On January 24 to a packed house, the Food, Drug and Cosmetic Law Section of the New York State Bar held its annual meeting. This year, the agenda featured presentations on medical devices, a Supreme Court update, an in-house/outside counsel panel to discuss effective relations for FDA/regulatory advice, a discussion of the Federal Sunshine Act, and "A View from the Inside" retrospective of some hot issues at FDA from a recent high-level official at FDA, including the new food and pharmacy initiatives under development.
In the Supreme Court update called "Pivotal Court Cases for FDA Practitioners 2012-2013 Updates", FLH Partner Brian J. Malkin, spoke on two cases to watch in the first quarter of 2013, Mutual Pharm. Co., Inc. v. Bartlett , No. 12-142 (U.S., cert. granted Nov. 30, 2012, argument scheduled Mar. 19, 2013) and Bowman v. Monsanto Co., No. 11-796 (U.S., cert. granted Oct. 5, 2012, argument scheduled Feb. 19, 2013). The question presented in Mutual v. Bartlett is:
Whether the First Circuit erred when it created a circuit split and held--in clear conflict with this Court's decisions in Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); and Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992)--that federal law does not preempt state law design-defect claims targeting generic pharmaceutical products because the conceded conflict between such claims and the federal laws governing generic pharmaceutical design allegedly can be avoided if the makers of generic pharmaceuticals simply stop making their products.
Bowman v. Monsanto is a case that my firm, Frommer Lawrence & Haug LLP, is arguing on behalf of petitioner Bowman, where the question presented is:
Patent exhaustion delimits rights of patent holders by eliminating the right to control or prohibit use of the invention after an authorized sale. In this case, the Federal Circuit refused to find exhaustion where a farmer used seeds purchased in an authorized sale for their natural and foreseeable purpose--namely, for planting. The question presented is: Whether the Federal Circuit erred by (1) refusing to find patent exhaustion in patented seeds even after an authorized sale and by (2) creating an exception to the doctrine of patent exhaustion for self-replicating technologies?
Mr. Malkin's summaries of these two cases may be found here. His presentation for these two cases, including topics for consideration by the Food, Drug, and Cosmetic Section may be found here.