Biosimilar manufacturers proceeding under the abbreviated approval pathway laid out in the Biologics Price Competition and Innovation Act (“BPCIA”) open themselves up to patent infringement litigation. But how soon can a biosimilar manufacturer be sued?
Previous cases have established that a biosimilar applicant cannot in general be sued prior to filing an abbreviated Biologic License Application (“aBLA”). See Sandoz Inc. v. Amgen Inc., 773 F.3d 1274 (Fed. Cir. 2014) (holding a cognizable case or controversy did not exists when applicant was conducting phase III clinical trials because there was no immediate threat of injury); Celltrion Healthcare Co. v. Kennedy Trust for Rheumatology Research, No. 14 CIV. 2256 PAC, 2014 WL 6765996, at *5 (S.D.N.Y. Dec. 1, 2014) (dismissing case for lack of actual controversy when Celltrion had not yet filed its aBLA because too much uncertainty remained before FDA approval).
Once the aBLA is submitted, 35 USC 271(e)(2) provides for an artificial act of infringement. Section 35 USC 271(e)(2)(C) states that “it shall be an act of infringement to submit— (i) with respect to a patent that is identified in the list of patents described in section 351(l) (3) of the Public Health Service Act (including as provided under section 351(l)(7) of such Act), an application seeking approval of a biological product, or (ii) if the applicant for the application fails to provide the application and information required under section 351(l) (2)(A) of such Act, an application seeking approval of a biological product for a patent that could be identified pursuant to section 351(l) (3)(A)(i) of such Act…”
There are thus two triggers for the artificial act of infringement under 271(e)(2)(C)— (i) submitting an application that is covered by a patent listed in the (l)(3) patent list exchanged during the patent dance under the BPCIA, or (ii) failing to provide the aBLA and associated manufacturing information to the reference product sponsor (“RPS”) under (l)(2)(A). Because (l)(2)(A) gives the biosimilar applicant 20 days to provide the aBLA to the RPS, the earliest time a biosimilar manufacturer could be sued under 271(e)(2)(C) is 21 days after FDA accepts the aBLA for review if the aBLA is not provided to the RPS; if it is provided, the earliest date would be when the RPS submits its list of patents under (l)(3) or (l(7).
In practice, however, biosimilar applicants may have more time. Because the acceptance of the aBLA is not publicly posted by the FDA, the RPS may not be aware that it has a right to sue. Also, as the BPCIA statute has been interpreted by the Federal Circuit, there is no requirement to engage in the patent dance, and therefore the applicant is not required to provide the RPS with any information regarding its aBLA (despite language in the statute saying it “shall provide” a copy of the application to the RPS). Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015).** Thus, the first public event cluing the RPS into FDA acceptance may occur when the FDA approves the drug, because FDA drug approvals are publicly posted by FDA.
There may be several ways in which the RPS may become aware of FDA acceptance before FDA approval, which could provide the RPS with a good faith basis for suing the biosimilar applicant. For example, if the biosimilar company is publicly traded, the biosimilar applicant may have a duty to inform its shareholders when it files aBLA applications and/or when the FDA accepts such filings for review. Any other press releases or announcements by the biosimilar applicant could also provide information to the RPS regarding the aBLA.
Even assuming the biosimilar applicant does not publicly disclose any information about its aBLA, the RPS may get wind of the application and send an inquiry to the biosimilar applicant. If the biosimilar applicant acknowledges FDA has accepted the aBLA for review, the RPS would be able to bring suit. Even if the biosimilar applicant refuses to answer, the RPS may still be able to bring suit. In the context of Hatch-Waxman litigation, the Federal Circuit has specifically rejected the notion that Rule 11 prohibits a patentee from bringing an infringement action based upon the submission of an ANDA where the patentee “is unable to obtain and set forth in [its] complaint facts showing infringement….” Hoffmann–La Roche, Inc. v. Invamed Inc., 213 F.3d 1359 (Fed. Cir. 2000). In Hoffmann–La Roche, the patent at issue concerned a process for manufacturing a drug. The defendant-ANDA filer provided the plaintiffs with a sample of the generic drug, but refused to disclose how it was manufactured. In the subsequently filed infringement action, the plaintiffs averred that in the absence of defendant’s manufacturing information, the plaintiffs had to resort to the judicial process to confirm their belief and to present the Court with evidence that the defendants infringed the asserted patents. In affirming the district court’s denial of sanctions, the Federal Circuit noted that “[i]t is difficult to imagine what else plaintiffs could have done to obtain facts relating to defendant’s alleged infringement of their process patents.” It is therefore an open question whether the courts would allow an RPS to sue under 271(e)(2)(C) when a biosimilar applicant refused to provide any information on the existence or status of an aBLA.
Thus, at earliest, a biosimilar applicant may be sued 21 days after its aBLA is accepted for FDA review, but the individual circumstances may in practice delay any infringement suit. Should the biosimilar applicant wish to delay suit, it should consider declining to engage in the patent dance and keeping FDA acceptance of the aBLA confidential as long as possible.
** The Supreme Court is currently reviewing the holdings of this case.