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Features
As the winter months approached, a storm was brewing in the antitrust world. The U.S. Courts of Appeals for the Sixth and Eleventh circuits have split over the per se illegality of Hatch-Waxman patent-settlement agreements by which a patent-holding drug maker pays a generic drug company to delay its entry into the market. The Federal Trade Commission (FTC) has harshly criticized these agreements, and now the Supreme Court has an opportunity to calm the fury.
The U.S. Court of Appeals for the Federal Circuit has confirmed that there is no patent infringement liability under 35 U.S.C. 271(g)(1) for the offshore use of a "research tool" patent when only the information gained from such offshore use is introduced into the United States.
Recent rulings of importance to you and your practice.
New guidelines for the design of drug labeling and packaging were announced March 3 by Britain's Health minister, Lord Philip Hunt.
Our legal system supports two regulators of the safety of prescription drugs ' the U.S. Food and Drug Administration and courts applying the tort liability regime. The FDA's mission, while narrowly circumscribed in its early years, grew dramatically over the last half of the twentieth century. Today, the FDA administers the most comprehensive drug regulatory system in the world.
In October, Eli Lilly and Co. became the latest drug manufacturer to announce that it will begin limiting quantities of pharmaceutical products shipped to Canadian wholesalers.
Nearly 83,000 Fen-Phen users, including those whose claims have already been approved, may have their payments delayed or denied due to a new scheme instituted by the trustees of the Wyeth Settlement Trust, according to a lawsuit filed Nov. 5 by New York City-based law firm Napoli, Kaiser, Bern & Associates. The suit was filed on behalf of several individuals who are awaiting payment of damages from the trust, formerly known as The American Home Products Settlement Trust.
Features
All the latest FDA news and information you need to know.