Kristin M. Cooklin focuses her practice on intellectual property litigation, particularly all phases of patent infringement litigation from pre-suit counseling through appeal. Kristin has litigated a wide array of technologies, including the biotech, chemical, and pharmaceutical fields. Her main area of experience is in Abbreviated New Drug Application (ANDA) patent litigation matters arising under the Hatch-Waxman Amendments to the Federal, Food, Drug and Cosmetic Acts ("Hatch-Waxman Act"), where she has counseled both innovator and generic pharmaceutical companies.
Kristin has handled litigation in the areas of respiratory pharmaceuticals, oral contraceptives, cosmetics, mechanical devices, trade secrets, copyrights and trademarks, in addition to general commercial litigation and counseling.
Kristin also has experience in patent prosecution and related counseling in the cosmetic, pharmaceutical and biotech fields, including experience handling all stages of proceedings before the United States Patent and Trademark Office. In addition, she has been involved in trademark prosecution, opinions regarding the validity, infringement and enforceability of patents and intellectual property due diligence. Kristin handles custody disputes serving as a court-appointed guardian ad litem in the District of Columbia and has tried pro bono cases for victims of domestic violence.
Kristin earned her B.S. in microbiology and biochemistry as well her as J.D., all cum laude, from Duquesne University. She is admitted to practice in Pennsylvania and the District of Columbia and is also a registered patent attorney licensed to practice before the U.S. Patent and Trademark Office. Kristin is also admitted to practice before the U.S. Court of Appeals for the Federal Circuit.
- Bayer Schering Pharma AG, et al. v. Sandoz Inc., et al. (Representing defendant Watson in ANDA patent infringement action involving generic YASMIN oral contraceptive drug. Defeated motion to extend the automatic 30-month stay on FDA approval of Watson's generic product, and obtained judgment of non-infringement on the pleadings; Federal Circuit affirmed defense judgment, April 16, 2012, sub nom Bayer Schering AG et al. v. Lupin Pharmaceuticals, et al.)
- In re: Armodafinil Patent Litigation (D. Del.) (Represented defendant Mylan in multidistrict ANDA patent infringement action involving generic NUVIGIL drug used to treat excessive sleepiness, successfully defeating motion for preliminary injunction and securing favorable settlement.)
- Duramed Pharmaceuticals, Inc. v. Watson Laboratories, Inc. (D. Nev. and Fed. Cir.) (Representing defendant in ANDA patent infringement action involving generic SEASONIQUE oral contraceptive drug. Successfully defended generic product launch and obtained Federal Circuit order affirming propriety of the product launch.)
- Teva Women's Health, Inc. v. Lupin, Ltd., et al. (D.N.J.) (Represented Watson in ANDA patent infringement action involving generic LoSEASONIQUE oral contraceptive drug, securing favorable settlement.)
- Arysta LifeScience North America LLC v. Makhteshim Agan of North America, Inc. (E.D.N.C.) (Represented defendant in patent infringement action involving plant growth regulator mepiquat chloride, securing favorable settlement.)
- Bayer Schering Pharma AG et al. v. Watson Pharmaceuticals, Inc. et al. (D. Nev.) (Representing defendant Watson in ANDA patent infringement action involving generic YAZ oral contraceptive drug.)
- Sepracor Inc. v. Breath Limited. (Represented plaintiff Sepracor in ANDA litigation of generic version of Xopenex oral inhalation unit dose vials.)
- Sepracor Inc. v. Dey L.P. and Dey Inc. (Represented Sepracor in ANDA litigation of generic version of Xopenex oral inhalation unit dose vials.)
Admitted to practice: District of Columbia, Pennsylvania, United States Patent and Trademark Office, U.S. Court of Appeals for the Federal Circuit, Federal District Court for the Western District of Pennsylvania
Speeches & Presentations
"Damages and Injunctions: Exploring the Consequences and Conundrums of Launching at Risk," ACI’s Paragraph IV Disputes, West Coast Conference, San Francisco, CA
(December 7, 2011).
Speaker: Kristin M. Cooklin.
In the News
This Week's Legal Lions
April 19, 2013 — Law360
San Francisco-based partner, Mark Jansen is featured as a "legal lion" by Law360. The editors noted, "generic drug makers (were) vindicated in a federal circuit court ruling that two claims in Bayer HealthCare Pharmaceuticals Inc.'s patent for a contraceptive were obvious and therefore invalid. The court reached back to patent applications filed with Australian and European agencies in the early 1990s, which defendants had argued contained ideas similar to those in a Bayer patent for Yaz. The Intellectual Property Group team representing Watson Pharmaceuticals Inc. in this matter was led by Mr. Jansen and included Washington, D.C.-based attorneys Cedric Tan, partner; Neil M. McCarthy, senior counsel; and Kristin M. Cooklin, counsel.
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