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MaryJoy Ballantyne's practice focuses on food & drug law, intellectual property law, and patent litigation. Ms. Ballantyne advises major pharmaceutical companies on FDA regulatory and compliance issues, including GMP compliance and FDA enforcement actions. In addition, Ms. Ballantyne advises clients in the regulation of dietary supplements, over-the-counter drugs, and cosmetics. Ms. Ballantyne also advises clients on Hatch-Waxman issues including Orange Book patent listings and patent term extensions and has represented major pharmaceutical companies involved in Hatch-Waxman Paragraph IV litigation.
Representative Matters
- Advising a major pharmaceutical company in FDA enforcement actions.
- Advising a major pharmaceutical company in strengthening GMP compliance.
- Represented a major pharmaceutical company in patent litigation involving monoclonal antibodies used to treat cancer.
- Represented a major pharmaceutical company in Hatch-Waxman Paragraph IV litigation.
- Advised a major pharmaceutical company on listability of patents and pending patent applications in FDA Orange Book.
- Advised a major pharmaceutical company on patentability of pending patent application and the potential regulatory impact on bioequivalence studies of an ANDA filer who attempts to design around the patent to create a generic product.
Previous Experience
Prior to law school, Ms.Ballantyne worked for several years conducting basic science research in the fields of biochemistry, molecular biology, infectious diseases, and neurobiology at Cornell University and University of Utah School of Medicine. Following her years in the basic sciences, she was a Fixed Income research assistant in JP Morgan’s NY office and a policy analyst at the Institute of Medicine of the National Academy of Sciences in Washington, DC.
Memberships and Affiliations
- American Bar Association
- American Intellectual Property Law Association
Publications and Speeches
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