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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.
Why So Many Great Lawyers Stink at Business Development and What Law Firms Are Doing About It
Why is it that those who are best skilled at advocating for others are ill-equipped at advocating for their own skills and what to do about it?
Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.
A Lawyer's System for Active Reading
Active reading comprises many daily tasks lawyers engage in, including highlighting, annotating, note taking, comparing and searching texts. It demands more than flipping or turning pages.
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
Blockchain Domains: New Developments for Brand Owners
Blockchain domain names offer decentralized alternatives to traditional DNS-based domain names, promising enhanced security, privacy and censorship resistance. However, these benefits come with significant challenges, particularly for brand owners seeking to protect their trademarks in these new digital spaces.