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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.
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.
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.
Legal Possession: What Does It Mean?
Possession of real property is a matter of physical fact. Having the right or legal entitlement to possession is not "possession," possession is "the fact of having or holding property in one's power." That power means having physical dominion and control over the property.
The Anti-Assignment Override Provisions
UCC Sections 9406(d) and 9408(a) are one of the most powerful, yet least understood, sections of the Uniform Commercial Code. On their face, they appear to override anti-assignment provisions in agreements that would limit the grant of a security interest. But do these sections really work?