Source: https://www.klgates.com/Federal-Circuit-Confirms-Post-Licensure-Notice-of-Commercial-Marketing-Is-Mandatory-in-Biosimilar-Litigation-07-21-2016
Timestamp: 2020-08-08 14:33:34
Document Index: 232884036

Matched Legal Cases: ['§ 262', '§ 262', '§ 262', '§ 262', '§ 262', '§ 7001', '§ 262']

Federal Circuit Confirms Post-Licensure Notice of Commercial Marketing Is Mandatory in Biosimilar Litigation | HUB | K&L Gates
By: Trevor M. Gates, Peter Giunta, Kenneth C. Liao, Margaux L. Nair
As we have written previously,[4] the BPCIA was enacted in 2010 to “balanc[e] innovation and consumer interests”[5] by creating a framework and process under which an applicant may bring to market a product “biosimilar” to an FDA-approved reference product. Under the BPCIA, there is a “step-by-step process for exchanging information and channeling litigation about patents relevant to [a biosimilar-product] application.”[ 6] At issue in the present case was 42 U.S.C. § 262(l)(8)(A), which requires biosimilar applicants—after receiving FDA licensure approval—to provide a “reference product sponsor notice at least 180 days before marketing its ‘licensed’ product”[7] (the “Notice of Commercial Marketing”).
The Federal Circuit held that Apotex was required to give Amgen Notice of Commercial Marketing and that Amgen giving a Notice of Filing provided “only a factual distinction, not a legally material distinction, between its situation and that of Sandoz in Amgen v. Sandoz.”[21] The court found that it would not be extending Congress’s twelve-year minimum exclusivity period as a rule, because as time passes by, applications for biosimilars will be submitted with enough time for the FDA to grant licensure well before the twelve-year period elapsed.[22] Situations like Apotex faces, caused by the recent enactment of the BPCIA in 2010, will be less and less likely as time goes on because there is “no reason that the FDA may not issue a license before the 11.5 year mark and deem the license to take effect on the 12-year date.”[23] The court reiterated that the “statute must be interpreted as it is enacted, not especially in light of particular, untypical facts of a given case.”[24] The Federal Circuit also rejected Apotex’s argument that because it had followed the procedures under § 262(l), Amgen’s exclusive remedy for Apotex’s failure to give proper notice under (8)(A) should be an action for declaratory judgment on the patent under § 262(l)(9)(B).[25] The court distinguished the allowance of a remedy from a mandate that such a remedy be the sole remedy available to a plaintiff, finding that “‘equitable jurisdiction is not to be denied or limited in the absence of a clear and valid legislative command.’”[26]
Apotex petitioned the Supreme Court for a writ of certiorari on September 9, 2016, seeking review of the following two issues: (1) “[w]hether the Federal Circuit erred in holding that biosimilar applicants that make all disclosures necessary under the BPCIA for the resolution of patent disputes . . . must also provide the reference product sponsor with a notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A)”; and (2) “[w]hether the Federal Circuit improperly extended the statutory 12-year exclusivity period to [12.5] years by holding that a biosimilar applicant cannot give effective notice of commercial marketing . . . until it receives [FDA approval].”[27] The Supreme Court denied the petition on December 12, 2016, without comment.[28]
The questions Apotex presented are narrower than the cross-petitions in Sandoz, which remain pending before the Supreme Court. [29] The Court sought the opinion of the Acting Solicitor General concerning the Sandoz petitions, and in an amicus brief filed on December 7, 2016, the Solicitor concluded that the Court should hear the case. [30] If the Court agrees, it may address Apotex’s questions in the course of deciding Sandoz. Meanwhile, biosimilar applicants and other interested parties should continue to watch the Sandoz petitions and take any decisions into account in developing strategies.
[1] 42 U.S.C. § 262 et seq.
[2] Amgen Inc. v. Apotex Inc., No. 2016-1308 (Fed. Cir. July 5, 2016), available at http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/16-1308.Opinion.6-30-2016.1.PDF.
[3] Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015).
[4] See, e.g., BPCIA Statute: Has the Music Stopped or Will the Patent Dance Continue?; see also BPCIA Statute: Patent Dance Is Optional, But Opting Out Has Consequences.
[5] Apotex, at 5 (quoting Pub. L. No. 111-148, § 7001(b), 124 Stat. at 804).
[6] Apotex,at 3.
[9] Id. (quoting 42 U.S.C. § 262(k)(7)(A), (B)).
[10] Apotex, at 11.
[15] Id. at 11–12.
[17] Id. at 12–13 (quoting Sandoz, 794 F.3d at 1358).
[18] Apotex,at 14.
[19] The parties stipulated as to all of the other required elements to grant a preliminary injunction under eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 394 (2006).
[20] Apotex,at 14.
[24] Id. at 18 (quoting Sandoz, 794 F.3d at 1358).
[25] Apotex,at 21.
[26] Id. (citations omitted).
[27] Petition for Writ of Certiorari at i-ii, Apotex Inc. v. Amgen Inc., No. 16-332 (Sep. 9, 2016).
[28] Order List: 580 U.S., 2016 Term Court Orders, Supreme Court of the United States 2 (Dec. 12, 2016), https://www.supremecourt.gov/orders/courtorders/121216zor_dc8e.pdf.
[29] See Petition for Writ of Certiorari, Sandoz Inc. v. Amgen Inc., No. 15-1039 (Feb. 16, 2016); Petition for Writ of Certiorari, Amgen Inc. v. Sandoz Inc., No. 15-1195 (Mar. 21, 2016).
[30] See Brief for the United States as Amici Curiae at 25, Sandoz Inc. v. Amgen Inc., No. 15-1039 and Amgen Inc. v. Sandoz Inc., No. 15-1195 (Dec. 7, 2016) (“The petition and conditional cross-petition for a writ of certiorari should be granted.”).
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