As we covered in a previous post, the Court in Amgen v. Hospira ruled on some novel issues relating to litigation under the BPCIA during a hearing on discovery issues a few months ago.
To recap: this past May, the district court for the District of Delaware (Judge Andrews) held a hearing to resolve discovery disputes regarding two categories of information sought by Amgen:
(1) specific manufacturing information regarding Hospira’s proposed biosimilar epoetin alfa product, and
(2) FDA correspondence going forward between Hospira and FDA regarding Hospira’s proposed biosimilar.
(See Amgen’s letter to the Court regarding the discovery dispute, here, and Hospira’s letter in response, here.)
The Court rejected Amgen’s argument that the BPCIA compels production of manufacturing information even if it bears no relevance to the patents that the reference product sponsor (“RPS”) has asserted in litigation under the BPCIA. Judge Andrews noted that to the extent Amgen was requesting the specific manufacturing information in order to assess what other patents it might be able to assert against Hospira, this was not the proper way to do so. On the first category of requested information, the Court thus decided that Hospira would be compelled to produce the additional information only insofar as it was allegedly relevant to one of the claims already asserted in the case. (*Note: as explained in the parties’ filings on appeal, Hospira thereafter informed Amgen that it would not contest that its manufacturing process meets the relevant asserted claim limitation, and Hospira was therefore not required to produce the requested information under the district court’s limited ruling.)
The Court denied Amgen’s second request (to compel Hospira to produce FDA correspondence on a “going-forward basis” so that Amgen can determine when Hospira will be ready to launch, and whether Hospira amends its aBLA in a way that would implicate other Amgen patents). Hospira had agreed to produce FDA correspondence relevant to the pending infringement claims, but otherwise objected to the extent Amgen sought correspondence not related to the subject matter of the patents-in-suit. Judge Andrews stated that the requested scope of correspondence seemed to bear no relevance to the asserted patents, and stated that “the line that Hospira has drawn is the right line” regarding what FDA correspondence is properly discoverable in this case.
The transcript of the hearing during which these rulings were made is available here, attached to Amgen’s Notice of Appeal of the Court’s order denying Amgen’s motion to compel Hospira to produce the requested manufacturing information.
Hospira’s Motion to Dismiss
On July 8, 2016, Hospira filed a motion to dismiss Amgen’s appeal, alleging that the Federal Circuit “lacks jurisdiction over Amgen’s appeal of the district court’s discovery ruling because the discovery ruling is neither a ‘final decision’ of the district court nor a collateral order.” Hospira argues that “[t]he Court of Appeals’ jurisdiction is limited to the review of ‘final decisions of district courts,'” and the district court’s discovery ruling in this case is not a “final decision,” and is reviewable on appeal from a final judgment on the merits of the case.
Amgen’s Opposition to Motion to Dismiss
Amgen filed an opposition to Hospira’s motion to dismiss on July 18, 2016, arguing that its appeal “falls within a narrow exception to the final judgment rule,” as it is a “collateral order” that:
(i) “conclusively resolved the issue on appeal” (i.e. whether Hospira is required to produce the requested manufacturing information);
(ii) “decided an important issue separate from the merits” (i.e. “that discovery in a 35 U.S.C. § 271(e)(2)(C) patent infringement action is unavailable to remedy an applicant’s non-compliance with paragraph (2)(A)”); and
(iii) “is not effectively reviewable on appeal from final judgment because it will categorically deny [Reference Product] Sponsors the opportunity to seek pre-marketing injunctions on process patents.”
Amgen argues that under Amgen v. Sandoz, its remedy “for Hospira’s failure to comply with the disclosure provision of [the BPCIA’s] paragraph 2(A) is to file a patent infringement action under 35 U.S.C. § 271(e)(2)(C) and seek the manufacturing information in discovery.” According to Amgen, the district court’s ruling effectively forecloses Amgen from obtaining the requested information unless it has already initiated an infringement action to which the requested information is relevant; but, Amgen argues, it could not have brought the necessary infringement action without access to the requested information, which could provide the predicate factual basis required for such an action. The appeal, Amgen argues, thus “raises an important public interest [issue] under the BPCIA” that is “completely separate from the merits of the underlying case.” According to Amgen, “[i]f Hospira is able to rely on this Court’s decision in Amgen v. Sandoz to withhold information expressly called for by paragraph (2)(A) in the BPCIA pre-suit process, and then refuse to provide discovery of that withheld information in a subsequent suit, Hospira and future biosimilar applicants will be able to evade detection of patent infringement….”
Amgen also argues that the issue on appeal, i.e. whether an RPS can enforce its “unique set of rights” under the BPCIA “to assess its patent rights, sue for patent infringement, and obtain remedies before Hospira begins marketing its biosimilar product,” is not one that can await resolution on appeal of a final judgment on the merits of the underlying infringement case.
Hospira’s Reply in support of its Motion to Dismiss
Last week, on July 25, 2016, Hospira filed a reply in support of its motion to dismiss the appeal. Hospira argues that under Amgen v. Sandoz, the RPS does not have a procedural right to compel compliance with the disclosure provisions of BPCIA paragraph (l)(2)(A); thus, Amgen can compel production of the requested information only if it is relevant to the underlying claims in the litigation. The discovery dispute, Hospira argues, is therefore tied to the merits of the case, as the Federal Circuit would have to consider Amgen’s claims against Hospira to determine the relevance of the requested information–and “[b]ased on both Supreme Court and Federal Circuit precedent, wading into the merits at this stage of the litigation would respectfully be ill-advised and untimely.”
Furthermore, Hospira argues, the district court’s order “is effectively reviewable on appeal from final judgment,” and contrary to Amgen’s assertions, Amgen will not lose any rights if it appeals the discovery order following final judgment in the underlying case. Hospira argues that under the BPCIA patent dance provisions, “Amgen had the ability and indeed was required to list any potentially relevant cell culture patents on its paragraph (3)(A) list. Alternatively, if it felt that Hospira had violated paragraph (2)(A), it could have included the cell culture patents in an immediate infringement claim against Hospira. Instead, it chose to sue on some patent claims, and later instigate a discovery dispute concerning [cell-culture] documents unrelated to its current infringement claims that it is not entitled to obtain in this lawsuit.” This “piecemeal litigation strategy,” Hospira contends, “is precisely what the BPCIA sought to avoid.” Even so, Hospira argues, if Amgen “were ultimately successful on appeal” at a later date, it “would still be able to seek both injunctive relief and damages after final judgment.”
We will continue to track this appeal and the underlying district court litigation, in which Hospira’s motion to dismiss Amgen’s BPCIA notice-provision remains pending. Stay tuned to the Big Molecule Watch for further developments.