Generics seeking approval of FDA may infringe: uncertainty reigns over a law that overturns Federal Circuit's denial of an industry exemption
Article Abstract:
Congress broadened the experimental-use infringement exemption under 35 U.S.C. section 271(e)(1) after the Federal Circuit limited it in Roche Products, Inc v. Bolar Pharmaceuticals Co. The law puts the interests of the public in getting generic versions of drugs over the rights of the patent holder by allowing competitors to import or use infringing products for obtaining research data necessary for FDA approval. However, the courts have yet to resolve questions over the exemption's scope, such as whether patented products' use for research on a non-infringing product is exempted.
Publication Name: The National Law Journal
Subject: Law
ISSN: 0162-7325
Year: 1995
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Court clarifies Process Patents Act; recent decisions by the Federal Circuit interpret the statute's 'materially changed' standard
Article Abstract:
The US Court of Appeals for the Federal Circuit has handed down rulings on the Process Patent Amendments Act of 1988, which makes it an infringement to import a materially changed product. What constitutes materially changed has been an issue of much contention in these cases. The legislative history of the act makes clear that Congress wanted the courts to decide when something had been materially changed on a case-by-case basis. This act is important to high-technology industries, which rely largely on process patents to recoup their research and development expenses.
Publication Name: The National Law Journal
Subject: Law
ISSN: 0162-7325
Year: 1996
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Analyzing the Federal Circuit's record on injunctions
Article Abstract:
The preliminary injunction has been made a more useful tool in the litigation of patent cases by a decision of the Federal Circuit Court of Appeals in Smith International Inc v Hughes Tool Co in 1983. The proof of irreparable harm to the plaintiff is now presumed in circumstances where infringement of a valid patent is demonstrated. There have been more requests for preliminary injunction but statistics indicate that the quantity of dubious claims have increased, and the number of injunctions granted has stayed about the same.
Publication Name: The National Law Journal
Subject: Law
ISSN: 0162-7325
Year: 1992
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- Abstracts: Contracts - Financial Institutions Reform, Recovery, and Enforcement Act - Federal Circuit holds federal government liable for breach of thrift contracts. Winstar Corp v. United States
- Abstracts: E.C. cases may create uncertainty. NFL sues to protect blackouts; League has winning streak. Decisions may signify a judicial turnabout
- Abstracts: Firms eschew expertise of consultants; lawyers have failed to exploit the advice of expert speakers in areas such as financial planning, stress, teamwork and creativity
- Abstracts: The merger review process at the Federal Trade Commission: administrative efficiency and the rule of law. The function, flexibility, and future of United States judges of the executive department
- Abstracts: The lingering shame of 'Plessy v. Ferguson.' (100th anniversary of U.S. Supreme Court's 'separate but equal' decision)