Amgen v. Hospira

Federal Circuit:  [O]nce a patent is listed by the sponsor, the BPCIA’s (Biologics Price Competition and Innovation Act) information exchange further requires the applicant to “provide to the . . . sponsor, with respect to each patent listed . . . a detailed statement that describes, on a claim by claim basis, the factual and legal basis of the opinion of the subsection (k) applicant that such patent is invalid, unenforceable, or will not be infringed.” 42 U.S.C. § 262(l)(3)(B)(ii) In other words, once a sponsor lists a patent under paragraph (l)(3)(A), the applicant must once again come forward with additional disclosures under paragraph (l)(3)(B) that inform whether “a claim of patent infri http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/16-2179.Opinion.8-8-2017.1.PDFngement . . . could” or could not “reasonably be asserted.” If the applicant fails to comply with its obligation to respond under paragraph (l)(3)(B), the sponsor would have a reasonable basis for asserting a claim of patent infringement. . . Thus, if a sponsor forms a belief based on an inquiry limited by an applicant’s withholding of information, the sponsor has still satisfied Rule 11.

These considerations dispel the notion that Amgen would have needed to bring suit simply based on its own unsupported belief. Hospira, in fact, agrees that Amgen could have validly listed its cell-culture patents under paragraph (l)(3)(A) and that Hospira would have been obligated to respond with “detailed statement[s]” under paragraph (l)(3)(B). In this scenario, Amgen would have had an opportunity to assess the reasonableness of its litigation position long before filing suit and being exposed to Rule 11 sanctions or antitrust liability. Thus, the reasonableness requirement of paragraph (l)(3)(A) does not preclude a sponsor from listing a patent for which an applicant has not provided information under paragraph (l)(2)(A).5 The denial of discovery in this case does not undermine the purpose of the BPCIA.

The district court correctly denied Amgen’s motion to compel on the ground that the composition of Hospira’s cell-culture media was of “no relevance to the patents that are asserted.” J.A. 37. Amgen has not established a clear and indisputable right to discovery of the information it seeks. It therefore has not established the prerequisites for this court to issue a writ of mandamus. 

http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/16-2179.Opinion.8-8-2017.1.PDF