Case Name: Reckitt Benckiser Pharms., Inc. v. Biodelivery Services Ltd., Case No. 5:13-CV-760-TWB, 2014 U.S. Dist. LEXIS 69805 (E.D.N.C. May 20, 2014) (Boyle, J.) 

Drug Product and Patent(s)-in-Suit: Suboxone® (buprenorphine); U.S. Pat. No. 8,475,832 (“the ’832 patent”)

Nature of the Case and Issue(s) Presented: The issues presented were whether defendant’s actions were sufficient to support declaratory judgment jurisdiction and whether defendant’s conduct supports a claim for patent infringement under 35 U.S.C. § 271(e)(4).

Reckitt Benckiser (“RB”) owns the ’832 patent, which covers sublingual and buccal film compositions used in the treatment of opioid dependence. Those compositions are marketed as Suboxone. RB owns two NDAs covering Suboxone: one covers sublingual film delivery and the other covers a tablet version of the drug.

Biodelivery Services (“Biodelivery”) filed its own NDA seeking approval to manufacture and sell a drug called Bunavail®, which is also an orally-administered mucoadhesive formulation designed to treat opioid dependency. RB filed suit, seeking declaratory judgment that the drug described in Biodelivery’s NDA is infringed by one or more claims of the ’832 patent. In its second count, RB alleges that Biodelivery’s submission of its NDA is an act of infringement under 35 U.S.C. § 271(e)(4). Biodelivery moved to dismiss count one of the complaint under Fed. R. Civ. P. 12(b)(1) for lack of subject matter jurisdiction. Biodelivery also moved to dismiss count two under Fed. R. Civ. P. 12(b)(6) for failure to state a claim upon which relief can be granted. The court granted both of Biodelivery’s motions.

Why Biodelivery Prevailed:  RB filed its complaint on October 29, 2013. Biodelivery filed its NDA in July 2013. The court noted that at the time it considered the issue, the FDA still had not acted on the Biodelivery’s NDA. RB argued that this fact was irrelevant because Biodelivery had announced its intent to market Bunavail once it had obtained the FDA’s approval. But the court noted that RB’s claim rested on two completely contingent events: (i) eventual FDA approval of Biodelivery’s NDA; and (ii) Biodelivery’s decision to market its drug pursuant to that NDA. The court also noted that any actions Biodelivery had taken to date, such as research and development, were protected by the safe harbor provision of 35 U.S.C. § 271(e)(1). Last, the court indicated that infringement allegations could be based on evidence that the alleged future infringer had engaged in marketing or solicited orders for its product, but RB had produced no such proof. RB did provide evidence that Biodelivery included information about the new drug in its annual report, and had issued a press release in relation to its NDA, but the court did not find this evidence persuasive. Accordingly, the court granted Biodelivery’s motion to dismiss count one of the complaint, based on a lack of subject matter jurisdiction.

Next, the court considered RB’s argument that the filing of Biodelivery’s NDA constituted an artificial act of infringement under 35 U.S.C. § 271(e)(2). Biodelivery filed its NDA pursuant to 21 U.S.C. § 505(b)(2), which covers NDAs where a listed drug is similar to the new drug. Unlike an applicant for a generic drug, a 505(b)(2) applicant is permitted to choose the most appropriate listed drug for reference, and is not required to choose the most similar listed drug. The applicant must also make one of four certifications: (i) that no patent information has been filed; (ii) that the patent has expired; (iii) that the patent will expire on a specific date; or (iv) that the patent is invalid or will not be infringed by the manufacture, use, or sale of the drug for which the application is submitted. In its application, Biodelivery selected Suboxone^® sublingual tablets as the reference drug (as opposed to the film whose formulation was covered by the claims of the ’832 patent). Biodelivery also did not file a paragraph IV certification as part of its application. Because § 271(e)(2) clearly defines an infringing act as filing an ANDA for a drug claimed in a patent or the use of which is claimed in a patent, the Court determined that it was not applicable. In the absence of a paragraph IV certification, RB’s count two was dismissed for failure to state a claim upon which relief could be based.