Can a party that did not submit an abbreviated biologics license application or an abbreviated new drug application, but will market the biosimilar or generic product after U.S. Food and Drug Administration approval, be sued for patent infringement or for a declaratory judgment alleging future infringement?
This question is pending before the U.S. District Court for the District of New Jersey in Amgen Inc. v. Adello Biologics LLC, where co-defendants Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals Inc. seek dismissal, alleging that Amgen failed to state a claim under Federal Rule of Civil Procedure 12(b)(6) and further, because subject matter jurisdiction is lacking under FRCP 12(b)(1).[1]
Amgen’s complaints allege that Adello Biologics LLC infringed under Section 271(e)(2)(C) of the Patent Act by submitting an aBLA to manufacture a biosimilar of Amgen’s Neupogen.[2] Amgen further alleges that Amneal will infringe under Section 271(g) by importing and selling the biosimilar, which Adello manufactures using processes allegedly covered by Amgen’s patents.
In its motion to dismiss, Amneal argues that Amgen fails to state a claim for infringement under Section 271(e)(2)(C) because Amneal did not “submit” the Neupogen aBLA. Amneal further argues that there is no “current case or controversy of sufficient immediacy and reality” to support jurisdiction over a declaratory judgment action because it will only be responsible for the future “marketing, selling and pricing” of the accused biosimilar after FDA approval.[3]
After examining the different types of conduct that could trigger and support a Biologics Price Competition and Innovation Act or ANDA litigation, we examine the arguments presented in Amneal’s and Amgen’s briefs.
Submission of an aBLA or ANDA Is an “Act of Infringement”
The submission of an aBLA — like the submission of an ANDA — is an “artificial act of infringement” allowing a patent owner to file suit.[4] But against whom can it file?
Amneal did not submit the aBLA for Neupogen, and argues that it did not infringe under this provision. In support, it cites the U.S. Supreme Court’s statements in Sandoz Inc. v. Amgen Inc. that “[t]he complex statutory scheme [of the BPCIA] establishes processes both for obtaining FDA approval of biosimilars and for resolving patent disputes between manufacturers of licensed biologics and manufacturers of biosimilars.”[5] According to Amneal, this “carefully calibrated scheme” limits actions for infringement to “submitters,” and it therefore is not an infringer.[6]
Although only Adello submitted the aBLA, courts have held that multiple parties can be “submitters.” For example, in Cephalon Inc. v. Watson Pharmaceuticals Inc., both Watson Pharmaceuticals and Watson Pharma Inc., its whollyowned subsidiary, “took part in preparing the ANDA,” as “employees of each prepared and executed ANDA-related documents.”[7] The court held that both defendants “submitted” the ANDA. Other decisions have also relied on the corporate relationship between two affiliates in holding that both “submitted” an ANDA.[8]
One factor to consider in evaluating who submits an FDA application is whether the purported “submitter” will benefit from FDA approval. In In re Rosuvastatin Calcium Patent Litigation, Apotex Corp., the U.S. subsidiary of Apotex Inc., “signed and filed” an ANDA on behalf of Apotex Inc. The paragraph IV certification, however, was made by Apotex Inc. Astra Zeneca filed suit against Apotex Corp. — and not Apotex Inc.[9]
Apotex Corp. moved to dismiss, arguing it did not submit the ANDA within the meaning of Section 271(e)(2)(A). The court denied the motion, finding that Apotex Corp. was a “submitter” because it “filed the ANDA and actively participated with Apotex Inc. in preparation of the ANDA, and [it] intend[ed] to directly benefit from the ANDA by selling the drug product in the United States … upon approval of the ANDA.”[10] Although a parent-subsidiary relationship existed between defendants, the U.S. Court of Appeals for the Federal Circuit emphasized the relevance of future marketing and sale of the generic product in finding jurisdiction.[11]
Here, Amneal did not submit the Neupogen aBLA, because it did not commit an act of infringement under Section 271(e)(2)(C). And yet although it does not have a corporate relationship with Adello, Amneal will “benefit directly” if Adello’s aBLA is approved. The question is whether this fact should be considered and if so, is it enough to establish a case or controversy supporting jurisdiction?
Inducement of Infringement Under Section 271(b)
Amgen did not assert a claim of inducement under Section 271(b) against Amneal.[12] The Federal Circuit, however, has recognized that inducement claims are possible in Hatch-Waxman actions. But in most instances the inducement claim was lodged against the ANDA filer — not a third party such as Amneal.[13]
Inducement of Filing an FDA Application
In Shire LLC v. Amneal Pharmaceuticals LLC, the Federal Circuit held that conduct that merely assists another party in filing an ANDA is protected by the Hatch-Waxman safe harbor, 35 U.S.C. § 271(e)(1).[14] There, the court held that Johnson Matthey, which supplied the active ingredient to Amneal to allow it to file an ANDA, was not liable because “these sales and the ANDA defendants use of the API for filing the ANDA were … protected by the safe harbor of § 271(e)(1).”[15]
Inducement of Future Commercial Conduct
Inducement claims have been allowed against non-related entities that will supply and market an infringing product after FDA approval. For example, in Cephalon Inc. v. Watson Pharmaceuticals Inc., the district court sustained inducement claims lodged against related defendants and recognized that future “manufacturing, marketing or selling” was relevant. [16] Moreover, in SmithKline Beecham Corp v. Geneva Pharmaceuticals Inc., the court permitted SmithKline to amend its complaint to add Sumika, a third party that would manufacture and sell the generic product after FDA approval.[17]
The Federal Circuit specifically addressed inducement by third parties in Forest Laboratories Inc. v. Ivax Pharmaceuticals Inc.[18] There, Forest sued Ivax, the ANDA filer, and Cipla, the intended supplier of the generic drug, after FDA approval. The court enjoined both Ivax and Cipla from making, using, and selling the generic drug because the arrangement between the two “was undoubtedly a cooperative venture, and Cipla was to manufacture and sell infringing products to Ivax for resale in the United States.”[19] As particularly relevant here, the court held that the defendants were “partners.”[20]
Here, Amneal will not manufacture — but only sell — the Neupogen biosimilar. But since courts have allowed claims for inducement of future conduct after FDA approval,[21] it is conceivable that Amgen could have alleged an inducement claim against Amneal.
Declaratory Judgment Actions Based on Future Conduct
Amgen and Amneal dispute whether jurisdiction in a declaratory judgment action can be based solely on the future marketing and sales by the accused defendant. Amneal stresses the lack of an actual controversy of “sufficient immediacy” to warrant a declaratory judgment, while Amgen argues that allowing the actions to proceed against Adello and Amneal will promote judicial economy and efficiency since both actions have critical facts in common.
Amneal Argues That No Justiciable Controversy Exists
Amneal stresses the lack of an actual controversy of “sufficient immediacy” to warrant declaratory relief.[22] Citing Sandoz, it argues that allowing Amgen’s action to proceed “would upend the complex statutory scheme Congress established on the BPCIA for litigating biosimilar cases,”[23] especially because Adello’s aBLA has not been approved.[24] In other words, “[t]hat Amneal might someday infringe” does not satisfy the case or controversy requirement.[25]
Stressing the absence of FDA approval, Amneal cites Abbott Diabetes Care Inc. v. DexCom Inc., where the court dismissed Abbotts’s declaratory judgment claim because “the absence of FDA approval is evidence that the dispute between the parties is neither real nor immediate.”[26] But although the court dismissed the declaratory judgment claim in Abbott, it still addressed the merits of dispute; it did not dismiss the direct infringement claim because the defendant had exhibited two purported infringing devices at a trade show.[27]
Amneal also cites In re Rosuvastatin Calcium Patent Litigation, where a declaratory judgment action for infringement was dismissed while the action under Section 271(e)(2) proceeded.[28] Because the Hatch-Waxman 30-month stay precluded imminent marketing of the generic product, dismissal of the declaratory judgment claim in In re Rosuvastatin had little, if any, effect on resolving the pending dispute.[29]
Amneal next cites Eisai Co. Ltd. v. Mutual Pharmaceutical Co. Inc.,[30] Reckitt Benckiser Pharmaceutical Inc. v. Biodelivery Sciences, Internaional Inc.,[31] and Abbott Laboratories v. Zenith Laboratories, Inc.[32] where declaratory judgment actions were dismissed.[33] But in Eisai and Reckitt, paragraph IV certifications were lacking, and thus no actions were proper under Section 271(e)(2). This apparently influenced the courts to dismiss the declaratory judgment actions as well. In Abbott, the asserted patent was not listed in the Orange Book when the ANDA was...
