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Follow-On Biologics: Intellectual Property and Innovation Issues
This report reviews doctrinal and policy issues pertaining to follow-on biologics. The report first introduces the application of federal food and drug legislation to follow-on biologics. It next turns to the patent implications of marketing follow-on biologics. Following this review of substantive law, the remainder of the report introduces innovation policy issues pertaining to follow-on biologics.
Intellectual Property Rights Violations: Federal Civil Remedies and Criminal Penalties Related to Copyrights, Trademarks, and Patents
This report provides information describing the federal civil remedies and criminal penalties that may be available as a consequence of violations of the federal intellectual property laws: the Copyright Act of 1976, the Patent Act of 1952, and the Trademark Act of 1946 (conventionally known as the Lanham Act).
Exporting Software and the Extraterritorial Reach of U.S. Patent Law: Microsoft Corp. v. AT&T Corp.
Generally speaking, United States patent law does not have extraterritorial effect. The exception, however, is § 271(f) of the Patent Act, which makes it an act of patent infringement to manufacture within the United States the components of a patented invention and then export those disassembled parts for combination abroad into an end product. This report discusses Microsoft Corp. v. AT&T Corp. (550 U.S. ___ , No. 05-1056, decided April 30, 2007), in which the U.S. Supreme Court held that software companies are not liable for patent infringement under § 271(f) when they export software that has been embodied in machine-readable, physical form (a CD-ROM, for example), with the intent that such software be copied abroad for installation onto foreign-manufactured computers.
An Examination of the Issues Surrounding Biotechnology Patenting and Its Effect Upon Entrepreneurial Companies
The biotechnology industry is notable both for its heavy concentration of small businesses and its weighty research and development (R&D) expenditures. Given the small size and heavy expenses of many biotechnology firms, their ability to raise venture capital may be of some consequence. The patent law has been identified as a facilitator of these R&D financing efforts. Congress may choose to exercise oversight on these issues. Such consideration would likely include examination of U.S. commitments in international agreements along with other factors.
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