Patent Term Extensions and Restoration under the Hatch-Waxman Act
William J. Stilling of Parsons Behle & Latimer
A utility patent confers the right to exclude others from making, using, offering to sell, or selling an invention in the United States. The patent term measures the time period in which a patent holder may exercise patent rights. During a patent's exclusivity period, the patent owner(s) may capitalize on the patent in a variety of ways including manufacturing, marketing, licensing, or selling an invention.
Stanford Biotech Strategies Seminar. Seminar Summaries of Speakers Michael Shuster and Lynn Pasahow of Fenwick & West.
FindLaw M V
Michael Shuster spoke on protecting early stage technology. Lynn Pasahow presented an update on biotech patent litigation with a special focus on selected recent cases.
FTC Brushes Off Bristol's Attempt to Scrub Generic Competition
M. June Casalmir and Bernard Rhee of Bryan Cave LLP
On March 7, the FTC announced its settlement of claims against Bristol Myers Squibb ("Bristol") for employing patent listings in the FDA's "Orange Book" to delay the entry of generic competitors for three of Bristol's brand name pharmaceutical products. The settlement is the latest in a series of initiatives by the agency aimed at preventing misuse of Hatch-Waxman Act proceedings to forestall competition in the pharmaceutical marketsÂand yet another sign that protecting generic entry and expansion is serious business to the FTC.
The FDA Alert--October 1999
Akin Gump Strauss Hauer & Feld LLP
On August 6, 1999, the Food and Drug Administration (FDA) proposed to amend its current regulations governing the 180-day market exclusivity that is granted to certain generic drug products. This proposed rule represents a significant change to the current landscape of drug exclusivity.
Waxman-Hatch Law: What's Better For The Nation's Public Health, More Research Or Cheaper Generic Drugs?
Connolly Bove Lodge & Hutz LLP
The United States Patent Laws grant to a patentee the right to prevent others from.
IP Litigation: Who's Who
Marzena Czarnecka of Lexpert
Intellectual property is big money. Worldwide patent licensing revenues rose from about US$15 billion in 1990 to well over US$100 billion in 2001. In 2001 alone, licensing patents and other intellectual property (IP) brought IBM US$1.5 billion. Anyway you slice it, this is serious money.
Drug Price Competition and Patent Term Restoration Act
U.S. Dept. of Health and Human Services, Office of the General Counsel
Publication from the Food and Drug Administration which explains Title II of the Drug Price Competition and Patent Term Restoration Act under which certain patent holders have the opportunity to extend the terms of certain patents.
Stanford Biotech Strategies Seminar. Seminar Summaries of Speakers Elaine Levin and Lawrence Sung, Ph.D. of Preston Gates & Ellis.
K&L Gates LLP
Elaine Levin gave an overview of problems facing small biotech companies. Lawrence Sung, Ph.D., provided an update on inventorship/ ownership considerations and the common law ÃÂresearch useÃÂ exemption.