October 20, 2017

Case Name: Reckitt Benckiser Pharms., Inc. v. Dr. Reddy’s Labs. S.A., No. 14-1451-RGA, 2017 U.S. Dist. LEXIS 140633 (D. Del. Aug 31, 2017) (Andrews, J.)

Drug Product and Patent(s)-in-Suit: Suboxone® (buprenorphine HCl / naloxone HCl); U.S. Patent No. 8,017,150 (“the ’150 patent”)

Nature of the Case and Issue(s) Presented: The ’150 patent covers Suboxone, a sublingual film used to treat opioid dependence. Plaintiffs, the holder of the ’150 patent and the patent’s exclusive licensee, brought suit against Defendants, alleging that Defendants’ generic product infringed the ’150 patent. In response, Defendants argued that their product did not infringe the ’150 patent and, even if it were to, the ’150 patent was invalid as obvious. The court agreed with Defendants that their product did not infringe the ’150 patent, but also found that Defendants had not met their burden in proving that the ’150 patent was obvious.

Why Defendants Prevailed: Reviewing the specification and the claims of the ’150 patent, the court determined that the patent claimed only the use of polyethylene oxide and hydrophobic cellulosic polymers, but the specification described polyvinyl pyrrolidone (“PVP”) as an alternative to hydrophobic cellulosic polymers. Because PVP was described in the specification but was not claimed, the court applied the dedicated disclosure rule from PSC Computer Prods., Inc. v. Foxconn Int’l, Inc., 355 F.3d 1353 (Fed. Cir. 2004). The dedicated disclosure rule provides that “if one of ordinary skill in the art can understand the unclaimed disclosed teaching upon reading the written description, the alternative matter disclosed has been dedicated to the public.” PSC, 355 F.3d at 1360. Thus, the court ruled that the use of PVP, as in the generic product, had been dedicated to the public and could not infringe the patent.

Having determined that the ’150 patent was not infringed, the court nevertheless performed a validity analysis of the patent. Because the cited prior art did not disclose the elements of the claims of the ’150 patent, and even taught away from the claimed invention, Defendants did not meet the burden to prove the ’150 patent invalid.