Copyright (c) 2008 All rights reserved. http://works.bepress.com/eric_chan Recent documents in Eric David Chan en-us Thu, 03 Jan 2008 00:05:26 PST 3600 http://works.bepress.com/eric_chan/2 http://works.bepress.com/eric_chan/2 Wed, 23 May 2007 16:50:16 PDT Patent law is inherently territorial; a patent covers infringing activity only within the borders of the nation in which it should granted. However, this makes enforcing patent rights worldwide a daunting challenge. Rather than recklessly extending the extraterritorial reach of U.S. patent law, a better alternative would be to assert claims for infringement of multiple foreign patents in a single, U.S. forum. This paper focuses on the new barriers raised to the prospects for such consolidated, multinational patent infringement proceedings by Voda v. Cordis, decided by the Federal Circuit in February. Voda held that federal supplemental jurisdiction should almost never exist over foreign patent claims due to "discretionary" considerations of comity, fairness, judicial economy, and convenience. The paper analyzes Voda's erroneous statutory construction of the federal supplemental jurisdiction statute, 28 U.S.C. §1367, which arguably confuses the question of whether there is jurisdiction with the propriety of exercising it. It then explores the limited implications of the decision in light of the availability of federal diversity jurisdiction as an alternative to supplemental jurisdiction. More importantly, this paper also provides a comprehensive response to Voda's ill-informed and narrow treatment of §1367(c)'s discretionary considerations. First, considerations of international comity may in some situations demand adjudication of foreign patent claims - particularly when the needs of the international system and the need to do justice to individual parties are taken into account. Second, since the central obstacle to asserting a foreign patent claim in U.S. court is the difficulty of adjudicating foreign patent validity, and nothing more, an "inter partes" approach to validity provides an adequate workaround to fairness and Act of State concerns. Rather than waging a losing battle to exclude foreign patent claims from the federal courts, the Federal Circuit would be better off creating guidelines for when foreign patent claims may be properly asserted. Towards this end, this paper situates Voda within the worldwide debate on consolidated patent infringement, and attempts to provides preliminary suggestions for further inquiry - though a comprehensive examination of such guidelines is beyond its scope. Eric D. Chan International Law Intellectual Property Law http://works.bepress.com/eric_chan/1 http://works.bepress.com/eric_chan/1 Mon, 09 Apr 2007 23:14:40 PDT The neuroelectronic interface is an emerging technology that uses electric signals to communicate directly with the human brain. It promises to make possible a new generation of user-worn prosthetic devices that can be controlled at the speed of thought, functioning as actual extensions of the human body. Prototypes already exist, though they are still in development - artificial retinas, which can provide replacement sight for the blind; sophisticated prosthetic limbs. Though current applications are geared towards replacing lost natural function, there is no reason that these brain-computer interface devices cannot also be used to enhance the capabilities of a healthy human body. Neuroelectronic devices may not only allow humans to run faster, jump higher, and see farther, but they might potentially impart new forms of sensory perception and control over the world that were previously unimaginable. This paper explores the new safety risks and burgeoning legal and ethical implications of neuroelectronic enhancement devices under U.S. Food & Drug Administration law. It argues that the Premarket Approval regime administered by FDA's Center for Devices and Radiological Health is deficient in two respects when it comes to these futuristic devices. First, by focusing on device approval as the sole regulatory event, FDA fails to effectively ensure the safety and effectiveness in the long term-over the life of a user. Second, FDA's "procedural" regulatory regime does not consider the moral, ethical and social considerations-"substantive" concerns-that enhancement devices will implicate. Only regulation that accounts for these issues can raise public awareness and prevent the inevitable public backlash and moratorium on neuroelectronic development when something goes wrong. This paper thus proposes two main modifications to existing FDA device law. FDA should create a new "Class IV" designation for neuroelectronic devices, implementing along the way a two-tiered approval process to better assess long-term risks of safety and effectiveness. In order to consider the broader questions of enhancement itself, a"Class IV-E" sub-designation should be established to review Class IV devices that have "significant potential" to enhance human abilities. Eric D. Chan Law and Technology Science and Technology Food and Drug Law