Gibbons Law Alert
Courts continue to wage a valiant effort to create consistency and provide guidance in the numerous false marking cases launched in the aftermath of Bon Tool. Defendants accused of false marking may seek dismissal on the basis that plaintiff lacks standing. In so doing, defendants often argue that plaintiff was not in the business and suffered no competitive injury as a result of false marking.
In Re Acer America Corp. is the latest in a growing body of opinions authored by the Federal Circuit finding that the United States District Court for the Eastern District of Texas has abused its discretion in denying the transfer of a case to a more convenient venue under 28 U.S.C. § 1404(a). The United States Court of Appeals for the Fifth Circuit launched the opening salvo against the Eastern District’s unwillingness to transfer cases in its In re Volkswagen of America, Inc. opinion, and the Federal Circuit repeatedly has followed suit, granting writs of mandamus in favor of transfer in In re Nintendo Co., In re Hoffman-La Roche, Inc., In re Genentech, and In re TS Tech.
On December 1, 2010, the latest version of the Federal Rules of Civil Procedure went into effect. As part of the new rules, significant changes were made to Rule 26 regarding the discovery of information from experts retained to provide testimony. As of Wednesday, witnesses who were not previously required to provide a written report must now provide a summary disclosure of their opinion. In addition, draft expert reports and some communications between expert witnesses and counsel will no longer be discoverable, and expert reports will now only need to contain information regarding “facts or data considered by the witness in forming” an opinion.
The Federal Circuit’s recent decision in AstraZeneca LP v. Apotex Inc. illustrates the tension that generic drug manufacturers may face between complying with FDA labeling requirements and avoiding trespassing on others’ patent rights. In that decision, the Federal Circuit affirmed the District Court of New Jersey’s ruling enjoining Apotex’s “at risk” launch of a generic version of an inhaled corticosteroid for asthma patients. In short, AstraZeneca owned a method patent on once-daily dosing of the drug at issue. Although Apotex omitted all references to once-daily dosages from its product label, it was required by the FDA to include “downward titration” language that encouraged patients to reduce their daily intake of the drug to the lowest dose that provides a beneficial effect. AstraZeneca argued that this language induced patients to infringe its method patent, and the court agreed.
On October 7, 2010, the U.S. Patent & Trademark Office (USPTO) issued a press release announcing the adoption of new procedures for measuring the quality of patent examination that will be implemented during the start of the 2011 fiscal year. After requesting public comment in both the Federal Register and Official Gazette and holding two round table discussions, a joint USPTO-Patent Public Advisory Committee (PPAC) Task Force developed a new composite quality metric including seven factors, and an associated procedure for obtaining measurements, identifying systemic problems and providing remediation through examiner training.
Recently, the U.S. District Court for the Southern District of New York ruled that a generic drug manufacturer may not be required to provide advance notice to the innovator of their intent to launch at-risk a competing product. This decision is noteworthy in that it contrasts with the practice in the District Court of New Jersey where at least one generic company has been ordered to provide advance notice to the brand companies of an impending at-risk launch.
On Tuesday, October 5, 2010, at 6:00 pm, the Gibbons Institute of Law, Science & Technology and the New Jersey Intellectual Property Law Association (NJIPLA) will host the 8th Annual Fall Lecture Series, “Inventing Our Way Out of Joblessness,” featuring The Honorable Paul R. Michel, Former Chief Judge of the U.S. Court of Appeals for the Federal Circuit.
“Congress Needs to Act” is the first article published by Judge Paul R. Michel since his retirement from the Federal Circuit, where he served as the Chief Judge. Judge Michel’s below speech was given on July 21, 2010, at the Global Intellectual Property Center of the U.S. Chamber of Commerce, providing commentary on the current state of the nation’s patent system and how the system can be improved to bolster US economic growth.
When the United States Court of Appeals for the Federal Circuit decided Bon Tool, it unwittingly triggered an avalanche of litigation against major corporations brought under 35 U.S.C. § 292, the false marking statute. The opinion resolved a split of authority regarding whether a manufacturer of a product could be subjected to a fine based on each article that had been falsely marked, or each decision to mark the article. Combined with the fact that the qui tam nature of the false marking statute obviated the need to establish traditional Article III standing, a new breed of patent trolls sprung into existence seemingly overnight, dedicated to the task of tracking down mis-marked products, and seeking to share half of a maximum $500 per falsely marked item bounty. The economic appeal in bringing such suits is obvious. A major manufacturer could potentially produce millions of falsely marked articles. Even if a court decided not to assess the full $500 penalty (which it has discretion to do), a successful plaintiff could still stand to reap a sizeable award based on the sheer number of falsely marked articles injected into the stream of commerce. Since that time, several cases have been decided that have helped to provide guidance to litigants on both sides of this rapidly evolving area of law.
The Gibbons Institute of Law, Science & Technology hosted a webinar on July 1 to discuss the U.S. Supreme Court decision in Bilski v. Kappos that addressed the limitations on the patentability of business methods. More than 50 people listened to this webinar, which featured Erik Lillquist, Senior Associate Dean and Professor of Law, Seton Hall University School of Law; Robert E. Rudnick, Director, Intellectual Property, Gibbons P.C., and David W. Opderbeck, Associate Professor of Law and Director, Gibbons Institute of Law, Science & Technology, Seton Hall University School of Law.