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LexOrbis | USA, India | 29 Jul 2019
Competitive generic therapy: Manna for generic companies
The US Food and Drug Administration (FDA) has over the years come up with initiatives to protect the interests of both the Patented and generic drug
Windels Marx Lane & Mittendorf LLP | USA | 15 May 2019
Hatch-Waxman Team Wins Appeal for Dr. Reddy's Laboratories in esomeprazolenaproxen (Vimovo)
On Wednesday, May 15, a Windels Marx IP - Hatch-Waxman Act team achieved a significant victory on behalf of firm client Dr. Reddy’s Laboratories
Windels Marx Lane & Mittendorf LLP | USA | 10 May 2019
Hatch-Waxman Team Wins a Motion For Judgment on the Pleadings for Slayback in Liquid Bendamustine (BELRAPZO)
On Thursday, May 9, a Windels Marx IP - Hatch-Waxman Act team achieved an important victory on behalf of firm client Slayback Pharma LLC (“Slayback”)
Harness, Dickey & Pierce, PLC | USA | 23 Jan 2019
Secret Sales Can Qualify as Prior Art under the AIA
The America Invents Act (AIA) did not change the well-established meaning of “on sale” from the pre-AIA version of 35 U.S.C. 102. Helsinn Healthcare
Finnegan, Henderson, Farabow, Garrett & Dunner LLP | USA | 31 Dec 2018
Preclinical Patent Considerations
All pharmaceutical companies, whether they are an innovator or a generic, must navigate the same complex legal and regulatory framework to bring a
Banner Witcoff | USA | 21 Dec 2018
Endo v. Teva: Courts Continue to Invalidate Patent Claims Without Construing Them
Endo Pharmaceuticals Inc. and Mallinckrodt LLC sued for patent infringement against multiple defendants who had filed Abbreviated New Drug
Banner Witcoff | USA | 21 Dec 2018
Endo v. Teva: Courts Continue to Invalidate Patent Claims Without Construing Them
Endo Pharmaceuticals Inc., and Mallinckrodt LLC sued for patent infringement against multiple defendants who had filed Abbreviated New Drug
Harness, Dickey & Pierce, PLC | USA | 7 Dec 2018
Judicially Created Double Patenting Does Not Limit Statutory Patent Term Extension
In Novartis AG v. Ezra Ventures, LLC, 2017-2284 (December 7, 2018), the Federal Circuit affirmed the district court’s determination that
Banner Witcoff | USA | 3 Dec 2018
Allergan v. Teva Pharmaceuticals USA: Will the Recognized Commercial Success of Restasis Demonstrate Non-Obviousness?
At the November 6, 2018, oral arguments at the U.S. Court of Appeals for the Federal Circuit, Allergan and the St. Regis Mohawk Tribe faced off
Winston & Strawn LLP | USA | 2 Nov 2018
Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc., Nos. 2017-2078 and 2017-2134 (Fed. Cir. Sep. 10, 2018)
The patentee sued the Abbreviated New Drug Application (ANDA) filers for infringement of patents covering its multiple sclerosis treatment, Ampyra
