ANDA Litigation
Caesar Rivise offers its pharmaceutical clients an exceptionally high level of litigation experience nationwide in today’s quickly changing, complex and high-stakes patent litigation environment, particularly in cases involving Paragraph IV patent challenges under the Hatch-Waxman Act. The ANDA team’s legal expertise and pharmaceutical industry know-how are hallmarks of Caesar Rivise. The firm counsels its clients, including generic pharmaceutical companies, API suppliers and distributors, on all related matters. This includes product design and clearance on pharmaceutical products with an eye toward avoiding, where possible, litigation based on innovative design around, as well as obtaining patents for such clients on novel drug delivery forms and molecules. The firm also utilizes its patent litigation strategies to attempt to resolve litigation with settlements at early stages of the litigation to reduce litigation costs. The firm also counsels clients on at-risk launches and has orchestrated the most profitable and one of the largest at risk launches in pharmaceutical history.
Related Representative Matters
- Boehringer et al. v. InvaGen (10/25/18 D.NJ) represented generic in ANDA litigation successfully invalidating asserted patents covering Tradjenta® (linagliptin) and Jentadueto® (linagliption and metformin)
- Successfully represented generic pharmaceutical company in ANDA litigation involving Niaspan® (niacin extended release)
- In re ‘318 Patent Litigation, 578 F.Supp.2d 711 (D. Del. 2008), aff’d, 583 F.3d 1317 (Fed. Cir. 2009). Represented one of generic manufacturers in a patent infringement suit filed under 35 U.S.C. § 271(c)(2) regarding ANDA filing for an Alzheimer’s drug sold under the name Razdyne®/Reminyl® (galanthamine)
- Sanofi-Aventis, Sanofi-Synthelabo, Inc., and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership v. Apotex, Inc., represented generic in ANDA litigation on Plavix® involving largest at risk launch in history
- Roxane Labs Inc. v. Invagen Inc., successfully represented defendant generic company in transferring case from Ohio to NJ, defeated Preliminary Injunction, affirmed on appeal and obtained stipulation of non-infringement, affirmed on appeal, in suit by another generic regarding calcium acetate tablets (PhosLo® brand) and ultimately awarded client $2 million in attorney fees finding the case “exceptional”
- Genzyme v. Pentech Pharmaceuticals, Inc. represented generic in ANDA litigation on Hectorol® invalidating 2 Orange Book listed patents, with third patent being delisted as a result of suit
- Biovail Laboratories, Inc. v. Torpharm. Inc., successfully represented generic company in ANDA litigation involving Tiazac® (diltiazem hydrochloride)
- Represented a generic pharmaceutical company in an Inter Partes Reexamination proceeding which invalidated all the claims of the patent at issue
- Represented a generic pharmaceutical company in an Ex Parte Reexamination proceeding in which the claim at issue was found invalid by the Patent Office
