The U.S. Court of Appeals for the Federal Circuit (CAFC) recently demonstrated how a patent’s specification can influence claim construction, particularly when broad and/or ambiguous claim terms are used. In MedCo v. Mylan, the CAFC found that Mylan’s abbreviated new drug application (ANDA) for a generic of MedCo’s ANGIOMAX® did not infringe MedCo’s U.S. Patent Nos. 7,582,727 and 7,598,343 because the specifications of the patents led the court to interpret the “batches” recitation of the claims at issue as requiring a different compounding process than the compounding process in Mylan’s ANDA.
The CAFC interpreted the “batches” recitation as requiring a compounding process that achieves a batch consistency (i.e., a “same compounding process”) for the “batches.” The CAFC further found that the compounding process had to be the “efficient mixing process” described in “Example 5” of the specification because “apart from efficient mixing, no part of the patents’ disclosure teaches another method capable of producing consistent batches.” MedCo v. Mylan, No. 2015-1113 at *14 (CAFC, April 6, 2017). The CAFC noted that “Example 5 … is not merely the only disclosed embodiment of efficient mixing—it is the only description of efficient mixing in the patents in suit that casts light on what efficient mixing is and that enables one of ordinary skill in the art to achieve the objects of the claimed invention” (emphasis in original). MedCo v. Mylan, No. 2015-1113 at *23 (CAFC, April 6, 2017). Because Mylan’s ANDA did not require the same process to generate batches of its generic drug, it was not found to infringe.