Law Commons^™

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 …

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 …

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, …

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 …

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 …

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 …

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 …

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 …

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 — …