Law Commons^™

A Pathway To Follow-On Biologics, Jeanne Yang

UC Law Science and Technology Journal

Over the past several decades, advances in biotechnology and medicine have created an influx of biologics. Biologic products have shown great promise as effective treatments for cancer, autoimmune diseases, and other serious afflictions. Many drug manufacturers have been enticed by the promise of patent protection and strong market rates and have entered the field, developing innovative, therapeutic biologics. Consequently, there has also been a demand for generic follow-on biologics. There are two major factors limit the reach of biologic development: cost and safety. The need for an abbreviated approval system for follow-on biologics has been clearly demonstrated, and some options …

Locked-In To Their Decisions: Investigating How The States Govern Revocation Of Advance Directives And How Three States Make Revocation Impossible For People With Locked-In Syndrome, Peter C. Harman

UC Law Science and Technology Journal

Since the late 1970s, most states have enacted laws that allow people to set out their health care preferences in advance directives. Advance directive statutes give people the opportunity to make important health care choices in advance, while they still have the mental acuity to make well-informed decisions. These statutes also allow the declarant to change his or her mind in the future, either by revoking the advance directive or by modifying his or her previously expressed preferences.

However, there is one class of people who still have full mental faculties, but have lost the opportunity to change their minds …

Provigil: A Case Study Of Anticompetitive Behavior, Michael A. Carrier

UC Law Science and Technology Journal

Using the sleep-disorder drug Provigil as a case study, this article exposes a new type of anticompetitive harm that stems from the combination of two distinct activities. First, brand-name drug firms such as Cephalon, the developer of Provigil, have settled patent litigation by paying generic firms to delay entering the market. Second, brand firms, frequently at the end of a patent term, have engaged in "product hopping," switching from one means of administering a drug (e.g., tablet) to another (e.g., capsule). The story of Provigil demonstrates the anticompetitive harm that can result from the combination of these two activities.

Branded Versus Generic Competition - A Kind Word For The Branded Drugs, Richard A. Epstein

UC Law Science and Technology Journal

Much of the extensive commentary on the six month coexclusivity period allowed by the Hatch-Waxman Act focuses excessively on attempts by pioneer drug companies to extend their joint monopoly power by making complex deals with the first new entrant. In this article, I broaden the analytical framework to address a more serious problem that the conventional analysis overlooks: the decreased rate of innovation in the medical field that is attributable in large part to shorter patent exclusivity periods resulting from heightened requirements for FDA approval. As the low-hanging fruit disappears, the rate of new drug discovery drops just as the …

Analyzing The Non-Competition Covenant As A Category Of Intellectual Property Regulation, Charles Tait Graves

UC Law Science and Technology Journal

Non-competition covenants operate as a type of intellectual property regulation-somewhat akin to trade secret law-but are rarely analyzed as such. Some commentators believe non-compete covenants are a problem for regional economic development. Others promote their enforceability on a theory that restrictive covenants reflect the employer's provision of employee training appropriately allow litigants to avoid having to prove a trade secret case against a departing employee. This article disagrees with the latter group and offers an intellectual property-based analysis of non-competition covenants. At the heart of this essay is a fifteen-point synopsis of how non-competition covenants function with respect to innovation …

Licensee Patent Validity Challenges Following Medimmune: Implications For Patent Licensing, Alfred C. Server, Peter Singleton

UC Law Science and Technology Journal

The recent Supreme Court decision in MedImmune v. Genentech, resolved a jurisdictional question while refusing to address questions regarding application of the common law doctrine of licensee estoppel. This doctrine prevents a licensee enjoying the benefits of a license agreement from challenging the validity of the underlying patent. Although the Supreme Court in Lear v. Adkins rejected application of the doctrine where the licensee had ceased making payments under the agreement, it left open the same question which the MedImmune Court mentioned, but refused to address. Namely: Whether the doctrine still applies to a non-repudiating licensee in good standing. In …

Thirty-Two Short Stories About Intellectual Property, Lorie Graham, Stephen Mcjohn

UC Law Science and Technology Journal

In the United States, intellectual property law is usually viewed as serving an economic policy, by providing an incentive for authors and inventors to create works. The incentive policy, however, ill fits the actual contours of intellectual property law and how artists and inventors use it. Adding other approaches offers a fuller explanation. Intellectual property plays a greater role than economic theory suggests in disclosing technology, and in serving to coordinate cultural values in technology. Intellectual property can serve human rights (similar to the moral rights approach in some jurisdictions) by allowing people to control the way that their works …

Subverting New Media For Profit: How Online Social Media Black Markets Violate Section 5 Of The Federal Trade Commission Act, Peter Touschner

UC Law Science and Technology Journal

Social media can be broadly defined as a category of sites centered on user participation and user-generated content. Prominent social media sites include Facebook, YouTube, Delicious, Digg, Reddit, and Twitter. In the U.S., interaction on such sites accounts for nearly a quarter of all time spent on the Internet, topping email and games as the most popular online activity. Given the rise of social media and its increasing influence over consumer market choices, a few firms have sought to game social media systems by setting up "black markets" for social media votes and actions. These firms act as middlemen, charging …

Limits On Hard-To-Reproduce Inventions: Process Elements And Biotechnology's Compliance With The Enablement Requirement, Dmitry Karshtedt

UC Law Science and Technology Journal

In the recently decided case of Abbott Laboratories v. Sandoz, Inc., the Federal Circuit resolved a long-standing split of authority between its panels by holding that a claim to a product that includes process elements (a "product-byprocess" claim) is infringed only if the product is made using that process. This article advances the proposal that product-by-process claims can help patentees meet the enablement requirement of the Patent Act, while still offering a reasonably broad scope of protection. For claims to new materials whose behavior and utility can be highly process-dependent and whose structure cannot be fully ascertained by analytical methods …

Provigil: A Commentary, Daniel A. Crane

UC Law Science and Technology Journal

This commentary addresses the "product hopping" analysis in Professor Carrier's case study of Cephalon's Provigil and Nuvigil sleep disorder drugs. Professor Carrier suggests that Cephalon introduced Nuvigil near the end of Provigil's patent term to sidestep generic competition. This piece examines several points raised by that paper, including the fact that Cephalon did not withdraw Provigil from the market when it introduced Nuvigil, that the advantages of Nuvigil over Provigil are not well established, and the suggestion that courts should get into the business of scrutinizing "product hopping." In addition, it is yet uncertain whether consumers will prefer Nuvigil to …

The Geosynchronous Orbit And The Outer Limits Of Westphalian Sovereignty, Nima Nayebi

UC Law Science and Technology Journal

The Outer Space Treaty of 1967 provides that outer space is the province of all humankind and is to be used for the benefit of all countries. Nonetheless, the allocation of highly desirable "real estate" in the geosynchronous orbit ("GSO") around the Earth's equator is a point of international controversy. Developing equatorial countries have asserted sovereignty over the orbital space "above" their territorial borders with the hope of extracting rent from developed countries that launch satellites into the GSO. So far, the international community has rejected this notion, but the legal status of the GSO remains in limbo. This Note …