Min. Order (Apr. 20, 2020) (granting Sandoz's motion to intervene); Min. Order (Apr. 27, 2020) (granting Mylan's motion to intervene).

Now pending before the Court are cross-motions for summary judgment filed by Teva, ECF No. 31, the federal defendants, ECF No. 36, Mylan, ECF No. 34, and Sandoz, ECF No. 38. For the reasons explained below, Teva's motion is denied and the motions of the federal defendants and the intervenor-defendants are granted.

I. BACKGROUND

A. Statutory and Regulatory Background

FDA administers two statutory frameworks for the regulation and approval of two distinct categories of therapeutic products. The FDCA's section 505 governs the approval of new "drugs," 21 U.S.C. § 355, while the PHSA's section 351 governs the approval of new biological products or biologics, 42 U.S.C. § 262. "A biologic is a type of drug derived from natural, biological sources such as animals or microoorganisms," in contrast to "traditional

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drugs, which are typically synthesized from chemicals." Sandoz Inc. v. Amgen Inc. ("Sandoz"), 137 S. Ct. 1664, 1669-70 (2017). Both drugs and biological products are used to treat and prevent disease in the human body. See 21 U.S.C. § 321(g)(1)(B)-(C) (defining a "drug" as an "article[] intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease" or "intended to affect the structure or any function of the body of man"); 42 U.S.C. § 262(i)(1) (stating that a "biological product" must be "applicable to the prevention, treatment, or cure of a disease or condition of human beings").

1. Approval of Drugs Under the FDCA

The FDCA controls the approval of "drugs" by FDA through any of three pathways available under section 505. First, an applicant may file a new drug application ("NDA") containing scientific data collected by the applicant, 21 U.S.C. § 355(a), (b)(1), which demonstrates that the drug is safe and effective for use as labeled, id. § 355(d). Second, an applicant may file an NDA relying on scientific investigations "not conducted by or for the applicant and for which the applicant has not obtained a right or reference or use" to show safety and efficacy, if accompanied by additional information specified in the statute. Id. § 355(b)(2). Drugs approved through either of these pathways are commonly referred to as "brand-name" drugs.

Finally, an applicant may file an abbreviated new drug application ("ANDA") to bring a generic version of a previously approved brand-name drug (the "reference listed drug") to market. Id. § 355(j). An ANDA relies on FDA's previous finding that the reference listed drug is safe and effective. Thus, to gain approval for an ANDA, an applicant must show that the proposed generic drug is "the same as" the reference listed drug, id. § 355(j)(2)(A) (ii), (iii), a standard that requires the generic drug to be "identical in active ingredient(s), dosage form, strength, route of administration, and conditions of use," 21 C.F.R. § 314.92(a)(1). The applicant

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must also establish that the proposed generic is "bioequivalent to" the reference listed drug, meaning that the generic drug "can be expected to have the same therapeutic effect" as the reference listed drug. 21 U.S.C. § 355(j)(2)(A)(iv). FDA makes active-ingredient-sameness determinations for ANDAs "on a case-by-case basis." Admin. Record ("AR") at 728.¹

As part of the NDA process, applicants seeking FDA approval must provide information about "any patent which claims the drug" that is the subject of the NDA "or which claims a method of using" the drug "with respect to which a claim of patent infringement could reasonably be asserted." 21 U.S.C. § 355(b)(1), (2)(A), (c)(2). The FDA lists all such patents in a publication entitled Approved Drug Products with Therapeutic Equivalence Evaluations and commonly known as the "Orange Book." See id. § 355(j)(7); FDA, Approved Drug Products with Therapeutic Equivalence Evaluations iv-xi (40th ed. 2020), https://www.fda.gov/media/71474/download. "Process patents" (that is, patents claiming methods of manufacturing or producing a drug) are not among the patents provided during the NDA process and therefore are not included in the Orange Book. See 21 C.F.R. § 314.53(b)(1).

If an ANDA applicant seeks to market a generic version of a brand-name drug before a related patent in the Orange Book has expired, the ANDA applicant must file a "Paragraph IV certification," certifying that the unexpired patent "is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the [ANDA] is submitted." 21 U.S.C. § 355(j)(2)(A)(vii)(IV); see also Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 676-77 (1990).

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The ANDA applicant must also provide notice of the Paragraph IV certification, setting forth "a detailed statement of the factual and legal basis of the opinion of the applicant that the patent is invalid or will not be infringed," to both the patent holder and the NDA holder. 21 U.S.C. § 355(j)(2)(B)(iv)(II). The filing of a Paragraph IV certification is deemed "an [artificial] act of infringement," sufficient to form the basis of a patent infringement action, if the purpose of the certification "is to obtain approval under" the FDCA "to engage in the commercial manufacture, use, or sale of a drug . . . claimed in a patent or the use of which is claimed in a patent before the expiration of such patent." 35 U.S.C. § 271(e)(2). The NDA or patent holder may therefore bring a patent infringement suit based on the Paragraph IV certification alone. See id. § 271(a)-(c), (e)(2); Eli Lilly & Co., 496 U.S. at 678; Caraco Pharm. Lab'ys., Ltd. v. Forest Lab'ys., Inc., 527 F.3d 1278, 1283 (Fed. Cir. 2008). In contrast, the potential infringement of a process patent does not require a Paragraph IV certification and thus does not trigger a patent holder's right to bring a preapproval infringement suit.

2. Approval of Biological Products Under the PHSA

Section 351 of the PHSA, as amended by the BPCIA, provides two avenues to FDA approval of biologics. First, applicants seeking to bring a new biological product to market must submit a biologics license application ("BLA") for FDA approval. 42 U.S.C. § 262(a). FDA may license a new biologic if, among other criteria, the manufacturer shows that the product is "safe, pure, and potent." Id. § 262(a)(2)(C)(i)(I).

Second, the PHSA provides an abbreviated pathway to approval, created by the BPCIA, for "biosimilars," which are "biologic product[s] that [are] highly similar to a biologic product that has already been approved by the [FDA]." Sandoz, 137 S. Ct. at 1669. An applicant seeking approval of a biosimilar must submit an abbreviated biologics license ("aBLA"). 42 U.S.C. § 262(k). An aBLA need not replicate the "safe, pure, and potent" showing made in the

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BLA for the previously approved biologic product (the "reference product"). See id. § 262(k)(2)(A)(iii). Instead, an aBLA applicant must show that its product is "highly similar" to the previously approved biologic product (the "reference product") and that "no clinically meaningful differences" with respect to "safety, purity, and potency" exist between the two products. 42 U.S.C. § 262(i)(2)(A), (B); see also id. § 262(k)(2)(A)(i)(I).

The BPCIA's amendments to the PHSA "establish[] processes both for obtaining FDA approval of biosimilars and for resolving patent disputes between manufacturers of licensed biologics and manufacturers of biosimilars." Sandoz, 137 S. Ct. at 1669. As soon as the initial approval process for a biosimilar is underway, the patent dispute process commences. FDA notifies an aBLA applicant when its application has...