Showing all posts written by Rory Lootsma
Federal Circuit Upholds Lower Court Decision in Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc.
By Rory Lootsma
(August 18, 2022) The Federal Circuit has affirmed that Eagle Pharmaceuticals, Inc. did not infringe Par Pharmaceutical, Inc. patents, easing Eagle’s path to market a generic competitor to Par’s Vasostrict®
product. Par had alleged that Eagle’s abbreviated new drug application (ANDA) infringed U.S. Patent Nos. 9,744,209 and 9,750,785, both titled “Vasopressin formulations for use in treatment of hypotension.” An example molecular structure is shown here:
Some of Par’s arguments had alleged that because the pH of Eagle’s products would be so close to Par’s claimed ranges for pH, inevitable drift in pH would occur over time, causing infringement. In affirming, Chief Judge Moore explained that the District Court had not committed clear error in finding otherwise. The infringement inquiry “begins and ends” with Eagle’s ANDA specification, so predicting future drift cannot show infringement.
Thus, the Federal Circuit upheld the District Court’s decision against Par Pharmaceutical and affirmed the finding of no infringement. The Federal Circuit’s decision is available here.
On April 11, 2022, Niazi Licensing Corporation (“Niazi”) succeeded in part in its appeal at the Federal Circuit in Niazi Licensing Corporation v. St. Jude Medical S.C. Inc. Niazi’s lawsuit alleged that St. Jude Medical S.C. Inc.’s (“St. Jude”) CPS telescoping catheter system infringed U.S. Patent No. 6,638,268, entitled “Catheter to Cannulate the Coronary Sinus” (the “‘268 patent”).
The district court determined that the terms “resilient” and “pliable” in the claims rendered all but one claim of the ‘268 patent indefinite and, therefore, invalid. However, the Federal Circuit reversed the district court’s holding and instead found that, although the terms may be broad, they are not uncertain. The Federal Circuit held that intrinsic record and extrinsic evidence are sufficient to inform a skilled artisan of the meanings of the terms with reasonable certainty. The court sent the case back to the district court to resolve any outstanding questions of whether St. Jude infringed the claims and whether St. Jude’s remaining invalidity defenses are applicable.
The Federal Circuit’s complete decision is available here.