By Kurt R. Karst –
Whether notice of commercial marketing given before FDA approval can be effective and whether, in any event, treating [Public Health Service Act (“PHS Act”) § 351(l)(8)(A) (42 U.S.C. § 262(l)(8)(A))] as a standalone requirement and creating an injunctive remedy that delays all biosimilars by 180 days after approval is improper.
Those are the questions presented by Sandoz Inc. (“Sandoz’s”) in a Petition for Writ of Certiorari submitted to the U.S. Supreme Court earlier this week on the last possible day permitted for such a petition. The highly anticipated petition is the first time – but certainly won’t be the last time – the Supreme Court has been asked to take up an issue raised by the text of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). The Sandoz Petition appeals one aspect of a highly fractured July 21, 2015 opinion handed down by the U.S. Court of Appeals for the Federal Circuit in a dispute between Amgen Inc. (“Amgen’s”) and Sandoz over Sandoz’s ZARXIO (filgrastim-sndz), a biosimilar version of Amgen’s NEUPOGEN (filgrastim) (see our previous post here). FDA licensed ZARXIO on March 6, 2015 under BLA 125553.
The provision at issue – PHS Act § 351(l)(8)(A) – states that a biosimilar (or subsection (k) “applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).” A 2-1 panel majority of the Federal Circuit ruled that licensure of a biosimilar application is required before an “operative notice” of commercial marketing can be given. Specifically, in overturning a lower court decision on this issue, the Federal Circuit stated:
We believe that Congress intended the notice to follow licensure, at which time the product, its therapeutic uses, and its manufacturing processes are fixed. When a subsection (k) applicant files its aBLA, it likely does not know for certain when, or if, it will obtain FDA licensure. The FDA could request changes to the product during the review process, or it could approve some but not all sought-for uses. Giving notice after FDA licensure, once the scope of the approved license is known and the marketing of the proposed biosimilar product is imminent, allows the RPS to effectively determine whether, and on which patents, to seek a preliminary injunction from the court. . . . We therefore conclude that, under paragraph (l)(8)(A), a subsection (k) applicant may only give effective notice of commercial marketing after the FDA has licensed its product.
In a dissenting opinion, Judge Chen found the 180-day notice of commercial marketing provision to be optional, just like the BPCIA’s so-called “patent dance” provisions (which were also ruled on in the Federal Circuit’s opinion).
The importance of final resolution of the meaning of the BPCIA’s 180-day notice of commercial marketing provision – either in the context of Sandoz’s Petition, if it is granted, or in another case that could ultimately reach the Supreme Court (there are at least three similar lawsuits pending around the country, including this one) – cannot be understated. The Federal Circuit's ruling on the notice of commercial marketing provision, if it is upheld, could have everlasting effect on the biosimilars industry (more so that the Court's ruling on the optional nature of the statute’s patent dance provisions). And reference product sponsors may find (and argue for) new ways to apply it, perhaps in the context of supplemental applications submitted to FDA seeking changes to a licensed Section 351(k) biosimilar product. Such supplemental applications may seek changes to the manufacturing process of a biosimilar product, or to add into labeling an indication previously omitted because of unexpired patent or non-patent exclusivity (e.g., orphan drug exclusivity) protections on the reference product. Why not argue for a 180-day notice in those situations as well?
Sandoz rolls through many of these concerns in the company’s Petition, so we’ll just let the company do the talking here:
In a fragmented decision, the Federal Circuit has disrupted the careful balance struck by Congress between competition and innovation. If not reversed, the Federal Circuit’s ruling will delay access by patients to all biosimilars for six months longer than Congress intended. The Federal Circuit reached that result by adding an extra-textual limitation to the BPCIA’s “Notice of commercial marketing” provision. That provision calls for “notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k),” i.e., the abbreviated biosimilar pathway. 42 U.S.C. § 262(l)(8)(A) (emphasis added). The Federal Circuit held that an applicant “may only give effective notice of commercial marketing after the FDA has licensed its product.” App., infra, 20a (emphasis added).
A majority of the Federal Circuit panel then enforced that erroneous reading by divorcing that provision from the BPCIA’s patent resolution regime and replacing the remedies expressly provided in the BPCIA with a new remedy: “a 180-day injunction beyond the express twelve-year statutory exclusivity period.” App., infra, 43a-44a (Chen, J., dissenting). As Judge Chen recognized in dissent, the majority effectively awarded sponsors “an extra-statutory exclusivity windfall” of 180 days more than Congress expressly granted. App., infra, 44a (Chen, J., dissenting). The Federal Circuit’s decision cannot be squared with the BPCIA’s text and purpose, and it conflicts with this Court’s precedents. As the district court observed, if Congress had wanted to add six months to the statutory exclusivity period, “it could not have chosen a more convoluted method of doing so.” App., infra, 76a.
By its plain terms, the notice of commercial marketing provision simply calls for 180 days’ notice before a biosimilar is marketed. Regardless of whether notice is given before or after FDA approval of the biosimilar, the notice would serve the statute’s purpose of giving the reference product sponsor at least 180 days to initiate suit. But special notice after FDA approval would be superfluous, as FDA licensure is a public act. The Federal Circuit reached its erroneous conclusion by reading too much into the word “licensed” in subsection (l)(8)(A). That adjective merely refers to the biosimilar product that will be marketed, which will be licensed by the time of marketing. Nothing in the text provides that an applicant must wait until the FDA publicly approves its biosimilar, then provide “notice” of its self-evident intent to market that approved biosimilar, and then wait six months more before marketing its product.
The Federal Circuit compounded this error by disconnecting Section 262(l)(8)(A) from the BPCIA’s patent resolution regime and by creating a new remedy nowhere provided by the BPCIA: an injunction against commercial marketing until 180 days after post-approval notice is given. If Congress had so intended, it knew how to stay FDA approval for 180 days; it also knew how to authorize injunctions to enforce the notice provision. It did neither. Instead, it provided sponsors with a powerful remedy: a patent suit for artificial infringement that could be brought even before FDA approval. 42 U.S.C. § 262(l)(9)(B), (C); 35 U.S.C. § 271(e)(2)(C). Although Amgen brought such a suit, it made no attempt (and still has not) to seek an injunction based on any alleged patent infringement by Sandoz.
Without any such patent showing by Amgen, the plain terms of the BPCIA authorized Sandoz to make its biosimilar filgrastim product Zarxio® immediately available to cancer patients upon FDA approval: (1) Sandoz already had provided Amgen more than 180 days’ notice of its intent to market, giving Amgen time to bring suit (which it did) and seek a patent-based injunction (which it did not), and (2) any statutory exclusivity period had expired, as Amgen already had enjoyed 24 years of exclusivity. See App., infra, 8a-9a. Instead, due to the Federal Circuit’s erroneous interpretation of the notice of commercial marketing provision, competition was excluded from the market well beyond the exclusivity period granted by Congress, and cancer patients had to wait many months after FDA approval of Sandoz’s product for access to more affordable medicine.
Sandoz’s petition does not address one aspect of Judge Lourie’s opinion that has long intrigued us: his suggestion that an additional 180 days of marketing exclusivity is not necessarily a consequence of the Federal Circuit decision. In that opinion Judge Lourie stated:
Furthermore, requiring FDA licensure before notice of commercial marketing does not necessarily conflict with the twelve-year exclusivity period of § 262(k)(7)(A). It is true that in this case, as we decide infra, Amgen will have an additional 180 days of market exclusion after Sandoz’s effective notice date; that is because Sandoz only filed its aBLA 23 years after Amgen obtained FDA approval of its Neupogen product. Amgen had more than an “extra” 180 days, but that is apparently the way the law, business, and the science evolved. That extra 180 days will not likely be the usual case, as aBLAs will often be filed during the 12-year exclusivity period for other products.
It’s possible that Judge Lourie envisioned that FDA will provide tentatively or conditionally approve biosimilars during the reference product’s exclusivity period and that this tentative or conditional approval would then allow a notice of first commercial marketing to be provided under the statute. It’s not clear that this is an interpretation of the statute that would withstand judicial review. And absent FDA following up on Judge Lourie’s suggestion, we may not have an answer to that issue in the near-term.
What are the chances that the Supreme Court will take up the Sandoz Petition? That’s difficult to say, of course. And the recent passing of Justice Antonin Scalia adds more unknowns to the mix.