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Full-Text Articles in Law
A Functional Approach To Judicial Review Of Ptab Rulings On Mixed Questions Of Law And Fact, Rebecca S. Eisenberg
A Functional Approach To Judicial Review Of Ptab Rulings On Mixed Questions Of Law And Fact, Rebecca S. Eisenberg
Articles
The Court of Appeals for the Federal Circuit (“Federal Circuit”) has long relied on active appellate review to bring uniformity and clarity to patent law. It initially treated the PTO the same as the federal district courts, reviewing its factual findings for clear error and its legal conclusions de novo. Following reversal by the Supreme Court in Dickinson v. Zurko, the Federal Circuit began giving greater deference to PTO factual findings. But it continued to review the PTO’s legal conclusions de novo, while coding an expansive list of disputed issues in patent cases as legal conclusions, even when they …
Diagnostics Need Not Apply, Rebecca S. Eisenberg
Diagnostics Need Not Apply, Rebecca S. Eisenberg
Articles
Diagnostic testing helps caregivers and patients understand a patient's condition, predict future outcomes, select appropriate treatments, and determine whether treatment is working. Improvements in diagnostic testing are essential to bringing about the long-heralded promise of personalized medicine. Yet it seems increasingly clear that most important advances in this type of medical technology lie outside the boundaries of patent-eligible subject matter. The clarity of this conclusion has been obscured by ambiguity in the recent decisions of the Supreme Court concerning patent eligibility. Since its 2010 decision in Bilski v. Kappos, the Court has followed a discipline of limiting judicial exclusions from …
Obvious To Whom? Evaluating Inventions From The Perspective Of Phosita, Rebecca S. Eisenberg
Obvious To Whom? Evaluating Inventions From The Perspective Of Phosita, Rebecca S. Eisenberg
Articles
In this Article, I consider the possibility of giving the USPTO input from currently active technological practitioners in evaluating the obviousness of claimed inventions. Such input could potentially serve three useful functions. First, it could improve the accuracy of USPTO decisionmaking by providing access to the perspective of actual practitioners as to the obviousness of inventions from the perspective of the hypothetical PHOSITA. Second, it could help the USPTO document the evidentiary basis for rejections that rest in part upon tacit knowledge within technological communities. Third, it could provide a quality control mechanism that would improve the credibility of USPTO …
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Other Publications
It's a great honor for me to be invited to deliver the Levine Distinguished Lecture at Fordham, and a great opportunity to try out some new ideas before this audience. As some of you know, I've been studying the role of patents in biomedical research and product development ("R&D") for close to twenty years now, with a particular focus on how patents work in "upstream" research in universities and biotechnology companies that are working on research problems that arise prior to "downstream" product development. But, of course, the patent strategies of these institutions are designed around the profits that everyone …
Re-Examining The Role Of Patents In Appropriating The Value Of Dna Sequences, Rebecca S. Eisenberg
Re-Examining The Role Of Patents In Appropriating The Value Of Dna Sequences, Rebecca S. Eisenberg
Articles
As public and private sector initiatives race to complete the sequence of the human genome, patent issues have played a prominent role in speculations about the significance of this achievement. How much of the genome will be subject to the control of patent holders, and what will this mean for future research and the development of products for the improvement of human health? Is a patent system developed to establish rights in mechanical inventions of an earlier era up to the task of resolving competing claims to the genome on behalf of the many sequential innovators who elucidate its sequence …
Intellectual Property Issues In Genomics, Rebecca S. Eisenberg
Intellectual Property Issues In Genomics, Rebecca S. Eisenberg
Articles
Controversy over intellectual property rights in the results of large-scale cDNA sequencing raises intriguing questions about the roles of the public and private sectors in genomics research, and about who stands to benefit (and who stands to lose) from the private appropriation of genomic information. While the US Patent and Trademark Office has rejected patent applications on cDNA fragments of unknown function from the National Institutes of Health, private firms have pursued three distinct strategies for exploiting unpatented cDNA sequence information: exclusive licensing, non-exclusive licensing and dedication to the public domain.
Opinion Letter As To The Patentability Of Certain Inventions Associated With The Identification Of Partial Cdna Sequences, Rebecca S. Eisenberg, Robert P. Merges
Opinion Letter As To The Patentability Of Certain Inventions Associated With The Identification Of Partial Cdna Sequences, Rebecca S. Eisenberg, Robert P. Merges
Articles
You have asked for our legal opinion on the patentability of inventions claimed in U.S. patent applications 07/716,831, filed June 21, 1991 (the '831 application, or .'831"), 07/837,195, filed September 25, 1992 ("'195"), and 07/952,911, filed February 12, 1993 (."911"), all filed in the name of Craig Venter and others and assigned to the National Institutes of Health "(NIH)." We understand that NIH has abandoned these patent applications and has no present intention of filing similar applications in the future, but that NIH remains interested in the patenting of human DNA sequences from a broader public policy perspective. We have …
Reply To Comments On The Patentability Of Certain Inventions Associated With The Identification Of Partial Cdna Sequences, Rebecca S. Eisenberg, Robert P. Merges
Reply To Comments On The Patentability Of Certain Inventions Associated With The Identification Of Partial Cdna Sequences, Rebecca S. Eisenberg, Robert P. Merges
Articles
A brief reply is in order to clarify our position on the patenting of research tools. We stand by the statement that "there are reasons to be wary of patents on research tools," but that statement should not be understood as a broad condemnation of patents on research tools in all contexts. Indeed, immediately after the cited language our opinion letter acknowledges that withholding patent protection from research tools could undermine private incentives to develop research tools and to make them available to investigators or lead to greater reliance on trade secrecy. Unlike the government, which purports to pursue patent …
Patenting The Human Genome, Rebecca S. Eisenberg
Patenting The Human Genome, Rebecca S. Eisenberg
Articles
The increasing promise of federal funding for mapping and sequencing the human genome has brought with it renewed attention in the research science community to issues of intellectual property protection for products of biotechnology research. Echoing concerns raised a decade ago in the debate over commercialization of academic biomedical research, scientists have called for the free availability of all information generated through the Human Genome Project and have argued against allowing private intellectual property rights in such knowledge. Meanwhile, private parties have quietly been obtaining patents on bits and pieces of the human genome from the Patent and Trademark Office …