On September 18, 2015, Amgen Inc. (Amgen) sued Hospira Inc. (Hospira) in the U.S. District Court for the District of Delaware for allegedly violating the information sharing and advance-notice provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) as well as for infringement of U.S. Patent Nos. 5,856,298 and 5,756,349.
In December 2014, Hospira submitted a 351(k) application (Biologic License Application No. 125545) to the U.S. Food and Drug administration (FDA) for a biosimilar version of Amgen’s anti-anemia drug EPOGEN® (epoetin alfa). EPOGEN® was approved by the FDA for the treatment of anemia associated with chronic renal failure (including end-stage renal disease). Over time, additional approvals were obtained, specifically, for use in patients with certain cancers suffering from anemia due to concomitant chemotherapy and in patients with HIV infection and anemia due to antiviral drugs. Since approval, Amgen has manufactured and sold EPOGEN® in the U.S. for the treatment of anemia associated with chronic kidney disease in patients with dialysis. FDA is expected to complete its review of Hospira’s product by November 2015.
On February 23, 2015, Hospira notified Amgen that its 351(k) application had been accepted by the FDA. On March 3, 2015, Hospira provided a copy of its application to Amgen but did not provide its marketing information as required by the information-sharing provisions of the BPCIA. Amgen sent four letters to Hospira (on March 31, April 17, April 27 and May 1, 2015) identifying that the manufacturing information was missing. Hospira allegedly refused to provide this information (and thus, did not provide the information within 20 days of receiving notification of FDA acceptance of its application for review).
Despite the absence of the manufacturing information, Amgen engaged Hospira in the patent exchange process of the patent dance. Specifically, Amgen provided Hospira with a list of patents Amgen believed could be reasonably asserted within 60 days of receipt of Hospira’s 351(k) application. Additionally, within 60 days of receiving Hospira’s statement, Amgen provide its reciprocal statement on a claim-by-claim basis as well as the factual and legal basis for its opinion that each patent was infringed as well as a response to Hospira’s statement regarding validity and enforceability. However, Amgen alleges that Hospira has refused to engage in “good-faith negotiations” to agree which, if any, patents would be the subject of an action for patent infringement. Instead, Hospira decided simply to “accept” the patent listed by Amgen.
Regarding the advance-notice provisions, on April 9, 2015, Hospira provided Amgen with 180-day advance notice of commercial marketing. On May 8, 2015, Amgen objected stating that the notice was premature (and hence invalid) but Hospira allegedly refused to withdraw it. On August 18, 2015, after the Federal Circuit issued its decision in Amgen v. Sandoz (Amgen), Amgen renewed its objection and requested Hospira confirm that it would follow the law. However, according to the complaint, Hospira allegedly refused to acknowledge the import of the holding in Amgen and according to correspondence dated August 19 and September 15, 2015, took the position that it would not provide any notice of commercial marketing. Specifically, in its complaint Amgen states that “Hospira has categorically represented to Amgen that it does not intend to provide Amgen with notice of commercial marketing after the FDA licenses the Hospira Epoetin Biosimilar Product and 180 days before commercial marketing of the Hospira Epoetin Biosimilar Product is to be begin”.
In addition to patent-specific relief, some of the relief Amgen requested includes:
- An order enjoining Hospira from commercially marketing its biosimilar version of EPOGEN® until Amgen is restored to the position it would have been had Hospira met its obligations under the BPCIA;
- An order enjoining Hospira from continuing to seek FDA review of its 351(k) application and/or compelling Hospira to suspend FDA review of its application until Hospira obtained permission from Amgen to use the EPOGEN® license or Hospira has restored Amgen the benefits afforded to reference product sponsors under the BPCIA;
- A declaration that the notice of commercial marketing that Hospira provided on April 9, 2015 was ineffective;
- An injunction requiring Hospira to provide Amgen, on or after FDA licensure of its biosimilar, notice of the date of first commercial marketing and prohibiting Hospira from beginning such marketing until 180 days after Hospira provides the requisite notice; and
- A declaration that Hospira violated the BPCIA by failing to provide Amgen with its manufacturing information by the statutory deadline.
Please continue to watch the BRIC Wall Blog for updates on this and other biosimilar litigation.
This post was written by Lisa Mueller