Law Commons^™

The Replicability Crisis In Patent Law, Janet Freilich

Indiana Law Journal

There is a “replicability crisis” in the scientific literature. Scientists attempting to redo experiments in reputable, peer-reviewed journals have found that staggering numbers of these experiments—up to 90%—do not work. Patents, like scientific articles, contain experiments. These experiments often form the backbone of the patent and provide crucial support for patentability. Patent examiners use these experiments to evaluate whether the invention works, and thus whether the patent should be granted. The replicability crisis in the scientific literature is therefore of utmost importance to the patent system. Transferring the insights of the replicability crisis to patents begs the question of whether …

A Siri-Ous Societal Issue: Should Autonomous Artificial Intelligence Receive Patent Or Copyright Protection?, Samuel Scholz

Cybaris®

No abstract provided.

Can An Improved Disclosure Mechanism Moderate Algorithm-Based Software Patentability In The Public Interest?, Vinicius Sala

Cybaris®

No abstract provided.

Is Dna Really A Natural Product? It's Time To Separate Fact From (Legal) Fiction: An Examination Of Dna Patentability As A Biological Algorithm In The Post-Myriad Era, Nicholas Ulen

Chicago-Kent Law Review

In 2013, the United States Supreme Court delivered its landmark decision in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., holding isolated DNA unpatentable, thereby invalidating the claims of thousands of DNA patents in the process. The opinion, delivered by Justice Thomas, reasoned that the act of separating DNA from the body did not sufficiently transform the molecule beyond what naturally exists. Yet the Court found that line to be crossed when it held certain artificially synthesized complementary DNA molecules coding for the exact same gene patentable. Unlike the Federal Circuit, the Court focused its analysis not on the …

Computational Experimentation, Tabrez Y. Ebrahim

Faculty Scholarship

Experimentation conjures images of laboratories and equipment in biotechnology, chemistry, materials science, and pharmaceuticals. Yet modern day experimentation is not limited to only chemical synthesis, but is increasingly computational. Researchers in the unpredictable arts can experiment upon the functions, properties, reactions, and structures of chemical compounds with highly accurate computational techniques. These computational capabilities challenge the enablement and utility patentability requirements. The patent statute requires that the inventor explain how to make and use the invention without undue experimentation and that the invention have at least substantial and specific utility. These patentability requirements do not align with computational research capabilities, …

Noa V. Doa: Increasing Medical Diagnostic Patentability After Mayo, Karen Mckenzie

Marquette Intellectual Property Law Review

The medical diagnostics market is expected to reach 65 billion by 2018. In March 2012, in Mayo Collborative Services v. Prometheus Labs, Inc. , ("Mayo") the U.S. Supreme held that the Mayo Clinic (the "Clinic") had not infringed on Prometheus Labs’ (“Prometheus”) diagnostic patent because the Prometheus patent involved ineligible subject matter, and was therefore invalid. Section 101 of the Patent Act defines eligible subject matter an “any new and useful process, machine, manufacture, or composition of matter” as patentable subject matter. Courts have held that Section 101 contains an implicit exception, making laws of nature, natural phenomena, and abstract …

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 …

Alice: The Status Quo Or Total Chaos?, Matthew Moldovanyi

Journal of Law, Technology, & the Internet

"On June 19, 2014 the Supreme Court handed down a highly important opinion discussing what is considered patentable subject matter in the United States. The case, Alice Corporation v. CLS Bank International, involved a group of patents for computer software that mitigated settlement risk in financial transactions. The Court held that these patents were not drawn to patent eligible subject matter under 35 U.S.C. § 101 (2012) because the claims were directed toward abstract ideas, which are unpatentable." "This ruling has drawn decidedly mixed reactions from commentators in the legal field. Moreover, this case leaves United States Patent and Trademark …

Patent Law Challenges For The Internet Of Things, W. Keith Robinson

Faculty Journal Articles and Book Chapters

In the near future, emerging technologies will allow billions of everyday devices to be connected via the Internet. This increasingly popular phenomenon is referred to as the Internet of Things (“IoT”). The IoT is broadly defined as technology that allows everyday devices to (1) become “smart” and (2) communicate with other smart devices. Estimates indicate that the market for smart devices, such as wearables, will grow to $70 billion dollars in the next ten years. Like many other emerging technologies, the entrepreneurs and companies developing these applications will seek patent protection for their inventions. In turn, the current U.S. patent …

One Hundred Nos: An Empirical Analysis Of The First 100 Denials Of Institution For Inter Partes And Covered Business Method Patent Reviews, Jonathan R. K. Stroud, Jarrad Wood

Jonathan R. K. Stroud

Tasked in 2011 with creating three powerful new patent review trial regimes, the U.S. Patent and Trademark Office—through the efforts of their freshly empowered quasi-judicial body, the Patent Trial and Appeals Board—set to creating a fast-paced trial with minimal discovery and maximum efficiency. In the first two years of existence, the proceedings have proved potent, holding unpatentable many of the claims that reach decisions on the merits. Yet a small subsection of petitions never make it past the starting gate, resulting in wasted time and effort on the parts of petitioners—and likely sighs of relief from the rights-holders. Parties on …

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 …

What Should Be Patentable? A Proposal For Determining The Existence Of Statutory Subject Matter Under 35 U.S.C. Sec. 101, Andrew Beckerman Rodau

Andrew Beckerman Rodau

The question of what type of inventions should be protectable under patent law is a controversial issue that has received significant attention. Recent Supreme Court decisions reject a bright line test in favor of a more-opened ended approach to determining patent eligibility. Unfortunately, this provides limited guidance to lower courts and consequently the issue remains unsettled. Most inventions fit within the statutory requirements defining patent-eligible inventions. This article will examine the scope of patent-eligible subject matter defined by patent law section 101. It will look at judicial interpretation of the statute including exceptions judicially engrafted onto the statute by the …

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 precedents concerning the …

The Technological Edge, Elizabeth I. Winston

Scholarly Articles

To grant a patent to natural phenomena hinders innovation, taking back from the public that which the public has a right to possess. To deny a patent to man’s manufacture undercuts the fundamental bargain of the patent system. All inventions, at their core, may be deemed natural, rendering it difficult to distinguish between man’s manufacture and natural phenomena. Determining whether the innovative aspect of the product is a technological one, rather than a natural one, can clarify whether the patent grant promotes the progress of science and the useful arts. The higher the level of skill in the art required …

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

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 of flexible …

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

Publications

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.

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

Publications

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 a …

Tax Strategies Are Not Patentable Inventions, Andrew A. Schwartz

Publications

No abstract provided.

Inoculation Inventions: The Interplay Of Infringement And Immunity In The Development Of Biodefense Vaccines, Cynthia M. Ho

Journal of Health Care Law and Policy

No abstract provided.

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 …

Public Access Versus Proprietary Rights In Genomic Information: What Is The Proper Role Of Intellectual Property Rights?, Janice M. Mueller

Journal of Health Care Law and Policy

No abstract provided.

Reaching Through The Genome, Rebecca S. Eisenberg

Book Chapters

The past two decades have been a period of rapid evolution in the science of biotechnology and therefore in patent strategies, if not in patent law itself. Patent law takes a long time to catch up with science, and commentators take a long time to catch up with the law, but patent lawyers don’t have that luxury. They have to keep ahead of the game, figuring out claiming strategies that allow their clients to capture the value of future discoveries. I want to discuss some of these strategies today.

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.

The Role Of Patents In Exploiting The Genome, Rebecca S. Eisenberg

Book Chapters

The sequencing of the human genome is a great scientific accomplishment that opens the door to further scientific inquiry of a sort that would otherwise be impossible. In addition to being passionately interested in the patent issues this research presents, as a legal scholar I have a long-standing interest in the role of intellectual property in interactions between the public and private senators and between universities and private firms in research science, with a focus on biomedial research. However, although the Human Genome Project has provided a rich terrain for exploring these issues, I am puzzled that intellectual property issues …

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

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 …

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

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 a broader public policy perspective. We have …

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 …