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.
Prominent Trial Lawyer Loses Support Fight
July 28, 2005
Recently, a prominent Georgia trial lawyer was ordered to pay his former paramour $6 million in child support payments. Willie Gary, whose law practice is based in Florida, claimed in court papers to have a net worth of $60 million. <i>Gowins v. Gary</i>, No. 2004CV88406. (Fult. Super. Ct., July 15, 2004). Gary is known in Georgia law circles for his representation of race discrimination plaintiffs against The Coca-Cola Co., and Centennial Olympic Park bombing victims suing Atlanta Olympic organizers. His Web site boasts of winning a $240 million verdict against The Walt Disney Co. in 2001 in an intellectual property theft case; a $139.6 million verdict against brewer Anheuser-Busch; and a half-billion-dollar verdict against the Loewen Group, a large Canadian funeral-home chain.
IP News
June 29, 2005
Highlights of the latest intellectual property news from around the country.
Is It a Mark Or Not? Strategies for Overcoming Refusals Based on Genericness, Ornamentation and Functionality
June 29, 2005
While most trademark practitioners are prepared to handle an initial refusal to register a mark from the U.S. Patent and Trademark Office ("PTO") based on likelihood of confusion or descriptiveness grounds, many are considerably less comfortable responding to refusals in which the PTO challenges whether a particular mark even qualifies for trademark status. Such refusals are often based on genericness, ornamentation, or functionality grounds. Strategies for overcoming such refusals are discussed in detail below.
Time-Dependent Claim Terms Remain Stuck in the Past
June 29, 2005
In a decision that is certain to impact both patent prosecution and patent litigation strategies, the U.S. Court of Appeals for the Federal Circuit recently ruled that the literal scope of claims reciting time-dependent claim terms is limited to the technologies existing at the time of the invention. <i>See PC Connector Solutions LLC v. Smartdisk Corp.</i>, 406 F.3d 1359 (Fed. Cir. 2005). Further, the court stated that such claims would not be infringed by later arising technology even under the doctrine of equivalents. This case, in combination with the Federal Circuit's earlier decision in <i>Kopykake Enterprises, Inc. v. The Lucks Company</i>, 264 F.3d 1377 (Fed. Cir. 2001), demonstrates that patent practitioners must be extremely careful when using words such as "conventional," "normal," "standard" or "traditional" in the claims or in specification definitions of claim terms. On the other hand, those accused of infringement should argue for the inclusion of such terms during claim construction, particularly when the accused device comprises technology developed after the invention date of the patent-in-suit.
Drug Labeling Patents: A New Line of Defense for Protecting Old Drugs?
June 29, 2005
Pharmaceutical companies have had some success extending the lives of their patent portfolios by obtaining patents that claim the combination of a known drug, a container for holding it, and a label providing instructions for a new use of the drug. These "drug labeling patents" have given such companies a leg up in their ongoing battle with generic drug manufacturers. However, a little-noticed judicial decision handed down by the Court of Appeals for the Federal Circuit ("Federal Circuit") has cast serious doubt over whether drug labeling claims constitute patentable subject matter.
