Ipsen Biopharmaceuticals, Inc. v. Becerra
| Decision Date | 08 May 2023 |
| Docket Number | 22-cv-860 (DLF) |
| Parties | IPSEN BIOPHARMACEUTICALS, INC., Plaintiff, v. XAVIER BECERRA, Secretary, United States Department of Health and Human Services, et al., Defendants. |
| Court | U.S. District Court — District of Columbia |
Ipsen Biopharmaceuticals, Inc. brings this case against the Secretary of Health and Human Services and the Commissioner of the Food and Drug Administration (FDA) under the Administrative Procedure Act (APA), arguing that the FDA's decision to regulate its product as a drug, rather than a biological product, was arbitrary, capricious, an abuse of discretion, and contrary to law. Compl. ¶¶ 1-7, Dkt. 1. InvaGen Pharmaceuticals, Inc. intervened as a defendant. Minute Order of May 12, 2022. Before the Court are Ipsen's Motion for Summary Judgment, Dkt. 26, and the FDA's and InvaGen's Cross Motions for Summary Judgment, Dkts. 27, 28. For the reasons that follow, the Court will grant FDA's and InvaGen's motions and deny Ipsen's motion.
The Food, Drug, and Cosmetic Act () prohibits the introduction of “any new drug” into interstate commerce without prior approval by the FDA. 21 U.S.C. § 355(a). For this purpose, the Act defines “drug” to include “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Id. § 321(g)(1)(B)-(C).
As relevant here, there are three pathways through which new drugs may obtain FDA approval. First, a company may submit a new drug application (NDA) under § 505(b) of the Drug Act. 21 U.S.C. § 355(b). A new drug application is approved only if the company demonstrates, usually through clinical trials, that its drug is safe and effective for its proposed use. See Id. § 355(b)(1)(A), (d) (specifying other requirements for NDAs). Second and alternatively, once the exclusivity and patent rights of a drug's sponsor have expired, see, e.g., id. § 355(j)(2)(A)(vii), (5)(B)(iv), other companies seeking to market generic versions of that drug may submit an abbreviated new drug application (ANDA). Id. § 355(j). The FDA may approve an ANDA only upon finding that the generic drug is “bioequivalent” to a listed drug in several respects, including active ingredient, conditions of use, route of administration, dosage, and strength. Id. § 355(j)(4)(F) (); id. § 355(j)(8)(B) (defining “bioequivalent”).
The third option, a § 505(b)(2) application, is “a sort of hybrid of the other two pathways.” Veloxis Pharms., Inc. v. FDA, 109 F.Supp.3d 104, 108-09 (D.D.C. 2015) (citation omitted). The § 505(b)(2) pathway allows a company to submit an NDA that relies, in whole or in part, on clinical studies that another entity conducted for an already-approved listed drug. Id.; see 21 U.S.C. § 355(b)(2). This middle-ground pathway is often used if a company's product is similar to-but not the bioequivalent of-a listed drug, for example due to a difference in strength or route of administration. Veloxis, 109 F.Supp.3d at 109.
Different rules apply to products that qualify as “biological products.” The Public Health Service Act () defines “biological product” to mean “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product . . . applicable to the prevention, treatment, or cure of a disease or condition of human beings.” 42 U.S.C. § 262(i)(1). This definition has changed over time. Although it previously excluded proteins that were “chemically synthesized,” Congress revised it in 2019 to include all proteins, regardless of their origin. Compare id. § 262(i)(1) (2012) (), with id. § 262(i)(1) (2020) (); Further Consolidated Appropriations Act of 2020, Pub. L. No 116-94, § 605, 133 Stat. 2534, 3127 (Dec. 20, 2019). The FDA since promulgated a rule to define a “protein” as “any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size” where the “amino acid chains . . . are associated with each other in a manner that occurs in nature.” 21 C.F.R. § 600.3(h)(6).
The Biologics Act contains two pathways for approving products that qualify as biological products. First, a company that seeks to market a new biological product may submit to the FDA a biological license application (BLA). 42 U.S.C. § 262(a)(1). The agency may approve that application upon finding that the product is “safe, pure, and potent,” usually shown through clinical trials, and that its production facility is “designed to assure” that quality. Id. § 262(a)(1)(C). Second, like the Drug Act, the Biologics Act also offers an abbreviated application process: when a company seeks to market a product that is “biosimilar” to or “interchangeable” with a product that has already been approved, it may submit an abbreviated biological license application (ABLA). Id. § 262(k). For this purpose, one product is “biosimilar” to another if it is “highly similar” to that product and if “there are no clinically meaningful differences” between the products “in terms of the safety, purity, and potency.” Id. § 262(i)(2). Likewise, one product is “interchangeable” with another if it is “biosimilar” to that product and if it “can be expected to produce the same clinical result . . . in any given patient.” Id. § 262(k)(4)(A). The FDA may approve an ABLA upon finding sufficient evidence of either biosimilarity or interchangeability. Id. § 262(k)(3). But, unlike for other drugs, biological products that do not qualify as biosimilar or interchangeable have no intermediate pathway that would enable an applicant to rely on another listed biological product's clinical studies. See Hr'g Tr. at 25, 27.
Whether a new drug qualifies as a biological product has several implications. First, as suggested above, that classification determines whether the drug is subject to the general approval regime in § 505 of the Drug Act or the more specific regime in the Biologics Act. See 42 U.S.C. § 262(j) (). The question also determines whether licensing a generic version of the drug requires filing an ANDA or an ABLA, and thus the legal standard the generic must satisfy. Compare 21 U.S.C. § 355(j)(4) (), with 42 U.S.C. § 262(k)(3) (). And, as noted, the Biologics Act does not provide a pathway akin to the Drug Act's § 505(b)(2) that allows an applicant to rely on a listed product's clinical studies even if it is not considered a generic that qualifies for an abbreviated application. Compare 21 U.S.C. § 355(b)(2) (providing this pathway in the Drug Act), with 42 U.S.C. § 262(a)(2)(C) ().
Recognizing that the FDA's classification decisions have substantial effects on the drug market, Congress has required the FDA to reconsider them over time. As relevant here, the Biologics Price Competition and Innovation Act of 2009 provided that, beginning on March 23, 2020, any “approved application for a biological product under section 505 of the [Drug Act] shall be deemed to be a license for the biological product” under the Biologics Act. Pub. L. No. 111148, tit. VII, § 7002(e)(4), 124 Stat. 804, 817 (Mar. 23, 2010). In other words, the Act required the FDA to, on March 23, 2020, transition substances that were approved as drugs, but now meet the current definition of “biological products,” to the Biologics Act. Consistent with that mandate, on that date the FDA published a list of biological products that it deemed to be licensed under the Biologics Act, although they were initially approved under the Drug Act. See FDA, List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020, A.R. 2168-76.
Ipsen manufactures, markets, and sells a drug called Somatuline Depot. Compl. ¶ 8. The drug effects an “extended-release dosing of its active ingredient lanreotide acetate, a molecule that mimics the naturally occurring hormone somatostatin.” Id. ¶ 44. The FDA approved the drug in 2007 pursuant to § 505 of the Drug Act. Id. ¶ 45; A.R. 342-71. Somatuline Depot is licensed “for the treatment of patients suffering from a rare hormonal disorder called acromegaly,” which “results from a production of excess growth hormone [] by the pituitary gland.” Compl. ¶ 45.
Although the FDA initially approved Somatuline Depot as a drug, Ipsen argues that the substance meets the amended definition of “biological product.” Id. ¶¶ 49-52. More precisely, it contends that Somatuline Depot qualifies as a “protein,” and thus a biological product, under the Biologics Act-i.e., it is an “alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size.” 21 C.F.R. § 600.3(h)(6); Compl. ¶ 50 (). Ipsen reasons that Somatuline Depot contains...
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