514 F.Supp.3d 66
D.D.C.2020Background
- Teva’s Copaxone (glatiramer acetate) was approved as a drug (NDA) in 1996; generics (ANDAs) later approved (e.g., Sandoz, Mylan).
- The BPCIA (2010) amended the PHSA to include “protein” within the definition of "biological product" and required transition of qualifying NDAs/ANDAs to BLAs/aBLAs by March 23, 2020; Congress removed a parenthetical exception for "chemically synthesized polypeptides" in 2019.
- FDA spent ~2011–2020 developing a definition of “protein” (agency working group, guidance, proposed rule, final rule): it adopted a definition requiring a specific, defined amino-acid sequence (and a 40–100 amino-acid size proxy) and removed its separate regulatory definition of “chemically synthesized polypeptide” after the 2019 Act.
- FDA determined (Mar. 20, 2020 decision memorandum) that Copaxone is not a "protein" or "analogous" to a protein because its amino-acid sequences are generated by reaction chemistry (variable, not a single defined sequence), and therefore it was not transitioned to a BLA on March 23, 2020.
- Teva sued under the APA seeking reclassification of Copaxone as a biological product; cross-motions for summary judgment followed. The court denied Teva’s motion and granted the federal defendants’ and intervenors’ motions.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Article III standing (competitive injury) | Teva: denial of transition causes ongoing lost sales because state automatic-substitution laws let pharmacists dispense generics for NDA drugs; reclassification would block substitution until interchangeability found | Defs: harm speculative (dependent on third-party actions/interchangeability); other alleged injuries speculative | Held: Teva has standing based on concrete, ongoing competitive losses from substitution; injury traceable and redressable by reclassification injunction |
| Procedural challenge to FDA Final Rule (notice-and-comment) | Teva: Final Rule was procedurally defective because FDA did not reopen comment after Congress removed the parenthetical exception in 2019 | Defs: FDA had repeatedly proposed & solicited comment on the exact definition of “protein” for years; deletion of the parenthetical did not change the standalone term "protein" so no new notice required | Held: Rulemaking process provided adequate notice and comment; Final Rule validly promulgated and entitled to Chevron deference |
| Statutory meaning of “protein” (Chevron) | Teva: FDA’s “specific, defined sequence” requirement improperly distinguishes natural vs. synthetic proteins and is inconsistent with Congress’s 2019 amendment | Defs: "Protein" is a scientific term; consensus supports a defined amino-acid sequence; FDA’s technical interpretation is reasonable | Held: "Protein" ambiguous on Step One; FDA’s interpretation is a reasonable, expert-driven construction and survives Chevron Step Two |
| Application to Copaxone (arbitrary & capricious) | Teva: FDA applied the rule inconsistently (e.g., Vitrase/Creon treated as proteins) and contradicted its prior ANDA-sameness findings | Defs: FDA reasonably distinguished products: natural protein mixtures may have defined sequences per DNA template; Copaxone’s batch-to-batch sequence variability lacks a single specific sequence; FDA rationally explained the differences | Held: FDA’s decision that Copaxone lacks a specific, defined sequence and is not a protein is not arbitrary or capricious; differences with ANDA-sameness standard are explained |
| "Analogous product" provision | Teva: "analogous" unambiguously covers products that induce/modulate immune responses (or otherwise should include Copaxone) | Defs: "Analogous" is ambiguous; FDA reasonably read it to require sharing a core defining property of proteins (the specific, defined sequence) | Held: "Analogous product" ambiguous; FDA’s narrower construction (requiring specific defined sequence) is reasonable and its application to Copaxone was not arbitrary |
Key Cases Cited
- Chevron U.S.A., Inc. v. Natural Resources Defense Council, 467 U.S. 837 (agency interpretation framework)
- Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664 (2017) (discussing biosimilar/aBLA procedures and patent-dispute "patent dance")
- Regents of Univ. of Cal. v. Department of Homeland Security, 140 S. Ct. 1891 (agency must defend based on reasons it gave when acting)
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (standing requirements)
- Kisor v. Wilkie, 139 S. Ct. 2400 (deference to agency interpretations of ambiguous rules)
- Encino Motorcars, LLC v. Navarro, 136 S. Ct. 2117 (procedural defects can vitiate deference)
- Motor Vehicle Mfrs. Ass’n v. State Farm, 463 U.S. 29 (arbitrary and capricious standard)