MGM v. Grokster: Inducement Theory Leaves Unanswered Questions
In <i>MGM Studios, Inc. v. Grokster, Ltd.</i>, No. 04-480 (June 27, 2005), the Supreme Court decided that the defendants could be held liable for copyright infringement perpetrated by the users of their respective software. Rather than clarifying the "significant noninfringing use" standard from <i>Sony Corp. of America v. Universal City Studios, Inc.</i>, 464 U.S. 417 (1984), to determine whether the defendants could be held liable for distributing a product with knowledge that it could be used to infringe, the Court utilized an alternative approach of finding liability. Turning to common law precedent and patent law, the unanimous Court held that liability may be based on purposeful, culpable expression under an inducement theory of secondary infringement. While some of the potential implications of this decision can be predicted, the full effect will not likely be clear for some time.
Merck KGaA v. Integra Lifesciences I, LTD Uncertainty in the Scope of the Section 271(e)(1) Exemption
On June 13, 2005, the Supreme Court in <i>Merck KGaA v. Integra Lifesciences I, Ltd.</i>, 545 U.S. ___, 2005 WL 1383624 (2005) ruled that the safe-harbor infringement exemption of 35 U.S.C. '271(e)(1) may apply to non-clinical research on a patented compound as long as there is a reasonable basis to believe that the compound tested could itself be the subject of an FDA submission or that experiments with the compound will produce the kinds of information relevant to an Investigational New Drug Application ("IND") or a New Drug Application ("NDA"); the exemption may apply even though the patented compound never itself becomes the subject of an FDA submission or the experimental results arising from its use never reported in a submission. The decision reversed the holding of the Federal Circuit (331 F.3d 860 (Fed. Cir. 2003)) that the exemption applies only to research used to obtain information that is submitted to the FDA as part of an application for regulatory approval. The Court expressly refused, however, to consider whether '271(e)(1) might exempt "research tools" from infringement liability. Although the Court interpreted the reach of the '271(e)(1) exemption broadly, the issue of whether use of patented research tools falls within it remains unresolved.
Using Daubert to Defeat Causation in the Delayed Diagnosis Claim
<b><i>Part Two of a Two-Part Article</i></b>: The <i>McDowell</i> case discussed in the first part of this article presented the question of "whether it is so if an expert says it is so." <i>See Viterbo v. Dow Chem. Co.</i>, 826 F.2d 420, 421 (5th Cir. 1987). <i>Daubert</i> and its progeny answered in the negative and established that an expert may not present a bare causation conclusion to the jury when that expert has no scientific basis for that conclusion or for any of the predicate inferences leading up to it. The <i>McDowell</i> claim failed because a physician's personal clinical experience, sometimes called anecdotal experience, is simply not a proper scientific basis for causation opinion testimony.
<b>Commentary:</b> 'Unanimous' Vote In Grokster Has Split Views
In its opinion, the Supreme Court clearly focused the test for copyright infringement liability on the subjective question of the purpose of the software's distribution ' an approach that better comports with basic notions of fairness than that of the courts below. But read together, the plurality opinion and two concurring opinions raise a new set of disquieting questions.
Remedying <i>Grokster</i>
Don't you hate it when you ask someone a question and, rather than answering it, they choose to answer a different one? Then you understand the frustration…
Drug and Medical Device Manufacturers
Following a guilty plea last year by a major pharmaceutical company, Associate Attorney General Robert McCallum declared that "[t]he Department of Justice is committed to rooting out and prosecuting health care fraud. It is of paramount importance that the Department use every legal tool at its disposal to assure the health and safety of the consumers of America's health care system." The tools -- the variety of different criminal statutes and theories used to prosecute drug and device manufacturers -- are so diverse as to defy easy summary.
Should We All Move to Canada?
The high cost of prescription medications in the United States has been troubling health care providers and their patients for years. Physicians worry that it will do no good to prescribe a medication to someone who won't be able to afford to buy it, and patients who try to save money by taking less than the prescribed dose worry that that they're putting their health in danger. Any failed medical treatment that harms a patient is fertile ground for a lawsuit against the physician, even if he or she is not the one to blame. Should medical practitioners suggest imported drugs to their patients who might otherwise not be able to afford their prescribed medications?
Drug and Medical Device Manufacturers
Following a guilty plea last year by a major pharmaceutical company, Associate Attorney General Robert McCallum declared that "[t]he Department of Justice is committed to rooting out and prosecuting health care fraud. It is of paramount importance that the Department use every legal tool at its disposal to assure the health and safety of the consumers of America's health care system." The tools -- the variety of different criminal statutes and theories used to prosecute drug and device manufacturers -- are so diverse as to defy easy summary.
