The Weakening of Pharmaceutical Method Patents: The Federal Circuit Addresses the ‘FDA Conundrum’
Brian Higgins and Jay Lessler, partners with Blank Rome, recently authored an article entitled "The Weakening of Pharmaceutical Method Patents: The Federal Circuit Addresses the ‘FDA Conundrum’" that was published in the March 2014 edition of Indian Journal of Intellectual Property Rights.
Mr. Higgins and Mr. Lessler's article focused on the requirements for generic drugs issued by the U.S. Food and Drug Administration ("FDA"). These requirements may prevent a generic manufacturer from altering a drug product to unequivocally avoid patent infringement, and may also require a generic manufacturer to use a patented method for quality control purposes. These situations are called the ‘FDA conundrum.’