Hatch-Waxman, Generic Drugs | JD Supra Law News

Supreme Court Hears Arguments on "Pay for Delay" Agreements

by Michelle Kim, Seth Mailhot | Sheppard Mullin Richter & Hampton LLP on 4/5/2013

On March 25, 2012, the Supreme Court heard oral argument on the legality of “reverse payment” or “pay for delay” agreements between brand-name and generic drug manufacturers....more

In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation (Fed. Cir. 2013)

by Andrew Williams | McDonnell Boehnen Hulbert & Berghoff LLP on 3/1/2013

On the first day of February, the Federal Circuit rejected Impax's efforts to get out from under a preliminary injunction in a case captioned In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation. ...more

Par/Paddock Answers FTC Before Supreme Court

by Kevin E. Noonan | McDonnell Boehnen Hulbert & Berghoff LLP on 2/28/2013

Par PharmaceuticalPar/Paddock, one of the generic drug company defendants in FTC v. Actavis Inc. et al. (the "reverse payment" ANDA settlement case now before the Supreme Court) filed its reponsive brief last week. In it,...more

Cephalon, Inc. v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2013)

by Kevin E. Noonan | McDonnell Boehnen Hulbert & Berghoff LLP on 2/15/2013

Whether ANDA litigation has had a positive or negative impact on generic drug availability is an open question, in view of several recent reports looking at the effects such litigation has had on both branded and generic...more

The Continuing Saga of Reverse Payment Patent Litigation

by Howard Ullman on 1/25/2013

In FTC v. Watson Pharmaceuticals, Inc. (Supreme Court No. 12-416), the FTC unsurprisingly filed a merits brief this month again arguing that pay-for-delay (or “reverse payment”) patent settlements are presumptively...more

Supreme Court Declines Opportunity to Clarify Scope of Hatch-Waxman Safe Harbor

by Loeb & Loeb LLP on 1/17/2013

The U.S. Supreme Court on Jan. 14, 2013, denied GlaxoSmithKline’s petition for certiorari seeking review of the Federal Circuit’s interpretation of the Hatch-Waxman safe-harbor provision at 35 USC 271(e)(1) in Classen...more

Jumping the Line: Generic drug makers aren’t waiting until patents expire

by MoFo Tech on 12/4/2012

Since passage of the Hatch-Waxman Act in 1984, generic drug companies have used its Abbreviated New Drug Application (ANDA) process to bring cheaper versions of brand-name drugs to market after their patents expire. In the...more

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Hatch-Waxman › Generic Drugs