The Biologics Price Competition and Innovation Act: Innovation Must Come Before Price Competition
Robert N. Sahr In an effort to reduce the costs of medicine for patients, Congress must be especially careful not to impair the ability of the biotechnology industry to thrive by substantially diminishing profitability. Currently, the biotechnology industry is “still relatively nascent” and is largely fueled by venture capital investment. Of the approximately 1400 biotechnology companies operating in the United States today, only twenty are profitable. Many of these companies are small, with revenues of under a million dollars per year, and do not even have a product on the market yet. Leaders in the biotechnology industry have expressed concern...
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...