In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit reversed the district court in part, finding that Allergan’s composition claims and most of its method claims are invalid as obvious, but upholding one method claim...more
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
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 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
In This Issue:
Federal Courts Debate Safe Harbor Exemption for Patent Infringement Under 35 U.S.C. § 271(e) Following Merck v. Integra; If I Prioritize Examination of My Application, Should the Patent Office?;...more
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
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
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
Late last year, in AstraZeneca v. Aurobindo (In re Rosuvastatin Calcium Patent Litigation), the Federal Circuit affirmed that a reissue patent covering the active ingredient of Crestor® was valid, enforceable, and infringed...more
In This Issue:
..News From the Bench:
- Clarification of the “Vitiation Test” when applying the Doctrine of Equivalents.
- The “Success More Likely Than Not” and “Ordinary Observer” Standards for a...more
On December 7, 2012, the Supreme Court granted certiorari in FTC v. Watson Pharmaceuticals. The Supreme Court is now poised to resolve the circuit split on the treatment of so-called “pay for delay” Hatch-Waxman Act patent...more
The Supreme Court granted certiorari Friday in Federal Trade Commission v. Watson Pharmaceuticals, Inc., one of two cases with certiorari petitions before the Court relating to reverse payment settlement agreements in ANDA...more
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
On September 16, 2011, the America Invents Act (AIA) ushered in major changes to the U.S. patent system, including changes affecting assertion of patent infringement against multiple, unrelated accused infringers. Effective...more
Originally published in Law360, New York on November 15, 2012.
Signed into law by President Obama on Sept. 16, 2011, the America Invents Act represents the most sweeping changes to U.S. patent law in over 60 years....more
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