Amgen has initiated new litigation over the patent provisions of the BPCIA, this time against Hospira in the U.S. District Court for the District of Delaware, regarding Hospira’s biosimilar application for FDA licensure of a biosimilar version of Amgen’s Epogen (epoetin alfa) product, which was approved by FDA in 1989 and is used for the treatment of anemia. The case is Amgen v. Hospira, No. 15-cv-839 (D. Del., filed Sept. 18, 2015).
As we’ve covered extensively in previous posts and in a webinar, Amgen is the plaintiff in the pioneer BPCIA case, Amgen v. Sandoz–the first case to reach judicial interpretations of the information disclosure provisions of the BPCIA’s “patent dance.” Although the impact of its decision is undergoing further litigation (see, for example, our posts on Janssen v. Celltrion), the Federal Circuit in Amgen v. Sandoz ruled on the issues of (1) whether the BPCIA information disclosure provisions are mandatory such that a reference product sponsor (“RPS”) can seek a court order compelling a biosimilar applicant to comply with provisions (2) when a biosimilar applicant may give effective notice of commercial marketing of its biosimilar product, and (3) whether such notice of commercial marketing is mandatory. Both Amgen and Sandoz have filed petitions for rehearing en banc for reconsideration of the panel’s split decision (see our posts here, here, and here).
Hospira has also been involved in early BPCIA litigation, as one of the defendants in Janssen v. Celltrion, a case pending in the District of Massachusetts (see our posts here).
In its most recent case against Hospira, Amgen makes some familiar claims regarding the interpretation of the BPCIA and its patent information exchange provisions. Amgen requests a “declaration of its rights under the [BPCIA]” and injunctive relief enforcing Amgen’s interpretation of the patent dance provisions. In its complaint, Amgen also claims that Hospira infringes two patents (U.S. Patent Nos. 5,856,298 and 5,756,349).
On February 23, 2015, Hospira notified Amgen that its 262(k) application for a biosimilar version of Epogen had recently been accepted for filing by FDA. On March 3, 2015, Hospira provided Amgen a copy of its biosimilar application. Hospira has allegedly refused to provide Amgen with “other information describing the processes used to manufacture the Hospira Epoetin Biosimilar Product as required by § 262(l)(2)(A).” (Compl. ¶ 46). The parties thereafter exchanged lists and detailed statements regarding patents that could reasonably be asserted against Hospira for its biosimilar epoetin product. Instead of negotiating with Amgen to narrow the list of patents to be litigated, Hospira apparently agreed that every patent Amgen listed could be asserted in a first wave of patent litigation.
On April 8, 2015, Hospira provided Amgen with a notice of commercial marketing purportedly in accordance with 262(l)(8). After the Federal Circuit issued its decision in Amgen v. Sandoz, Hospira notified Amgen that it would actually not provide any notice of commercial marketing under 262(l)(8), as such notice was not required in its case.
Amgen notes that according the FDA’s Authorization Performance Goals and Procedures, FDA may complete its final review of Hospira’s biosimilar application before November, 2015.
Amgen’s complaint alleges:
- “Hospira has chosen to withhold the manufacturing information that 42 U.S.C. § 262(l)(2)(A) required Hospira to provide to Amgen within 20 days of the FDA having accepted Hospira’s biosimilar application for review…thereby limit[ing] Amgen’s ability to identify patents that could reasonably be asserted against Hospira, [and] forcing Amgen to initiate this lawsuit to get the withheld information through discovery.” (Compl. ¶ 12).
- “Hospira has refused to engage in the good-faith negotiations with Amgen required by 42 U.S.C. §262(l)(4),” (to come to an agreement on a list of patents to be asserted in a first wave of infringement litigation), “purport[ing] to bypass its obligations by merely declaring that it was ‘accepting’ the patents that Amgen had initially listed.” (Compl. ¶¶ 13, 58).
- “Hospira has declared that it will not comply with 42 U.S.C. § 262(l)(8)(A), which requires Hospira to provide Amgen with 180 days’ notice of its first commercial marketing, on or after FDA licensure of the Hospira Epoetin Biosimilar Product.” (Compl. ¶14)
- “Hospira has infringed patents that Amgen has identified under 42 U.S.C. § 262(l)(3)(A) and, upon information and belief, Hospira will infringe one or more claims of these patents should it commercially manufacture, use, offer for sale, sell, or import into the United States the Hospira Epoetin Biosimilar Product.” (Compl. ¶15).
Amgen argues that the BPCIA struck a careful balance between innovation and competition for biologic products, with the patent information exchange provisions playing a crucial role in the compromise: “On one side of the balance, the BPCIA created an abbreviated approval pathway” to allow biosimilar applicants to reference an approved biologic product “rather than incurring the delay and costs of generating its own clinical data.” (Compl. ¶¶28, 30). “On the other side of the balance, Congress implemented a detailed procedure to protect the interests of the RPS, tying this procedure to the biosimilar applicant’s choice to submit a [biosimilar application] under, and gain the benefit of, the abbreviated § 262(k) pathway.” (Compl. ¶33). Part of this “detailed procedure,” Amgen continues, is a requirement that the biosimilar applicant provide notice of commercial marketing not later than 180 days before the date of first commercial marketing of the biosimilar product.
Amgen details the investment, cost, and clinical testing required for an RPS to develop a biologic product, and argues that in exchange for “avoiding” these expenses by using the BPCIA’s abbreviated approval pathway, a biosimilar applicant must comply with all the steps of the BPCIA’s patent information exchange provisions. As such, Amgen claims, “Hospira’s choice to submit its BLA using the abbreviated subsection (k) pathway triggered its mandatory obligation to also comply with the disclosure obligations at the outset of FDA review. 42 U.S.C. § 262(l)(1)(B)(i).” (Compl. ¶ 41).
While Amgen references the Federal Circuit’s holding in Amgen v. Sandoz that “Sandoz’s failure to provide its BLA and other manufacturing information to Amgen…did not violate the BPCIA,” it quotes at length Judge Newman’s dissent on that issue, and notes that “Amgen is currently seeking en banc review of the panel majority’s erroneous decision.” (Compl. ¶49).
Amgen also cites the Federal Circuit’s opinion in Amgen v. Sandoz for support of its claim against Hospira regarding the BPCIA’s notice provision. According to Amgen, Hospira has taken the position that, under (l)(8) and the Federal Circuit’s interpretation of that provision, Hospira is not required to provide any notice of commercial marketing to Amgen. (Note that Hospira has made a similar argument in Janssen v. Celltrion–see our post here). Amgen argues that the Federal Circuit decided this issue already in favor of Amgen’s interpretation that “[t]he biosimilar applicant’s obligation to provide this advance notice of commercial marketing is mandatory…[and] not conditioned on performance of any act by the RPS, nor exempted if the biosimilar applicant fails to make the initial disclosures under 42 U.S.C. § 262(l)(2)(A).” (Compl. ¶35).
As noted above, Amgen’s Complaint also asserts two patents. Regarding its ‘298 patent, Amgen claims “[o]n information and belief” that “Hospira intends to, and will, manufacture, use, offer to sell, or sell within the United States the Hospira Epoetin Biosimilar Product before the expiration of the ‘298 Patent.” (Compl. ¶96). Amgen states that such “information and belief” includes “Hospira’s failure to state otherwise in its disclosures required by the BPCIA.” Interestingly, this possibility–that an RPS might use traditional discovery mechanisms in a lawsuit initiated “on information and belief” to seek information withheld by a biosimilar applicant who opts not to engage in the patent dance–was suggested by Judge Seeborg in the district court opinion in Amgen v. Sandoz (see the district court opinion at 11, n. 6: “[A] reference product sponsor who believes it may have an infringement claim can file suit to access the biosimilarity BLA, manufacturing process, and other relevant information via discovery—as in any other typical instance of potential infringement.”)
We will be monitoring this new case closely, and will post further developments here on the Big Molecule Watch.