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Claiming Metabolites: Federal Circuit Poses New Challenges to Patent Applicants
After they are administered, or taken by the patient, many drugs are converted into other chemical compounds or other physical forms, as the drugs are processed within the body of the patient. Often these compounds, known as metabolites, are the “active ingredient” that is responsible for the desired result, such as lowering blood pressure or cholesterol levels. The Court of Appeals for the Federal Circuit has also long recognized this effect and has held that the ingested form of a drug or its “metabolites” can be patented. Thus, an optimal patent strategy would require an inventor to patent both the pre-ingested form of the drug and its new physical forms or metabolites, as formed in the body (“in vivo“). However, the in vivo fate of the drug may not be learned until long after the “parent” drug has been tested and patented.
Two recent Federal Circuit decisions, Novartis Pharm. v. Eon Labs, 363 F.3d 1306 (Fed. Cir. 2004) and Schering Corp. v. Geneva Pharmaceuticals, Inc., 339 F.3d 1373 (Fed. Cir. 2003) will make it much more difficult for holders of “metabolite patents” to enforce them against accused infringers. In Novartis, the patent on the immunosuppression drug, cyclosporin, had expired, but Novartis had obtained a patent on an injectable “hydrosol” formulation of the drug. A hydrosol is a fine suspension, or colloid, of solid particles in a water-alcohol solution.
In Vivo Infringement Argued
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.
The Stranger to the Deed Rule
In 1987, a unanimous Court of Appeals reaffirmed the vitality of the "stranger to the deed" rule, which holds that if a grantor executes a deed to a grantee purporting to create an easement in a third party, the easement is invalid. Daniello v. Wagner, decided by the Second Department on November 29th, makes it clear that not all grantors (or their lawyers) have received the Court of Appeals' message, suggesting that the rule needs re-examination.
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.