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Amgen’s Federal Circuit Appeal: the Importance of Manufacturing Information to Biosimilar Litigation

Amgen has filed its appeal brief in Amgen v. Hospira, following the Federal Circuit’s denial of Hospira’s motion to dismiss the appeal for lack of jurisdiction.  The appeal presents an important question for biosimilar litigation:  where biosimilar applicants fail to provide manufacturing information in the pre-litigation information exchanges of the Biologics Price Competition and Innovation Act (BPCIA), are they required to provide that information in litigation even if it is irrelevant to the asserted patents?  The question is particularly important because if the answer is no as the district court held, then innovator companies will be forced to assert manufacturing patents that they do not know to be infringed in order to be able to obtain discovery to evaluate their infringement.  Amgen also addresses whether the Federal Circuit has jurisdiction to hear the appeal under either the collateral order doctrine or the All Writs Act.

Amgen makes three main arguments as to why manufacturing information that was withheld under the BPCIA’s pre-litigation information exchanges must be disclosed during discovery irrespective of what specific patents are first asserted in the litigation.

First, Amgen argues that the Federal Circuit held in Amgen v. Sandoz that discovery was the appropriate means to access information that a biosimilar applicant failed to provide during the BPCIA’s statutory information exchange under paragraph 262(l)(2)(A).  According to Amgen, the district court misinterpreted the Federal Circuit’s decision and erred in not compelling Hospira to provide the manufacturing information required by 262(l)(2)(A) unless it was relevant to a patent already in suit.  Amgen argues that the statement in Amgen v. Sandoz that an innovator company can “access the required information through discovery” is not an observation “in passing” as Hospira argues.  Rather, it is central to the Federal Circuit’s decision since the court interpreted the statute to provide discovery in litigation as the remedy for a biosimilar applicant’s failure to comply with the BPCIA.

Second, Amgen addresses Hospira’s argument that Amgen is barred from suing on its cell-culture manufacturing patents (and therefore from obtaining the discovery relevant to those patents) because it did not list them during the BPCIA’s pre-litigation information exchanges.  Amgen explains that the innovator company is only required to provide a list of patents, including manufacturing patents, under paragraph 262(l)(3)(A) of the BPCIA after the biosimilar applicant provides both its biosimilar regulatory “application” and the manufacturing “information” called for by paragraph 262(l)(2)(A), which Hospira did not do.  The BPCIA states that the innovator company provides its list of patents that can be reasonably asserted “[n]ot later than 60 days after the receipt of the application and information under paragraph [262(l)(2)(A)].”  According to Amgen, this condition precedent was never met and so it cannot be barred from later asserting its patents after obtaining needed discovery.  Amgen also argues that it could not know which patents “could reasonably be asserted” and therefore listed without first obtaining Hospira’s manufacturing information.  Amgen explains that it makes no sense to require an innovator company to list all of its patents in the dark and that doing so would flout the BPCIA’s text and purpose and create burdens for both sets of parties, including having to provide validity and infringement contentions for patents that may never need to be litigated.

Third, Amgen responds to Hospira’s contention that the scope of Rule 26 prohibits discovery of manufacturing information relevant to whether unasserted patents are infringed.  Amgen states that Hospira implicitly argues “that Amgen should have sued Hospira on Amgen’s entire portfolio of cell-culture patents and then sought discovery to find out which, if any, of those patents are infringed.”  Amgen states that this “cannot be what the BPCIA contemplates” or what the Federal Circuit intended when it stated in Amgen v. Sandoz that the remedy for a biosimilar applicant’s failure to comply with 262(l)(2)(A) is a suit for patent infringement and that the innovator company then can “access the required information through discovery.”  According to Amgen, it should not have to assert patents if it does not have sufficient information to know whether they are or are not infringed, due to a lack of disclosure of manufacturing information.

As to the jurisdictional question, Amgen argues that the district court’s order is reviewable under the collateral order doctrine due to its importance: “this is the first district court ruling after [Amgen v. Sandoz] to address the [innovator company’s] ability to access the Applicant’s manufacturing information in discovery where the Applicant refused to provide it in accordance with subparagraph 262(l)(2)(A).”  Amgen explains that the issue is separate from the merits of the district court action “precisely” for the reason that the district court refused to allow the discovery under Amgen v. Sandozi.e., because the information is not relevant to the patents that are in suit.   Moreover, Amgen points out that there can be no effective appellate review after a final judgment since Hospira may well have launched its biosimilar by that time and that the BPCIA, by contrast, affords review of manufacturing information so that an infringement suit can precede the launch of the biosimilar.

Finally, Amgen addresses the All Writs Act, 28 U.S.C. § 1651(a), which authorizes federal courts to “issue all writs necessary or appropriate in aid of their respective jurisdictions.”  Amgen notes that while it “did not frame its appeal as a petition for a writ of mandamus, the Court has the power to convert the appeal into such a petition.”  Amgen argues that a writ of mandamus is appropriate because the district court’s holding – that a biosimilar applicant cannot be compelled to provide manufacturing information unless it is also relevant to a patent already in the suit – “misunderstood this Court’s decision in [Amgen v. Sandoz], and threatens to undermine the balance that Congress struck.”  Amgen states that the issue is indisputably important to a functional framework for biosimilar litigation and requests that the Federal Circuit correct the district court’s “clear error” by a writ of mandamus, holding that an innovator company has a right to access the manufacturing information through discovery irrespective of the patents that are asserted.

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