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Case Briefing
FDA Not Required to Police Orange-Book Listings
The FDA does not have a duty under the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (the Hatch-Waxman Act) to review the substance of patents filed in its Orange Book to make sure that the patent holder has not, in contravention of 21 U.S.C.S. ' 355(c)(2), listed a patent unrelated to the subject drug. Apotex Inc. v. Thompson, No. 02-1295, 2003 U.S. App. LEXIS 21818 (Fed. Cir. 10/27/03).
SmithKline Beecham Corp. is the holder of an NDA for the pharmaceutical Paxil', the active ingredient in which is paroxetine hydrochloride hemihydrate. On Dec. 29, 1992, the FDA approved SmithKline's NDA for the use of Paxil' to treat depression. Pursuant to 21 U.S.C. ' 355(b)(1), SmithKline referred in its NDA to its U.S. Patent No. 4,721,723 (the '723 patent), which claims crystalline paroxetine hydrochloride hemihydrate. Accordingly, the FDA listed the '723 patent in the Orange Book when it approved SmithKline's NDA.
Yachts, Jets, Horses & Hooch: Specialized Commercial Leasing Models
Defining commercial real estate asset class is essentially a property explaining how it identifies — not necessarily what its original intention was or what others think it ought to be. This article discusses, from a general issue-spot and contextual analysis perspective, how lawyers ought to think about specialized leasing formats and the regulatory backdrops that may inform what the documentation needs to contain for compliance purposes.
Hyperlinked Documents: The Latest e-Discovery Challenge
As courts and discovery experts debate whether hyperlinked content should be treated the same as traditional attachments, legal practitioners are grappling with the technical and legal complexities of collecting, analyzing and reviewing these documents in real-world cases.
Identifying Your Practice's Differentiator
How to Convey Your Merits In a Way That Earns Trust, Clients and Distinctions Just as no two individuals have the exact same face, no two lawyers practice in their respective fields or serve clients in the exact same way. Think of this as a "Unique Value Proposition." Internal consideration about what you uniquely bring to your clients, colleagues, firm and industry can provide untold benefits for your law practice.
Risks and Ad Fraud Protection In Digital Advertising
The ever-evolving digital marketing landscape, coupled with the industry-wide adoption of programmatic advertising, poses a significant threat to the effectiveness and integrity of digital advertising campaigns. This article explores various risks to digital advertising from pixel stuffing and ad stacking to domain spoofing and bots. It will also explore what should be done to ensure ad fraud protection and improve effectiveness.
Turning Business Development Plans Into Reality
This article offers practical insights and best practices to navigate the path from roadmap to rainmaking, ensuring your business development efforts are not just sporadic bursts of activity, but an integrated part of your daily success.