Law Commons^™

Patents For Sharing, Toshiko Takenaka

Michigan Technology Law Review

Spurred by the Internet, emerging technologies have changed the way commercial firms innovate and have made it possible for individuals to play an important role in that innovation. Producers in the Information Communication Technologies (ICT), and other sectors dealing with complex technologies with many separately patentable components, find it increasingly difficult to make products without infringing on patents held by others. Numerous overlapping patents often cover such products. Producers have developed a new way to use patents: as inclusive rights for sharing their technologies with others through cross-licensing and other private ordering arrangements in order to ensure the freedom to …

The Uneasy Case For Patent Law, Rachel E. Sachs

Michigan Law Review

A central tenet of patent law scholarship holds that if any scientific field truly needs patents to stimulate progress, it is pharmaceuticals. Patents are thought to be critical in encouraging pharmaceutical companies to develop and commercialize new therapies, due to the high costs of researching diseases, developing treatments, and bringing drugs through the complex, expensive approval process. Scholars and policymakers often point to patent law’s apparent success in the pharmaceutical industry to justify broader calls for more expansive patent rights.

This Article challenges this conventional wisdom about the centrality of patents to drug development by presenting a case study of …

Steering Consumers Toward Driverless Vehicles: A Federal Rebate Program As A Catalyst For Early Technology Adoption, Marie Williams

Michigan Telecommunications & Technology Law Review

In the not-too-distant future, your car could drive itself; technology companies and automobile manufacturers alike are currently developing driverless vehicle technology. While there are many touted benefits to driverless vehicles, perhaps the most important societal benefit is a reduction in automobile accidents. Currently, car crashes are one of the leading causes of death in the United States, and the majority of accidents are caused by human error. Unlike humans, driverless vehicles will not get distracted, significantly decreasing the number of car crash fatalities that happen each year.

In order for driverless vehicles to save lives, driverless vehicles must be on …

Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai

Articles

As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly turning to "large molecule" biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings. This Article provides a fresh diagnosis of and prescription for this major public policy problem. It argues that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of Food and …

Managing Cyberthreat, Lawrence J. Trautman

Lawrence J. Trautman Sr.

Cyber security is an important strategic and governance issue. However, because most corporate CEOs and directors have no formal engineering or information technology training, it is understandable that their lack of actual cybersecurity knowledge is problematic. Particularly among smaller companies having limited resources, knowledge regarding what their enterprise should actually be doing about cybersecurity can’t be all that good. My goal in this article is to explore the unusually complex subject of cybersecurity in a highly readable manner. First, an examination of recent threats is provided. Next, governmental policy initiatives are discussed. Third, some basic tools that can be used …

Federalist Society’S Intellectual Property Practice Group And Its Stanford Law School Present A Debate On Open Source And Intellectual Property Rights, Lawrence Lessig, F. Scott Kieff, G. Marcus Cole

University of Massachusetts Law Review

Transcript of the Federalist Society’s Intellectual Property Practice Group and its Stanford Law School Chapter debate on Open Source and Intellectual Property Rights with panelists Professor Lawrence Lessig from Stanford University and Professor F. Scott Kieff from Stanford University and moderated by Professor G. Marcus Cole from Stanford Law School. This debate took place on Wednesday, March 30, 2005 in Palo Alto, California.

Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled

Yaniv Heled

Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …

After Myriad: Reconsidering The Incentives For Innovation In The Biotech Industry, Daniel K. Yarbrough

Michigan Telecommunications & Technology Law Review

35 U.S.C. § 101 allows a patent for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Recently, the Supreme Court issued several key decisions affecting the doctrine of patentable subject matter under § 101. Starting with Bilski v. Kappos (2011), and continuing with Mayo Collaborative Services, Inc. v. Prometheus Laboratories (2012), Association for Molecular Pathology v. Myriad Genetics (2013) and, most recently, Alice Corporation Pty. Ltd. v. CLS Bank International (2014), every year has brought another major change to the way in which the Court assesses patentability. In Myriad, the …

Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled

Michigan Telecommunications & Technology Law Review

Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …

Patenting By Entrepreneurs: An Empirical Study, Ted Sichelman, Stuart J.H. Graham

Michigan Telecommunications & Technology Law Review

[T]he Ewing Marion Kauffman Foundation--an organization that studies and promotes entrepreneurship in the United States--funded an effort at the University of California, Berkeley School of Law, to undertake the first comprehensive survey of the relationship between patenting and entrepreneurship in the United States. The authors, along with other investigators, administered the survey in 2008 to approximately 15,000 startup and early-stage companies in the biotechnology, medical device, information technology (IT) hardware, and software and Internet sectors. A portion of the survey examined why entrepreneurs, startups, and early-stage companies do (and do not) seek patents. This Article reports and analyzes results from …

Slides: Finding Flows: Fish Still Need Water Everyday, Melinda Kassen

Western Water Law, Policy and Management: Ripples, Currents, and New Channels for Inquiry (Martz Summer Conference, June 3-5)

Presenter: Melinda Kassen, Director of the Western Water Project, Trout Unlimited

12 slides

Agenda: Endangered Species Act Congressional Field Tour, University Of Colorado Boulder. Natural Resources Law Center

Endangered Species Act Congressional Field Tour (August 17-19)

The Center sponsored its third annual field tour for staff members of the United States Congress, the United States Environmental Protection Agency, and the Colorado state legislature.

Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg

Articles

Controversy over recent revelations concerning the adverse cardiovascular effects of selective cyclooxygenase- 2 (COX-2) inhibitors has generally been framed as a story of regulatory failure, in which the Food and Drug Administration (FDA) has failed in its mission to protect the public from unsafe products. But this simplistic understanding of the mission of the FDA seems to make failure all but inevitable, if the reliable observation of the risks and benefits of a drug requires rigorous long-term studies. Perhaps in an earlier era the goal of drug regulation was simply to protect the public from poisons. Today, drug regulation guides …

Obvious To Whom? Evaluating Inventions From The Perspective Of Phosita, Rebecca S. Eisenberg

Articles

In this Article, I consider the possibility of giving the USPTO input from currently active technological practitioners in evaluating the obviousness of claimed inventions. Such input could potentially serve three useful functions. First, it could improve the accuracy of USPTO decisionmaking by providing access to the perspective of actual practitioners as to the obviousness of inventions from the perspective of the hypothetical PHOSITA. Second, it could help the USPTO document the evidentiary basis for rejections that rest in part upon tacit knowledge within technological communities. Third, it could provide a quality control mechanism that would improve the credibility of USPTO …

Conference Summary: Water, Climate And Uncertainty: Implications For Western Water Law, Policy, And Management, Steve Bailey

Water, Climate and Uncertainty: Implications for Western Water Law, Policy, and Management (Summer Conference, June 11-13)

7 pages.

"Steve Bailey, National Center for Atmospheric Research"

The Long Time Scales Of Human-Caused Climate Warming: Further Challenges For The Global Policy Process, Jerry D. Mahlman

Water, Climate and Uncertainty: Implications for Western Water Law, Policy, and Management (Summer Conference, June 11-13)

28 pages.

"Jerry D. Mahlman, Senior Research Fellow, National Center for Atmospheric Research"

"Presented at the Pew Center Workshop on The Timing of Climate Change Policies, The Westin Grand Hotel, Washington, DC, October 10-12, 2001"

"Cite As: Mahlman, J.D. 2001. The Long Time Scales of Human-Caused Climate Warming: Further Challenges for the Global Policy Process. Pew Center Workshop on the Timing of Climate Change Policies, October 10-12, Pew Center on Global Climate Change, Arlington, VA."

Theorizing Behavioral Law And Economics: A Defense Of Evolutionary Analysis And The Law, Neel P. Parekh

University of Michigan Journal of Law Reform

Behavioral law and economics (BLE) provides a steady stream of empirical evidence that counters the predictions of law and economics. Despite this research and data, however, many theorists argue that BLE ultimately fails because it posits no underlying theory. This Note argues that perspectives from evolutionary biology, evolutionary psychology, and the brain sciences can provide the missing motivational theory for BLE's empirical findings. The Note also examines the implications a more consistent and reasoned consideration of evolutionary analysis and the law (EA) has for our legal regime. In theorizing BLE and defending EA, this Note aims to show how evolutionary …

Upstream Patents = Downstream Bottlenecks, Rebecca S. Eisenberg, Michael A. Heller

Articles

Thirty years ago in Science, Garrett Hardin introduced the metaphor "tragedy of the commons" to help explain overpopulation, air pollution, and species extinction. People often overuse resources they own in common because they have no incentive to conserve. Today, Hardin's metaphor is central to debates in economics, law, and science and powerful justification for privatizing commons property. While the metaphor highlights the cost of overuse when governments allow too many people to use a scarce resource, it misses the possibility of underuse when governments give too many people rights to exclude others. Privatization can solve one tragedy, but cause another.

Limiting The Role Of Patents In Technology Transfer, Rebecca S. Eisenberg

Other Publications

Federal policy since 1980 has reflected an increasingly confident presumption that patenting discoveries made in the course of government-sponsored research is the most effective way to promote technology transfer and commercial development of those discoveries in the private sector. Policymakers in the past may have thought that the best way to achieve widespread use of government-sponsored research was to make the results freely available to the public; the new pro-patent policy stresses the need for exclusive rights as an incentive for industry to invest in bringing new products to market.

Patents And The Progress Of Science: Exclusive Rights And Experimental Use, Rebecca S. Eisenberg

Articles

In this article I analyze the proper scope of an experimental use exemption from patent infringement liability by comparing the rationales behind promoting technological progress through granting exclusive patent rights in inventions with competing arguments for promoting scientific progress by allowing all investigators to enjoy free access to the discoveries of other scientists. I begin by reviewing key features of the patent laws and theoretical justifications for granting patent monopolies in order to clarify the implications of existing patent doctrine and theory for an experimental use exemption. I then look to the literature in the sociology, history, and philosophy of …

Proprietary Rights And The Norms Of Science In Biotechnology Research, Rebecca S. Eisenberg

Articles

As basic research in biotechnology yields increasing commercial applications, scientists and their research sponsors have become more eager to protect the commercial value of research discoveries through intellectual property law. Some scientists fear that these commercial incentives will weaken or even undermine the norms that have traditionally governed scientific research. In this Article, Professor Eisenberg examines the interaction of proprietary rights in inventions with these traditional scientific norms. Trade secrecy, she argues, is an undesirable strategy for protection of basic research discoveries because it impedes dissemination of new knowledge to the scientific community. She finds that patent law is in …