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Adverio Pharma GmbH v. Alembic Pharmaceuticals Limited

United States District Court, D. Delaware

February 13, 2019


          Jack B. Blumenfeld, Jeremy A. Tigan, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, Delaware Adam K. Mortara, J. Scott McBride, Nevin M. Gewertz, BARTLIT BECK HERMAN PALENCHAR & SCOTT LLP, Chicago, Illinois Meg E. Fasulo, BARTLIT BECK HERMAN PALENCHAR & SCOTT LLP, Denver, Colorado Attorneys for Plaintiffs

          Kenneth L. Dorsney, MORRIS JAMES LLP, Wilmington, Delaware Lorraine Hernandez, Robert G. Schuler, KEGLER BROWN HILL RITTER, Columbus, Ohio Attorneys for Defendant INC Research LLC


          Stark, U.S. District Judge.

         Pending before the Court is Defendant INC Research, LLC's ("INC") motion to dismiss (D.I. 15) Plaintiffs Adverio Pharma GmbH, Bayer AG, and Bayer Healthcare Pharmaceuticals Inc.'s (collectively, "Adverio" or "Plaintiffs") complaint. (D.I. 1) Having considered the parties' submissions (D.I. 16, 20, 21, 22, 31) and heard oral argument (D.I. 32 ("Tr.")), the Court will grant the motion.


         Plaintiffs have legal rights in relation to New Drug Application ("NDA") No. 204819, which covers their branded drug product Adempas®, indicated for the treatment of persistent/recurrent chronic thromboembolic pulmonary hypertension or pulmonary arterial hypertension. (D.I. 1 ¶ 32)[1] Plaintiffs also have legal rights in U.S. Patent No. 6, 743, 798 (the '"798 patent"), entitled "Substituted Pyrazole Derivatives Condensed with Six-Membered Heterocyclic Rings," which is listed in the "Orange Book" - i.e., "Approved Drug Products With Therapeutic Equivalence Evaluations" - as associated with Adempas®. (Id. ¶¶ 28, 33)[2]

         Defendants Alembic Pharmaceuticals Limited ("APL") and its two wholly-owned subsidiaries, Alembic Global Holding SA and Alembic Pharmaceuticals, Inc. (collectively, the three Alembic Defendants are referred to hereinafter as "Alembic"), seek to market a generic version of Adempas® (the "ANDA Product") prior to the expiration of the '798 patent. (Id. ¶¶ 1, 9, 10) Accordingly, Alembic has filed with the United States Food & Drug Administration ("FDA") Abbreviated New Drug Application ("ANDA") No. 211127. (Id. ¶ 1) On December 1, 2017, Alembic provided notice to Plaintiffs "that Alembic had submitted ANDA No. 211127 seeking approval to commercially manufacture, use, import, offer for sale, and sell Defendants' ANDA Product." (Id. ¶ 25) Alembic certified its belief that its proposed generic drug product would not infringe the '798 patent and that the patent is invalid. (Id. ¶ 38; see also 21 U.S.C. § 255(j)(2)(B))

         In response, Adverio filed its complaint on January 9, 2018, within the 45 days permitted for a patentee in this situation to obtain the benefit of an automatic 30-month stay of FDA approval of an ANDA. See 21 U.S.C. § 355(c)(3)(C); D.I. 1 ¶ 41. In its complaint (see D.I. 1 ¶ 45), Adverio alleges that Alembic's submission of its ANDA to the FDA is an act of patent infringement pursuant to 35 U.S.C. § 271(e)(2)(A), which provides:

It shall be an act of infringement to submit [to the FDA] an application [for approval of a drug product] if the purpose of such submission is to obtain approval ... to engage in the commercial manufacture, use, or sale of a drug ... claimed in a patent....

         Adverio further names INC as a Defendant. The complaint's allegations against INC are sparse. Other than statements relating to INC's connections to Delaware, the allegations against INC consist entirely of the following:

8. ... On information and belief, INC Research is in the business of, among other things, performing contract research for pharmaceutical companies.
11. On information and belief, Alembic Pharma and/or INC Research are designated U.S. FDA agent(s) for APL.
12. On information and belief, Defendants acted in concert to prepare and submit ANDA No. 211127 to the FDA.

(D.I. 1¶¶8, 11, 12)

         Other than the collective, generalized allegation "[o]n information and belief that all Defendants, presumably including INC, "acted in concert to prepare and submit" the ANDA (id. ¶ 12), there is no specific, express allegation that INC played any role in the preparation of the ANDA. Nor is there any specific, express allegation that INC will benefit financially from the FDA's approval of the ANDA or that INC intends to (or will be) involved in the commercial manufacture, use, or sale of the proposed ANDA Product. The complaint does not seek any particular relief against INC, apart from the relief already sought from "Defendants" as a whole.


         Evaluating a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6) requires the Court to accept as true all material allegations of the complaint. See Spruill v. Gillis,372 F.3d 218, 223 (3d Cir. 2004). "The issue is not whether a plaintiff will ultimately prevail but whether the claimant is entitled to offer evidence to support the claims." In re Burlington Coat Factory Sec. Litig.,114 F.3d 1410, 1420 (3d Cir. 1997) (internal quotation marks omitted). Thus, the Court may grant such a motion to dismiss only if, after "accepting all well-pleaded allegations in the complaint as true, and viewing them in the light most favorable ...

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