Law Commons^™

Legal And Scientific Flaws In The Myriad Genetics Litigation, Eric Grote

Eric Grote

In Association for Molecular Pathology v. Myriad Genetics, the Supreme Court held that Myriad’s isolated BRCA DNA patent claims were invalid because an isolated DNA with the same sequence as a natural DNA is a product of nature. The decision has two fundamental flaws. First, due to a faulty claim construction by the trial court, the Supreme Court was never informed that isolated DNA is a synthetic molecule that is not actually isolated from nature, or that isolated DNA lacks functional information encoded by chemical modifications present in natural human DNA. Second, the Court ignored a long line of …

The Infringement Continuum, Bernard H. Chao

Bernard H Chao

For many years, patent law has struggled with the issue of permissible claim scope. A patent’s specification and its claims often suffer from a surprising disconnect. The specification generally describes an invention in terms of one or more specific implementations; suggesting a relatively narrow invention. But claims are drafted far more broadly. They frequently encompass unforeseen variations and even cover after arising technology.

Although there are numerous existing doctrines that try to prevent claims from straying too far from their specification, these doctrines offer binary outcomes ill-suited for patent law. Under these doctrines, as a claim encompasses subject matter further …

Reports Of Its Death Are Greatly Exaggerated: Ebay, Bosch, And The Presumption Of Irreparable Harm In Hatch-Waxman Litgation, Kenneth C. Louis

Kenneth C. Louis

No abstract provided.

Fixing Frand: A Pseudo-Pool Approach To Standards-Based Patent Licensing, Jorge Contreras

Jorge L Contreras

Technical interoperability standards are critical elements of mobile telephones, laptop computers, digital files, and thousands of other products in the modern networked economy. Most such standards are developed in so-called voluntary standards-development organizations (SDOs) that require participants to license patents essential to the standard on terms that are “fair, reasonable and non-discriminatory” (FRAND). FRAND commitments are thought to avoid the problem of patent hold-up: the imposition of excessive royalty demands after a standard has been widely adopted in the market. While, at first blush, FRAND commitments seem to assure product vendors that patents will not obstruct the manufacture and sale …

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 …

Policy Tailors And The Rookie Regulator, Sarah Tran

Sarah Tran

Commentators have long lamented the lack of policy tailoring in the patent system. But unlike other administrative agencies, who regularly tailor regulatory policies to the needs of specific industries, the U.S. Patent and Trademark Office (“PTO”) was widely believed to lack the authority and institutional competence for such policymaking. This Article provides the first comprehensive analysis of recent legislative reforms to the PTO’s policymaking authority. It shows the reforms empower the PTO to have a larger say in patent policy than ever before. The big question is thus: to what extent is it good policy for a rookie regulator to …

Could A Hub And Spoke, Homegrown Ceo Strategy Boost The Success Of University Start-Ups?, Brendan O. Baggot, Martin R. Graf Phd

Brendan O. Baggot

How can universities make more money with their spinout company (SpinCo)‐suitable technologies? By “growing” their own CEOs to improve both the quality and quantity of startup company leaders available, that’s how. Surprisingly, however, at most universities little or no effort is made to interweave this critical need into tech transfer efforts.

Patent Reversion: An Employee-Inventor's Second Bite At The Apple, Richard Kamprath

Richard Kamprath

In an attempt to more fully compensate employee-inventors without harming the return on investment of employers, a patent reversion is proposed in which the rights to the patent revert to joint ownership between the original inventor and the current owner. In Section I, the background of the relationship between employer and employee-inventor will be discussed in terms of patent rights. This section will outline the problems inherent in the pre-assignment status quo of these rights from employees to employers. Section II will begin with Part A, which is a review of previously proposed solutions to the under-compensation of employee-inventors. The …

Interests In The Balance: Fda Regulations Under The Biologics Price Competition And Innovation Act, Parker Tresemer

Parker Tresemer

Recent biotechnology advances are yielding potentially life-saving therapies, but without FDA regulations designed to minimize product costs, patients will continue to be unable to afford these expensive biologic products. Many believe that these prohibitive costs stem from weak competition from generic biologic products, also known as follow-on biologics. To correct this deficiency, and to address the often conflicting regulatory and policy concerns associated with biologic products, Congress enacted the Biologics Price Competition and Innovation Act. The Act created an abbreviated approval pathway for biologic products and, if effective, could increase competition while driving down product costs. But legislation alone is …

Patent Busting With Prior Art?, Brendan O. Baggot

Brendan O. Baggot

Although there are many routes to invalidating a patent, what are the chances of finding prior art missed during U .S. prosecution? What are some of the factors that influence the outcome of a patent search? How can one assess a priori the likelihood of uncovering “new” prior art? How does the specific technology affect the outcome? These and other

User Innovator Community Norms At The Boundary Between Academic And Industrial Research, Katherine J. Strandburg

Katherine J. Strandburg

In this essay, I consider norms of sharing research tools and materials in what has been called Pasteur’s Quadrant, in which basic science and applied research overlap. I employ a user innovation paradigm, along with a rational choice approach to social norms, to address the issue. The convergence of academic research with commercial interests has two different types of consequences for sharing norms. First, a research tool or material developed in a nonprofit research context may be a dual-purpose innovation with both research and nonresearch uses. Thus, for example, a genetic assay may be useful in research and as a …

Norms And The Sharing Of Research Materials And Tacit Knowledge, Katherine J. Strandburg

Katherine J. Strandburg

As discussed in Wesley Cohen’s chapter in this volume, recent empirical studies have documented that scientists experience increasing difficulty obtaining tangible research materials from other scientists, while they express fewer concerns than many had anticipated about do-it-yourself tools that can be made in the laboratory, even when those tools are patented. In this Chapter I use a rational choice model of social norms to elucidate some factors that affect the likelihood that a research community will adopt a sharing norm. Based on those factors, I discuss some means by which sharing of tangible research materials can be encouraged. The analysis …