Brian P. Murray is a litigation attorney in Holland & Knight's Chicago office and a member of the firm's Intellectual Property Group. Mr. Murray practices in the areas of intellectual property and technology-driven litigation, including cases arising under the Hatch-Waxman Act.
Mr. Murray has represented clients in patent litigation, including Hatch-Waxman patent litigation, concerning technological issues such as crystal forms (polymorphs), methods of treatment, molecules and chemical genus, integrated medical devices such as metered dose inhalers, and various formulations, including solid oral dosage forms, oral liquid dosage forms, injectables and transdermal/buccal dosage forms.
Mr. Murray's has litigated cases arising under the Hatch-Waxman Act relating to the following products:
Mr. Murray has experience in pre-suit strategy, utilizing his background in pharmaceutical research and development to assist clients in product selection and portfolio management, product and formulation development, proposed labeling language, and litigation and regulatory strategies. During litigation, Mr. Murray is particularly experienced in streamlining the discovery process to allow the focus to be on the merits of the case. Mr. Murray's scientific background and pharmaceutical industry experience is of particular value in the claim construction process and in working with expert witnesses, especially in focusing on and making clear case-dispositive issues, and taking several Hatch-Waxman cases through to trial.
In addition to litigation, Mr. Murray counsels clients in a wide range of issues relating to pharmaceutical and biological technologies, including formulation development, product selection and regulatory issues before the U.S. Food and Drug Administration (FDA). For example, Mr. Murray has provided counseling, insight and assisted in drafting responses to FDA citizen petitions seeking to delay generic competition. Mr. Murray has also assisted clients in responding to FDA complete response letters pertaining to pending abbreviated new drug application (ANDA) filings, and drafted controlled correspondence to the FDA concerning possible generic exclusivity forfeiture.
Mr. Murray also devotes time to his pro bono practice, including advising on a charitable research grant foundation on best practices concerning open access to data and publications arising from research funded by the foundation.
Prior to attending law school, Mr. Murray worked as a formulation development scientist at Caraco Pharmaceutical Laboratories and further gained experience in active pharmaceutical ingredient (API) and custom intermediate synthesis development at Fabbrica Italiana Sintetici S.p.A.
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