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The Preclinical Research Statutory Infringement Exemption: How Far Back Is 'Reasonably Related'?
On June 13, 2005, the U.S. Supreme Court expanded the safe harbor provision of 35 U.S.C. '271(e)(1) to the “use of patented compounds in preclinical studies … as long as there is a reasonable basis for believing that the experiments will produce 'the types of information that are relevant to an [Investigational New Drug application ("IND")] or [New Drug Application ("NDA")].'” Merck KGaA v. Integra Lifesciences I, Ltd., __ U.S. __, 125 S.Ct. 2372, 2383-84 (U.S. 2005) (quoting Brief of U.S. as Amicus Curiae 23) (“Integra II“).
Integra Lifesciences I, Ltd. (“Integra”) sued Merck KGaA and Scripps Research Institute (collectively, “Merck”) for infringement of five patents related to methods for contacting cells with tripeptides of the sequence Arg-Gly-Asp (“RGD peptides”). See, e.g., U.S. Patent No. 4,988,621. The patented methods promote cell adhesion, inhibit cell proliferation, and selectively detach malignant cells, amongst other claimed results.
As a defense to infringement, Merck raised the research exemption under 35 U.S.C. '271(e)(1) (the “'271(e)(1) exemption”) for its developmental work from 1995 to 1996. The district court ruled, and the Federal Circuit affirmed, however, that Merck's RGD peptides infringed four of the five asserted Integra patents and that the '271(e)(1) exemption did not apply. According to the Federal Circuit: the “Scripps work sponsored by Merck was not clinical testing to supply information to the FDA, but only general biomedical research to identify new pharmaceutical compounds.” Integra Lifesciences I, Ltd. v. Merck KGaA, 331 F.3d 860, 866 (Fed. Cir. 2003) (“Integra I“).
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?