By Kurt R. Karst –
One day in the future, reporting on biosimilar patent dance challenges lodged pursuant to the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) will be considered passé. Such challenges will be as commonplace as Hatch-Waxman Paragraph IV challenges. Indeed, earlier this week, FDA released a report that the Agency has held nearly 90 meetings with more than 50 companies interested in biosimilars, and last week, CDER Director Janet Woodcock testified before a Senate Committee that as of July 31, 2015, 57 proposed biosimilar products were in FDA’s Biosimilar Product Development Program. But we’re not yet even close to that future date. Today, each BPCIA patent dance lawsuit holds the potential to alter the future course of the law. And because of that potential, we try to keep a close eye on the biosimilars scene.
BPCIA-related lawsuits come in many flavors, several of which we have not yet even tasted. (Consider, for example, the palate-expanding experience that awaits us when the duo of Amgen and Allergan face off against Roche and Genentech over a biosimilar version of Avastin (bevacizumab) – see here – or when FDA is eventually challenged over the Agency’s implementation of the law.) Initially, there were the declaratory judgment cases filed by biosimilar applicants (see our previous post here). Then there were the challenges alleging that biosimilar applicants violated the BPCIA for failure to participate (or to cooperate) in the patent dance process and for providing inadequate or ineffective notice of commercial marketing (see our previous post here). More recently, there has been a post-patent dance challenge involving a biosimilar version of Amgen’s NEULASTA (pegfilgrastim) – see here – and that also involves an allegation of ineffective notice. For the most part, courts are still working on sorting out the second wave of BPCIA lawsuits involving participation in the patent dance process (PHS Act § 351(l)(2)-(l)(7)) and the timing of 180-day commercial notice (PHS Act § 351(l)(8)). Both issues are in dispute in a recent Complaint filed by Amgen against Hospira concerning a biosimilar version of EPOGEN (epoetin alfa) (BLA 103234).
Amgen’s Complaint (Case No. 1:15-cv-00839-RGA) – the first BPCIA-related Complaint filed in the U.S. District Court for the District of Delaware – alleges that Hospira violated PHS Act §§ 351(l)(8)(A), (l)(2)(A), and (l)(4) after Hospira engaged Amgen upon FDA notification that the Agency accepted Hospira’s BLA for a biosimilar version of EPOGEN. (The Complaint also alleges infringement of three patents, one of which was included in Amgen’s disclosure under PHS Act § 351(l(3)(A).) These issues, insofar as they concern the mandatory or voluntary nature of the patent dance process and the timing of notice, were tackled by the U.S. Court of Appeals for the Federal Circuit in a July 21, 2015 decision, but the decision has been appealed.
According to Amgen, “Hospira has chosen to ignore certain statutory requirements of the BPCIA that Congress put in place to protect innovators such as Amgen. Rather than follow the requirements of the BPCIA, Hospira has selectively decided to comply with certain provisions while refusing to comply with others.” First, Amgen alleges that “[a]lthough Hospira provided a copy of the Hospira BLA to Amgen, it did not provide Amgen with the other information describing the processes used to manufacture the Hospira Epoetin Biosimilar Product as required by § 262(l)(2)(A),” and that Hospira has repeatedly refused to provide information specifically identified by Amgen. None of the correspondence identified in Amgen’s Complaint is attached to the Complaint, so we’re unclear what that information is exactly. Is it information included in a Drug Master File (i.e., a submission of information to FDA to permit the Agency to review such information in support of a third party’s submission without revealing the information to the third party), or in some other submission to FDA? “By unlawfully withholding the information required by 42 U.S.C. § 262, Hospira has thereby frustrated the statutory purpose and deprived Amgen of the opportunity to seek redress for potential infringement. Amgen may therefore seek to assert additional patents following eventual receipt of Hospira’s manufacturing information to be produced in discovery in this action under the Federal Rules,” says Amgen in its Complaint.
Notwithstanding the alleged absence of certain information from Hospira, Amgen engaged Hospira in the patent exchange process of the patent dance. But Amgen says that Hospira has failed to cooperate. After accepting Amgen’s patent list provided pursuant to PHS Act § 351(l)(3)(A), “Hospira refused to engage in any of the negotiations required by [PHS Act § 351(l)(4)(A)]” in violation of the statute, according to Amgen.
Turning to notice of commercial marketing, Amgen says that the 180-day notice Hospira provided on April 8, 2015 is invalid. The Federal Circuit recently ruled in a severely split decison that valid notice can only be provided on or after FDA licensure of a biosimilar BLA. “Despite its obligation under § 262(l)(8)(A), Hospira provided Amgen with a purported (8)(A) notice on April 8, 2015, before Amgen had provided its initial disclosure of patents under (3)(A) and before Hospira received FDA approval for its Hospira Epoetin Biosimilar Product” (emphasis in original), says Amgen. “In serving a purported ‘notice of commercial marketing’ before its biosimilar product is licensed, Hospira intends to deprive Amgen of the statutory time period for considering the need for and, if appropriate, seeking adjudication of, a potential preliminary injunction motion. Therefore, Hospira intends to continue violating this provision of the BPCIA absent an order of the Court compelling Hospira to comply.”
In addition to patent-specific relief, Amgen has a laundry list of BPCIA-specific relief the company wants from the court. The relief includes: (1) orders “enjoining Hospira from commercially marketing the Hospira Epoetin Biosimilar Product until Amgen is restored to the position it would have been in had Hospira met its obligations under the BPCIA,” “enjoining Hospira from continuing to seek FDA review of its [biosimilar] application and/or compelling Hospira to suspend FDA review of its [biosimilar] application until Hospira has obtained permission from Amgen to use the EPOGEN® (epoetin alfa) license or Hospira has restored to Amgen the benefits afforded to Reference Product Sponsors in the BPCIA,” and “requiring Hospira to provide Amgen ‘such other information that describes the process or processes used to manufacture the biological product that is the subject of’ the Hospira BLA; (2) declarations that Hospira’s April 9, 2015 notice of commercial marketing is ineffective, and that Hospira has violated the BPCIA by failing to provide to Amgen by the statutory deadline certain manufacturing informatin; and (3) an injunction requiring notice of commercial marketing from Hospira to Amgen on or after FDA licensure of Hospira’s EPOGEN biosimilar application and prohibiting Hospira from launching its biosimilar until 180 days after notice is provided.