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Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg Jun 2019

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Articles

This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of ...


Prometheus Rebound: Diagnostics, Nature, And Mathematical Algorithms, Rebecca S. Eisenberg Jan 2013

Prometheus Rebound: Diagnostics, Nature, And Mathematical Algorithms, Rebecca S. Eisenberg

Articles

The Supreme Court’s decision last Term in Mayo v. Prometheus left considerable uncertainty as to the boundaries of patentable subject matter for molecular diagnostic inventions. First, the Court took an expansive approach to what counts as an unpatentable natural law by applying that term to the relationship set forth in the challenged patent between a patient’s levels of a drug metabolite and the indication of a need to adjust the patient’s drug dosage. And second, in evaluating whether the patent claims add enough to this unpatentable natural law to be patent eligible, the Court did not consult ...


Better Mistakes In Patent Law, Andres Sawicki Jan 2012

Better Mistakes In Patent Law, Andres Sawicki

Articles

This Article analyzes patent mistakes-that is, mistakes made by the patent system when it decides whether a particular invention has met the patentability requirements. These mistakes are inevitable. Given resource constraints, some might even be desirable. This Article evaluates the relative costs of patent mistakes, so that we can make better ones.

Three characteristics drive the costs of mistakes: their type (false positive or false negative), timing (early or late), and doctrinal basis (utility, novelty, nonobviousness, and so on). These characteristics make some mistakes more troubling than others.

This Article compares the costs of making mistakes of different types, at ...


Wisdom Of The Ages Or Dead-Hand Control? Patentable Subject Matter For Diagnostic Methods After In Re Bilski, Rebecca S. Eisenberg Jan 2012

Wisdom Of The Ages Or Dead-Hand Control? Patentable Subject Matter For Diagnostic Methods After In Re Bilski, Rebecca S. Eisenberg

Articles

In 1980, the Supreme Court gave a reassuring signal to the then-nascent biotechnology industry about the availability of patent protection for the fruits of its research when it upheld the patentability of a genetically modified living organism in Diamond v. Chakrabarty. Twenty-five years later, the Court seemed poised to reexamine the limits of patentable subject matter for advances in the life sciences when it granted certiorari in Laboratory Corporation v. Metabolite. But the Federal Circuit had not addressed the patentable subject matter issue in Laboratory Corporation, and the Court ultimately dismissed the certiorari p etition as improvidently granted. Five years ...


Pharma's Nonobvious Problem, Rebecca S. Eisenberg Jan 2008

Pharma's Nonobvious Problem, Rebecca S. Eisenberg

Articles

This Article considers the effect of the recent decision of the U.S. Supreme Court in KSR International Co. v. Teleflex, Inc. on the nonobviousness standard for patentability as applied to pharmaceutical patents. By calling for an expansive and flexible analysis and disapproving of the use of rigid formulas in evaluating an invention for obviousness, KSR may appear to make it easier for generic competitors to challenge the validity of drug patents. But an examination of the Federal Circuit's nonobviousness jurisprudence in the context of such challenges reveals that the Federal Circuit has been employing all along the sort ...


The Patent Office Meets The Poison Pill: Why Legal Methods Cannot Be Patented, Andrew A. Schwartz Jan 2007

The Patent Office Meets The Poison Pill: Why Legal Methods Cannot Be Patented, Andrew A. Schwartz

Articles

In 2003, for the first time in its 170-year history, the United States Patent Office began awarding patents for novel legal innovations, in addition to traditional inventions such as the telephone or airplane. Commentators have accepted the Patent Office's power to grant legal method patents, but at the same time have criticized this new type of patent on policy grounds. But no one has suggested that the Patent Office exceeded its authority by awarding patents for legal methods, until now.

In the Patent Act of 1952, which is still in effect today, Congress established certain requirements for patentability, including ...


Patents On Legal Methods? No Way!, Andrew A. Schwartz Jan 2007

Patents On Legal Methods? No Way!, Andrew A. Schwartz

Articles

An “invention,” as used in the United States patent laws, refers to anything made by man that employs or harnesses a law of nature or a naturally occurring substance for human benefit. A watermill, for instance, harnesses the power of gravity to run machinery. But legal methods, such as tax strategies, are not inventions in this sense, because they employ “laws of man” — not laws of nature to produce a useful result.


Tax Strategies Are Not Patentable Inventions, Andrew A. Schwartz Jan 2006

Tax Strategies Are Not Patentable Inventions, Andrew A. Schwartz

Articles

No abstract provided.


Obvious To Whom? Evaluating Inventions From The Perspective Of Phosita, Rebecca S. Eisenberg Jan 2004

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 ...


Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg Jan 2003

Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg

Articles

Advances in fundamental biomedical research play an important and growing role in the development of new therapeutic and diagnostic products. Although the development of pharmaceutical end products has long been a proprietary enterprise, biomedical research comes from a very different tradition of open science. Within this tradition, long-standing norms call for relatively unfettered access to fundamental knowledge developed by prior researchers. The tradition of open science has eroded considerably over the past quarter century as proprietary claims have reached farther upstream from end products to cover fundamental discoveries that provide the knowledge base for future product development.


Re-Examining The Role Of Patents In Appropriating The Value Of Dna Sequences, Rebecca S. Eisenberg Jan 2000

Re-Examining The Role Of Patents In Appropriating The Value Of Dna Sequences, Rebecca S. Eisenberg

Articles

As public and private sector initiatives race to complete the sequence of the human genome, patent issues have played a prominent role in speculations about the significance of this achievement. How much of the genome will be subject to the control of patent holders, and what will this mean for future research and the development of products for the improvement of human health? Is a patent system developed to establish rights in mechanical inventions of an earlier era up to the task of resolving competing claims to the genome on behalf of the many sequential innovators who elucidate its sequence ...


The Promise And Perils Of Strategic Publication To Create Prior Art: A Response To Professor Parchomovsky, Rebecca S. Eisenberg Jan 2000

The Promise And Perils Of Strategic Publication To Create Prior Art: A Response To Professor Parchomovsky, Rebecca S. Eisenberg

Articles

In a provocative recent article in the Michigan Law Review, Professor Gideon Parchomovsky observes that a firm racing with a competitor to make a patentable invention might find it strategically advantageous to publish interim research results rather than risk losing a patent race. This strategy exploits legal rules limiting patent protection to technological advances that are new and "nonobvious" in light of the "prior art" or preexisting knowledge in the field. By publishing research results, a firm adds to the prior art and thereby limits what may be patented in the future. Parchomovsky posits that, before it is able to ...


Analyze This: A Law And Economics Agenda For The Patent System, Rebecca S. Eisenberg Jan 2000

Analyze This: A Law And Economics Agenda For The Patent System, Rebecca S. Eisenberg

Articles

Legal scholars and economists might enhance the value and impact of their work by making more effective use of each other's knowledge and capabilities. Legal scholars can offer a more nuanced understanding of the legal rules that underlie the patent system and the doctrinal levers that might be manipulated in furtherance of public policy goals. Economists bring to bear a set of analytical and methodological tools that could shed considerable light on what these doctrinal levers are doing and which of them we ought to be manipulating. Together, we have a better chance of asking the right questions and ...


Intellectual Property At The Public-Private Divide: The Case Of Large-Scale Cdna Sequencing, Rebecca S. Eisenberg Jan 1996

Intellectual Property At The Public-Private Divide: The Case Of Large-Scale Cdna Sequencing, Rebecca S. Eisenberg

Articles

The Human Genome Project provides fertile ground for studying the role of intellectual property at the wavering boundary between public and private research science. It involves a major commitment of both public and private research funds in an area that is of significant interest both to research scientists working in university and government laboratories and to commercial firms. It thus provides a wealth of new scientific discoveries that are simultaneously potential candidates for commercial development and inputs into further research. Its obvious implications for human health raise the stakes of getting the balance between private property and public access right ...


Opinion Letter As To The Patentability Of Certain Inventions Associated With The Identification Of Partial Cdna Sequences, Rebecca S. Eisenberg, Robert P. Merges Jan 1995

Opinion Letter As To The Patentability Of Certain Inventions Associated With The Identification Of Partial Cdna Sequences, Rebecca S. Eisenberg, Robert P. Merges

Articles

You have asked for our legal opinion on the patentability of inventions claimed in U.S. patent applications 07/716,831, filed June 21, 1991 (the '831 application, or .'831"), 07/837,195, filed September 25, 1992 ("'195"), and 07/952,911, filed February 12, 1993 (."911"), all filed in the name of Craig Venter and others and assigned to the National Institutes of Health "(NIH)." We understand that NIH has abandoned these patent applications and has no present intention of filing similar applications in the future, but that NIH remains interested in the patenting of human DNA sequences from ...


Patenting The Human Genome, Rebecca S. Eisenberg Jan 1990

Patenting The Human Genome, Rebecca S. Eisenberg

Articles

The increasing promise of federal funding for mapping and sequencing the human genome has brought with it renewed attention in the research science community to issues of intellectual property protection for products of biotechnology research. Echoing concerns raised a decade ago in the debate over commercialization of academic biomedical research, scientists have called for the free availability of all information generated through the Human Genome Project and have argued against allowing private intellectual property rights in such knowledge. Meanwhile, private parties have quietly been obtaining patents on bits and pieces of the human genome from the Patent and Trademark Office ...


The Patentability Of A Mental Process, John B. Waite Jan 1917

The Patentability Of A Mental Process, John B. Waite

Articles

The fact of possession has been so correlated with the theory of property that it is difficult to dissociate ownership from the possibility of physical possession. One finds that the average lawyer, even though he may defind a right in rem as a right enforcible against any person, is extremely apt, unless after especial thought, to explain that it is enforcible against anyone because it pertains to a thing capable of physical possession and control, a thing that could be actually sequestered, from all other persons. Not at all infrequently the term property has been judicially stripped even of its ...


The Patentability Of A Principle Of Nature, John B. Waite Jan 1917

The Patentability Of A Principle Of Nature, John B. Waite

Articles

The extent to which courts will go in conceding patentability to a natural law, or principle of nature, is evidenced in the case of Minerals Separation Co. v. Hyde, 37 Sup. Ct. -, decided by the Supreme Court, December 11, 1916. It has always been more or less an axiom of patent law that the discovery of a principle of nature does not entitle the discoverer to a patent for it. The case usually thought of first as authority therefor, is that of Morton v. New York Eye Infirmary, 5 Blatch. 116, 2 Fisher 320. The patentees in that case had ...