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News from the FDA
FDA Will Not Interfere with Sales of Authorized Generics During Exclusivity Periods
The FDA issued responses to three Citizen Petitions last month, the cumulative effects of which will promote earlier access to lower-priced prescription drugs. In one action, the FDA denied petitions submitted by Mylan Pharmaceuticals Inc. and Teva Pharmaceuticals USA Inc. seeking to prohibit the marketing and distribution of reduced-price “authorized generic” versions of brand-name products during 180-day exclusivity periods. The agency also denied a petition submitted by Pfizer Inc., seeking to prevent generic applicants' waiver of 180-day exclusivity. In announcing these actions, the Agency stated that allowing eligible generic applicants to waive the exclusivity promotes competition by enabling other generic applicants to market their products sooner, and the agency could see “no reason to interfere with the marketing of authorized generics and waiving 180-day exclusivity, two long-standing, pro-competitive business practices.”
Proposed Change For Albuterol Oral Pressurized Metered-Dose Inhalers
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?