We Are Pleased to Announce the
Publication of Our Winter 2004 Issue
Consumer Protection, Patents and Procedure: Generic Drug Market Entry and the Need to Reform the Hatch-Waxman Act
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. [more
Application of the DMCA Safe Harbor Provisions to Search Engines
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. [more
The Wiretap Act and Web Monitoring: A Breakthrough for Privacy Rights?
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.
And in Our Previous Issue...
The FCC’s Broadband over Power Line Inquiry: Considering Radio-Frequency Interference Rules of the Road for the Third High-Speed Communications Wire
This article examines the Federal Communications Commission’s Broadband Over Power Line (BPL) Systems Notice of Inquiry proceeding, including the issues raised by the Commission with respect to the nature of this new high-speed Internet communications medium and the radio frequency interference and technical challenges it poses. Also analyzed are the filings of the numerous commenters in this proceeding.
The article contends that more testing is needed to gauge precisely the degree of harmful interference posed by BPL, but that the Commission should allow deployment of BPL under the Commission’s existing Part 15 rules for Carrier Current Systems operating on an unlicensed basis. Such BPL systems should, however, be subjected to careful interference monitoring and, if serious interference with licensed spectrum users results, the Commission should impose remedies such as confinement of BPL signals within certain ranges of the spectrum and notching of BPL signals within bands in which there are impacted licensed users. The Commission may also wish to segregate its regulatory treatment of BPL: The Commission may, on the one hand, wish to take actions to encourage deployment of the energy utility systems applications that are unique to BPL, while, on the other, choose not to provide advantages to BPL systems that merely provide consumer high-speed access to the Internet, given the robust competition for such high-speed access already present, or soon to develop, in many markets.
Thinking Outside the Box: Child Pornography, Obscenity and the Constitution
The constitutionality of virtual child pornography as a form of speech remains a critical issue. In the wake of the U.S. Supreme Court’s decision in Ashcroft v. Free Speech Coalition, which struck down portions of the Child Pornography Prevention Act of 1996, and subsequent legislation passed by Congress, a different approach to evaluating the constitutional protection of sexually explicit speech is needed: a focus on the harms posed by such expression, rather than on its offensiveness or means of production, two characteristics that are but a part of the critical issue of harm. If a legislature instead defined child pornography as “sexually explicit speech that proximately causes physical harm through the reckless instigation of illegal acts,” then the context of the situation could be evaluated in an effort to judge recklessness, as well as the sufficiency of the connection between the speech and the harm. [more
Bad Faith and the Public Domain: Requiring a Pre-Lawsuit Investigation of Potential Trade Secret Claims
Overbroad trade secret allegations threaten important social interests in employee mobility and a robust public domain. This article proposes that courts require trade secret plaintiffs to conduct a pre-lawsuit investigation into the public domain to ascertain whether information is truly secret, or face attorneys’ fees for pursuing a claim based on non-secret information that a reasonable search would have located. This requirement, if widely adopted, would put teeth into the underutilized fee-shifting statutes enacted with the Uniform Trade Secrets Act. Patent law, a useful analogy, requires a pre-lawsuit infringement investigation.
With a heightened awareness today of the need to protect the public domain for the important social interests it furthers, it is time that courts follow the lead of patent law and require that would-be trade secrets plaintiffs conduct a pre-lawsuit secrecy investigation. The result would be beneficial for both trade secret plaintiffs and defendants, would reduce many of the common disputes arising during trade secret litigation, and would protect the public interests at stake in trade secret lawsuits.
Technological Protection Measures in the United States, the European Union and Germany: How Much Fair Use Do We Need in the “Digital World”?
As digital technological advances have created new opportunities for exploiting copyrighted works, governments worldwide have sought to recalibrate the balance between preserving the protection copyright holders deserve while maintaining the proper degree of access for “fair users.” The WIPO Copyright Treaty (“WCT”), which devised new legal measures for achieving this balance, has been implemented in the United States through the Digital Millennium Copyright Act and in several Member States in the European Union through the EU Copyright Directive. Because differences exist in how the United States and EU Member States, particularly Germany, have implemented the WCT, an examination of these systems reveals some advantages and disadvantages that point toward a refined balance between copyright protection and fair use.
While both the U.S. and EU/German systems prohibit the circumvention of, and the trafficking in, access control devices, the United States regime does not prohibit the circumvention of copy control devices. Consequently, U.S. users who can circumvent a copy control device without trafficking in such devices may make fair use of the copyrighted material. The EU/German system does not permit the user to circumvent the copy control devices in any respect, but it does require the copyright holder to provide the user, in exchange for compensation, with the means to bypass the copy control devices and make fair use of the copyrighted material. This requirement, which expands the degree to which copyrighted material is made more accessible for fair use, gives the EU/German system a decided advantage over the U.S. regime, though the EU/German system has drawbacks that impair its effectiveness.