In a recent hearing held in Amgen v. Hospira, the parties offered arguments on some novel issues relating to litigation under the BPCIA, particularly:
- Whether a reference product sponsor (“RPS”) can compel a biosimilar applicant to produce manufacturing information that may be relevant to other patents it holds, but is not relevant to the patents it has asserted in litigation (in other words: whether the patents asserted by the RPS in an infringement action under the BPCIA limits the scope of discovery regarding the proposed biosimilar product); and
- What patents the RPS must identify on its “list of patents for which the reference product sponsor believes a claim of patent infringement could reasonably be asserted by the reference product sponsor” under BPCIA step (l)(3)(A) in order to preserve its ability to assert that patent in any later action for patent infringement.
The Court held the hearing to resolve a discovery dispute regarding two categories of information sought by Amgen: (1) specific manufacturing information regarding Hospira’s proposed biosimilar, 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.)
Scope of Discovery in Infringement Actions Under the BPCIA
First, Amgen sought an order to compel Hospira to produce specific manufacturing information regarding four components of the cell culture medium used in the manufacture of Hospira’s proposed biosimilar product.
Hospira had already produced its abbreviated biologics license application (i.e. its biosimilar application or “aBLA”) which, as the Court noted, is hundreds of thousands of pages long and describes manufacturing information for the proposed biosimilar; but Amgen argued that it did not provide the specific information relating to the four components of the cell culture medium that Amgen now seeks.
Amgen argued that the information should be produced on two grounds:
(1) the information is potentially relevant to one of the asserted claims in the case, and
(2) Amgen brought this case under the BPCIA, and the purpose of that statute is to resolve patent disputes before the launch of Hospira’s product; but resolution of any patent disputes may not be possible without the requested information, as such information may implicate other Amgen patents that Amgen has not yet identified or asserted.
Amgen argued that Hospira should have produced the requested information already pursuant to the disclosure provisions of the BPCIA, which provide in (l)(2)(A) that the biosimilar applicant shall provide its aBLA and “such other information that describes the process or processes used to manufacture the biological product that is the subject of such application.” According to Amgen, although the Federal Circuit in Amgen v. Sandoz held that the RPS could not bring a cause of action for an alleged violation of the (l)(2)(A) disclosure provision, Amgen was still entitled to such information during discovery. Amgen added that the possibility of obtaining such information during discovery was one reason the Federal Circuit ruled the way it did in Amgen v. Sandoz—i.e. that the Federal Circuit reasoned that disclosure under (l)(2)(A) is not mandatory because a reference product sponsor still has the opportunity to obtain information through well-worn paths of discovery.
Hospira characterized Amgen’s argument as essentially “an attempt to argue that the BPCIA trumps Rule 26 and relevance on the discovery standards” and “a back-door private right of action on what they perceive to be a violation of Section (2)(A).” The requested information, Hospira argued, is not relevant to any allegations Amgen has asserted, and therefore not subject to discovery under Rule 26. Judge Andrews noted that he “appreciate[d]” the argument that Congress did not intend for the BPCIA to “circumvent” Rule 26 relevance requirements, but asked whether the purpose of the BPCIA would be defeated if a biosimilar applicant were not required to produce additional information that was related to its proposed product but unrelated to claims in the infringement litigation. Hospira responded that under the BPCIA, the RPS has the ability to define the scope of discovery once it receives the aBLA and manufacturing information, because at that point, under provision (l)(3)(A), it can assert any patent for which it believes a claim of patent infringement could reasonably be asserted.
The RPS’s Listing of Patents that “Could Reasonably Be Asserted” Against the Biosimilar Applicant
Following up on this line of argument, Judge Andrews asked both parties why—given (l)(3)(A)’s apparently liberal standard for which patents an RPS may list and potentially assert in a later infringement action—an RPS would take a conservative approach and list only a limited number of patents, as Amgen appears to have done in this case. Hospira suggested that an RPS might seek to preserve its right to sue for a violation of (l)(2)(A), which Judge Andrews found unpersuasive. Amgen suggested that RPSs face a difficult calculation when deciding which patents to list under (l)(3): notwithstanding the “reasonableness” standard for listing patents that may be asserted, the RPS must be mindful that in the Hatch-Waxman context, brand companies have been faulted for listing too many patents as covering its product in the Orange Book. Amgen emphasized that the RPS is supposed to make a “reasonable” determination—not “an uninformed determination”—that the patents it lists in (3)(A) may be asserted in a later infringement action, and just listing additional patents does not require an applicant to produce additional information under the BPCIA.
Amgen stated that if it obtained the requested information and identified additional patents to assert against Hospira, it would seek to amend its Complaint. Hospira argued that Amgen missed its opportunity to identify those patents for litigation when it failed to list them during the (l)(3) step, and that Hospira would oppose any motion to amend on the grounds that the BPCIA bars Amgen from asserting patents that were not on its (l)(3)(A) list and not acquired in the interim. Amgen responded that to the extent there is any bar on asserting additional patents, that bar applies only to patents that Amgen “should have listed” on its (3)(A) list—and patents for which it lacked sufficient information to form a “reasonable belief” that Hospira infringed would not be considered a patent that “should have been listed” under (l)(3)(A).
The Court’s Conclusions
After consulting Amgen v. Sandoz, Judge Andrews decided that insofar as the requested manufacturing information was allegedly relevant to one of the asserted claims in the case, Hospira must produce such information on that basis. Judge Andrews denied the broader asserted basis for Amgen’s request—that the BPCIA compelled the production of the requested information regardless of its relevance to the asserted patents—noting that on this broader basis, Amgen’s request was a “fishing expedition” disfavored by the Federal Rules. Judge Andrews added that to the extent Amgen sought information to assess what other patents it might have been able to assert against Hospira, this was not the proper way to do so.
Amgen also sought an order 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 it amends its aBLA in a way that would implicate other Amgen patents. (Note: the two patents Amgen has asserted in the pending litigation have both expired—Amgen explained that its grounds for asserting expired patents is the “possibility of some degree of injunctive relief based on prior infringement” regarding products that were “manufactured and infringed under the patent.”) Hospira objected to the extent Amgen sought correspondence not related to the subject matter of the patents-in-suit, but agreed to produce FDA correspondence relevant to the pending infringement claims.
Judge Andrews stated that the balance favored Hospira, as the requested scope of correspondence seemed to bear no relevance to the asserted patents.
Decision on Pending Motion to Dismiss BPCIA Notice Claims Not Likely Until Federal Circuit Issues Decision in Amgen v. Apotex
Judge Andrews noted in closing that he was unlikely to rule on Hospira’s pending motion to dismiss Amgen’s (8)(A) claim—the claim that Hospira has violated BPCIA provision (8)(A) by refusing to provide post-licensure notice of commercial marketing—before the Federal Circuit issues an opinion in Amgen v. Apotex, as that decision will likely provide some guidance on the (8)(A) notice issues. For coverage of the Federal Circuit hearing in Amgen v. Apotex, see our post here.