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Patent Protection or <i>Per Se</i> Antitrust Violation?
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 Issue
At the heart of the storm lies the following question: When does a patent-holding drug company step beyond the bounds of the legal monopoly granted by its patent and into the realm of per se antitrust liability? The Hatch-Waxman Act sets the background for the two circuit court cases. In 1984, Congress passed the Hatch-Waxman Act, formally known as the Drug Price Competition and Patent Term Restoration Act (21 USC ' 355) with the express purpose of “mak[ing] available more low-cost generic drugs.” H.R. Rep. No. 98-857, pt.1, at 14-15 (1984), reprinted in 1984 USCCAN 2647. The Hatch-Waxman Act establishes a special FDA approval procedure for generic drug companies. The generic must file an Abbreviated New Drug Application (ANDA) and certify that its generic drug will not infringe any existing patent (a “paragraph IV certification”). The act also provides a 180-day exclusive marketing period to the first company to file an application with the FDA for a particular generic drug.
Major Differences In UK, U.S. Copyright Laws
This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.
Strategy vs. Tactics: Two Sides of a Difficult Coin
With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.
The Article 8 Opt In
The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.
Removing Restrictive Covenants In New York
In Rockwell v. Despart, the New York Supreme Court, Third Department, recently revisited a recurring question: When may a landowner seek judicial removal of a covenant restricting use of her land?