Science and Technology Law Commons^™

Bitcoin: An Innovative Alternative Digital Currency, Reuben Grinberg

UC Law Science and Technology Journal

Bitcoin is a digital, decentralized, partially anonymous currency, not backed by any government or other legal entity, and not redeemable for gold or other commodity. It relies on peer-to-peer networking and cryptography to maintain its integrity. Compared to most currencies or online payment services, such as PayPal, bitcoins are highly liquid, have low transaction costs, and can be used to make micropayments. This new currency could also hold the key to allowing organizations such as Wikileaks, hated by governments, to receive donations and conduct business anonymously. Although the Bitcoin economy is flourishing, Bitcoin users are anxious about Bitcoin's legal status. …

Fda Enforcement Of Criminal Liability For Clinical Investigator Fraud, Vandya Swaminathan, Matthew Avery

UC Law Science and Technology Journal

Clinical investigator fraud is a very real problem, and falls squarely within FDA's mandate to protect the public health. The Eighth Circuit has held that under this mandate, FDA has the authority to impose affirmative duties to protect the public health by promulgating relevant regulations. FDA did promulgate such regulations, and the Eighth Circuit held that a failure to follow these regulations is a violation of section 355(i) of the FDCA. A violation of section 355(i) is considered a violation of section 331(e), and a violation of 331(e) can result in criminal sanctions under section 333(a). Thus, this tenuous chain …

Finding A Fit: Gene Patents And Innovation Policy, Erica L. Anderson

UC Law Science and Technology Journal

The district court's decision in Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office (the Myriad litigation) that isolated DNA does not constitute patentable subject matter because the isolated DNA is not markedly different from the naturally occurring DNA sequence redrew the lines of patentable subject matter. The Federal Circuit has subsequently overturned that holding; however, it remains unclear whether gene patents serve the patent system's underlying objective to encourage innovation. For the most part, courts have defined what constitutes patentable subject matter, but as the Myriad litigation demonstrates, courts may not be the best institution to consider these …

Induced Infringement As A Strict Liability Claim: Abolishment Of The Specific Intent Requirement, Soonbok Lee

UC Law Science and Technology Journal

This Note argues that the specific intent requirement for § 271(b) should be abolished. It shows that the language of § 271(b) does not provide textual support for the specific intent requirement. Additionally, it argues that the specific intent requirement is contrary to early case law before the enactment of the 1952 Patent Act and is in conflict with many aspects of patent law including the utilitarian policies, the doctrine of equivalents and basic risk allocation. Finally, this Note demonstrates that the overlapping scope of § 271(b) and § 271(c) necessitates the specific intent requirement because Congress intended § 271(b) …

Indirect Exploitation Of Intellectual Property Rights By Corporations And Investors: Ip Privateering And Modern Letters Of Marque And Reprisal, Tom Ewing

UC Law Science and Technology Journal

Competitive pressures and rent-seeking behaviors have motivated companies and investors to develop indirect techniques for beneficially exploiting third-party intellectual property rights (IPRs) that qualitatively depart from the direct exploitation tools honed during the past thirty years of the pro-patent era. Among other things, companies have realized that they do not even need to own IPRs in order to consequently benefit from their exploitation. This phenomenon is labeled here "IP privateering" because of its similarities to an historic method of waging war on the high seas. This Article classifies IP privateering as a species of aggressive non-practicing entities (NPEs). The parameters …

Beyond Confusion - Survey Evidence Of Consumer Demand And The Entire Market Value Rule, Patricia Dyck

UC Law Science and Technology Journal

The doctrine of apportionment serves to limit recovery for patent infringement to the economic value contributed by the infringed patent. However, the entire market value rule allows plaintiffs to base their recovery on the entire value of a product, if an infringing feature of the product is the basis for consumer demand for the product. Large damages awards produced by the application of the entire market value rule have prompted appeals for damages reform. In the recent America Invents Act, the legislature did not address damages reform, noting that the judiciary is currently reinvigorating the doctrine of apportionment. Indeed, the …

Open Source And The Age Of Enforcement, Heather J. Meeker

UC Law Science and Technology Journal

The last five years have seen the first serious enforcement efforts by licensors of open source software, so we are truly at the dawning of the age of enforcement. But open source claims are not like other claims. Understanding the distinctions between open source software claims and other intellectual property claims is key to reacting to open source claims gracefully, effectively, and with a minimum of embarrassment and cost. This Article provides a survey of where we stand today and demonstrates how this area of law has developed. We will be soon nearing the point where catalogs of open source …

Practical Considerations In The Indirect Deployment Of Intellectual Property Rights By Corporations And Investors, Tom Ewing

UC Law Science and Technology Journal

Competitive pressures and rent-seeking behaviors have motivated companies and investors to develop indirect techniques for beneficially exploiting third-party intellectual property rights (IPRs) that qualitatively depart from the direct exploitation tools honed during the past thirty years of the ongoing pro-patent era. Companies and investors have learned that they do not even need to own IPRs in order to consequently benefit from their exploitation. This phenomenon is labeled here "IP privateering" because of its similarities to an historic method for waging war on the high seas. This Article probes certain practical limitations of this newly identified strategy. Specifically, this Article explores …

Customers, Co-Workers And Competition: Employee Covenants In California After Edwards V. Arthur Andersen, David L. Simson

UC Law Science and Technology Journal

California law is well settled that most contractual provisions prohibiting competing with or soliciting customers of a former employer are unenforceable under California Business and Professions Code 16600, unless the activity involves misappropriation of trade secrets or confidential information. Nonetheless, case law appears to hold that a restriction on one type of post-employment activityhiring away former co-workers-might still be permitted. In 2008, the California Supreme Court once again addressed the scope of section 16600. This Note examines employee nonsolicitation covenants in light of that decision, including whether they remain legally defensible, and whether they retain any value for the employer …

The Medicines Patent Pool: Promoting Access And Innovation For Life-Saving Medicines Through Voluntary Licenses, Krista L. Cox

UC Law Science and Technology Journal

Monopolies over many life-saving drugs have led to high prices that remain out of reach for patients in the developing world, leading to a crisis of access over these essential medicines. High intellectual property barriers harm not only access to medicines, but can also impact future innovation. In order to address this problem, a proposal for a "patent pool" emerged that would rely on voluntary licenses by patent holders to enable the production of more affordable generic medicines. This article briefly describes the history of patent pools before focusing specifically on the UNITAID-supported Medicines Patent Pool. It analyzes the specific …

Understanding And Incentivizing Biosimilars, Robin Feldman, Jason Kanton

Faculty Scholarship

No abstract provided.

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 …

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 …

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.

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 …

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 …

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 …

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 …

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 …

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 …

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 …

The Exportability Of The Principles Of Software: Lost In Translation, Michael L. Rustad, Maria Vittoria Onufrio

UC Law Science and Technology Journal

The American Law Institute approval of The Principles of Software Contracts is a significant milestone in the history of software law. The project began in 2004 because of the flaws of the Uniform Computer Information Transactions Act concerning this issue, problems strengthened by the widely held perception that the law at the time was "undeveloped, confused, and conflicting." Software licensing is presently America's third largest industry and has suffered from the mechanical extension of the law of sales to software over the last forty years, much like courts imported "horse and buggy law" to resolve problems posed by the automobile. …

Shifting The Burden: Proving Infringement And Damages In Patent Cases Involving Inconsistent Manufacturing Techniques, Julie E. Zink

UC Law Science and Technology Journal

The law is clear that it is the plaintiff-patentee's burden to prove both infringement and damages. It is unclear, however, in cases involving inconsistent manufacturing techniques, what level of evidence is required to meet this burden and when, if at all, such burden should pass to the defendant-infringer to provide rebuttal evidence. One consideration in this analysis is when findings of infringement can extend to the entire product line. Another matter considered in this paper is how the court deals with the confusion of goods and the commingling of records. This Article examines the various patent doctrines that may have …

State And Local Policy As A Tool To Complement And Supplement The Fda Law, Leslie Zellers, Ian Mclaughlin

UC Law Science and Technology Journal

With the recent passage of the Family Smoking Prevention and Tobacco Control Act of 2009, the U.S. Food and Drug Administration now has the authority to regulate tobacco sales, marketing, and use. Though this law is a beneficial step, some gaps remain. There are significant merits to state and local governments enacting local laws to fill these gaps. State and local governments can also effectively partner with the Food and Drug Administration in enforcing various provisions of the law. There are a great deal of local policy options available to state and local governments. This Article provides both recommendations and …

A Dreadful Prognosis: Patentability Of Diagnostic And Personalized Medical Procedures In The Wake Of In Re Bilski, Matthew D. Show

UC Law Science and Technology Journal

Over the past few decades, patent applicants in certain technological fields are discovering a conflict inherent between the nature of their claimed inventions and judicial interpretation of Jefferson's Patent Act language throughout the 19th and 20th Centuries. This conflict is particularly apparent in the fields of diagnostic and personalized medicine. This note discusses both modern Supreme Court precedent regarding the requirements for a patentable method claim as how Bilski v. Doll, a business method case, threatens to make such methods unpatentable. Additionally, this note offers the results of an analysis demonstrating how patent agents and attorneys currently draft these types …

A Brief History Of The Commercial Speech Doctrine (With Some Implications Tobacco Regulation), Ashutosh Bhagwat

UC Law Science and Technology Journal

The passage of the Family Smoking Prevention and Tobacco Control Act of 2009 delegated substantial new responsibility to the U.S. Food & Drug Administration. Charged with implementation of the Act, the Food & Drug Administration issued a call for public comment on what approaches to take. The University of California, Hastings College of the Law hosted a symposium on the topic in August 2009, at which Professor Ashutosh Bhagwat gave commentary on the areas of tobacco advertising and marketing. This essay is based upon Professor Bhagwat's remarks at this event. Tracing the Supreme Court's jurisprudence of the commercial speech doctrine …

Search Query Privacy: The Problem Of Anonymization, Ron A. Dolin

UC Law Science and Technology Journal

Search queries may reveal quite sensitive information about the querier. Even though many queries are not directly associated with a particular person, it has been argued that the IP addresses and cookies of the users can often be sufficient to figure out who the querier is, especially if tied to information from ISPs regarding IP address assignments at the time of the relevant query. Given that the queries have been subject to discovery both by various governments and third parties, there has been great concern for how to keep such queries private. A typical approach to such privacy legislation, especially …

Injunctive Relief Post Ebay And The Various Applications Of The Four-Factor Test In Differing Technological Industries, Engey Elrefaie

UC Law Science and Technology Journal

In the 2006 opinion for eBay v. MercExchange the Supreme Court struck down the Federal Circuit's blanket rule of granting injunctions for patent infringement. Outlining a four-factored test, the Court declared that injunctive relief should be determined based on "principles of equity." This note discusses the implications of this decision on the biotechnology and software industries, and how lower courts have applied this test to reach varying results.

Reach Through Royalties As A Workaround For Patent Exhaustion, Patrick Hagan

UC Law Science and Technology Journal

Reach through royalties (RTRs) allow companies that license patented research tools to profit from inventions created by others using these tools. Support for RTRs is split; some disfavor them for their potential anti-commons effects, while others believe RTRs provide important services, such as research tool valuation. This piece argues that RTRs should be allowed, outlining their current use in the United States and the financial implications for both tool licensers and researchers.