Schiff Hardin Recognized as a Top Hatch-Waxman Defense Firm


Schiff Hardin Recognized as a Top Hatch-Waxman Defense Firm

News Release |

Schiff Hardin LLP has been recognized as one of the top law firms defending Abbreviated New Drug Application (ANDA) litigation in the 2017 Hatch-Waxman/ANDA Litigation Report compiled by legal data analytics firm Lex Machina. Schiff Hardin is now ranked fourth for representing the most defendants in ANDA cases filed since 2015, growing from ninth for ANDA cases since 2009. The firm has represented over a dozen generic pharmaceutical companies on more than 100 pharmaceutical products in ANDA patent litigation and 505(b)(2) applications in that time.

The 2017 Hatch-Waxman/ANDA Litigation Report surveys the patent litigation landscape related to ANDAs submitted to the U.S. Food and Drug Administration under the Hatch-Waxman Act, covering more than 2,600 cases filed in U.S. district courts between January 1, 2009 and March 31, 2017.

Schiff Hardin also succeeds at plaintiff-side patent litigation. In a recent success, the firm secured a rare preliminary injunction in New Jersey federal court that enabled U.S. manufacturer and firm client Fresenius Kabi USA, LLC to retain its market share for a patented thyroid treatment formulation. The court also found that Fresenius is likely to succeed on the merits at trial, despite six separate arguments raised by the defense.

Over the last decade, Schiff Hardin has built one of the premier Hatch-Waxman Litigation practices in the nation, representing four of the world’s leading generic pharmaceutical companies. The firm was among the first law firms to represent generic pharmaceutical companies seeking to make medicine affordable to patients in Hatch-Waxman matters.