Articles

Patent Infringement in the Context of Follow-On Biologics

Janet Freilich

This Article fills a gap in the literature by conducting a comprehensive analysis of patent infringement in the context of follow-on biologics. Patent infringement is an important topic because, like small molecule generic drugs, follow-on biologics are likely to begin their life facing infringement suits. Because it is tremendously expensive to develop a follow-on biologic, it is vital that there be consistency in how they are treated in the courts once the inevitable patent infringement suits arrive.... Read more about Patent Infringement in the Context of Follow-On Biologics

Moore is Less: Why the Development of Induced Pluripotent Stem Cells Might Lead Us to Rethink Differential Property Interests in Excised Human Cells

Osagie K. Obasogie
Helen Theung

Since Moore v. Regents of the University of California, there has been a wide-ranging debate regarding the holding of the case and its implications for property law. Moore stands for the notion that individuals do not have a property interest in ordinary cells taken from their bodies during medical procedures nor the commercial products that researchers might develop from them. At the same time, cases such as Davis v. Davis and Hecht v.... Read more about Moore is Less: Why the Development of Induced Pluripotent Stem Cells Might Lead Us to Rethink Differential Property Interests in Excised Human Cells

  • January 15, 2013
  • Stan. Tech. L. Rev. 51

Unchaining Richelieu's Monster: A Tiered Revenue-Based Copyright Regime

Martin Skladany

This Article proposes a tiered revenue-based copyright regime, which would require copyright holders to select one of two different copyright terms. The first tier would provide a fixed, nonrenewable copyright term of 10-14 years, while the second tier would offer a one-year copyright term that could be indefinitely renewed as long as the work is successful enough to meet or exceed a revenue threshold.... Read more about Unchaining Richelieu's Monster: A Tiered Revenue-Based Copyright Regime

  • January 7, 2013
  • Stan. Tech. L. Rev. 131

Negotiating Cloud Contracts: Looking at Clouds from Both Sides Now

W. Kuan Hon
Christopher Millard
Ian Walden

Contract terms for cloud computing services are evolving, driven by users’ attempts to negotiate providers’ standard terms to make them more suitable for their requirements, as well as market developments, particularly among cloud integrators. This Article, drawing on sources including interviews with cloud computing providers, users and other market actors, is the first in-depth research into how cloud contracts are negotiated.... Read more about Negotiating Cloud Contracts: Looking at Clouds from Both Sides Now

  • January 7, 2013
  • Stan. Tech. L. Rev. 81

Why the “Scope of the Patent” Test Cannot Solve the Drug Settlement Problem

Michael A. Carrier

One of the most difficult legal issues today involves settlements by which brand-name drug companies pay generic firms to delay entering the market. Such conduct requires courts to consider not only patent and antitrust law, but also the Hatch-Waxman Act, the complex regime governing behavior in the pharmaceutical industry. Courts have analyzed these agreements by relying on a test that asks if the settlement falls within the “scope of the patent.” They have found, in nearly all of these cases, that it does.... Read more about Why the “Scope of the Patent” Test Cannot Solve the Drug Settlement Problem

Luck/Unluck of the Draw: An Empirical Study of Examiner Allowance Rates

Sean Tu

The United States Patent and Trademark Office is tasked with reading and reviewing patent applications to determine those applications which qualify for patent protection. Each application is reviewed by a specific patent examiner who should apply the standards of patentability in an even, fair, unbiased and consistent manner. This task requires the examiner not only to be internally consistent with the applications she reviews, but consistent with the behavior of other examiners within the same art unit. I find this may not be the case.... Read more about Luck/Unluck of the Draw: An Empirical Study of Examiner Allowance Rates

  • August 29, 2012
  • Stan. Tech. L. Rev. 10

Blinded by (a Lack of) Science: Limitations in Determining Therapeutic Equivalence of Follow-On Biologics and Barriers to Their Approval and Commercialization

Trevor Woodage

Over the past twenty years, an increasing number of disease therapies based on recombinant DNA technology have been developed and commercialized. These treatments, commonly known as biologics, can be very effective. They can also be extraordinarily expensive. In an effort to ensure the availability and affordability of biologics, Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) in 2010.... Read more about Blinded by (a Lack of) Science: Limitations in Determining Therapeutic Equivalence of Follow-On Biologics and Barriers to Their Approval and Commercialization

  • July 16, 2012
  • Stan. Tech. L. Rev. 9

The ITU and the Internet's Titanic Moment

Patrick S. Ryan

Try this: Mention the International Telecommunication Union (ITU) to a few casual Internet users, Netizens, or even the most senior-level computer programmers and technology experts and gauge their reaction. Few are likely to know what you’re talking about. Most will likely think you’re referring to either a telecommunications labor union or some kind of international working group. Only the most informed will know that the ITU is one of the most influential (and in fact the oldest) technology-based standard-setting and treaty-making institutions in the world.... Read more about The ITU and the Internet's Titanic Moment

  • July 16, 2012
  • Stan. Tech. L. Rev. 8

Social Media Privacy: A Dozen Myths and Facts

Lothar Determann

Social networks and media are one of the latest frontiers for lawyers, lawmakers, politicians, entrepreneurs and academics. No one seems to claim that social media is the final frontier or even a particularly revolutionary frontier. After all, media and social networks have been around for thousands of years in one form or another. But, most are genuinely fascinated with the new opportunities, risks, and questions presented by the recent rapid rise of novel technology platforms that allow people all over the world to connect and communicate in new ways.... Read more about Social Media Privacy: A Dozen Myths and Facts

  • July 10, 2012
  • Stan. Tech. L. Rev. 7

The Year in "First Amendment Architecture"

Marvin Ammori

2011’s “Person of the Year,” according to Time Magazine, was “The Protestor.” That year, protestors across the world led and persisted through the historic Arab Spring. From Tunisia to Egypt and beyond, these protestors may have spawned a democratic awakening in the Middle East. They took to physical spaces like Tahrir Square in Cairo and to virtual spaces on Facebook and Twitter to express their dissent and assemble against undemocratic regimes.... Read more about The Year in "First Amendment Architecture"

  • July 10, 2012
  • Stan. Tech. L. Rev. 6

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