Amy’s clients range from large international pharmaceutical corporations to smaller companies producing innovative drugs and drug products. She prepares and prosecutes domestic and international patent applications and provides counseling and strategic guidance to build commercially valuable patent portfolios.
A significant portion of Amy’s practice also involves conducting due diligence reviews for licensing or acquisition of therapeutics for human and animal health, including negotiating and drafting resulting agreements. Moreover, Amy provides due diligence support and coordination of collaborative relationships, including assumed responsibility for existing portfolios. She advises on the prosecution of patents subject to joint development arrangements to maximize commercial prospects for all parties involved.
Amy has managed global patent portfolios for multiple pharmaceutical, biotech, and veterinary clients across several therapeutic and diagnostic areas, including the original drafting of patent applications for new chemical entities that have gone on to become marketed products. She provides strategic guidance, including freedom-to-operate analyses, and invalidity and non-infringement opinions, as well as life cycle management analyses, product portfolio reviews and litigation support for innovator companies.
Furthermore, Amy advises clients on the regulatory issues associated with the research and development of pharmaceuticals, biologics, medical devices and veterinary products. Her experience includes coordinating regulatory and patent exclusivities, as well as supporting in-house regulatory staff at client companies as development assets move through the FDA approval process. Amy provides strategic guidance to coordinate Hatch-Waxman patent term extension strategies and other important data and marketing exclusivities.
Clients value Amy’s unique perspective that is focused on understanding the science behind an innovation and, more importantly, understanding the intended commercial prospects for the innovation so that, working together, they may create a valuable exclusivity profile unique to each asset.
Informed by time spent in the boardroom and the C-suite, Amy poses the questions other patent lawyers may not think to ask. Regardless of the challenge at hand, Amy is committed to finding patent solutions that are both grounded in science and serve her client’s broader business objectives.
Professional and Community Involvement
Council Member, North Carolina Bar Association Intellectual Property Section
Member, Intellectual Property Owners Association
IAM Patent 1000, 2019
Articles in the National Law Review database by Amy H. Fix