In re Fenofibrate Patent Litigation

When a patent claim calls for a quantity “between” two numbers, it should be construed to cover only that specific range and it should not be read to cover “a range between two values which are themselves ranges.”

Opinion (Rakoff): Lupin Atlantis Holdings alleged that Mylan Inc., Mylan Pharmaceuticals Inc., Apotex Inc. and Apotex Corp. literally infringed two of its patents by seeking approval to manufacture generic versions of its ANTARA drug. Mylan and Apotex moved for summary judgment of noninfringment for both patents. Both patents covered the use of fenofibrate to treat high cholesterol and triglycerides, covering combinations of finofibrate and binding cellulose derivate over the range of 5:1 and 15:1. Mylan’s formulation, as disclosed in its ANDA, used fenofibrate in a 4.7:1 ratio. To literally infringe a patent, every claim of the patent must be met exactly by the accused device with any deviation defeating infringement. Lupin argued that 4.7:1 fell within the range of 5:1 to 15:1, because 4.7 rounds to 5. The Federal Circuit has held that a claim that calls for a quantity “between” two numbers should be construed to cover only that specific range, not the “range between two values which are themselves ranges.” Because Mylan’s formulation was outside of the range in Lupin’s patents, the district court GRANTED Mylan’s motion for summary judgment. Apotex argued that it did not infringe Lupin’s patents because its formulation did not use two of the chemicals included in the patents. Lupin argued, however, that Apotex’s motion was premature, because Apotex could alter its formulation before its products were placed on the market. Since the Federal Circuit only looks to the four corners of the ANDA, and because Apotex’s ANDA did not describe a drug that literally infringed Lupin’s patents, the court GRANTED Apotex’s motion for summary judgment.