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Evolution of the Patent Infringement Safe Harbor
Since its enactment in 1984, the scope of the “safe harbor” provision of the patent code, codified at 35 U.S.C. '271(e)(1), has been in flux. The provision is intended to exempt from infringement certain acts related to the development of drugs and medical devices that are subject to FDA regulatory approval, to enable competitors to immediately enter the market upon patent expiration. However, the contours and boundaries of the safe harbor have been a consistent source of controversy in the courts.
Although some argue that the provision was intended to provide a narrow exception to patent infringement to facilitate the development of generic drugs, many court decisions have expanded the scope of the safe harbor over time. Other appellate cases have attempted, with some success, to set limits. A recent Southern District of California decision in Isis Pharms., Inc. v. Santaris Pharma A/S Corp., No. 3:11-cv-2214-GPC-KSC, 2014 U.S. Dist. LEXIS 26148, (S.D. Cal. Feb. 27, 2014), reconsideration denied , 2014 U.S. Dist. LEXIS 72755, suggests a renewed desire to reign in the scope of the safe harbor and set a minimum threshold for exemption.
Evolution of the Safe Harbor
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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.
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Legal Possession: What Does It Mean?
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