Can Failure-to-Warn Claims Against Generic Drug Manufacturers Be Preempted?
May 26, 2009
The tension between the salutary purposes of the Hatch-Waxman Act (low-cost drugs widely and quickly available to patients) and the necessity to change label warnings when science or adverse event reports show a newly appreciated risk, presents a Hobson's choice to generic drug companies, complicated by the FDA's own interpretation of its CBE regulations as inapplicable to them.
Boom, Boom, Boom
April 30, 2009
While it is helpful to be able to research issues online and communicate with key employees while sitting at the board table, I find that the level of distraction from the board's deliberations has diminished the value of these meetings, for me and for the company. While this problem is certainly not limited to e-commerce or technology firms, I think that the great reliance on such technology by their executives and directors makes the legal duty to "pay attention" even more of a pressing issue for such firms.
Who Should Monitor Online Counterfeiters?
April 30, 2009
Oral arguments will soon be heard by the U.S. Court of Appeals for the Second Circuit in the highly watched dispute between renowned jeweler Tiffany & Co. and eBay, the popular online auction site, over who bears the burden of "policing" online counterfeit activity. Evidencing the tension between e-commerce and brand owners, eBay, Tiffany and several amici curiae have advanced their positions to the circuit. This article summarizes some of the arguments.
Trademark Protection in Cyberspace Rescued
April 30, 2009
A recent decision of the U.S. Court of Appeals for the Second Circuit, <i>Rescuecom Corp. v. Google Inc.</i>, has clarified precedent that had been assumed to foreclose Lanham Act challenges to the surreptitious use of trademarks to compete in cyberspace. In the wake of <i>Rescuecom</i>, that interpretation has been rejected, and advertisers have a potent weapon to protect their trademarks against unfair competition on the Web.
Natural Orifice Surgery
April 28, 2009
Natural orifice transluminal endoscopic surgery ' often referenced by the acronym NOTES ' is becoming increasingly popular. Here is a discussion of potential avenues of liability claims associated with the surgery.
The Autism Cases, and What's Next
April 28, 2009
The fight to get recognition of a link between autism and childhood vaccines took a heavy blow in February when the U.S. Court of Federal Claims found no such connection in the three test cases before it. Results of recent studies certainly portended these outcomes, but hope remained that the so-called Vaccine Court ' the Office of Special Masters of the U.S. Court of Federal Claims ' might side with the claimants.
The Third Amendment to the Chinese Patent Law
April 27, 2009
The Third Amendment to the Chinese Patent Law is expected to bring the law into closer conformity with international standards, particularly commensurate with U.S. Patent contract and litigation practice, even though several changes such as the absolute novelty requirement still clearly reflect the influence of European Patent laws on the development of the Chinese Patent Law. The Third Amendment includes changes to patent application and enforcement processes, ownership rights, compulsory licensing rules, international exhaustion rights, penalties for patent infringement, prior art defenses, and exemptions, summarized in this article.
