Pharmaceuticals
Members of our Pharmaceuticals team apply their legal expertise and advanced degrees in chemistry, pharmacy and other disciplines to provide our clients with legal services including:
- Patentability Opinions
- Freedom to Operate Opinions
- Patent Preparation, Prosecution and Procurement
- Representation in Post-Grant Proceedings in the U.S. Patent and Trademark Office, Including Interferences, Reexaminations, Inter Partes Review, and Post Grant Reviews
- Due Diligence Studies
- License counseling, negotiation and drafting
- Alternative Dispute Resolution
- Litigation, including patent infringement and ANDA litigation
- ANDA development and design of finished dosage forms
- Patent protection, enforcement and design around drug delivery forms and molecules
Related Representative Matters
- Served as an arbitrator in a dispute over alleged breaches of a license agreement for proprietary rights relating to cannabis transdermal patches, plus counterclaims for fraud and tortious interference
- 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)
- Prepared memorandum on patent infringement damages for pharmaceutical client and assisted in decision which saved hundreds of millions of dollars
- 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 leading multinational life sciences company in freedom-to-operate clearance searches and licensing opportunity identification
