This week, the Federal Circuit issued a much-anticipated precedential decision in Amgen, Inc. v. Hospira, Inc., No. 2016-2179 (Fed. Cir. Aug. 10, 2017), rejecting Amgen’s efforts to compel discovery regarding aspects of Hospira’s biosimilar application relevant to patents Amgen chose not to identify during the “patent dance” established by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). While much of the court’s discussion is dictum, the opinion nonetheless provides important guidance to reference product sponsors regarding what patents can and should be identified under 42 U.S.C. § 262(l)(3)(A).

The underlying litigation arose when Hospira filed an application under § 262(k) seeking to market a biosimilar version of Amgen’s approved biological product known as EPOGEN®. Hospira provided Amgen with a copy of its biosimilar application but did not provide further manufacturing information. Amgen requested further information regarding cell culture media used in producing Hospira’s biosimilar product, but Hospira contended that its application satisfied its disclosure obligations under the BPCIA and declined to provide further information. Amgen proceeded to identify patents on which “a claim of patent infringement could reasonably be asserted” upon production and sale of Hospira’s proposed biosimilar, pursuant to § 262(l)(3)(A). Amgen identified several patents that claim the biological product and methods of using that product. Amgen declined, however, to identify any patents covering cell culture processes used in manufacturing the biological product because Amgen could not “assess the reasonableness of asserting claims for infringement” of those patents without the requested cell culture information from Hospira. Amgen ultimately filed suit against Hospira based on product and method-of-use patents.

During discovery, Amgen sought information regarding Hospira’s cell culture processes. Hospira refused to produce the requested cell culture information, and Amgen filed a motion to compel. The district court denied Amgen’s motion, concluding that the requested cell culture information had “no relevance to the patents that are asserted.” Amgen appealed that interlocutory order to the Federal Circuit.

The Federal Circuit panel—in an opinion by Judge Dyk joined by Judges Bryson and Chen—dismissed Amgen’s appeal, concluding that it lacked jurisdiction because the district court’s discovery order was neither a final judgment nor an appealable collateral order. The court also rejected Amgen’s alternative request for mandamus, concluding that Amgen had not established a clear and indisputable right to the requested discovery because all parties agreed that cell culture information was not relevant under FRCP 26 to the patents actually in suit.

Most interesting, however, was the court’s additional discussion of pleading standards under FRCP 11. Amgen argued that, absent broad discovery, a biosimilar applicant like Hospira could block assertion of manufacturing patents by withholding manufacturing data during the patent dance. Amgen argued that in such situations reference product sponsors could not form a good-faith belief that manufacturing patents “could reasonably be asserted” and would risk Rule 11 sanctions by listing such patents under § 262(l)(3)(A). The court sought to assuage those concerns by noting that the BPCIA calls on reference product sponsors to list those patents that could reasonably be asserted and “provides no sanction for holding or asserting a mistaken belief in good faith.” Furthermore, the court stated that Rule 11 permits allegations filed “to the best of the person’s knowledge, information, and belief” and those that will “likely” have evidentiary support after further investigation or discovery. Accordingly, the court suggested that a reference product sponsor that “forms a belief based on an inquiry limited by the applicant’s withholding of information” would satisfy Rule 11. Amgen thus could have listed cell culture patents under § 262(l)(3)(A).

While the court’s discussion of what patents Amgen could have listed under § 262(l)(3)(A) and how subsequent pleadings might have fared under Rule 11 likely constitute dicta, those statements nevertheless are likely to carry considerable weight with district courts and future Federal Circuit panels considering the scope of permissible pre-suit patent listings and infringement claims in BPCIA litigation. Reference product sponsors should know to list all potentially relevant patents early, regardless of perceived deficiencies in a biosimilar applicant’s initial disclosures.

Other Notable Decisions – Week of August 11, 2017

AIA America, Inc. v. Avid Radiopharmaceuticals, No. 2016-2647 (Fed. Cir. Aug. 10, 2017) (precedential). The Federal Circuit affirmed an award of attorney’s fees under 35 U.S.C. § 285, holding that the Seventh Amendment right to a jury trial does not apply to fee requests under § 285. The district court awarded fees against the plaintiff-appellant AIA America following a jury trial on standing; the jury concluded that AIA America lacked standing to assert the patents-in-suit because individuals associated with AIA America had intentionally misrepresented inventorship and assignment information when prosecuting and obtaining title to those patents. AIA America appealed, arguing that the Seventh Amendment requires a jury to find facts underlying fee awards under § 285. The court rejected that argument, concluding that § 285 provides an equitable rather than legal remedy and therefore does not implicate the constitutional right to jury trial.