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Drug Labeling Patents: A New Line of Defense for Protecting Old Drugs?
Pharmaceutical companies have had some success extending the lives of their patent portfolios by obtaining patents that claim the combination of a known drug, a container for holding it, and a label providing instructions for a new use of the drug. These “drug labeling patents” have given such companies a leg up in their ongoing battle with generic drug manufacturers. However, a little-noticed judicial decision handed down by the Court of Appeals for the Federal Circuit (“Federal Circuit”) has cast serious doubt over whether drug labeling claims constitute patentable subject matter.
Drug Labeling Patents
For a blockbuster drug, each additional month of market exclusivity can mean $50 million or more in revenue. Pharmaceutical companies thus employ a variety of strategies to extend patent protection as far as possible. For example, early stage patents protecting a drug are typically directed to the specific composition of matter and related compounds classes or chemical structures. During the drug development stage, patents are typically directed to potential therapeutic uses and demonstrated biologic activity. During the clinical stage, patents may be directed to specific formulations, dosage forms and manufacturing methods. Finally, after-market modifications may warrant patent protection for improved pharmacokinetics or side effect profiles. All of these patents work together to fully protect the enormous amounts of innovation involved in bringing a successful drug to market.
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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?