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Pharmaceuticals

Selected Works

Selected Works

2014

Articles 1 - 2 of 2

Full-Text Articles in Law

Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled Oct 2014

Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled

Yaniv Heled

Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …


Patent Trolling--Why Bio & Pharmaceuticals Are At Risk, Robin C. Feldman, W. Nicholson Price Ii Dec 2013

Patent Trolling--Why Bio & Pharmaceuticals Are At Risk, Robin C. Feldman, W. Nicholson Price Ii

Robin C Feldman

Patent trolls — also known variously as non-practicing entities, patent assertion entities, and patent monetizers — are a top priority on legislative and regulatory reform agendas. In the modern debates, however, the biopharmaceutical industry goes conspicuously unmentioned. Although biopharmaceuticals are paradigmatically centered on patents, conventional wisdom holds that biopharmaceuticals are largely unthreatened by trolls. This article shows that the conventional wisdom is wrong, both theoretically and descriptively. In particular, the article presents a ground-breaking study of the life science holdings of 5 major universities to determine if these might be attractive to monetizers. 

This was deliberately a light, rather than …