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Congress Considering Legislation Intended To Reverse The Recent Trend Toward Devaluation Of The Us Patent Right, Christopher M. Holman
Congress Considering Legislation Intended To Reverse The Recent Trend Toward Devaluation Of The Us Patent Right, Christopher M. Holman
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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, …
The Supreme Court’S Devaluation Of U.S. Patents, Christopher M. Holman
The Supreme Court’S Devaluation Of U.S. Patents, Christopher M. Holman
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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
Charting The Contours Of Copyright Regime Optimized For Engineered Genetic Code, Christopher M. Holman
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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
Eli Lilly V. Teva: Generic Companies Infringe Under Akamai Iv In Case Of Divided Infringement, Christopher M. Holman
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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 Mayo Framework Is Bad For Your Health, Christopher M. Holman
The Mayo Framework Is Bad For Your Health, Christopher M. Holman
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This Article begins by providing a brief historical retrospective of the development of the patent eligibility doctrine, and then delves into the related questions of: (1) what are the Supreme Court’s policy objectives for the recent reinvigoration of the patent eligibility doctrine; and (2) has it achieved those objectives? The article then discusses three important out-standing questions regarding the application of the new test for patent eligibility: (1) what constitutes a natural phenomenon; (2) what constitutes an inventive step; and (3) what, if any, role does preemption play in the analysis? The article then provides four examples of recent lower …
Are Engineered Genetic Sequences Copyrightable?: The U.S. Copyright Office Addresses A Matter Of First Impression, Christopher M. Holman, Claes Gustafsson, Andrew W. Torrance
Are Engineered Genetic Sequences Copyrightable?: The U.S. Copyright Office Addresses A Matter Of First Impression, Christopher M. Holman, Claes Gustafsson, Andrew W. Torrance
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In spite of the compelling logic that would support extending copyright to engineered DNA sequences, copyright protection for genetic code has not been legally recognized in the US, or as far as we know anywhere. The Copyright Act is silent on the point, the courts do not appear to have ever addressed the question, and the Copyright Office has taken the position that an engineered genetic sequence is not copyrightable subject matter. In an attempt to advance the conversation, we submitted an engineered DNA sequence to the Copyright Office for registration, and then appealed the Office’s decision refusing to register …
The Critical Role Of Patents In The Development, Commercialization And Utilization Of Innovative Genetic Diagnostic Test And Personalized Medicine, Christopher M. Holman
The Critical Role Of Patents In The Development, Commercialization And Utilization Of Innovative Genetic Diagnostic Test And Personalized Medicine, Christopher M. Holman
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Arguments in favor of reining in the availability of effective patent protection in the area of genetic diagnostic testing are based largely on two fundamental misconceptions regarding the role of patents in this important area of technological innovation. The first is the mistaken assumption that patents negatively impact patient access to genetic diagnostic testing by preventing research that might lead to new or improved versions of a genetic test and by increasing the cost of testing services. The second is the failure to appreciate the substantial positive role patents play in in the development and utilization of genetic diagnostic tests. …
Developments In Synthetic Biology Are Altering The Ip Imperatives Of Biotechnology, Christopher M. Holman
Developments In Synthetic Biology Are Altering The Ip Imperatives Of Biotechnology, Christopher M. Holman
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While the accomplishments of the biotechnology industry have been substantial, recent technological advances promise to dramatically increase the power and utility of the discipline over the coming years. The term “synthetic biology” has been coined to describe the application of these powerful new tools to the engineering of synthetic genetic sequences and organisms. In essence, synthetic biology represents the next iteration in the ongoing evolution of biotechnology, and hopes run high that in time, the fruits of synthetic biology will dwarf the past successes of conventional biotechnology. There is, however, some concern that the current patent-centric approach to Intellectual Property …
Do Biotech Patent Lawsuits Really “Overwhelmingly Lose?”: A Response To Our Divided Patent System, Christopher M. Holman
Do Biotech Patent Lawsuits Really “Overwhelmingly Lose?”: A Response To Our Divided Patent System, Christopher M. Holman
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On October 14, 2014, Stanford’s Professor Mark Lemley tweeted “My new study with Allison & Schwartz shows that software and biotech patent lawsuits overwhelmingly lose.” He was referring to an article entitled Our Divided Patent System, co-authored by Lemley and two other prominent law professors. Taken at face value, the assertion that “biotech patent lawsuits overwhelmingly lose” would seem to hold troubling implications for biotechnology. In order to better understand the basis for Lemley’s assertion, I reanalyzed the underlying data and found that the situation is not nearly as bleak as his tweet might suggest. My significantly different interpretation of …
Is Lilly Written Description Paper Tiger?: Comprehensive Assessment Of The Impact Of Eli Lilly And Its Progeny In The Courts And Pto, Christopher M. Holman
Is Lilly Written Description Paper Tiger?: Comprehensive Assessment Of The Impact Of Eli Lilly And Its Progeny In The Courts And Pto, Christopher M. Holman
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In University of California v. Eli Lilly, decided by the Federal Circuit in 1997, the court established for the first time a new form of patent law's written description requirement, apparently targeted specifically at biotechnology. To this day, the conventional wisdom is that the so-called Lilly written description requirement (LWD) exists as a biotechnology-specific super-enablement requirement, substantially more stringent than the enablement requirement (the conventional standard for patentability), and standing as an impediment to effective patent protection for biotechnology inventions. My objective in writing this article was to test this conventional wisdom, by conducting a comprehensive search for all LWD …
Protein Similarity Score: Simplified Version Of The Blast Score As Superior Alternative To Percent Identity For Claiming Genuses Of Related Protein Sequences, Christopher M. Holman
Protein Similarity Score: Simplified Version Of The Blast Score As Superior Alternative To Percent Identity For Claiming Genuses Of Related Protein Sequences, Christopher M. Holman
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Recombinant proteins form the basis for most of the products of biotechnology, including drugs, diagnostics, research reagents, genetically modified organisms and industrial enzymes. However, the nature of proteins and the rules of patentability conspire to make it difficult to achieve adequate patent protection for novel proteins and the polynucleotides that encode them. Narrow patent claims limited to protein sequences sharing a high degree of structural identity can generally be designed around by introducing structural changes in the claimed protein, thereby avoiding the patent without substantially altering the protein's function. However, inventors are generally restricted in their ability to broadly claim …