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No Case or Controversy for Sandoz Without Biosimilar Application: Federal Circuit
Practical Law Legal Update 3-591-4369 (Approx. 4 pages)
No Case or Controversy for Sandoz Without Biosimilar Application: Federal Circuit
by Practical Law Intellectual Property & Technology
| Published on 09 Dec 2014 • USA (National/Federal) |
In Sandoz Inc. v. Amgen Inc., the US Court of Appeals for the Federal Circuit affirmed the US District Court for the Northern District of California's dismissal of Sandoz's suit seeking a declaratory judgment that certain patents licensed to Amgen Inc. were invalid, unenforceable and will not be infringed because there is no immediate and real threat of infringement creating an actual case or controversy.
On December 5, 2014, the US Court of Appeals for the Federal Circuit issued an opinion in Sandoz Inc. v. Amgen Inc., affirming the US District Court for the Northern District of California's dismissal of Sandoz's declaratory judgment suit, finding that no case or controversy existed between the parties (No. 2014-1693, (Fed. Cir. Dec. 5, 2014)). The Federal Circuit agreed and concluded that Sandoz had not sufficiently alleged an immediate and real injury sufficient enough to create subject matter jurisdiction.
Amgen Inc. is the exclusive licensee of US Patent Nos. 8,063,182 and 8,163,522, which claim the protein etanercept, the active ingredient in Enbrel, a biological product used to treat arthritis. In 1998, Amgen's predecessor, Immunex, received an Food & Drug Administration (FDA) Biologics License for Enbrel under 42 U.S.C. § 262(a) and 21 C.F.R. 601.
In 2010, Sandoz began a series of meetings with the FDA to plan for an application to market a biosimilar product to Enbrel. Sandoz began Phase III clinical trials for its contemplated etanercept product in 2013, and on the same day it began its trials, filed its complaint against Sandoz seeking declaratory judgment that:
- Sandoz's manufacture, use, sale, offer for sale, or importation of its version of etanercept will not infringe, directly or indirectly, any valid claim of either of Amgen's patents.
- Both patents are unenforceable due to prosecution laches.
- Both patents are invalid.
While Sandoz has consulted closely with the FDA and states that it splans to seek approval for its etanercept product, it had not filed an application under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which establishes an FDA-approval process for products shown to be biosimilar to a reference product.
The district court granted Amgen's motion to dismiss the complaint on the following grounds:
- Sandoz had not established a case or controversy because it had not shown a real and immediate injury or threat of future injury caused by Amgen.
- Sandoz could not bypass the procedures of the BPCIA for the narrowing and resolution of patent disputes between biosimilar applicants and reference-product sponsors.
In affirming the district court's ruling, the Federal Circuit focused its inquiry on whether Sandoz adequately presented a case of sufficient immediacy and reality by assessing:
- How far in the future the potential infringement is.
- Whether the passage of time might eliminate or change the dispute.
- How much, if any, harm the potential infringer is experiencing at the time of the suit.
- Whether the plaintiff will take an action that will expose it to potential infringement liability.
The Federal Circuit concluded Sandoz had not presented a case or controversy based on the following factors:
- Sandoz does not have, and has not even sought, market approval from the FDA and may or may not receive approval in the future.
- Sandoz is not engaged in any activity that would expose it to infringement liability. Sandoz is conducting clinical trials outside the US and moreover 35 U.S.C. § 271(e)(1) provides a safe harbor that exempts from infringement the use of patented compounds reasonably related to developing and submitting information to the FDA.
- Sandoz's clinical trials are still ongoing and may uncover unanticipated problems with etanercept that will further delay, or perhaps forestall, Sandoz's ability to apply for FDA approval.
- Further factual development is needed to aid the court's ability to identify and define the issues for resolution.
- Congress has not provided for litigants to engage suits where the potential infringer has not filed an FDA application for the approval required before it can undertake the activity for which it may want to clarify its liability.
Because the court affirmed the district court's decision on the basis of lack of case or controversy, it did not reach the court's secondary reasoning regarding the BPCIA.