On November 8, 2016, Amgen asked the Supreme Court to deny Apotex’s September 9, 2016 petition for review in Apotex v. Amgen, No. 16-332. Apotex had asked the High Court to clarify 42 U.S.C. § 262(l)(8)(A) of the Biologics Price Competition and Innovation Act (BPCIA), which contains a “notice of commercial marketing” that the courts, biosimilar applicants, and reference product sponsors alike have been wrestling to interpret. The provision states that a biosimilar applicant shall provide notice to the Reference Product Sponsor (RPS) “not later than 180 days before the date of the first commercial marketing of the biological product licensed under” the abbreviated pathway. In its petition, Apotex has presented two questions related to this notice provision: (1) whether the Federal Circuit in Amgen v. Apotex, 827 F.3d 1052 (Fed. Cir. 2016) erred in holding that biosimilar applicants who comply with subparagraph (2)(A) of the BPCIA must also provide the RPS with a notice of commercial marketing; and (2) if so, whether the timing of this notice must post-date FDA licensure of the biosimilar.
In its opposition, Amgen first attacks the petition as procedurally incorrect, noting that Apotex asks for review of a decision affirming a preliminary injunction, which merged with the lower court’s final decision entering a permanent injunction. Amgen claims that the absence of an appeal from that final decision moots this appeal from the grant of a preliminary injunction.
As to Apotex’s first question, Amgen asserts that Apotex does not dispute that notice is required for applicants that do not engage in the information exchange of the BPCIA. In addition, Amgen contends that the statutory language of the notice provision does not distinguish between biosimilar applicants who comply with 262(l)(2)(A) (which requires an applicant to provide a copy of its abbreviated Biologics License Application (aBLA) and other manufacturing information to the RPS) and those that do not. The Federal Circuit in Amgen v. Apotex unanimously agreed with Amgen that the “asserted distinction” was false and that the 180-day commercial marketing provision applies to every biosimilar applicant, every RPS, and every licensed biosimilar. In so doing, the Federal Circuit has found that the BPCIA provisions of information exchange and notice are unlinked, pointing to statutory language which does not condition notice on complying with the information exchange provisions of the BPCIA. (Opp. at 25.)
Amgen also addresses an alleged “new argument” raised by Apotex in its petition: that by providing its aBLA and complying with subsection (2)(A), the RPS has “all the information it needs to pursue an orderly defense on its patent rights” and thus has no need for notice of commercial marketing. (Opp. at 28.) Amgen points to two problems with this rationale. First, according to Amgen, there is the possibility of newly issued or newly licensed patents that the RPS could not have listed on its initial lists and that could not have been the subject of the first round of litigation. (Opp. at 29.) Without a notice period, the RPS would not have sufficient time to seek a preliminary injunction on these new patents. Second, the parties may be in a better situation to evaluate their patent positions after licensure when the “product, uses, and processes are fixed by the license”. (Opp. at 5 and 29).
Amgen also addresses Apotex’s second question (regarding timing of notice), maintaining first that the question is improper because it exactly duplicates an issue raised in Sandoz v. Amgen, No. 15-1039 and its counter-petition, Amgen v. Sandoz, 15-1195. There, Sandoz asked the Court to consider whether 42 U.S.C. § 262(l)(2)(A) requires a biosimilar applicant to divulge its aBLA and related manufacturing information to an RPS, and, if so, whether effective notice must post-date FDA licensure. Apotex has encouraged the Court to hear its case alongside the Sandoz petitions because they present different factual scenarios under which the notice issue arises, namely distinctions in conduct—Apotex provided its aBLA to Amgen pursuant to subparagraph 262(l)(2)(A)—Sandoz did not. In response, Amgen asserts that the factual distinction between this case and Sandoz has no bearing on the legal question of the correct timing of notice. Thus, according to Amgen, Apotex’s second question merely “duplicates” the question already before the Court, which, if the Court wishes to address, the Court will do so by granting certiorari in the Sandoz case.
Amgen then focuses on construction of the phrase “product licensed” in 262(l)(8)(A). Based on the plain meaning and overall context of the term, Amgen argues that the phrase means that effective notice of commercial marketing can only be given after the FDA has approved an applicant’s aBLA and there is thus, a “product licensed”. (Opp. at 32). Amgen argues that this makes sense because notice after FDA licensure ensures that the scope of the approved license is known. Prior to this, the FDA can request changes to the product or manufacturing during the review process or approve some but not all the applied-for uses of the drug.
Amgen emphasizes that 180 days post-approval provides flexibility to the parties to select the most relevant patents for a first-phase lawsuit. For example, an RPS might identify patents in its initial patent list ((3)(A) list) directed to both the biosimilar molecule itself and methods-of-use covering specific therapeutic indications. While the molecule patent may be a good candidate to assert in a first-phase lawsuit, the methods-of-use patents may not because the FDA might not ultimately approve the particular therapeutic indications covered by those patents. By delaying litigation on the methods-of-use patents in that case, according to Amgen, the parties avoid litigating irrelevant patents. The biosimilar applicant can also capitalize on the flexibility afforded by the 180-day period to make use of inter partes review to challenge patents before the U.S. Patent and Trademark Office. It can also use the information exchange of the patent dance to delay or avoid needless expenditures of litigating patents likely to expire near the expected date of FDA approval. According to Amgen, interpreting the statute to require post-licensure notice allows for a defined period time in which the controversy can “fully crystalize”. (Opp. at 39).
In response to arguments “lamenting” an extra six months of exclusivity, Amgen clarifies that exclusivity is a term of art in the regulatory field that refers to limits on the FDA’s ability to review or approve products via a specific regulatory pathway, but does not afford market exclusivity or FDA exclusivity. (Opp. at 34-36). For example, Amgen points out that while the FDA cannot approve a biosimilar filed through the abbreviated pathway during this 12-year period, it can approve the same biologic though the traditional regulatory approval pathway. Indeed, this occurred for Amgen’s NEUPOGEN® (filgrastim) product-at-issue when Teva obtained approval of a filgrastim product, GRANIX®, using its own clinical data, not that of the RPS. GRANIX® now competes directly on the market with NEUPOGEN®. Thus, while Sandoz’s filgrastim product ZARIXIO® waited 180 days after FDA approval to enter the market, Amgen did not enjoy “market exclusivity” during this time. Likewise, Amgen would not have market exclusivity in the 180-day period after Apotex’s biosimilar was approved. Amgen thus contends that the BPCIA’s requirement for notice is not intended to afford continued exclusivity, but rather a time for the RPS and courts to effectively address a preliminary injunction.
Apotex’s reply is due around November 21, 2016. It is noteworthy that the FDA has not yet approved Apotex’s aBLA for the biosimilar at issue in this case.
We will continue to monitor this litigation and provide updates.
