Merck KGaA v. Integra Lifesciences I, LTD Uncertainty in the Scope of the Section 271(e)(1) Exemption
July 29, 2005
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.
MGM v. Grokster: Inducement Theory Leaves Unanswered Questions
July 29, 2005
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.
IP News
July 29, 2005
Highlights of the latest intellectual property news from around the country.
Registration of Nontraditional Trademarks in the U.S. and EU
July 29, 2005
In recent years, innovative approaches toward brand creation and marketing have given rise to a new family of trademarks, referred to as nontraditional marks, which include, among others, color, motion and non-visual marks. Trademark laws in both the United States and Europe are being clarified to accommodate these new marks. Many such provisions are harmonious across both regions, but there are some procedural and substantive differences that should be considered before a company invests its time and resources into the creation of an international nontraditional brand. Further, registration of most nontraditional marks often requires a showing that the mark acquired distinctiveness through extensive use, which can be a heavy burden to meet under the law of both jurisdictions.
Using Daubert to Defeat Causation in the Delayed Diagnosis Claim
July 29, 2005
<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.
Verdicts
July 29, 2005
Recent rulings you need to know.
Is Patient Satisfaction a Factor in Lawsuits?
July 29, 2005
Doctors feel hurried these days, and they resent it. They believe that the demands of their days have caused them to spend less time with patients. They also believe that their patients resent it. Let's look at what has really happened to the office visit -- and then let's see if better patient satisfaction levels correlate with fewer lawsuits.
Agreement in Principle Made to Settle Majority of Zyprexa' Litigations
July 29, 2005
Eli Lilly and Company announced on June 9 that it had agreed in principle to a settlement with most of the plaintiffs involved in the Zyprexa liability litigation. Eli Lilly, an Indiana company, expects to take a pretax charge of at lease $700 million in the second quarter of 2005 to cover the settlement costs.
