Source: https://saludequitativa.blogspot.com/2015/12/c-will-always-follow-p-except-when.html
Timestamp: 2020-08-12 15:50:22
Document Index: 358627295

Matched Legal Cases: ['§ 351', '§ 351', '§ 351', '§ 351', '§ 351', '§ 351']

GESTIÓN EN SALUD PÚBLICA: “C” Will Always Follow “P”, Except When the BPCIA is the “BCPIA”, Says District Court in NEULASTA Decision
Posted: 15 Dec 2015 01:09 AM PST
Apotex would have this Court limit the Sandoz decision, and the mandatory nature of [PHS Act § 351(l)(8)(A)], to instances where the applicant did not comply with [§ 351(l)(2)] and make the notice provision of [§ 351(l)(8)(A)] optional in instances where the applicant did comply with [§ 351(l)(2)]. This scenario was addressed by Judge Chen in his dissent to the Sandoz decision: “While the result in the latter scenario comes from the plain language of the statute, not so with the former. Nothing in the statute supports this peculiar outcome.” This Court agrees. The scenario proposed by Apotex would result in confusion and uncertainty, as well as inconsistent results, depending on which route a subsection (k) applicant chooses to travel. Nothing in the statute or the Sandozdecision leads to or supports such a result; neither the statute nor the Sandoz decision condition the 180 day notice provision of [§ 351(l)(8)(A)] upon a subsection (k) applicant’s compliance with [§ 351(l)(2)].
As noted above, Apotex immediately appealed Judge Cohn’s decision to the Federal Circuit. Although Apotex may not have any better luck with that Court than the company had with the Florida District Court, we suspect the endgame here is to try and get the U.S. Supreme Court to take up the issue (if that Court does not take it up in a different appeal, perhaps an appeal of theSandoz decision, or in one of the other pending cases where Judge Cohn's decision has already been submitted as supplemental authority).