Science and Technology Law Commons^™

Patent Protection Of Pharmacologically Active Metabolites: Theoretical And Technological Analysis On The Jurisprudence Of Four Regions, Richard Li-Dar Wang, Pei-Chen Huang

Santa Clara High Technology Law Journal

Active metabolite patents have been instrumental for brandname pharmaceutical companies to maintain their exclusivity even after the drug patents expire. This strategy obstructs market entry of generic medicine and reduces affordable drugs. The authors review jurisprudence from the United States, Europe, India, and Taiwan in search for practical solutions to confront this problem. Given the unique pharmacological value that active metabolites may possess, patent protection for those purified or synthesized in vitro should be preserved, but for those produced by metabolism should be declined. Except India, most countries under investigation comport with this dichotomy. Their jurisprudence may be subsumed into …

Copyright Subject Matter And A "Light" For Designers' Rights, Matteo Mancinella

Santa Clara High Technology Law Journal

Copyright protection in the fashion industry is currently the focus of intense debate in the United States, particularly centered on the utility of special legislation to protect designs from knock-offs. This article focuses on the importance of copyright protection for fashion designers, and the obstacles to copyright currently faced by fashion designers.

What is the legal rationale for not providing copyright protection for fashion design? Why are designers’ creations not granted copyright protection? Unlike authors and musicians, fashion designers can only enjoy protection afforded by trademark for logos. Clothing is considered a “useful article”—not eligible for copyright protection—unless it is …

Open Source Software Compliance: The Devil Is Not So Black As He Is Painted, Maxim V. Tsotsorin

Santa Clara High Technology Law Journal

Many commercial enterprises effectively utilize open source code when developing various software products—virtually every software developer uses open source in his or her work. But along with economic benefits and production efficiency come significant legal risks, exacerbated by the wide availability of OSS components. While some licenses are permissive and demand very little, others require any work based on, or even containing only parts of an open source code, to be distributed only as OSS.

Most commercial enterprises and software developers recognize potential business and legal risks and implement some sort of compliance mechanism as a best practice. But what …

Will Fda Data Exclusivity Make Biologic Patents Passé?, Vincent J. Roth

Santa Clara High Technology Law Journal

Much controversy has ensued over the current twelve-year data exclusivity period afforded to biosimilars, pursuant to the Biologics Price Competition and Innovation Act of 2009 (BPCI).

Many commentators speculate whether data exclusivity will overtake patents as the preferred method of intellectual property protection for new biologic drugs. A comparison of data exclusivity with the patent system, however, reveals few similarities and many differences. Moreover, legislative gaps and absent industry mechanisms leave a void that is a barrier to entry in the biosimilars market, referred to here as “regulatory impracticality.”

A survey was conducted with senior management at biopharma companies regarding …

State Taxation Of Cloud Computing, Stephen J. Lusch

Santa Clara High Technology Law Journal

As the digital environment in which we live continues to change at speeds that were unfathomable two decades ago, archaic state tax systems have struggled to keep pace. Cloud computing is the latest innovation to introduce considerable complexity into the state and local tax system. Cloud computing is prevalent in many aspects of the user experience with companies such as Apple, Amazon, and Google now providing their traditional services via a cloud component. With three primary service models and countless transactional forms, cloud computing is difficult to fit into most current tax systems. Though some jurisdictions have begun to issue …

Downloading, Distributing, And Damages In The Digital Domain: The Need For Copyright Remedy Reform, Joe Donnini

Santa Clara High Technology Law Journal

Should copyright remedy laws be changed to address the proliferation of sharing of online content? On one hand, harsh penalties may improve compensation and infringement deterrence; on the other hand, harsh penalties may harm the interests of free expression and the enrichment of society through sharing. This article focuses on identifying the ideal level of enforcement and proposes a new remedy scheme to appropriately address social media sharing versus commercial misappropriation.

In order to do that, Part I of this article explores the purposes of compensation and deterrence that are behind the copyright statutory remedy scheme. Thereafter, Part II sheds …

Ten Years Of Inter Partes Patent Reexamination Appeals: An Empirical View, Eric J. Rogers

Santa Clara High Technology Law Journal

An empirical analysis of the first ten years of decisions by the Board Patent Appeals and Interferences regarding inter partes patent reexamination appeals was conducted. The analysis of 101 cases focused on answering three broad questions: (1) How accurate are the specialist patent examiners of the Central Reexamination Unit of the U.S. Patent and Trademark Office? (2) Do patent owners or third party requestors fare better in appeals of decisions in inter partes reexamination proceedings? (3) Which types of appeals are more likely to be successful? The examiners’ determinations were upheld more than three fourths of the time; third party …

Has Delaware Become The "New" Eastern District Of Texas? The Unforeseen Consequences Of The Aia, Fabio E. Marino, Teri H.P. Nguyen

Santa Clara High Technology Law Journal

To stem the rising tide of patent suits brought by non-practicing entities (NPEs), Congress enacted the anti-joinder provisions of the Leahy-Smith America Invents Act (AIA) while, at nearly the same time, the Federal Circuit issued a series of decisions making it easier for defendants to transfer multi-defendant cases filed by NPEs away from the Eastern District of Texas. The unexpected result of these initiatives, however, has been that NPEs have selected the District of Delaware as their new “forum of choice,” making it the most popular forum for patent litigation in the country and displacing the Eastern District of Texas.

Copyright's Hand Abstractions Test For Patent's Section 101 Subject-Matter Eligibility, Mark R. Carter

Santa Clara High Technology Law Journal

Since the Federal Circuit’s 2007 In re Bilski decision and the Supreme Court’s 2008 Bilski v. Kappos decision, patent law’s subject-matter eligibility standard under 35 U.S.C. §101 has been uncertain. This paper posits patent law’s patent-ineligible abstract ideas are science concepts and science laws, composed of science concepts, as defined by science philosophers. Somewhat analogous to copyright law, it also presents a downward patent-eligibility Hand abstractions test from an alleged abstract idea, natural law, or natural phenomenon to independent claims as a coherent, systematic, and practical approach to judging utility-patent eligibility. Patent claims manifest an innate vertical abstractions ladder, so …

Why International Inventors Might Want To Consider Filing Their First Patent Application At The United States Patent Office & The Convergence Of Patent Harmonization And E-Commerce, Michael H. Anderson, Daniel Cislo, Jaime Saavedra, Kimberly Cameron

Santa Clara High Technology Law Journal

On March 16, 2013, the United States implemented the Leahy-Smith America Invents Act (AIA). Enactment of the AIA substantially enhances the value of U.S. provisional and non-provisional patent applications (PPAs and NPAs) to foreign applicants. Here, the authors endeavor to outline the procedural and strategic considerations facing foreign applicants for PPAs by offering a brief survey of protective foreign patent application law, followed by an analysis of the modern benefits of PPA filing in the post-AIA world. The analysis here suggests that the traditional benefits to foreign filers of PPAs encompassing term extension, cost-efficiency and secrecy have been amplified by …

In Privity With The Public Domain: The Standing Doctrine, The Public Interest, And Intellectual Property, Russell W. Jacobs

Santa Clara High Technology Law Journal

This Article explores two recent Supreme Court cases—Association of Molecular Pathology v. Myriad Genetics, Inc. and Golan v. Holder—and other intellectual property litigation in the context of the standing doctrine and the public interest.

These cases present significant public policy questions, but the adversarial nature of the courts makes them ill-equipped to consider the multiple public interests and multiple stakeholder perspectives. As a result, adjudication of these cases in the courts results in propertization of the intellectual property interests, the exclusion of non-parties from the formation of policy, and the exhaustion of any further policy debate after the court decision. …

A Witness Against Himself: A Case For Stronger Legal Protection Of Encryption, Benjamin Folkinshteyn

Santa Clara High Technology Law Journal

This Article examines the application of the Fifth Amendment privilege against self-incrimination to compelled disclosure of unencrypted data. Such disclosure can include provision of passwords to access encrypted data as well as, increasingly, providing unencrypted data after compelled decryption.

The pervasiveness and persistence of electronic data drastically increases the availability of information with potential evidentiary value that has not previously existed with physical evidence. The courts have struggled with finding the appropriate balance in determining the scope and applicability of the privilege against self-incrimination to electronic evidence. The lack of precise physical world analogues to encryption has led to particular …

Litigation Following A Cyber Attack: Possible Outcomes And Mitigation Strategies Utilizing The Safety Act, Brian E. Finch, Leslie H. Spiegel

Santa Clara High Technology Law Journal

Liability for a cyber attack is not limited to the attackers. An attack may be foreseeable in some circumstances, and the failure of the target or the other entities to take steps to prevent the attack can constitute a breach of duty to injured victims. In the absence of the protections provided by the Support Anti-Terrorism By Fostering Effective Technologies (SAFETY) Act, a cyber attack on a chemical facility could give rise to a number of common-law tort and contract claims against the target of the attack and other entities, potentially including the target’s cyber security vendors. This article discusses …

Choosing The Genetics Of Our Children: Options For Framing Public Policy, Girard Kelly

Santa Clara High Technology Law Journal

This paper examines the controversial topic of choosing our children’s genes through human germ-line manipulation otherwise known as Inheritable Genetic Modification (IGM) with current Assisted Reproductive Technologies (ARTs) and future Reproductive Genetic Biotechnologies (RGBs) such as genetic engineering. The purpose of the paper is to examine these potentially revolutionary biotechnologies and the emerging social, and bioethical perspectives advanced by both proponents and opponents—in the context of the legal and regulatory policies impacting ARTs and RGBs. Lastly, the paper recommends new public policy and regulatory frameworks to support future research and development of RGBs by providing legislative guidance to policymakers to …

Bringing Standards To Life: Synthetic Biology Standards And Intellectual Property, Andrew W. Torrance, Linda J. Kahl

Santa Clara High Technology Law Journal

In aspiring to become a true engineering discipline for the biological sciences, the field of synthetic biology has a unique opportunity to create and encourage the widespread adoption of standards to enhance innovation and social impact in the field. This article presents a study of the standards setting efforts by the institutions, firms, governments, and individuals within the field of synthetic biology.

Numerous standards have been proposed in synthetic biology, including those relevant to structure, function, description, measurement, data, information exchange, software, biosafety and biosecurity, and even law. At the present time, the adoption of technical standards has been relatively …

Information Costs And Reverse Payment Settlements: Bridging The Gap Between The Courts And The Antitrust Agencies, Brenna E. Jenny

Santa Clara High Technology Law Journal

Reverse payment settlements have attracted increased scrutiny due to the controversial presence of a payment from a brand-name drug company to a generic company that is ostensibly preparing to infringe on the branded company’s patent. The antitrust agencies and the courts settled into an intergovernmental stalemate regarding the appropriate framework of analysis to apply when reviewing antitrust challenges to these settlements. The FTC and DOJ have viewed the deals skeptically as a vehicle for competitors to split monopoly profits, but the lower courts have generally been deferential to what they identified as an exercise of a patent holder’s lawful right …

Cyberattacks On Medical Devices And Hospital Networks: Legal Gaps And Regulatory Solutions, Katherine Booth Wellington

Santa Clara High Technology Law Journal

Cyberattacks on medical devices and hospital networks are a real and growing threat. Malicious actors have the capability to hack pacemakers and insulin pumps, shut down hospital networks, and steal personal health information. This Article analyzes the laws and regulations that apply to cyberattacks on medical devices and hospital networks and argues that the existing legal structure is insufficient to prevent these attacks. While the Computer Fraud and Abuse Act and the Federal Anti-Tampering Act impose stiff penalties for cyberattacks, it is often impossible to identify the actor behind a cyberattack—greatly decreasing the deterrent power of these laws. Few laws …

Turning A New Leaf: A Privacy Analysis Of Carwings Electric Vehicle Data Collection And Transmission, Francesca Svarcas

Santa Clara High Technology Law Journal

No abstract provided.

The Patent Remedy Dynamic [Georgetown-Stanford Conference], Colleen Chien

Faculty Publications

Panel discussion on the NPEs, patent damages, including review of expert testimony, the effect of RAND and other policies on standard-setting cases at the ITC and in district courts, and other patent remedy issues.

Copyrights In The Stream: The Battle On Webcasting, Eldar Haber

Santa Clara High Technology Law Journal

The Internet threatens many right holders who consistently battle against technologies that enable people to use their copyrighted materials without their consent. While copyright holders have succeeded in some cases, their main battle against peer-to-peer (P2P) file-sharing has yet to be resolved. Another technology that threatens right holders’ business models, especially in the film industry, is the distribution of their content freely via webcasting. Although right holders have paid little attention to webcasting as they continue their campaign against P2P file-sharing, it poses similar threats and presents the likely possibility of a future copyright battle.

This Article examines copyright and …

Best Practices For The Law Of The Horse: Teaching Cyberlaw And Illuminating Law Through Online Simulations, Ira Steven Nathenson

Santa Clara High Technology Law Journal

In an influential 1996 article entitled Cyberspace and the Law of the Horse, Judge Frank Easterbrook mocked cyberlaw as a subject lacking in cohesion and therefore unworthy of inclusion in the law school curriculum. Responses to Easterbrook, most notably that of Lawrence Lessig in his 1999 article The Law of the Horse: What Cyberlaw Might Teach, have taken a theoretical approach. However, this Article—also appropriating the “Law of the Horse” moniker—concludes that Easterbrook’s challenge is primarily pedagogical, requiring a response keyed to whether cyberlaw ought to be taught in law schools. The Article concludes that despite Easterbrook’s concerns, cyberlaw presents …

The Shape Of Things To Come: What We Can Learn From Patent Claim Length, Kristen Osenga

Santa Clara High Technology Law Journal

Technology is always changing. Patent law is also constantly evolving, as the courts and Congress continue to make significant changes to this area of law. But what about patents themselves? Some studies have looked at how patent specifications have changed over time, but no one has looked specifically at the most important aspect of a patent, its claims. Given the changes in technology and law, one would anticipate patent claims to have evolved.

Despite the expectations, this paper concludes that patent claim shape is largely unaffected by time, technology, crowded fields, or prosecution time. This paper suggests a possible reason …

Why We Need A Strong Patent System And When: Filling The Void Left By The Bilski Case, Richard S. Gruner

Santa Clara High Technology Law Journal

Patent law is presently under-theorized. Patents are granted to serve as rewards for certain types of inventive successes, but the nature of the successes to be rewarded, the circumstances that should trigger rewards, and the size of the rewards that will best serve the public remain in substantial dispute. One of the primary reasons for these uncertainties is the incompleteness of underlying theories explaining why patented inventions deserve special treatment and rewards. The lack of good understanding of the theoretical justifications for patent rewards (and the limitations of those justifications) means that patent law standards are being reconsidered and revised …

Trademark And Copyright Enforcement In The Shadow Of Ip Law, William T. Gallagher

Santa Clara High Technology Law Journal

In recent years, as Congress has created new intellectual property (IP) rights and courts have often interpreted those rights broadly, legal scholars have frequently decried the expanded scope of protection afforded IP owners in most substantive areas of IP law. According to this critique, the over-expansion of IP rights throughout the past two decades harms competition, chills free speech, and diminishes the public domain as increasingly broad areas of social life are brought within the scope of strong IP protection. While this over-expansion theory reflects an important—indeed, foundational—policy debate concerning the proper balance between IP owners’ rights and the public’s …

Does Technology Require New Law?, David D. Friedman

Faculty Publications

Technological change affects the law in at least three ways: (1) by altering the cost of violating and enforcing existing legal rules; (2) by altering the underlying facts that justify legal rules; and (3) by changing the underlying facts implicitly assumed by the law, making existing legal concepts and categories obsolete, even meaningless. The legal system can choose to ignore such changes. Alternatively, it may selectively alter its rules legislatively or via judicial interpretation. In this essay I first discuss, as an interesting historical example, past technological changes relevant to copyright law and the law's response. I then go on …