Licensee Patent Validity Challenges Following MedImmune: Implications for Patent Licensing

This Article addresses the legal basis for resolving the licensor’s dilemma following MedImmune.  The MedImmune Court’s elimination of the jurisdictional barrier to a patent validity challenge by a licensee in good standing has been viewed by many as a pronounced shift in favor of the licensee in the balance of rights between licensor and licensee in patent license agreements.  Moreover, the Court’s ruling has given rise to a dilemma for patent licensors, namely, how to redress the shift in the balance of rights.  Specifically, the questions to be answered are as follows: (1) Is there a vestige of the doctrine of licensee estoppel to protect a patent licensor from a validity challenge by a licensee in good standing, and (2) if one cannot rely on the doctrine, are explicit contract provisions that prohibit, reduce the incentive for, and/or specify a consequence of, a licensee’s challenge of the validity of a licensed patent enforceable?

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Provigil: A Case Study Of Anticompetitive Behavior

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.

 by Michael A. Carrier*

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Provigil: A Commentary

Michael Carrier’s case study on Provigil offers new support for the view that Big Pharma is to blame for stymieing competition, retarding innovation, and inflating prices in the drug industry. Carrier argues that Cephalon was able to thwart generic entry by a combination of anticompetitive strategies. It entered into a reverse payment settlement agreement with generics seeking to enter the market. Having already spilled considerable ink on the patent settlements issue. I will focus my commentary on Carrier’s “product hopping” claims—essentially, that Cephalon rolled out Nuvigil merely to thwart competition. Since I have no expertise with the relevant products and no particular dog in the fight between Cephalon and its antagonists, I limit myself to three very general observations about the case study and its ostensible morals for public policy.

by Daniel A. Crane*

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Branded Versus Generic Competition?

 Transitions are times of danger in virtually all areas of human life.  More accidents are likely to occur when cars go in and out of parking spaces, or when planes take off or land. More medical mishaps are likely to happen in hospitals when there is a change in shifts between nurses.  The same pattern holds in the law of pharmaceutical patents, during the transition from a fully proprietary regime to one that allows for as many firms as possible to market a generic version of a once-protected pharmaceutical patent.To pass judgment on these issues, it is often necessary to ask the thankless question of whether the supposed advances in science exceed the preclusive effect that arises if the original product is removed from the Orange Book—or official FDA registry of drugs available for sale—in ways that limit competition.

by Richard A. Epstein*

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The Geosynchronous Orbit and the Outer Limits of Westphalian Sovereignty

The question confronting us today is: who  owns the GSO?  The inevitability of technological and scientific progress promises a future full of challenges for  space lawyers, who will ultimately be responsible for the composition of (and adherence to) international law in this new frontier.  In this Note, I will explore a topic that may initially seem like a plot out of Star Trek, but is very much real, and will become even more relevant as humanity ventures farther from home.

In recent years, “parking spots” in the geosynchronous orbit have become an increasingly hot commodity.  According to the National Aeronautics and Space Administration (NASA), since the launch of the first television satellite into a geosynchronous orbit in 1964, the number of objects in Earth’s orbit has steadily increased to over 200 new additions per year.  This increase was initially fueled by the Cold War, during which space was a prime area of competition between the United States and the Soviet Union.  Yet over two decades after the end of the US-Soviet space race, even the global financial crisis that began in 2007 does not seem to have diminished the demand for telecommunications satellites positioned in GSO.  This ongoing scramble to place satellites in GSO prompted some developing equatorial countries to assert sovereignty over the outer space “above” their territorial borders, presumably with the hope of extracting rent from the developed countries that circulate their technologies overhead.  So far, the international community has rejected this notion, but the legal status of the GSO remains in limbo.

by Nima Nayebi*

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Thirty-Two Short Stories About Intellectual Property

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.  However, 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 are publicly exploited and by allowing groups (such as indigenous peoples) to implement rights of self-determination, education, and media.  In assessing doctrine and theory, deductive reasoning from economic or legal principles is no more important than literary tools, like interpretation and narrative.  These points can best be illustrated by the following stories.

by Lorie Graham* and Stephen McJohn**

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Analyzing the Non-Competition Covenant as a Category of Intellectual Property Regulation

The employee non-competition covenant is a category of intellectual property regulation, but it is rarely recognized as such. This essay proposes a new critique of the employee non-competition covenant: When we examine such covenants as a category of intellectual property regulation, they do not meet the criteria that commonly justify intellectual property laws.  Restrictive covenants are not narrowly tailored to protect only new, creative information, they provide no incentives for innovation beyond those already found in trade secret law, and they provide little balance between the needs of individual, innovative employees and the interests of their more powerful employers.

by Charles Tait Graves*

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Limits on Hard-to-Reproduce Inventions: Process Elements and Biotechnology’s Compliance with the Enablement Requirement

Reproducibility is the touchstone of the scientific method and one of the strongest norms of the research community.  In order to be accepted as scientific fact, results of an experiment must be reproducible by an independent operator following the description given by the original inventor.  This Article maintains that the enablement requirement of § 112 ¶ 1, as informed by the reproducibility norm, calls for narrower claims to some inventions in the biotechnological arts.  In particular, this Article makes the case for more frequent use of process limitations in composition-of-matter claims to biological and biochemical inventions.

by Dmitry Karshtedt, Ph.D.*


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An Accurate Diagnosis, But Is There A Cure?: An Appreciation of The Role of Science in Law by Robin Feldman

Professor Feldman has provided an accurate and unsettling diagnosis of the law’s misuse of science.  Her central thesis is that the law defers to science far too much either by cloaking legal criteria in scientific terms, thus avoiding hard and indeed intractable problems, or by deferring to scientific experts essentially to decide difficult cases. Diagnosis is often a royal road to cure, but sometimes the patient is incurably ill with the disease the diagnosis accurately identifies.  I fear that the legal patient in this case is incurably, but let us hope not terminally, ill.

by Stephen J. Morse*

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Subverting New Media for Profit: How Online Social Media “Black Markets” Violate Section 5 of the Federal Trade Commission Act

“Black markets” in social media votes and actions have in no way reached critical mass.  The number of sponsored “tweets,” “diggs,” and “favorites” on any given day no doubt represents a miniscule portion of the vast, burgeoning sea of authentic social media messages that traverse the globe.  Nonetheless, enterprises like Subvert and Profit should give us pause.  In this Note I argue  the FTC is uniquely positioned to combat the problem. Given the substantial public interest in user trust in the social media context as well as the growing role played by social media in shaping consumer market decisions, the FTC would do well to fulfill its broad statutory mandate to protect the public from deceptive trade practices by investigating and—if and when it is deemed necessary—regulating “black markets” in social media votes and actions.

[1]by Peter Touschner*

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