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Drug development in the United States is expensive and time-consuming, which makes pharmaceutical patents an important asset for pharmaceutical companies to protect their investment in bringing new drugs to market.
The provisions of U.S. regulatory law regarding FDA approval for less than all the indications for which an innovator drug was approved under 21 U.S.C. § 355(j)(2)(A)(viii) (the...
Case Name: Vanda Pharms. Inc. v. Teva Pharms. USA, Inc., Nos. 22-7528, 22-7529 (CCC), 2023 WL 1883357 (D.N.J. Feb. 10, 2023) (Cecchi, J.) - Drug Products and...
Case Name: Vanda Pharms., Inc. v. Teva Pharms. USA, Inc., Civ. No. 18-651-CFC, 2022 WL 17593282 (Dec. 13, 2022) (Connolly, J.) Drug Product and Patent(s)-in-Suit: Hetlioz®...
The Federal Circuit recently affirmed a district court judgment of invalidity for obviousness and for noninfringement for a series of patents challenged in ANDA litigation, in Genentech...