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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 …
Supreme Court Asked To Consider Role Of Post-Filing Evidence In Assessing Obviousness Of Pharmaceutical Inventions, Christopher M. Holman
Supreme Court Asked To Consider Role Of Post-Filing Evidence In Assessing Obviousness Of Pharmaceutical Inventions, Christopher M. Holman
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On January 20, 2015, Bristol-Myers Squibb petitioned for certiorari in Bristol-Myers Squibb v. Teva Pharmaceutical, asking whether an assessment of obviousness should "consider post-filing evidence showing the actual differences between a patented invention and the prior art." The district court had found patent claims directed towards Entacavir (an anti-hepatitis drug) obvious in view of structural similarity between the drug and a prior art compound, in spite of the fact that the prior art compound was highly toxic and therefore not a viable candidate for use as a human drug. A Federal Circuit panel affirmed the district court's decision to disregard …
Bowman V. Monsanto Co.: Bellweather For The Emerging Issue Of Patentable Self-Replicating Technologies And Inadvertent Infringement., Christopher M. Holman
Bowman V. Monsanto Co.: Bellweather For The Emerging Issue Of Patentable Self-Replicating Technologies And Inadvertent Infringement., Christopher M. Holman
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The inherent tendency of patented seeds to self-replicate has led to fears that farmers might face liability for inadvertent patent infringement. To address the perceived problem, some have proposed severely limiting the availability of effective patent protection for self-replicating technologies. Typical examples include denying patent rights to "second generation" self-replicating products, and even broadly declaring such technologies ineligible for patent protection. The fact is, lawsuits against inadvertently infringing farmers remain of largely hypothetical concern. However, changes in the market could soon render such lawsuits a reality. In addressing the resulting policy concerns, Congress and the courts have at their disposal …
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 …