Hospira: Amgen's Biosimilar Lawsuit Fatally Flawed

Amgen Inc.'s lawsuit claiming Hospira Inc. violated certain provisions of the Biologics Price Competition and Innovation Act (BPCIA) – the law that established the regulatory pathway for the FDA to approve biosimilars – is fatally flawed because it's seeking to "privately enforce" statutory provisions, despite the fact the US Congress did not create a structure for such enforcement, the latter company charged in court documents filed this week.

Amgen has insisted that instead of following the BPCIA's requirements, Hospira has "selectively decided" to comply with certain provisions, while refusing to comply with others.

Specifically, Amgen last month accused Hospira, a unit of Pfizer Inc., of failing to provide manufacturing information within 20 days of the FDA's acceptance of the latter firm's so-called 351(k) marketing application for its epoetin alfa biosimilar, referenced on the former firm's Epogen, noted Alexandra Lu, an associate in the litigation group at Goodwin Procter's Boston office.

Amgen also said Hospira did not comply with the requirement to provide 180 days notice of first commercial marketing, she explained.

Hospira, however, has asked the US District Court for the District of Delaware to dismiss those counts – declaring that it timely produced its epoetin alfa application to Amgen and is not required to provide any notice of commercial marketing.

The case is one of three biosimilars lawsuits Amgen currently is pursuing in the courts. The company's other suits are against Novartis unit Sandoz, which involves the latter firm's Zarxio (filgrastim-sndz) – the first biosimilar approved in the US – and Apotex, which has a 351(k) application before the FDA seeking to market a pegfilgrastim biosimilar.

Those biosimilars are referenced on Amgen's Neupogen and Neulasta, respectively.

Amgen and Sandoz currently are waiting for a decision on whether the full US Court of Appeals for the Federal Circuit will rehear their arguments after a three-judge panel on July 21 gave each side a win, but also each side a loss.

The rulings in Amgen's three lawsuits – along with one filed by Johnson & Johnson unit Janssen against Celltrion involving its infliximab biosimilar – are expected to provide some of the earliest legal interpretations of the BPCIA, having broad implications for the future of the industry.

And innovators and biosimilars makers alike are vigorously fighting in the courts to ensure those BPCIA interpretations go in their favor.

In court documents, Hospira argued that after the FDA accepted the firm's 351(k) application for its epoetin alfa biosimilar, the company said it provided Amgen a copy, which contained "hundreds of thousands of pages" with "comprehensive and detailed information."

Hospira said it disagreed with Amgen that there were any deficiencies in the disclosures.

Hospira said it provided Amgen a notice of commercial marketing in April. But a month later, Amgen objected, arguing the notice was "premature," and therefore, ineffective because it was given too early.

Hospira pointed out that the Federal Circuit panel in July ruled 2-1 in the Sandoz suit that biosimilar makers could opt out of BPCIA's disclosure and negotiation procedures, commonly called the "patent dance," and therefore would not have to disclose their applications and manufacturing details, if they chose to do so.

So, Hospira said, the Sandoz ruling, as it currently stands, established that a notice of commercial marketing is not mandatory "unless" the applicant "completely fails" to participate in the BPCIA patent-exchange process.

"The BPCIA, as interpreted by the Federal Circuit in Sandoz, therefore prevents a situation where the applicant does not disclose its application and launches upon FDA approval without any prior notice," Hospira said.

Earlier, Amgen had identified three patents that it said it believed a claim of patent infringement could reasonably be asserted.

On June 19, Hospira provided Amgen with its detailed factual and legal basis for its opinion that the three identified patents were invalid and unenforceable and would not be infringed by the importation, commercial manufacture, offer to sell, sale, or use of the epoetin alfa biosimilar and said it did not intend to begin commercial marketing of the product before patent expiration.

And on Aug. 19, Hospira said it would accept the full list.

Amgen filed its suit on Sept. 18.

But Hospira said that while it looked forward to a trial on the merits concerning Amgen's infringement claims, the biosimilar maker said the California biotech giant's attempt to "carve out private rights of action in contravention of plain statutory text and clear congressional intent is legally meritless."

Essentially, Goodwin Procter's Lu told Scrip, Hospira is arguing the BPCIA claims in the lawsuit should be dismissed not only because the company has not violated the law, "but more fundamentally, because Amgen does not even have the right to bring such claims."

Hospira is contending Amgen cannot go through the courts to compel compliance with the information disclosure and notice provisions of the BPCIA, because the statute provides no recourse to the courts to enforce its provisions, she said, noting the company argued in its documents the law "contains no rights-creating language entitling Amgen to bring a private right of action to remedy any purported injury."

"Hospira likens this case to a line of Hatch-Waxman cases in which the Federal Circuit declined to create a private right of action where the statute did not explicitly provide one," Lu said.

"Here, too, Hospira argues, there is no evidence that Congress intended to create a private right of action to enforce compliance with the BPCIA patent information exchange and notice provisions, and therefore the court should similarly decline Amgen's invitation to find or create a private right of action in this case," she explained.

"It will be interesting to see how this issue plays out in this case and other pending BPCIA litigation," Lu said.

She noted that Hospira commented in a footnote that Amgen did not assert a private right of action in Amgen v. Sandoz, "so the Federal Circuit did not directly address this question of whether a private right of action exists under the BPCIA."

Now, Lu said, that question is before two courts – the US District Court for the District of Delaware in Amgen v. Hospira, and at the US District Court for the District of Massachusetts in and in Janssen v. Celltrion – a case in which Hospira also is a defendant.

"With familiar players litigating similar issues in different courts, it seems we may have the makings of a race to a decision on these post-Amgen v. Sandoz BPCIA questions," she declared.