Renita S. Rathinam Associate

Ms. Rathinam has served as litigation counsel in matters involving the chemical, pharmaceutical and mechanical arts and has significant experience in nearly all pre-trial, trial, and post-trial aspects of patent litigation.  Central to Ms. Rathinam's practice is Hatch-Waxman Act analysis, and as such she has represented a number of pharmaceutical companies in ANDA/NDA related actions.  She also engages in pharmaceutical/biotechnology patent infringement and validity opinion practice and counseling particularly in connection with preparation of Paragraph IV Notifications under section 505(b), as well as freedom-to-operate, due diligence and product clearance work, licensing and contract matters, including joint ventures.  Ms. Rathinam's practice additionally includes analysis of the Biologics Price Competition and Innovation Act (BPCIA) and counseling with respect to developments pertaining to implementation of the U.S. abbreviated approval pathway as well as litigation strategies particular to interchangeable, biosimilar, and biobetter products and platform technologies.

District of Columbia
U.S. Patent and Trademark Office

University of North Carolina School of Law (J.D.  2003)
Georgetown University (M.S. Biochemistry and Molecular Biology with honors, 2004)
Emory University (B.S. Biology, with honors, 2000)

AstraZeneca v. Hanmi Pharmaceutical, et al. - Civil Action No. 3:11-cv-00760 (D.N.J.) Representing Hanmi Pharmaceutical in NDA related litigation involving patents directed to esomeprazole salt (Nexium®) formulations.

CNH America v. Kinze Mfg. - Civil Action No. 08-945 (D. Del.) Represented CNH America LLC in patent infringement case involving patents on seed planters and seed metering devices.  (jury trial 2011) (post-trial motions pending).

Metzger v. CNH America LLC, - Civil Action No. 3:04-cv-50466 (N.D. Ill) Representing CNH America LLC in infringement action and as Third Party Requester in inter partes reexamination presently pending before the Board of Patent Appeals. (District court action stayed pending resolution of reexamination proceeding)

Eli Lilly v. Wockhardt et al. - Civil Action No. 1:08-cv-01547 (S.D. Ind.) Represented Wockhardt in Hatch-Waxman case involving patent on duloxetine hydrochloride (Cymbalta®) and methods of treatment.  (Settled 2011).

Titan Tire Corp. and The Goodyear Tire & Rubber Co. v. Case New Holland, et al - No. 07-63 (S.D. Iowa 2007) Represented Case New Holland in design patent infringement litigation involving patents directed to tire tread designs.  (Favorable Settlement 2010).

Mars vs. Natraceutical, S.A., Civil Action No. 02:07-CV-01574 (D. NJ) - represent Natraceutical in seven-patent infringement case relating to polyphenol-enriched chocolate products, cocoa powders and extracts.  Defeated Mars’ request for preliminary injunction.  Trial expected 2009.

Sanofi-aventis v. Wockhardt - C.A. No. 08-021 (D. Del.) Represented Wockhardt in multi-defendant ANDA litigation involving patent on alfuzosin hydrochloride (Uroxatral®).  (Settled 2009).

Forest Labs v. Wockhardt et al. - Civil Action No. 07-229 (D. Del) Represented Wockhardt in multi-defendant ANDA litigation involving use of memantine hydrochloride (Namenda®) in treatment of Alzheimer's disease. (Favorable settlement 2009.)

Merck v. Ranbaxy - Civil Action No. 07-229 (D. Del.) Represented Ranbaxy in ANDA litigation involving imipenem cilastatin antibiotic (Primaxin®).  (Favorable settlement 2008).

CNH America, LLC v. Clarke Machine, - Civil Action No. 07-4183  Represented CNH America, LLC in patent infringement action involving headers for combines.  (Favorable settlement with agreed injunction 2008).

In The Matter of Certain Buffer Systems and Components Thereof Used in Container Processing Lines, - 337-TA-609.  Represented Sidel Complainants in ITC investigation involving patents directed to accumulation tables for bottle packaging lines. (Favorable settlement 2008).

Kinzenbaw v. Case Corp., - Civil Action No. C01-133-LRR (N.D. Iowa)  Represented defendant Case Corporation in infringement litigation involving patents on technology planter toolbar pivot feature system in multi-week trial and in Federal Circuit appeal.  (Favorable verdict 2004, affirmed February 2006).

Associations

American Bar Association

American Intellectual Property Law Association

Women in Bio

Licensing Executive Society

District of Columbia Bar Association: Intellectual Property Section, Pro Bono Program

"Protection of Privileges and Immunities during patent litigation,"  Delhi and Mumbai, India (2006)

"Conducting Freedom to Operate Analyses," Delhi, India (2006)

"Authorized Generics Practice and the Battle Over Exclusivity in the U.S. Market,"  International Symposium, Global Perspective on Biotech and Pharma Patents, Ahmedabad, India (2007)

"U.S. Discovery Obligations and Process Overview," Valencia, Spain; Montreal, Canada (2007); Mumbai, India (2009)

"Divided Infringement -  Liability in Multi-Actor Scenarios Under Current U.S. Law," Seoul, Korea (2011)