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Consumer Protection, Patents and Procedure: Generic Drug Market Entry and the Need to Reform the Hatch-Waxman Act
by Andrew A. Caffrey, III & Jonathan M. Rotter
9 Va. J.L. & Tech. 1 (2004)   View PDF

As the importance of prescription drugs in our health care system and national economy has increased, there has been a concomitant increase in attention to the issue of access to these pharmaceuticals. Congress has sought to facilitate the entry of generic drugs into the ... [show]
As the importance of prescription drugs in our health care system and national economy has increased, there has been a concomitant increase in attention to the issue of access to these pharmaceuticals. Congress has sought to facilitate the entry of generic drugs into the drug market, beginning with the passage of the Hatch-Waxman Act of 1984, which provided a mechanism for faster generic drug entry. But abuse of the procedures established by the Hatch-Waxman Act has led to effects that are contrary to the intent of the act. The automatic stays granted to patent holders that postpone market entry by generics, along with the strategic use of statutory windows of exclusivity, have allowed patent holders to extend illicitly their hold on monopoly prices. These effects have been well documented by the FTC and have been the impetus for procedural change at the FDA. Consumer suits illustrate that consumers are also real parties in interest in controversies regarding generic drug entry. FTC recommendations and the recently adopted Gregg-Schumer Amendments would repair some major gaps in the original statutory framework, but opportunities for misuse will not be completely eliminated. Together with the FTC’s suggestions, our proposed changes — the duty to litigate, rather than settle, patent infringement suits; changes in the Orange Book listing practice; and a real market-based disgorgement of excess profits accrued during an automatic stay — would ensure that brand-name pharmaceutical companies receive their due patent protection, but nothing more. [hide]


Application of the DMCA Safe Harbor Provisions to Search Engines
by Craig W. Walker
9 Va. J.L. & Tech. 2 (2004)   View PDF

The Digital Millennium Copyright Act (“DMCA”) established procedures that Internet service providers can implement in order to gain protection from liability for copyright infringement by their users. Under the “notice and takedown” provisions of the DMCA, Internet service providers who receive notifications from copyright ... [show]
The Digital Millennium Copyright Act (“DMCA”) established procedures that Internet service providers can implement in order to gain protection from liability for copyright infringement by their users. Under the “notice and takedown” provisions of the DMCA, Internet service providers who receive notifications from copyright owners about allegedly infringing content must remove or disable access to that content in order to remain immune from claims for contributory liability. In response to such notifications, search engines have begun to remove links to allegedly infringing content from their search results. Unfortunately, application of the DMCA safe harbor provisions to search engines is problematic. Key portions of the statute refer to “subscribers” and “account holders,” making their application to search engines unclear because search engines typically do not have subscribers or account holders. Also, the lack of a subscription relationship between search engines and alleged infringers seems to make search engines more likely than other types of service providers to remove content overzealously in response to notifications. Finally, the combination of the unique importance of search engines for most Internet users and the availability of other means for copyright owners to protect their interests suggests that the burden of complying with the safe harbor procedures should not be placed on search engines. Given these concerns, a better alternative would be for Congress to grant search engines complete immunity from contributory liability for copyright infringing activities by third parties. [hide]


The Wiretap Act and Web Monitoring: A Breakthrough for Privacy Rights?
by Yonatan Lupu
9 Va. J.L. & Tech. 3 (2004)   View PDF

As Web sites have sought to distinguish themselves from their competitors in recent years, many Web site operators have turned to Web monitoring devices, such as cookies, as a means of customizing the sites to the individual user. Third-party businesses are increasingly performing this ... [show]
As Web sites have sought to distinguish themselves from their competitors in recent years, many Web site operators have turned to Web monitoring devices, such as cookies, as a means of customizing the sites to the individual user. Third-party businesses are increasingly performing this type of monitoring as a service to Web sites, by placing their own code into their client site’s code, collecting the data using their own servers, and then processing the data into aggregate statistics or even personalized profiles of visitors. The benefits afforded by this technology, however, are tempered by its capacity to capture – intentionally or unintentionally –personal information without notifying the average user. To protect their online privacy, individuals have relied on the Electronic Communications Privacy Act (ECPA), which allows for a private right of action against certain interceptions of electronic communications. However, the ECPA provides an exception for the interception of communications when a party to the communication has consented to the interception. Consequently, privacy challenges to the use of cookies routinely failed when the Web site operator had consented to the electronic interception of the cookie by third-party businesses. The First Circuit’s decision in In re Pharmatrak, however, revived this argument and seemed to indicate an increased willingness to limit the use of Web monitoring devices. Nonetheless, as this article concludes, this decision is limited to its relatively unusual facts and is therefore likely to do little to affect all but the most malicious and disreputable Web monitors. [hide]




   ISSN 2327-7777 (Print)
   ISSN 1522-1687 (Online)

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