Law Commons^™

Vanda V. West-Ward Pharmaceuticals: Good News For The Patent Eligibility Of Diagnostics And Personalized Medicine, With Some Important Caveats, Christopher M. Holman

Faculty Works

In Mayo v. Prometheus, decided in 2011, the U.S. Supreme Court invalidated patent claims directed towards diagnostic methods useful in the optimization of drug dosage for the needs of an individual patient, i.e., an example of personalized medicine, based on the Court’s determination that the claims were directed towards a patent ineligible law of nature. Notably, the claims in Mayo did not recite a step of applying the information generated by the test, e.g., a step of administering the drug to a patient at the optimized dosage. Some, including this author, have speculated that inclusion of such a step might …

Congress Considering Legislation Intended To Reverse The Recent Trend Toward Devaluation Of The Us Patent Right, Christopher M. Holman

Faculty Works

Decisions of the United States Supreme Court spanning the last quarter of a century that have, in the aggregate, substantially devalued the patent right. The Court’s four decisions reinvigorating and substantially raising the patent eligibility bar have probably resulted in the most critical commentary, but a host of other decisions have also served to erode the patent right in multiple dimensions, including the scope of potentially patent-able subject matter as well as the strength and enforce-ability of issued patents. In 2011 Congress joined in when it enacted the America Invents Act (AIA), which includes multiple provisions tending to devalue patents, …

Praxair V. Mallinckrodt: An Expanded Interpretation Of The Printed Matter Doctrine With Important Implications For Biotechnology, Christopher M. Holman

Faculty Works

Although the “printed matter doctrine” has a long history in U.S. patent law, until recently it has played a relatively minor role in policing patent-ability, so much so that an article published in 1994 essentially wrote it off as nothing more than an “archaic common law has-been.” Although the doctrine is rooted in the concept of patent eligibility, it is never mentioned in recent patent eligibility decisions of the U.S. Supreme Court such as Mayo and Alice, and patent law treatises and casebooks tend to give the doctrine little if any coverage. At its core, the printed matter doctrine has …

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 …

Open Source Approaches In Biotechnology: Utopia Revisited, Yann Joly

Maine Law Review

Tracing its origin to Greek antiquity, intellectual property has become an institution in modern legal systems worldwide. This growing importance of intellectual property was confirmed with the 1994 adoption of the Trade-Related Aspects of Intellectual Property Rights Agreement by the World Trade Organization (WTO), which harmonized the rules of intellectual property amongst the various members of the international community on the model of developed countries. However enshrined in the legal tradition, intellectual property law has also had its share of detractors and has recently come under severe criticism. The exercise of intellectual property rights in such diverse fields of creation …

A Virtue-Centered Approach To The Biotechnology Commons (Or, The Virtuous Penguin), David W. Opderbeck

Maine Law Review

The instrumentalist emphasis of the current biotechnology intellectual property rights (IPR) debate is not surprising. In the American tradition, intellectual property law has long been justified primarily by instrumentalist concerns. Thomas Jefferson famously acceded to the “embarrassment of patent and copyright monopolies because he believed a limited monopoly would encourage the production of new scholarship and inventions. The framers' willingness to allow this embarrassment for the greater good is enshrined in the Intellectual Property Clause of the U.S. Constitution. Countless judicial opinions refer to intellectual property law as a tool that provides necessary incentives to creators and innovators. Intellectual property …

Adoption Of The Bayh-Dolye Act In Developed Countries: Added Presure For A Broad Research Exemption In The United States?, Michael S. Mireles

Maine Law Review

Numerous developed countries, most if not all members of the Organization of Economic Cooperation and Development (OECD), including Japan, France, the United Kingdom, Germany, Austria, Denmark, Norway, Portugal, Spain, and Finland, have or are considering adopting legislation similar to the Bayh-Dole Act. These countries apparently believe that passage of legislation similar to the Bayh-Dole Act will lead to the transfer of government funded research results from the university laboratory to the marketplace and other economic activity. In the United States, the birthplace of the Bayh-Dole Act (the Act), it is not entirely clear whether its passage is the direct result …

Salmon With A Side Of Genetic Modification: The Fda’S Approval Of Aquadvantage Salmon And Why The Precautionary Principle Is Essential For Biotechnology Regulation, Kara M. Van Slyck

Seattle University Law Review

This Note seeks to address the issues concerning the FDA’s approval of genetically modified salmon for consumption, arguing that the FDA did not properly vet AquAdvantage salmon, as well as relied on inappropriate criteria in their approval of its market use. Part I provides a brief history of AquAdvantage salmon’s introduction to U.S. markets and the legal actions taken in response to the FDA ruling. Part II discusses the statutes and regulations fundamentally relevant to GE products, as well as a critique of the way each regulation was used to approve AquAdvantage. Part III offers a comparison to the European …

Balancing Open Source Paradigms And Traditional Intellectual Property Models To Optimize Innovation, Lisa M. Mandrusiak

Maine Law Review

Copyrights and patents grant property rights to creators and inventors in order to spur further innovation through the dual approach of increasing the amount of material in the public domain and rewarding inventors and creators for their efforts. However, in recent years, it has been postulated that extensive granting of copyrights and patents may in fact stifle additional creation and development. This led to a revolt in the computer programming industry and spawned the open source movement, which provides software with its source code and a license allowing for free creation and distribution of works. This movement attempts to spur …

The European Patent Office And The European Patent: An Open Avenue For Biotechnologists And "Living Inventions", Katrina Mcclatchey

Oklahoma Journal of Law and Technology

No abstract provided.

Agricultural Biogechnology: United States Statutory Law, Jo Lynn Jeter

Oklahoma Journal of Law and Technology

No abstract provided.

The International Treaty On Plant Genetic Resources For Food And Agriculture: Friend Of The International Farmer, Steven M. Ruby

Oklahoma Journal of Law and Technology

No abstract provided.

The Effect Of The "Onco-Mouse" Decisions On The Exception To Patentability For "Animal Varieties" Under The European Patent Convention, Katrina Mcclatchey

Oklahoma Journal of Law and Technology

No abstract provided.

Do The Evolution: The Effect Of Ksr V. Teleflex On Biotechnology, Josh Harrison

Oklahoma Journal of Law and Technology

No abstract provided.

Patent Arbitration: The Underutilized Process For Resolving International Patent Disputes In The Pharmaceutical And Biotechnology Industries, Alessandra Emini

Arbitration Law Review

No abstract provided.

"Playing God?": An Examination Of The Legality Of Crispr Germline Editing Technology Under The Current International Regulatory Scheme And The Universal Declaration On The Human Genome And Human Rights, Brooke Elizabeth Hrouda

Georgia Journal of International & Comparative Law

No abstract provided.

Agricultural And Food Law—Food Labeling And Biotechnology—The Food Fight Over Labeling Genetically Engineered Foods And A Natural Solution To Protect Agricultural Biotechnology In The Natural State, Katie W. Branscum

University of Arkansas at Little Rock Law Review

No abstract provided.

Genome Editing And The Jurisprudence Of Scientific Empiricism, Paul Enriquez

Vanderbilt Journal of Entertainment & Technology Law

Humankind has reached, in tow by the hand of a scientific breakthrough called CRISPR, the Rubicon of precise genetic manipulation first envisioned over fifty years ago. Despite CRISPR's renown in science and its power to transform the world, it remains virtually unaddressed in legal scholarship. In the absence of on-point law, the scientific community has attempted to reach some consensus to preempt antagonistic regulation and prescribe subjective standards of use under the guise of a priori scientific empiricism. Significant and complex legal issues concerning this technology are emerging, and the void in legal scholarship is no longer tolerable.

This Article …

Inventive Steps: The Crispr Patent Dispute And Scientific Progress, Jacob S. Sherkow

Other Publications

Recent decisions by patent offices in the USA and Europe concerning the revolutionary gene-editing technology, CRISPR/Cas9, have shed light on the importance — and puzzles — of one particular area of patent law: “nonobviousness”, as it known in the USA, or, in Europe, the “inventive step”. Patent law does not always neatly align itself with the realities of biological research. But these competing decisions from the U.S. Patent and Trademark Office and the European Patent Office have put those differences on parade. Unpacking these standards for CRISPR tell us a lot about how advances in biology are actually made — …

Crispr, Surrogate Licensing, And Scientific Discovery, Jorge Contreras, Jacob S. Sherkow

Other Publications

Several research institutions are embroiled in a legal dispute over the foundational patent rights to CRISPR-Cas9 gene-editing technology, and it may take years for their competing claims to be resolved. But even before ownership of the patents is finalized, the institutions behind CRISPR have wasted no time capitalizing on the huge market for this groundbreaking technology by entering into a series of licensing agreements with commercial enterprises. With respect to the potentially lucrative market for human therapeutics and treatments, each of the key CRISPR patent holders has granted exclusive rights to a spinoff or "surrogate" company formed by the institution …

A Biotechnology-Centric Look At Fee Shifting In Patent Litigation Post-Octane Fitness, Christopher M. Holman

Faculty Works

The U.S. Supreme Court’s 2014 decision in Limelight Networks v. Akamai Technologies decision (Akamai III), in conjunction with the Federal Circuit’s stance on divided infringement claims, effectively undermined the value of method claims, particularly in the realm of pharmaceuticals, diagnostics, and other biotechnology related innovation, by limiting the ability of patentees to establish liability in cases where steps of the claimed method are performed by multiple parties. On remand, the en banc Federal Circuit in Akamai Technologies v. Limelight Networks (Akamai IV) sought to address the problem by expanding the definition of direct infringement under 271(a) to encompass more scenarios …

Risk Regulation And Innovation: The Case Of Rights-Encumbered Biomedical Data Silos, Arti K. Rai

Faculty Scholarship

Recent Supreme Court cases on patent-eligible subject matter are likely to exacerbate the longstanding problem of biomedical data fragmentation. For each data silo, multiple overlapping legal claims and claimants must be addressed to achieve the benefits of pooling.

Commentators who have discussed the data aggregation challenge have generally focused on possibilities created through public funding, through collective action by research participants, or through pressure by payers. This Article emphasizes the important role of risk regulators, most notably the precedent offered by risk regulation in the area of clinical trial data.

While U.S. risk regulators have taken some positive steps, the …

The Supreme Court’S Devaluation Of U.S. Patents, Christopher M. Holman

Faculty Works

In a span of three weeks during the spring of 2017, the U.S. Supreme Court issued three patent decisions, bringing the total number of patent decisions for the 2016-2017 term to six. This means that the October 2016 term ties the previous record of six patent decisions in the October 2014 term. This represents a tremendous increase in the number of patent decisions compared to earlier times, and particularly the early days of the Federal Circuit. For reference, during the first quarter of a century the Federal Circuit was in existence, the Supreme Court heard on average less than one …

Charting The Contours Of Copyright Regime Optimized For Engineered Genetic Code, Christopher M. Holman

Faculty Works

There is a growing disconnect between the traditional patent-centric approach to protecting biotechnological innovation and the emerging intellectual property imperatives of “synthetic biology,” a promising new manifestation of biotechnology that enables the design and construction of artificial biological pathways, organisms or devices, as well as the redesign of existing natural biological systems. As explained in previous articles, one way to deal with this disconnect would be to expand the scope of copyrightable subject matter to encompass engineered genetic sequences, much in the way that copyright was expanded in the 1970s and 1980s to include computer programs. The present article expands …

Re-Framing Biotechnology Regulation, Alison Peck

Law Faculty Scholarship

Biotechnology is about to spill the banks of federal regulation. New genetic engineering techniques like CRISPR-Cas9 promise revolutionary breakthroughs in medicine, agriculture, and public health-but those techniques would not be regulated under the terms of the Coordinated Framework for Regulation of Biotechnology. This revolutionary moment in biotechnology offers an opportunity to correct the flaws in the framework, which was hastily patched together at the advent of the technology. The framework has never captured all relevant technologies, has never satisfied the public that risk is being effectively managed, and has never been accessible to small companies and publicly-funded labs that increasingly …

Eli Lilly V. Teva: Generic Companies Infringe Under Akamai Iv In Case Of Divided Infringement, Christopher M. Holman

Faculty Works

The U.S. Supreme Court’s 2014 decision in Limelight Networks v. Akamai Technologies decision (Akamai III), in conjunction with the Federal Circuit’s stance on divided infringement claims, effectively undermined the value of method claims, particularly in the realm of pharmaceuticals, diagnostics, and other biotechnology related innovation, by limiting the ability of patentees to establish liability in cases where steps of the claimed method are performed by multiple parties. On remand, the en banc Federal Circuit in Akamai Technologies v. Limelight Networks (Akamai IV) sought to address the problem by expanding the definition of direct infringement under 271(a) to encompass more scenarios …

The Case For Gmos: Dealing With Clashes Between Property Rights And Health And Safety Concerns, Kline C. Moore

Vanderbilt Journal of Transnational Law

A comparative analysis of international decisions concerning genetically modified organism (GMO) controversies reveals the judicial inconsistency that is often applied to the property rights of GMO producers and researchers. Courts often find that there are strong property right interests in GMOs, but when these rights clash with health and safety concerns, they are often minimized or completely forgotten; therefore, future growth in biotechnology is inhibited. This Note proposes a solution to this issue that better takes into account all stakeholders and allows for future investment and research into GMOs. The solution draws upon the lessons learned from current regulatory and …

The Gmo/Ge Debate, Joanna K. Sax

Faculty Scholarship

The scientific community and the public sphere are having different debates about the application of genetic engineering to improve our food supply. Many that are deeply steeped in the science view genetically engineered food as a more precise way to accomplish what we have been doing for centuries, which is genetically modifying our food supply. Some members of the public view genetically engineered food with skepticism especially as it relates to health, safety and the environment. A disconnect between the scientific consensus and public perception is not a new phenomenon. This Article attempts to bridge this gap by explaining what …

Patent Pacifism, Clark D. Asay

Faculty Scholarship

Over the last decade, much of the patent law literature has focused on the problem of “patent trolls,” or patent owners who don’t make products, but sue others that do. The basic complaint against these types of entities is that they impose a tax on innovation without providing offsetting societal benefits. Furthermore, their patent assertions have been on the rise, with a significant percentage of patent suits now attributable to them. In short, the troll phenomenon suggests a problem of excessive patent assertions.

But despite the importance of the troll phenomenon, the fact remains that most patents are never asserted, …

The Biotechnology Process Patent Act Of 1995: Providing Unresolved And Unrecognized Dilemmas In U.S. Patent Law, Becca Alley

Journal of Intellectual Property Law

No abstract provided.