Amgen, Inc. et al. v. Sandoz Inc.

Docket No. 2015-1499

July 21, 2015

Update:  See SCOTUS June 12, 2017 decision reversing the FC regarding 8A (“the applicant may provide [180 day] notice either before or after receiving FDA approval”).

Brief Summary: Opinion relates to interpretation of Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). aBLA may opt not to disclose application within 20-day “2A” deadline and RPS’s only option is litigation under 271(e)(2)(C)(ii). Effective notice of commercial marketing (“8A”) may only occur after the FDA has licensed the product.

Summary: Amgen appealed DC dismissal of its unfair competition and conversion, granting judgment that Sandoz properly interpreted the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), and denying Amgen’s motion for a preliminary injunction. The opinion notes that this case “presents issues of first impression relating to the [BPCIA]”. The BPCIA provides four- and 12-year exclusivity periods (dates of application and approval, respectively) from the date of first licensure of a reference product (providing reference product sponsor “up to [12] years of exclusivity against follow-on products, regardless of patent protection.”) The opinion explains the BPCIA to require an aBLA (or “subsection k”) applicant to disclose its application and manufacturing information to the BLS no later than 20 days after the FDA’s notification of acceptance (BPCIA paragraph (l)(2)(A)). The parties are then to exchange lists of patents for which they believe infringement could be asserted by the RPS, their respective positions regarding infringement, validity and enforceability thereof, a list of patents (“listed patents”) is produced (may take up to six months) that would be the subject of an immediate infringement action, and then the RPS must sue the applicant on the listed patents within 30 days. If the applicant does not notify the RPS within 20 days, that failure is an “artificial ‘act of infringement’” and the RPS may bring suit immediately. A 180-day notice of commercial marketing to the RPS is also required; the RPS then has a period of time to seek a preliminary injunction based on patents initially considered as possible “listed patents” but not selected as such and any newly issued or licensed patents (“non-listed patents”). If the applicant fails to comply with the 20-day “2A” deadline, the RPS (but not the applicant) may seek declaratory relief regarding “infringement, validity, or enforceability of any patent” claiming the product or its use under BPCIA paragraph (l)(9)(C). And 35 USC 271(e)(2)(C)(ii) was amended by the BPCIA to make a “2A” failure an act of infringement.

Amgen’s (the reference product sponsor, “RPS”) reference is Neupogen for which Sandoz filed an abbreviated BLA (“aBLA”) seeking approval of its filgrastim product (to be marketed as “Zarxio”). Sandoz “opted not to provide Amgen with [its] biosimilar application” and manufacturing information by the 20-day deadline (July 2014 letter). The opinion explains that Sandoz’s decision not to disclose its application was “expressly contemplated by the BPCIA” (i.e., not a violation of the BPCIA) and was “precisely an act of infringement under 271(e)(2)(C)(ii), for which 271(e)(4) provides the ‘only remedies’” (“those being based on a claim of patent infringement”). Thus, Amgen could only “access the required information through discovery.”

Regarding the 180-day notice of commercial marketing (BPCIA paragraph (l)(8)(A), “8A”), Sandoz argued it has provided Amgen with “operative notice of commercial marketing” when it informed Amgen with its initial July 2014 letter that it anticipated the application would be approved in “Q1/2 of 2015”. It also notified Amgen on the date of FDA approval (March 6, 2015). The FC panel agreed with Amgen (and not Sandoz or the DC) that the first notice was not an effective notice of commercial marketing as this can only occur after the FDA has licensed the product, thereby “ensur[ing] the existence of a fully crystallized controversy regarding the need for injunctive relief.” The opinion acknowledged that this conclusion provides Amgen with “an additional 180 days of market exclusion after Sandoz’s effective notice date” (to September 6, 2015) but notes this is only “because Sandoz…filed its aBLA 23 years after Amgen obtained approval of its Neupogen product” and “will not likely be the usual case, as aBLAs will often be filed during the 12-year exclusivity period for other products.” The 8A requirement is also explained to be “mandatory” regardless of whether the applicant complies with the 20-day 2A deadline. Regarding Amgen’s state (CA) unfair competition claims, the FC panel affirmed the DC properly dismissed those claims because Sandoz did not violate the 2A deadline and provided the required 8A notice. It also agreed with the DC that Amgen failed to prove its conversion claims. The DC’s denial of Amgen’s motion for a state law-based preliminary injunction was also affirmed (although an injunction pending appeal was extended until September 2, 2015).

Judge Newman’s dissent argues that Sandoz did not comply with either 2A or 8A and, therefore, should forfeit its “access to the benefits of the BPCIA.”

Judge Chen’s dissent argued the decision regarding 8A grants “Amgen, the RPS, an extra-statutory exclusivity windfall” (“this case requires us to ‘unravel the riddle, solve the mystery, and comprehend the enigma’ that is the BPCIA’…we must choose from a series of imperfect choices…I respectfully dissent from the majority’s holding that (l)(8) is a standalone provision with an inherent right to a 180 day injunction.”)

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