Use of Benefit Corporations to Accelerate Access to Affordable Vaccines
Julie Bateman Low- and middle-income countries face the heaviest burden from vaccine-preventable diseases, yet many of these countries cannot afford critical vaccines. Vaccines are often protected by patents so that pharmaceutical companies can recoup development costs. Consequently, vaccine manufacturers in developing countries must wait until the patents expire to produce lower-cost generic vaccines. Additionally, when the development of new vaccines relies on existing patents, such development is hindered. Benefit corporations offer an opportunity for the private and public sectors to align interests in accelerating critical vaccine development. Vaccine developers, restructured as benefit corporations, could commit to both special licensing agreements...
Was the FDA Exemption to Patent Infringement, 35 U.S.C. § 271(e)(1), Intended to Exempt a Pharmaceutical Manufacturer’s Activities in the Development of New Drugs?
Paul Wiegel Esq. The FDA exemption was not created to assist in the generation of new drug candidates, which are included in the broad interpretation of the “reasonably related” language by the Supreme Court in Merck. Applying the Supreme Court’s interpretation to the facts of Merck means that a pharmaceutical manufacturer may use the patented products and methods of another manufacturer to identify new drug candidates and not infringe. In fact there is almost no limit to what can be considered “reasonably related” to the development of information for submission to the FDA since a great deal of the research...