U.S. Likely to Adopt Post-Grant Oppositions
May 01, 2003
Adoption of post-grant oppositions appeared to be a shoe in at the combined meeting of the Interference Committees of the ABA, AIPLA and IPO held on April 14, 2003. Elimination of the 35 USC 135(b)(2) "clock" for interferences also appeared likely.
Standing to Assert a U.S. Patent: Do Infringement Actions Belong Solely to the 'Patentee'?
May 01, 2003
Who can sue on a U.S. patent? The answer is not always as clear-cut as one may think. A patent plaintiff or other party seeking to enforce rights in a U.S. patent portfolio will thus wish to ensure before commencing any such action that he enjoys sufficient legal standing with respect to the patents in his portfolio. Otherwise, a challenge to the plaintiff's legal standing may lead to unexpected chagrin for the would-be asserter of the patent and unlooked-for advantage on the part of the alleged infringer against whom the patent was to be asserted.
Foreseeability as a Bar to Proof of Patent Infringement
May 01, 2003
The doctrine of equivalents is a rule of equity adopted more than 150 years ago by the U.S. Supreme Court. Prosecution history estoppel is a rule of equity that controls access to the doctrine. In May 2002, the Court was called upon to revisit the doctrine and the estoppel rule in <i>Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. Ltd.</i> Ultimately the Court reaffirmed the doctrine and expanded the estoppel rule, but not without inciting heated debate over the Court's rationale — especially since it included a new and controversial foreseeability test in its analysis for estoppel.
Proactive Fraud Prevention
May 01, 2003
Way back in the 80s, companies in the U.S. Defense industry determined that it was in their best interests to band together and develop the Defense Industry Initiatives as a method to police themselves during a time when their industry was fraught with fraud and corruption. As an aftermath, ethics and compliance programs have been developed and implemented by the majority of U.S. companies. To further entice companies to establish an effective and proactive program designed to detect and, to the extent possible, prevent violations of law The Federal Sentencing Guidelines for Organizations, passed in November 1991, rewards these companies with relief when sentenced for violations of law.
In the Spotlight
May 01, 2003
On May 9, 2003, the U.S. Attorney's Office for the District of Massachusetts announced that Bayer Corporation, the pharmaceutical manufacturer, had been sentenced and ordered to pay a criminal fine of $5,590,800 stemming from its earlier plea of guilty to violating the Federal Prescription Drug Marketing Act by failing to list with the FDA its drug product, Cipro, that was privately labeled for an HMO. Such listing is required under the federal Food, Drug & Cosmetic Act. The Federal Prescription Drug Marketing Act, Pub. L. 100-293, enacted on April 22, 1988, as modified on August 26, 1992 by the Prescription Drug Amendments (PDA) Pub. L. 102-353, 106 Stat. 941, amended sections 301, 303, 503, and 801 of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. '' 331, 333, 353, 381, to establish requirements for distributing prescription drug samples.
Cases in Court
May 01, 2003
Recent rulings of importance to your practice.
Creating Private-Sector Standards of Conduct
May 01, 2003
Whether certain conduct is a crime depends on more than legislatures, judges, and juries. When prosecutors decide whether, whom, and what to charge, the policies underlying their decisions create operative standards of conduct. So, too, do those of agencies administering regulatory programs backed by criminal sanctions. But what about the private sector? Sensible standards of conduct articulated by trade associations can and should play a substantial role in drawing the line between acceptable business practices and bad conduct that can be subject to criminal sanctions.