FacultyFaculty/Author Profile

Jessica R. Wolff

Cooley LLP

San Diego, CA, USA

Jessica Wolff is a partner in the Intellectual Property Litigation practice group and is resident in the San Diego office.

Ms. Wolff advises pharmaceutical and biotech companies in intellectual property matters and has extensive experience litigating chemical and biotech patents on antibodies, DNA amplification techniques, drugs, formulations, genetic probes, viruses, and antigen assays. She has also represented start-ups and mature public companies in a wide variety of intellectual property disputes including patent, trade secret, and breach of IP license actions. Her litigation clients have included Masimo Corporation, Impax Laboratories, Mutual Pharmaceuticals, Phenomix, Biogen Idec, Sicor, Gen-Probe, AmpliMed, IDEXX, Intermedics, and Spectra-Physics. In addition to litigation, Ms. Wolff has managed worldwide patent portfolios, conducted freedom of use analyses for developing products, drafted invalidity and non-infringement opinions, conducted due diligences for pharmaceutical, biotech, medical device and clean tech companies and their investors.

Ms. Wolff has particular expertise in preparing and conducting Hatch Waxman litigation concerning generic drugs. Recently Ms. Wolff successfully represented a pharmaceutical company in a cutting edge Lanham Act litigation against five manufacturers of unapproved quinine sulfate that resulted in consent judgements and a preliminary injunction in separate litigation against another manufacturer. She also successfully represented a generic manufacturer of the antitumor drug Cisplatin in a bench trial which resulted in the invalidation of a patent which would have extended for an additional 15 years Bristol-Myers' $50 million/year exclusivity on the drug. In addition, she handled the appeal before the U.S. Court of Appeals for the Federal Circuit which affirmed the district court's ruling in her client's favor.

Ms. Wolff has prepared over 100 freedom to operate analyses and worked closely with clients to design around third-party patents. For example, she was instrumental in developing a non-infringing formulation of the anesthetic Diprivan and obtained patent protection to prevent further generic competition. Such strategic work has facilitated the launch of over 50 NDA, generic, and 505(b)(2) drug products.

Ms. Wolff has written and lectured on a variety of intellectual property topics, including a primer on Hatch-Waxman procedures and litigation, protecting IP for entrepreneurs, written description and enablement requirement for biotech inventions, coordination of FDA and patent prosecution strategies, 180-day exclusivity provisions, pending biosimilar litigation and polymorph patents.

Prior to law school, Ms. Wolff received her Bachelor's degree in Chemistry with a concentration in Cell Biology magna cum laude from Bryn Mawr College in 1986. During her junior year of college, she was a matriculated student at Cambridge University in England where she studied Pharmacology, Biochemistry, Inorganic chemistry and conducted basic research on metal colloids. She received her Master's degree in Organic Chemistry from the Massachusetts Institute of Technology in 1988. Her research focused on analogues of chorismic acid, a key intermediate in the biosynthetic pathway for aromatic compounds in lower organisms. Prior to attending law school, Ms. Wolff worked as a research scientist in the Cell Biology Department of Duke University Medical School designing and synthesizing 5-alpha-reductase inhibitors for the treatment of prostate cancer and osteoporosis.

University of California, Los Angeles School of Law
- JD, 1992
Massachusetts Institute of Technology
- MS Organic Chemistry, 1988
Bryn Mawr College
- AB Chemistry, 1986, magna cum laude

- Court of Appeals, Federal Circuit
- U.S. District Court, Central District of California
- U.S. District Court, Eastern District of California
- U.S. District Court, Northern District of California
- U.S. District Court, Southern District of California

Registered to practice before the United States Patent & Trademark Office (USPTO)

- American Chemical Society
- American Intellectual Property Law Association
- Athena
- San Diego Intellectual Property Law Association

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