Gibbons Law Alert

Gibbons Law Alert

Tagged: Patent

New Patent Quality Examination Metrics Attempt Greater Balance

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Posted in Patent / USPTO

On November 1, 2010

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.

Southern District of New York Denies Request for Advance Notice of an at Risk Launch

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Posted in Patent / Pharmaceuticals

On October 21, 2010

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.

Former Judge Paul Michel to Speak at Upcoming Fall Lecture Series Event

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Posted in Patent

On September 17, 2010

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.

Former Judge Paul Michel Discusses Proposed Changes to US Patent System

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Posted in Patent / USPTO

On July 23, 2010

“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.

Recent Developments in False Marking Litigation

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Posted in Patent

On July 20, 2010

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.

Gibbons Institute Webinar Discusses the Supreme Court’s Bilski Decision

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Posted in Patent

On July 8, 2010

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.

Supreme Court’s Bilski Decision Rejects Federal Circuit’s Machine-Or-Transformation Test For Business Method Patents

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Posted in Patent

On June 29, 2010

On June 28, 2010, the Supreme Court handed down a highly anticipated decision affirming the Federal Circuit in Bilski v. Kappos. At issue in Bilski was the patentability of a claimed business method or process for hedging against the risk of price changes in an energy market. The Court unanimously affirmed the Federal Circuit’s decision to reject Bilski’s process claims as being unpatentable, but split in its opinion as to the grounds for rejecting the claims.

12-Month Extension to the Provisional Patent Application Period – Buying More Time to Commercialize Your Invention

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Posted in Patent / USPTO

On April 22, 2010

On April 2, 2010, the USPTO issued a press release and published in the Federal Register a request for comment on a proposed change that would effectively give applicants a 12-month extension to the current provisional application period. Under the current rules, an applicant must file a nonprovisional application within 12-months after the filing of a provisional application pursuant to 35 U.S.C. § 119(e) and must thereafter complete any missing parts to that application within a time period of up to a maximum of seven months.

The Written Description Requirements of 35 U.S.C. §112 and Ariad Pharms. Inc. v. Eli Lilly & Co.

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Posted in Patent / Pharmaceuticals

On February 24, 2010

Recently certain members of the patent law bar have expressed surprise that the Federal Circuit has used the written description requirements of 35 U.S.C. §112, first paragraph to invalidate patents such as the University of California’s patent directed to insulin in Regents of the University of California v. Eli Lilly & Co., and Genentech’s patent directed to production of human growth hormone in Genentech, Inc. v. Novo Nordisk A/S. This issue has come to the forefront again in Ariad’s pending per curiam appeal from the Federal Circuit decision in Ariad Pharms., Inc. v. Eli Lilly & Co., vacated and rehearing en banc granted. Oral argument in the case was held on December 7, 2009. In the case under appeal, the Ariad patent was held not to meet the written description requirements of 35 U.S.C. §112, first paragraph.

Biosimilars: Data Exclusivity and the “Patent Protection Gap”

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Posted in Biotech / Patent / Pharmaceuticals

On February 17, 2010

Several bills are currently pending in Congress establishing expedited marketing approval pathways for biosimilar drugs. The proposed pathways are analogous to the pathway for small molecule chemical drugs established by the passage of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Act. The Hatch-Waxman Act includes a data exclusivity provision whereby the FDA is prohibited from approving a competitor’s drug application relying on the innovator’s data for a statutory period of time. Recent debates concerning the biosimilar bills have focused on the data exclusivity period. These debates highlight the differences between biological drugs and small molecule chemical drugs and why a longer exclusivity period may be necessary to fill the “patent protection gap.”

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