Designed and implemented the litigation strategy as counsel for the second generic challenger in a patent infringement case involving patentee's drug, TAMBACOR©, a heart medication with sales exceeding $150 million. Summary judgment of noninfringement was obtained in less than six months after patentee filed its complaint in the U.S. District Court for the District of Minnesota. This judgment began tolling the 180-day exclusivity period of the first generic challenger, who was still facing trial and not yet on the market. The Federal Circuit subsequently affirmed the decision and, in doing so, expedited the client's market entry by many years. The Federal Circuit's decision resulted in a leading opinion on the proper application of the Hatch-Waxman Act, Minnesota Mining & Manufacturing Co. v. Barr Labs.
Designed and implemented the litigation strategy as lead counsel for the declaratory-judgment plaintiff, a generic drug maker, in a patent infringement case involving Sanofi-Aventis’ drug RILUTEK©, before the Honorable Judge Farnan in the U.S. District Court for the District of Delaware. A preemptory declaratory judgment attack precluded patentee from relying on the statutory 30-month stay on approval, resulting in approval of the generic alternative only six months after the ANDA was filed. Impax Labs., Inc. v. Aventis Pharmaceuticals, Inc.
Defended Chi Mei Optoelectronics in patent infringement litigation involving plasma-enhanced chemical vapor deposition (PECVD) processes used to make TFT-LCDs. Jury trial on liability found no willfulness and awarded plaintiff less than 5 percent of requested damages. Plasma Physics v. Chi Mei Optoelectronics Display Corp., C.A. No. 08-1628 (E.D.N.Y).
Defended InnoLux Display Corp. in patent infringement litigation involving plasma-enhanced chemical vapor deposition (PECVD) processes used to make TFT-LCDs. Case settled on terms the client found favorable. (E.D.N.Y.).
Represented Wockhardt in ANDA litigation regarding LUNESTA®, the active ingredient of which is eszopiclone. Settled prior to trial on terms the client found favorable.
Represented Vonage Inc. in defense of a patent case in a jury trial in federal court in Kansas.
Represented CardSoft in a patent infringement action relating to point-of-sale devices. Granted Jury award in excess of $15.3 million.
Represented relator in qui tam action involving patent false marking.
Represented our client, Sandoz Inc., in a patent infringement action regarding Sandoz's ANDA to make a generic version of Medicis' acne product SOLODYN® (minocycline hydrochloride).
Lead counsel for Sandoz Inc., in a patent infringement action regarding Sandoz's ANDA to make a generic version of Endo's pain product OPANA® ER (oxymorphone hydrochloride).
Represented Apotex Inc., in a patent infringement action regarding Apotex's ANDA to make a generic version of Wyeth's anti-depressant product EFFEXOR XR® (venlafaxine hydrochloride). Settled on favorable terms during trial.
Represented Apotex Inc., in a patent infringement action regarding Apotex's ANDA to make a generic version of Sanofi-Aventis' anticancer product TAXOTERE®, the active ingredient of which is docetaxel. Following a two-week trial, obtained an order for Apotex striking down the patents-in-issue as invalid as obvious and unenforceable due to Sanofi-Aventis' inequitable conduct in procuring the patents. Successfully argued on appeal with the Federal Circuit affirming trial court decision (April 2012). Of import is that inequitable conduct defense remains viable in ANDA litigations because of this ruling.
Represented our client, Sandoz Inc., in a patent infringement action regarding Sandoz's ANDA to make a generic version of Allergan's glaucoma drops COMBIGAN® (brimonidine tartrate/timolol maleate.)
Represented Sandoz Inc., in a patent infringement action regarding Sandoz's ANDA to make a generic version of Merck's anti-nausea product EMEND® (aprepitant).
Designed and implemented the litigation strategy as lead counsel for defendant, a Taiwanese semiconductor manufacturer, in a patent infringement case involving DC/AC power inverters for LCD panels in portable electronic devices. The defense resulted in a judgment as a matter of law on the issues of direct and contributory infringement and plaintiff's abandonment of a $120 million-plus damage claim (jury finding of inducement was reversed on appeal).
Represented Chimei InnoLux Corporation, f/k/a InnoLux Display Corporation, in a patent infringement case involving brightness-enhancing films used in LCD devices. Plaintiff dismissed its case against our client, with prejudice, after the special master indicated he would recommend granting defendant's motion for summary judgment.
Represented our client in a patent infringement action regarding Actavis' ANDA to make a generic version of King's pain product AVINZA®, the active ingredient of which is morphine sulfate.
Represented our client, Mylan Pharmaceuticals, Inc., in a patent infringement action regarding Mylan's ANDA to make a generic version of Pfizer's cardiovascular product CADUET®, the active ingredients of which are atorvastatin calcium and amlodipine besylate. Settled prior to trial.
Represented Apotex Inc., in a patent infringement action regarding Apotex's ANDA to make a generic version of Procter's osteoporosis product ACTONEL® (risedronate).
Represented our client, Sandoz Inc., in a patent infringement action regarding Sandoz's ANDA to make a generic version of Abbott’s ZEMPLAR® (paricalcitol).
Represented Apotex Inc., in a patent infringement action regarding Apotex’s ANDA to make a generic version of LYSTEDA (tranexamic acid). Matter pending.
Represented Apotex Inc., in a patent infringement action regarding Apotex’s ANDA to make a generic version of ACULAR LS® (0.4% ketorolac tromethamine). Matter pending.
Represented Apotex Inc., in a patent infringement action regarding Apotex’s ANDA to make a generic version of PRISTIQ® (desvenlafaxine). Matter pending.
Represented Sandoz Inc., in a patent infringement action regarding Sandoz's ANDA to make a generic version of Shire’s ADHD product INTUNIV® (guanfacine hydrochloride). Matter pending.
Represented Sandoz Inc., in a patent infringement action regarding Sandoz’s ANDA to make a generic version of Roche’s VALCYTE® (valganciclovir hydrochloride). Matter pending.
Represented our client, Sandoz Inc., in patent infringement action regarding Sandoz’s ANDA to make a generic version of Helsinn’s anti-nausea product ALOXI® (palonosetron hydrochloride injection). Matter pending.
Represented our client in a patent infringement action regarding InnoPharma’s ANDA to make a generic version of Spectrum’s FUSILEV® (levoleucovorin). Matter pending.
Represented our client, Sandoz Inc., in a patent infringement action regarding Sandoz’s ANDA to make a generic version of Abbott’s cholesterol medication TRILIPIX® (fenofibric acid). Matter pending.
Represented our client, Sandoz Inc., in a patent infringement action regarding Sandoz’s ANDA to make a generic version of Abbott’s cholesterol product NIASPAN® (niacin). Matter pending.
Represented our client, Sandoz Inc., in a patent infringement action regarding Sandoz's ANDA to make a generic version of Alcon's eye allergy product PATANOL® (olopatadine hydrochloride).
Represented client CardSoft in patent infringement action against multiple defendants who manufactured and sold infringing electronic point-of-sale ("ePOS") terminals using “swipe-technology.” Successfully secured patent damages for client in excess of $15 million for CardSoft in jury trial against VeriFone Systems, Inc. and VeriFone, Inc. (VeriFone) and Hypercom Corp. (Hypercom).
Represented our client in a patent infringement action regarding Apotex’s ANDA to make a generic version of AVODART® (dutasteride). Matter pending.