By Kurt R. Karst –
There’s been a lot of activity in the budding biosimilars world this year, and it’s only February. On the FDA front, the Agency reportedly has 5 Section 351(k) biosimilars applications under review: (1) Sandoz’s version of Amgen’s NEUPOGEN (filgrastim); (2) Celltrion’s version of Johnson & Johnson’s REMICADE (infliximab); (3) Apotex’s version of Amgen’s NEULASTA (pegfilgrastim); (4) Apotex’s version Amgen’s NEUPOGEN; and (5) Hospira’s biosimilar version of Amgen’s EPOGEN (epoetin alfa) (also marketed by Johnson & Johnson as PROCRIT). Earlier this year, FDA held the first advisory committee meeting for a biosimilar – for Sandoz’s filgrastim (see our previous post here). A second advisory committee meeting for Celltrion’s infliximab was scheduled for March 17, 2015, but has been postponed “due to information requests pending with the sponsor of the application.” FDA action on Sandoz’s Section 351(k) application for filgrastim is expected within the coming weeks; however, even if FDA approves the application, it appears that the launch of the product will be delayed. In a recent court filing, Sandoz agreed that the company “will not launch its biosimilar filgrastim product in the United States until the earlier of April 10, 2015, or a ruling in Sandoz’s favor on Amgen’s Motion.” And that’s our segue to the litigation front of the biosimilars world, where things remain hot.
As we previously reported (here and here), last October, Amgen filed a Complaint in the U.S. District Court for the Northern District of California alleging that Sandoz has unlawfully refused to follow certain procedures created by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). In particular, Amgen alleges that Sandoz opted out of the information exchanges at PHS Act § 351 (l)(2)(A)-(l)(5), but that such option does not exist; and that despite Sandoz’s assertions that the company already provided 180-day notice of commercial marketing to Amgen required under PHS Act § 351(l)(8)(A), such notice cannot be provided until at least FDA approval of a Section 351(k) application. In making these allegations, Amgen asserts three causes of action: (1) unfair competition under Cal. Bus. & Prof. Code § 17200 et seq.; (2) conversion; and (3) infringement of U.S. Patent No. 6,162,427 covering a method of using NEUPOGEN to treat a disease requiring peripheral stem cell transplantation in a patient in need of such treatment.
Earlier this year, Amgen filed a Motion for Judgment on the Pleadings or, in the Alternative, Motion for Partial Summary Judgment. That triggered Sandoz to file a Cross-Motion for Judgment on the Pleadings and Opposition to Amgen’s Motion for Judgment on the Pleadings (Amgen’s opposition brief and Sandoz’a reply brief are available here and here). But as the days went by and the date by which FDA is scheduled to act on Sandoz’s Section 351(k) application crept closer (in early March), Amgen finally decided that the company needed to seek emergency relief.
On February 5th, Amgen filed a Motion for a Preliminary Injunction in a bid to restrain Sandoz from engaging in the commercial manufacture, use, offer to sell, sale within or importation into the U.S. of its biosimilar filgrastim product until the California District Court decides the parties’ Motions for Judgment on the Pleadings (and, if the court resolves those motions in Amgen’s favor, until, the parties have been placed in the position they would be in had Sandoz complied with the BPCIA). “Sandoz has sandbagged Amgen,” says Amgen in its court filing. “It has refused to provide its BLA and manufacturing information, frustrating Amgen’s ability to determine which of its many patents it can assert against Sandoz. And Sandoz intends to launch its product immediately upon FDA licensure, rather than waiting the 180 days required by the law. That is why Amgen brings this motion for a preliminary injunction.” Among other things, Amgen says that “[i]f Sandoz is permitted to launch its product without having provided the information and time to Amgen as the statute provides, Amgen will be irreparably harmed by losing the opportunity afforded it under the BPCIA to exercise its exclusionary patent rights and seek a preliminary injunction before Amgen is injured by the entry of Sandoz’s biosimilar product.” That irreparable harm will, according to Amgen, come in the form of harm to research and development, harm to new products in their infancy, price erosion for NEUPOGEN (and Amgen’s NEULASTA), and damage to customer relationships and loss of goodwill.
Hogwash!, says Sandoz in it opposition brief filed earlier this week. Amgen hasn’t established any of the four factors necessary to support a preliminary injunction: (1) whether Amgen will be irreparably harmed in the absence of an injunction; (2) Amgen’s likelihood of success; (3) the balance between the harm to Amgen and the harm to Sandoz; and (4) the public interest. It’s a chair without any legs – meaning that it’s either held up by magic, or that it must come crashing down to the ground.
Sandoz argues that Amgen’s Motion for a Preliminary Injunction fails for myriad reasons:
First, Amgen cannot show it is likely to succeed on the merits. Amgen seeks to convert a “notice” provision for resolving patent disputes into an “exclusivity” provision. Adopting Amgen’s interpretation would defy Congress’s intent (as expressed in the statute’s plain language) by extending the exclusivity period from 12 years to 12.5 years. . . .
Second, Amgen cannot show irreparable harm for multiple reasons . . . . Amgen claims that it has been harmed because it did not receive Sandoz’s filgrastim application in July 2014, and so it allegedly could not determine what patents it might potentially be able to assert against Sandoz. But that alleged harm is of Amgen’s own making. The BPCIA contemplates a maximum of 60 days for a Sponsor to identify any applicable patents after receiving a 42 U.S.C. § 262(k) application. Amgen cannot deny (and therefore ignores) that Sandoz offered to produce its Application seven months ago in July 2014, and multiple times since then, subject only to reasonable confidentiality protections. Amgen chose to decline all of those offers. . . . Amgen’s alleged harms are not only self-inflicted, they run afoul of two other black-letter rules governing preliminary injunctions: neither speculative injuries nor compensable monetary losses qualify as irreparable harm.
Third, the balance of equities heavily favors Sandoz. Sandoz is poised to launch the first biosimilar filgrastim in the United States, and an injunction would jeopardize the first-to-market advantage in which it has invested years of effort and tens of millions of dollars. By contrast, denial of the requested injunction would not impose any undue hardship on Amgen. . . .
Fourth, the public interest factor forecloses Amgen’s request. The BPCIA expressly seeks to balance two key public purposes: innovation and consumer interests. Amgen has been amply rewarded for its innovation, enjoying 24 years of exclusivity although Congress concluded in the BPCIA that 12 years meets the public’s interest in innovation.
A hearing on the outstanding Motion for Preliminary Injunction and Motions for Judgment on the Pleadings is scheduled for March 13, 2015 at 10:00 AM.