Ann M. Caviani Pease, Ph.D. co-chairs the firm’s intellectual property group, chairs its patent practice and is a member of the firm’s policy committee. A registered patent attorney, Dr. Pease counsels clients in the biotechnology, pharmaceutical, and life sciences industries on intellectual property strategy. Her practice includes developing and procuring worldwide patent portfolios surrounding developmental and commercial products; conducting patentability, freedom-to-operate, and validity assessments; preparing patentability, non-infringement, and invalidity opinions; evaluating intellectual property portfolios in connection with acquisitions, mergers, financings, collaborations, and/or partnering deals; and structuring/re-structuring developing and mature patent portfolios to maximize monetary value. In the area of pharmaceuticals and biopharmaceuticals, she advises innovators on patent life cycle strategies for developmental and commercial products, conducts pre-litigation diligence of patent portfolios covering commercial products and advises clients on Orange Book listing and Hatch-Waxman patent term extension strategies.
As a member of litigation teams, Dr. Pease has developed complex world-wide enforcement and defense strategies in suits involving multiple parties, as well as strategies that exploit concurrent adversarial proceeding before the U.S. Patent and Trademark Office, such as interference and ex parte and inter partes reexamination proceedings.
Dr. Pease is perennially ranked as one of the leading lawyers in the nation by Chambers USA, Legal 500 and U.S. News & World Report – Best Lawyers, Best Law Firms. Clients have told reviewers that “she has built up a loyal client following due to her ‘incisive understanding of the intricacies of patent law and procedure.’” Chambers USA also published “peers applaud Ann Caviani Pease as a ‘wonderfully bright patent prosecutor’ who ‘delves deep into the issues to resolve them.’” She has been recognized as a Best Lawyer by the San Francisco Business Times and as a “Life Science Star” in the Euromoney Legal Media Group's 2012 inaugural Expert Guide to Life Science Attorneys.
Significant Representations
- Endo Pharmaceuticals Inc., et al., v. Impax Laboratories, Inc., et al. (U.S. District Court, Districts of Delaware and New Jersey). Represented Endo Pharmaceuticals Inc. and Penwest Pharmaceuticals Co. (now a wholly owned subsidiary) in a series of related Hatch Waxman patent infringement actions filed against six generic companies—Impax, Sandoz, Actavis, Teva/Barr, Watson and Roxane—relating to Opana® ER, an extended release form of oxymorphone hydrochloride indicated for around-the-clock treatment of chronic pain. Product sales were over $200 million a year, and the different first filers on different dosage strengths, retroactive rejection by FDA of the first filer’s ANDA, and other matters created strategic complexity and the need to combine litigation and FDA strategy. Settled before trial with Actavis, Teva/Barr and Watson, during trial with Impax and Sandoz (after Endo presented its infringement case), and the action against Roxane was resolved after trial.
- Endo Pharmaceuticals Inc. and Teikoku Seiyaku, v. Watson Laboratories, Inc. (U.S. District Court, District of Delaware). Representing platintiffs Endo Pharmaceuticals Inc. and Teikoku Seiyaku Co. Ltd. in a Hatch Waxman patent infringement litigation involving Endo’s blockbuster hydrogel-based lidocaine patch, Lidoderm®, which is indicated for treatment of post-herpetic neuralgia. This flagship product has annual sales in excess of $750 million. The case settled following trial with Watson agreeing to stay out of the market for an agreed period of time.
- Endo Pharmaceuticals and Teikoku Seiyaku v. Mylan (U.S. District Court, District of Delaware). Representing plaintiffs in Hatch Waxman litigation relating to Mylan’s ANDA for Lidoderm®, an $800 million a year product. Brought novel claim challenging Mylan’s ability to invoke Hatch Waxman Act when it had violated FDA rules and failed to properly notify the plaintiffs of the filing of the ANDA.
- Norgine and Salix v. Novel (U.S. District Court, District of New Jersey). Representing Norgine, a UK company, which owns the rights to MOVIPREP colon cleansing agent for use prior to colonoscopy, in a patent litigation under the Hatch-Waxman Act against an ANDA filer on a generic colon cleanser product.
- Lectec v. Endo Pharmaceuticals, et al. (U.S. District Court, Eastern District of Texas). Represented Endo in defense of infringement case relating to patch technology, in which the plaintiff was seeking over $500 million in royalties. Obtained a highly favorable resolution in which Endo acquired rights to the patent, which was then listed on the Orange Book and used to pursue claims relating to ANDAs filed by Watson and Mylan.
- Tempesta v. Cariel and Jean. Represented Shaman Pharmaceuticals in an interference against Cariel relating to proanthocyanin compositions isolated from plants. Cariel conceded priority after Shaman demonstrated that Cariel engaged in inequitable conduct.
- Pevarello v. Lan. Represented Newron Pharmaceuticals SpA in an interference against Purdue Neuroscience Co. relating to therapeutics for neuropathic pain. Newron prevailed on substantive motions
Education
University of Wisconsin - Madison, B.S., Chemistry, 1985, with honors
University of California, Berkeley, Ph.D., Biophysical chemistry, 1990
Stanford Law School, J.D., 1995
National Institutes of Health, Post-Doctoral Fellowship
Court Admissions
United States Court of Appeals for the Federal Circuit
United States Patent and Trademark Office
Bar Admissions/Qualifications
California
Memberships
California Bar Association
San Francisco Intellectual Property Law Association
Publications and Lectures
- "Factoring the Role, Challenges, and Impact of Orange Book Listings and Delistings in Patent Portfolio Management," American Conference Institute's 9th Annual Maximizing Pharmaceutical Patent Life Cycles, New York (October 2008)
- "Re-Exploring Orange Book Listing and De-Listing Strategies," American Conference Institute's Conference on Maximizing Pharmaceutical Patent Life Cycles, San Francisco (2007)
- "Lessons Learned from Big Pharma: Minimizing Risk at Each Stage of a Therapeutic Product's Life Cycle," Dechert LLP Client Seminar, Millbrae, CA (2007)
- "Hatch-Waxman Overview: From Politics to Patents to Products," American Conference Institute's Seminar on Maximizing Pharmaceutical Patent Life Cycles, San Francisco (2006)
- "Protecting Your Products: Minimizing Risk at Each Stage of the Drug Product Life Cycle," Dechert LLP Client Seminar, Philadelphia (2005)
- "Hot Topics and Everyday Troubleshooting," Dechert LLP Intellectual Property Client Seminar, Philadelphia (2005)
- "Intellectual Property Portfolio Capitalization," chapter in Developing an IP Strategy for Your Company, Aspatore Books' "Inside the Minds" series (2005)
- "Patent Life Cycle Strategies: Claiming Strategies in Light of Hatch-Waxman and FDA Final Rule," IP Committee Meeting of BIO Organization, San Francisco (2004)
- "Drafting a Legally Sound Opinion on Invalidity and Non-Infringement," American Conference Institute's 3rd Annual National Patent Counsel's Forum on Freedom to Operate, San Francisco (2004)