395 F.Supp.3d 357
D. Del.2019Background
- Genentech and City of Hope own two patents covering the manufacturing process for bevacizumab (Avastin). They sued Amgen/Immunex under the BPCIA after Amgen sought FDA approval and planned commercial launch of a biosimilar, Mvasi (ABP215).
- Amgen filed a subsection (k) BLA for ABP215 in 2016; FDA approved the BLA in September 2017 for manufacturing at Amgen Thousand Oaks. Amgen sent § 262(l)(8)(A) notice of intent to commercially market in October 2017.
- Amgen later filed supplements to the BLA (S-003 and S-004) seeking approval for additional manufacturing at Immunex Rhode Island and labeling changes; those supplements were approved in December 2018 and June 2019.
- Genentech moved for an order prohibiting Amgen from marketing Mvasi until Amgen provided a new § 262(l)(8) notice 180 days prior to launch (Statutory Prohibition Motion), and separately sought a temporary restraining order to enjoin launch pending resolution/appeal.
- Genentech’s core contention: the post-approval supplements changed the licensed product such that the October 2017 notice no longer satisfied § 262(l)(8) and a new 180‑day notice was required.
- The court held the supplements did not create a new product for § 262(l)(8) purposes; Amgen’s October 2017 notice was sufficient and both Genentech motions were denied.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether FDA-approved post-license supplements create a distinct "biological product licensed under subsection (k)" requiring a new § 262(l)(8) notice | Supplements that changed manufacturing site and labeling produced a new product; thus the October 2017 notice was insufficient | FDA regulations and § 262 permit supplements to an approved BLA; product remains the same for § 262(l)(8) purposes and prior notice suffices | The court held supplements do not create a new "licensed under subsection (k)" product; Amgen's Oct. 2017 notice satisfied § 262(l)(8) |
| Whether the court should enforce § 262(l)(8) via mandatory relief without applying preliminary‑injunction factors | § 262(l)(8) is mandatory so enforcement should issue irrespective of traditional PI factors | Traditional preliminary‑injunction standards apply; movant must show likelihood of success | Court did not decide the standards question because Genentech failed on the merits; held Genentech also failed to show likelihood of success |
| Whether the FDA had authority to approve supplements after initial BLA approval | Supplement approvals amounted to new applications needing new notice | FDA regulations define supplements as changes to an approved license application; FDA may approve supplements after original approval | Court held FDA may approve supplements post‑license; supplements are changes to the same application/product |
| Whether a TRO is warranted to prevent Amgen from launching Mvasi pending resolution | Immediate launch would harm plaintiffs and requires emergency relief | Plaintiffs unlikely to succeed on the merits, so TRO should be denied | Court denied TRO because Genentech failed to show likelihood of success on the merits |
Key Cases Cited
- Sandoz, Inc. v. Amgen, 137 S. Ct. 1664 (2017) (describes the BPCIA's abbreviated approval pathway for biosimilars)
- United States v. Ron Pair Enters., Inc., 489 U.S. 235 (1989) (statutory interpretation begins with the statute's text)
- Lorillard v. Pons, 434 U.S. 575 (1978) (Congress presumed aware of administrative interpretations when re‑enacting or adopting provisions)
- N.L.R.B. v. Bell Aerospace Co., 416 U.S. 267 (1974) (deference to longstanding agency interpretation where Congress adopted prior law)
- AK Steel Corp. v. United States, 226 F.3d 1361 (Fed. Cir. 2000) (presumption that Congress knows administrative or judicial interpretation of incorporated law)
- Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343 (Fed. Cir. 2001) (a movant cannot obtain preliminary injunction without likelihood of success on the merits)
- Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7 (2008) (four‑factor test for preliminary injunctions)
- Hybritech Inc. v. Abbott Labs., 849 F.2d 1446 (Fed. Cir. 1988) (public interest factor in pharmaceutical preliminary relief analysis)