Whether a pharmaceutical company is bringing a new generic drug to market or defending its innovations from interlopers, Fox Rothschild is ready.

Our lawyers have significant experience with Abbreviated New Drug Applications (ANDAs) and the Hatch-Waxman Act, which established the approval pathway for generic drug products. From our nationwide network of offices, including locations in Delaware, New Jersey, California and other hubs of ANDA litigation, we provide clients the cost-effective solutions they need.

We understand the Act’s complexities, as well as the science involved. The team’s knowledge and patent litigation experience spans biotechnology, chemical and synthesis processes, as well as medical devices, formulations, experiments and polymorphic products.

We also are skilled with clearance and Paragraph IV opinions in support of ANDAs. We frequently assist clients with generating non-infringement, invalidity and freedom-to-operate opinions with respect to Orange Book-listed patents.

Below are representative cases our attorneys have worked on:

• Amgen/Servier v. Bionpharma (ivabradine) - Represented Bionpharma in favorable settlement with early Entry Date.
• Johnson & Johnson v. Unichem (cetirizine hydrochloride/pseudoephedrine hydrochloride) – Served Paragraph IV (PIV) notice letter on behalf of Unichem. No lawsuit was filed.
• Novartis v. Hetero, Bionpharma, Prinston (fingolimod) - Represented Hetero, Bionpharma and Prinston in favorable settlement on eve of trial.
• Lundbeck/Takeda v. Apicore/Mylan (vortioxetine) - Represented Apicore/Mylan in favorable settlement prior to claim construction.
• Supernus v. Actavis (oxcarbazepine) - Represented Actavis in bench trial in U.S. District Court for the District of New Jersey. The court ruled one of two patents did not infringe.
• Endo v. Actavis (low ABUK oxymorphone) - Represented Actavis in bench trial in U.S. District Court for the District of Delaware.
• Endo/Grunenthal v. Actavis (oxymorphone) - Represented Actavis in bench trial in U.S. District Court for the Southern District of New York, during which Grunenthal’s patents were invalidated.
• Pfizer v. Sandoz (temsirolimus) - Represented Pfizer in favorable settlement on eve of trial. No generic drug entered the market.
• Pfizer v. Watson (sirolimus/rapamune) - Represented Pfizer in bench trial where defendant was enjoined for infringing valid patents.
• Wyeth v. Ranbaxy (pseudoephedrine) - Represented Wyeth in favorable settlement. No generic drug entered the market.
• Eli Lilly v. Eagle Pharmaceuticals (pemetrexed) - Represented Eagle Pharmaceuticals in a 505(2)(B) Hatch-Waxman litigation. Achieved a claim construction victory on all disputed terms and obtained a favorable settlement before the end of a 7-day bench trial.
• Bristol Myers Squibb Co. v. Apotex (dasatinib) - Represented Bristol-Myers Squibb and obtained a favorable settlement shortly before trial. The court adopted proposed constructions for all 15 terms in dispute in favor of Bristol Myers.
• In Re: Desloratadine Patent Litigation - Represented Schering in a consolidated Hatch-Waxman litigation against 21 generic defendants. Obtained consent judgments with injunctions against all defendants.
• Allergan v. Watson Laboratories - Represented Watson, who was sued in U.S. District Court for the District of Delaware or infringement of three patents in response to Watson’s filing an ANDA seeking to market an extended release trospium chloride (generic to Santura XR) for the treatment of overactive bladder. We successfully demonstrated that the claims of the asserted patents were invalid (and thus unenforceable).
• Reckitt Benckiser and UCB Manufacturing v. Tris Pharma - Represented Tris Pharma, successfully excluding the plaintiffs’ expert report on infringement leading to summary judgement that our client did not infringe the asserted patent and ending the patent portion of the litigation in our client’s favor. The remaining trade secret case against our clients proceeded to trial, where we successfully argued that none of the asserted trade secrets were, in fact, trade secrets because each was in the public domain.
• Torrent Pharmaceuticals v. Novartis AG - Successfully challenged the validity of Orange Book listed patent. This was the first successful challenge in an Inter Partes Review to an Orange Book-listed patent brought by a generic pharmaceutical company.
• Novartis v. Noven Pharmaceuticals - Successfully challenged, in an Inter Partes Review, patents asserted by plaintiff in district court.
• In re Gabapentin Patent Litigation - Represented Teva in a patent infringement litigation concerning Teva’s generic equivalent to Pfizer’s Neurontin, an anti-epileptic drug.
• In re Metoprolol Succinate Patent Litigation, AstraZeneca v. KV Pharmaceuticals - Represented KV Pharmaceuticals, winning a victory on summary judgement. The court ruled the patents-in-suit invalid.