Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC, Mylan Inc.
846 F.3d 1213 (Fed. Cir. 2017)
Authored by John De Vito
Statement of Facts: Cumberland Pharmaceuticals, Inc. (“Cumberland”) owns U.S. Patent No. 8,399,445 (the “ ’445 patent”), which claims acetylcysteine compositions free of chelating agents. The FDA approved the ’445 patent, allowing Cumberland to market a chelating-agent free acetylcysteine composition. Mylan Institutional LLC (“Mylan”) filed its own application with the FDA to market a chelating-agent free acetylcysteine composition. Acetylcysteine compositions normally have a stability problem and a prior art response to the stability problem was to include edetate disodium (“EDTA”), a chelating agent.
In 2002, Cumberland sought permission from the FDA to market an EDTA-containing composition of acetylcysteine. On December 10, 2002, the FDA sent Cumberland a letter asking Cumberland to justify EDTA inclusion. On December 20, 2002, Cumberland sent a letter written by Leo Pavliv justifying EDTA inclusion. In a subsequent phone call on March 5, 2003, Mr. Pavliv expressed to the FDA that Cumberland intended to perform a stability study to determine whether it could create acetylcysteine formulations without EDTA or with less EDTA. The FDA approved Cumberland’s EDTA-containing acetylcysteine composition in a letter on January 23, 2004 and reminded Cumberland of its commitment to study acetylcysteine compositions with lower concentrations and no concentration of EDTA. After some months of encouraging data, Cumberland filed for a patent on August 24, 2005 and received U.S. Patent No. 8,148,356 (the “ ’356 patent”), the parent of the ’445 patent, for an EDTA and other chelating agent free acetylcysteine composition. In January 2011, the FDA approved Cumberland’s EDTA and other chelating agent-free acetylcysteine composition for the market. In December 2011, Mylan filed an application to market a generic version of Cumberland’s EDTA-free acetylcysteine composition. On May 17, 2012, Cumberland sued Mylan for infringement of its patent and amended its complaint on March 19, 2013 after Cumberland received the ’445 patent.
Procedural History: Cumberland brought suit in the United States District Court for the Northern District of Illinois. The district court ruled in favor of the plaintiff after a bench trial. The district court held that Mylan neither proved (1) that a representative at the FDA conceived the invention before Cumberland had nor (2) that Cumberland’s invention was obvious. Mylan appealed to the Federal Circuit.
Questions Presented: (1) Whether Cumberland derived the ’445 patent from a representative at the FDA under 35 U.S.C. § 271(e)(2)(A) when Cumberland agreed to study the stability of acetylcysteine compositions without or with diminished levels of EDTA. (2) Whether the ’445 patent was obvious under 35 U.S.C. § 271(e)(2)(A) when prior art teaches all of the elements of the invention except the removal of EDTA.
Holdings: The Federal Circuit affirmed the district court judgment that: (1) Mylan did not clearly and convincingly show that Cumberland derived the invention claimed in the ’445 patent from a representative at the FDA and (2) prior art gave no reasonable expectation that a formulation without chelating agents would be stable and, therefore, the invention claimed in the ’445 patent was not obvious.
Reasoning: Whether a patentee derived an invention from a prior conception is a mixed question of law and fact. A challenger asserting derivation must show by clear and convincing evidence that there was a prior conception of the claimed invention and that the conception was communicated to the patentee. Price v. Symsek, 988 F.2d 1187, 1190 (Fed. Cir. 1993) In this case, Mylan was required to show that someone at the FDA had a specific idea to remove EDTA from acetylcysteine, to not add another chelating agent, and that this idea was communicated to Cumberland. The FDA’s December 10, 2002 letter to Cumberland did not demonstrate a prior conception of the ’445 patent because it merely requested justification for the inclusion of EDTA. The request for justification for the inclusion of EDTA is not the same as an idea to remove EDTA and not replace it with other chelating agents. Mylan’s suggestion that the FDA’s request for justification led to the inevitable invention of EDTA-free acetylcysteine also fails because a research plan does not constitute a permanent idea required for derivation. Further, in communication to the FDA between December 2002 and March 2003, Mr. Pavliv of Cumberland was the first to suggest that Cumberland test the stability of acetylcysteine with EDTA and other chelating agents were removed.
Whether an invention was obvious is a question of law. A party claiming obviousness must demonstrate by clear and convincing evidence that an inventor using the teachings of prior art would have achieved the claimed invention with a reasonable expectation of success. Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,688 F.3d 1342, 1360 (Fed. Cir. 2012). Mylan claimed that Cumberland’s EDTA-containing acetylcysteine composition made its EDTA-free acetylcysteine composition obvious by teaching all of the elements of the invention in the ’445 patent except the removal of EDTA. Persons of ordinary skill in the prior art did not have a reasonable expectation of success at achieving a stable EDTA and other chelating agent free acetylcysteine composition. All prior acetylcysteine compositions contained EDTA and prior art taught that EDTA or other chelating agents were necessary for stable acetylcysteine compositions. Further, the FDA letter asking Cumberland to study EDTA did not suggest that Cumberland would have a reasonable expectation of success at achieving a stable acetylcysteine composition.