On April 3, 2017, the Federal Circuit heard oral argument concerning the discovery dispute between Amgen and Hospira in their litigation concerning Hospira’s proposed biosimilar of Amgen’s product Epogen®/ Procrit® (epoetin alfa) (audio available here). In this dispute, Amgen is seeking to compel production of information concerning Hospira’s manufacturing process, including information regarding four components of Hospira’s cell culture medium. Hospira argues that this information is not discoverable because it is not relevant to Amgen’s infringement allegations. The oral argument was primarily focused on the impact of the Federal Circuit’s holding in Amgen v. Sandoz on the scope and timing of discovery.
Amgen argued that under Amgen v. Sandoz, when there is an artificial act of patent infringement under the BPCIA, an RPS is allowed discovery with regard to potential infringement of any patent. In other words, according to Amgen, there is an ancillary discovery process implied by (l)(2)(A) that allows Amgen to obtain all the information relating to the aBLA product. Amgen argued that the scope of discovery is dependent on the aBLA product, not the asserted patents. Amgen therefore argued that under Amgen v. Sandoz, it should be granted the discovery and be permitted to assert additional patents based on that discovery.
When asked what is preventing Amgen from filing a new complaint under Section 271(e)(2)(C)(ii), Amgen stated that it could not assert any process patents against Hospira while satisfying Rule 11’s “reasonable belief of infringement” standard, because they did not have Hospira’s manufacturing information. Amgen was pressed as to why Rule 11 applies when Section 271(e)(2)(C) allows for a party to bring a suit for an artificial act of infringement when information is withheld. Amgen pointed to the practical considerations stemming from an inability to sufficiently plead infringement without having the manufacturing information. Amgen also argued that under (l)(2)(A), the scope of disclosure is not contingent on the patents asserted, but rather that substantially all information about both the product and the manufacturing process is required. Amgen argued that to decide otherwise would result in an inefficient process where all patents must be asserted up front in order to obtain the necessary discovery, and later dismissed if an infringement claim did not lie.
Hospira argued that the BPCIA does not trump Rule 26’s strictures on the scope of discovery, and because Amgen did not assert manufacturing process patents, it is not entitled to discovery of Hospira’s manufacturing information. Hospira argued that Section 271(e)(2)(C) has two subsections that deal with two distinct scenarios. Subsection (i) deals with cases where a patent is identified in the section 351(l)(3) list and subsection (ii) deals with cases where the applicant fails to provide the application and information required under section 351(l)(2)(A). Hospira also argued that it fully complied with the disclosure provisions of (l)(2)(A) by opting to provide comprehensive information concerning its product and processes within the 20-day BPCIA timeframe. Hospira argued that 271(e)(2)(C)(ii) does not apply when an aBLA filer opts into the patent dance and complies with the disclosure provisions of (l)(2)(A). For these reasons, Hospira’s position is that this litigation falls under 271(e)(2)(C)(i) and there is no ambiguity despite the fact that Amgen’s complaint only enumerates 271(e)(2)(C) without further specifying subsection (i) or (ii). Hospira went on to argue that even in cases where the aBLA filer does not fully comply, but makes a good faith effort to comply with the disclosure provisions of (l)(2)(A), 271(e)(2)(C)(ii) is not necessarily triggered. Hospira argued that this case is distinguishable from Amgen v. Sandoz because, unlike Sandoz, Hospira affirmatively opted into the patent dance and complied with the disclosure provisions of (l)(2)(A).
We previously covered the discovery dispute in Amgen v. Hospira here and here. We also reported on the appeal here and here. A full list of our coverage on the Amgen v. Hospira litigation is available here.