Source: https://www.fdli.org/2017/08/case-note-sandoz-v-amgen/
Timestamp: 2019-04-21 16:15:49+00:00

Document:
Sandoz, Inc. v. Amgen, Inc., 582 U.S. __, Nos. 15-1039, 15-1195, Slip. Op. (June 12, 2017).
On June 12, 2017, the Supreme Court decided the highly anticipated first case involving the Biologics Price Competition and Innovation Act (BPCIA).1 The Supreme Court addressed two related questions: (1) whether the statutory language instructing a biosimilar applicant to provide its application and manufacturing information to the reference biologic sponsor after FDA acceptance of the application is enforceable by injunction; and (2) whether the biosimilar applicant must give notice of intended commercial marketing to the reference biologic sponsor only after obtaining an approved license from FDA.2 Upholding the decision of the Federal Circuit on the first question (albeit using different reasoning) and reversing the Federal Circuit on the second question, the Court also introduced some uncertainty for the future.
On the second question, the Court reversed the Federal Circuit. The Court held that 42 U.S.C. §262(l)(8)(A) allows a biosimilar applicant to provide notice of commercial marketing to the reference biologic sponsor prior to obtaining a license from FDA.25 In other words, the 180-day notice may be provided either before or after receiving FDA approval. The Court arrived at this conclusion relying both on a plain language statutory interpretation and on a structural analysis of other timing provisions in the statute.26 This holding provides a significant advantage to biosimilar applicants. Requiring notice at any point 180 days before approval (after submission of the application) ultimately gives the reference sponsor less time as the only product on the market, while requiring 180-day notification only after FDA approval would benefit the reference sponsor.
The decision leaves biosimilar applicants with a few choices and some uncertainty. If an applicant declines to provide the application and manufacturing information to the reference product sponsor, it faces a potentially wide-ranging patent infringement challenge controlled by the sponsor. Conforming to the BPCIA “patent dance” procedures provides more predictability over the scope of patent litigation, yet forces disclosure of confidential product information. The Federal Circuit will also be revisiting the state law question, meaning that there may be possible injunctive or other relief available at the state level. Intertwined with this issue is whether the BPCIA preempts state law in this area. Lastly, FDA may step in and engage in rulemaking to interpret the timing of notice as it relates to the license given the agency’s broad rulemaking powers. Justice Breyer penned a short, yet intriguing, concurrence channeling Brand X,27 emphasizing that the Court’s interpretation of the statute was “reasonable” and that FDA had the authority to “depart from, or modify” that interpretation in the future.28 Stay tuned.
Pub. L. No. 111-148, §§ 7001–03, 124 Stat. 119, 804–21 (2010) (codified in scattered sections of 42 U.S.C. & 21 U.S.C.).
Sandoz, Inc. v. Amgen, Inc., 582 U.S. __, Nos. 15-1039, 15-1195, Slip. Op. (June 12, 2017). For coverage of the litigation leading into oral argument at the Supreme Court, see Andrew Wasson, Drugs and Biologics: New Administration, New Legislation, New Precedents, FDLI Update (May/June 2017), 4, 7.
The Drug Price Competition and Patent Term Restoration Act of 1984 (also known as the Hatch-Waxman Act) established the abbreviated new drug application process. Pub. L. No. 98-417, sec. 101, 98 Stat. 1585, 1585–92 (codified at 21 U.S.C. § 355(j)).
Sponsors of all new drugs approved through the [Food, Drug and Cosmetic Act] § 505(b) processes must provide FDA with a list of issued composition and method of use patents and must maintain the accuracy of that list. This includes all § 505(b)(1), (b)(2), and 505(j)(generic drugs). 21 CFR § 314.53. FDA publishes this list in the Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
Sponsors of all new drugs approved through the §505(b)(2) and §505(j) process must certify to FDA the current status of the reference listed drug product’s patents. One option is to certify that the reference drug patent or patents are invalid or unenforceable, triggering potential litigation. 21 U.S.C. § 355(b)(2)-(3); 21 U.S.C. §§ 355(j)(2)(A)-(D), (j)(5)(B)(i)-(iii), 5(C).
See 42 U.S.C. § 351(l)(1); 42 U.S.C. § (l)(3)(A)(i) & (ii).
42 U.S.C. § 351(l)(4)-(6); 42 U.S.C. § 351(l)(6)(B).
Zarxio (filgrastim-sndz) was approved by FDA on March 6, 2015.
Sandoz, Inc. v. Amgen, Inc., 582 U.S. __, Nos. 15-1039, 15-1195, Slip. Op. at 8 (June 12, 2017).
582 U.S. __, Nos. 15-1039, 15-1195, Slip. Op. at 8; 42 U.S.C. § 262(l)(9)(C).
1582 U.S. __, Nos. 15-1039, 15-1195, Slip. Op. at 8; 2015 WL 1264756, *7-*9 (ND Cal., Mar. 19, 2015).
Amgen v. Sandoz, United States District Court for the Northern District of California case no. 3:13-cv-02904-MMC (Nov. 12, 2013).
Amgen, Inc. v. Sandoz, Inc., 794 F.3d 1347, 1357-8 (Fed. Cir. 2015).
Amgen v. Sandoz, U.S. Supreme Court Docket, cert. granted 15-1195 (Jan. 13, 2017); Sandoz v. Amgen, U.S. Supreme Court Docket, cert. granted 15-1039 (Jan. 13, 2017).
582 U.S. __, Nos. 15-1039, 15-1195, Slip. Op. at 12.
582 U.S. __, Nos. 15-1039, 15-1195, Slip. Op. at 10-13.
582 U.S. __, Nos. 15-1039, 15-1195, Slip. Op. at 14.
582 U.S. __, Nos. 15-1039, 15-1195, Slip. Op. at 15.
Bristol Meyers Squib v. Superior Court of California, San Francisco County, 582 U.S. ___, No. 16-466, Slip Op. (June 19, 2017). Specifically, the case dealt with the scope of specific jurisdiction, holding that the “bare fact that BMS contracted with a California distributor is not enough to establish personal jurisdiction in the State.” Slip Op. at 3.
582 U.S. __, Nos. 15-1039, 15-1195, Slip. Op. at 16.
National Cable & Telecommunications Assn. v. Brand X Interest Services, 545 U.S. 967, 982-984 (2005).
582 U.S. __, Nos. 15-1039, 15-1195, Concurrence, at 1.

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