Main Menu Back to Page
{ Banner Image }

Showing 2 posts by Zachary W. Behler.

Regulators Can Sue Over Pay-for-Delay Drug Settlements Between Brand Name and Generic Drug Makers

generic drug makersOn June 17, 2013, the U.S. Supreme Court ruled that brand name drug makers can be sued for paying generic drug makers to delay the introduction of low-cost versions of popular medicines to the marketplace. The Court's 5-3 ruling is a victory for the Federal Trade Commission (“FTC”), and reverses a lower-court ruling that shielded drug makers from liability.

So-called "pay-for-delay" or reverse payment arrangements between brand name and generic drug makers result in payments being made to generic drug makers in order delay the launch of competing generic drugs. These settlements often stem from litigation, or threatened litigation, brought by brand name drug makers against generic drug makers who try to sell products prior to the patent expiration period. In this case, the FTC argued that pay-for-delay agreements cost consumers as much as $3.5 billion per year, while the pharmaceutical industry alleged that such deals are legitimate means of settling patent disputes. Read More ›

Categories: Pharmacy, Regulatory

Supreme Court Holds that a Patent of the Process of Administering a Drug is Invalid

patent of the process of administering a drugRecently in the case of Mayo Collaborative Services v Prometheus Laboratories, Inc., the Supreme Court of the United States found two patents invalid because they claimed subject matter that was not patentable.  The patents in this case covered processes that help doctors who use thiopurine drugs to treat patients with autoimmune diseases determine whether a given dosage was too high or too low. Read More ›

Categories: Patents