Impact of Hatch-Waxman goes beyond generics; the act, designed to facilitate the marketing of generic drugs, may hinder biotech protection

Article Abstract:

The exemption to the patent infringement provisions under 35 U.S.C. 271(e) exempting activities connected with the submission of information for agency approval, meaning primarily the Food and Drug Administration, was established to make it easier to market generic drugs after a patent expires but may impact products regulated as biologics or medical devices. Most biotechnology companies concentrate their research and development activities on such products, including vaccines, blood-derived products, and immunoglobulins. The exemption will therefore be significant for the biotechnology industry.

Pharmaceutical Preparation Manufacturing, Pharmaceutical preparations, Biotechnology industry, Biotechnology industries, Drugs, Generic drugs

---

ESOPS facilitate wealth tranfers; an employee stock ownership plan can provide tax-effective vehicle for succession planning

Article Abstract:

Estate planners and their clients in close corporations tend to overlook the flexibility and tax advantages of employee stock ownership plans. (ESOP) Shareholders must proceed in judging the viability of the ESOP for a closely held company from the premise that they are just faced with a qualified retirement plan under the Internal Revenue Code. ESOPs can also borrow money to buy stock, and a leveraged ESOP has unique opportunities that enable the creation of a private market. How to structure and finance the ESOP is detailed.

Management, Securities, Employee ownership, Close corporations, Closely held corporations

---

Digital tech may revolutionize global commerce: technological innovations amy facilitate a shift toward the trade of ideas only rather than goods

Article Abstract:

The digital revolution will make intellectual property the major component of trade, but it necessitates changes to harmonize the intellectual property laws of different countries. It will also change the way everyone thinks of property, just as the two past great revolutions, the development of agriculture and of industry, have changed our concepts of property rights. Part of the General Agreement on Tariffs and Trade will help harmonize intellectual property laws, as will a sound US model for other countries.

Social aspects, Innovations, International trade, Digital communications, international

Similar abstracts:

• Abstracts: New Japanese procedure code expands discovery; the code eases the requesting of, and increases the obligation to produce, needed documents
• Abstracts: Good governance requirements concerning the participation of interest groups in EU consultations. The constitutional status of the European Central Bank
• Abstracts: Although employers' restrictions on relationships between employees can give rise to claims, some restraints on office romances may withstand challenge
• Abstracts: Ohio's Hamilton County courts high technology; a wide area network will link the many departments of the judicial system in and around Cincinnati
• Abstracts: Equal Treatment Directive outlaws positive discrimination. EOC proposes fundamental restructuring of sex discrimination laws

This website is not affiliated with document authors or copyright owners. This page is provided for informational purposes only. Unintentional errors are possible.