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Articles 1 - 15 of 15
Full-Text Articles in Law
Learning From Past Mistakes — The Us Patent System And International Trade Agreements, Robin C. Feldman
Learning From Past Mistakes — The Us Patent System And International Trade Agreements, Robin C. Feldman
Robin C Feldman
To ensure that the TPP agreement works properly in practice with regard to patents and the governance of pharmaceuticals and semiconductors, strong mechanisms for enforcement and for rooting out system abuse are needed. To make this happen, regulators should learn from past mistakes of the U.S. patent system: the proliferation of non-practicing entities (NPEs), and strategic behavior that blocks or delays generic competition in the pharmaceutical industry. This Think Piece presents key findings of the author’s research on the complexity of the U.S. litigation and regulatory frameworks that have provided fertile ground for strategic behavior that can have negative effects …
Empirical Evidence Of Drug Pricing Games - A Citizen's Pathway Gone Astray, Robin C. Feldman, Evan Frondorf, Andrew Cordova
Empirical Evidence Of Drug Pricing Games - A Citizen's Pathway Gone Astray, Robin C. Feldman, Evan Frondorf, Andrew Cordova
Robin C Feldman
The FDA’s citizen petition process was created in the 1970s as part of an effort to fashion more participatory regimes, in which ordinary citizens could access the administrative process. The theoretical underpinnings hypothesize that a participatory structure will prevent regulatory agencies from being captured by the very industries they were intended to police. Anecdotal evidence suggests, however, that the FDA’s citizen petition process may have taken a different turn. This empirical study explores whether pharmaceutical companies are systematically using citizen petitions to try to delay the approval of generic competitors. Delaying generic entry of a drug — even by a …
Patent Licensing, Technology Transfer, & Innovation, Robin C. Feldman, Mark A. Lemley
Patent Licensing, Technology Transfer, & Innovation, Robin C. Feldman, Mark A. Lemley
Robin C Feldman
Traditional justifications for patents are all based on direct or indirect contribution to the creation of new products. Patents serve the social interest if they provide not just invention, but innovation the world would not otherwise have. Non-practicing entities (NPEs) as well as product-producing companies can sometimes provide such innovation, either directly, through working the patent or transfer of technology to others who do, or indirectly, when others copy the patented innovation. The available evidence suggests, however, that patent licensing demands and lawsuits from NPEs are normally not cases that involve any of these activities.
Some scholars have argued that …
Open Letter On Ethical Norms In Intellectual Property Scholarship, Robin C. Feldman, Mark A. Lemley, Jonathan S. Masur, Arti K. Rai
Open Letter On Ethical Norms In Intellectual Property Scholarship, Robin C. Feldman, Mark A. Lemley, Jonathan S. Masur, Arti K. Rai
Robin C Feldman
As scholars who write in intellectual property (“IP”), we write this letter with aspirations of reaching the highest ethical norms possible for our field. In particular, we have noted an influx of large contributions from corporate and private actors who have an economic stake in ongoing policy debates in the field. Some dollars come with strings attached, such as the ability to see or approve academic work prior to publication or limitations on the release of data. IP scholars who are also engaged in practice or advocacy must struggle to keep their academic and advocacy roles separate.
Our goal is …
Regulatory Property: The New Ip, Robin C. Feldman
Regulatory Property: The New Ip, Robin C. Feldman
Robin C Feldman
For thirty years, a new form of intellectual property has grown up quietly beneath the surface of societal observation. It is a set of government-granted rights that have the quintessential characteristic of intellectual property and other forms of property — that is, the right to exclude others from the territory.
The impact of this form of IP on the US health care system, in particular, is enormous. In 2014, more than 40% of all new drugs approved by the FDA came through just one of these portals, with the companies collecting regulatory property rights along the way.
Some forms of …
Patent Demands And Initial Public Offerings, Robin C. Feldman, Evan Frondorf
Patent Demands And Initial Public Offerings, Robin C. Feldman, Evan Frondorf
Robin C Feldman
Quantitative analysis of patent behavior is critical, as congressional and regulatory agencies consider the impact of patent trolling on modern markets. Anecdotal evidence has suggested that “non-practicing entities,” also known as “patent trolls,” specifically target companies for lawsuits, licensing demands, or other monetization activity as firms approach or complete major funding events, such as their initial public offering (IPO). To test this narrative, we survey in-house legal staff at companies that have recently gone public about their exposure to patent demands surrounding their first round of venture capital funding and their IPO. The study is one of the first attempts …
The Crispr Revolution: What Editing Human Dna Reveals About The Patent System’S Dna, Robin C. Feldman
The Crispr Revolution: What Editing Human Dna Reveals About The Patent System’S Dna, Robin C. Feldman
Robin C Feldman
Not since the invention that launched Genentech and the entire biotech industry has a life science invention offered such promise. If CRISPR lives up to that promise, the technology could well be one of the greatest life science inventions of all time. Gene editing techniques existed before, of course, but they were slow, inaccurate, and expensive. The CRISPR invention is like moving from the manual typewriter to modern word processing.
As we stand at this remarkable threshold, what of the patent system? Companies are racing to develop commercial applications for CRISPR, and researchers are using the technology, even though it …
Federalism, First Amendment & Patents: The Fraud Fallacy, Robin C. Feldman
Federalism, First Amendment & Patents: The Fraud Fallacy, Robin C. Feldman
Robin C Feldman
Few arguments echo as strongly throughout United States constitutional history as those related to the role of the states in the federal union. Shifting across time, the role of the states in general has moved from a model of dualism — characterized by a strict separation of federal and state dominion — to a model of overlapping and concurrent powers. In the modern context of overlapping powers, the preemption doctrine manages the intricate areas of overlap, with topics ranging from antitrust to immigration.
Yet the concept of federalism, as applied by the circuit courts in relation to patents, has traveled …
Do Patent Licensing Demands Mean Innovation?, Robin C. Feldman, Mark A. Lemley
Do Patent Licensing Demands Mean Innovation?, Robin C. Feldman, Mark A. Lemley
Robin C Feldman
A commonly offered justification for patent trolls or non-practicing entities (NPEs) is that they serve as a middleman, facilitating innovation and bringing new technology from inventors to those who can implement it. We survey those involved in patent licensing to see how often patent license demands actually led to innovation or technology transfer. We find that very few patent license demands actually lead to new innovation; most simply involve payment for the freedom to keep doing what the licensee was already doing. Surprisingly, this is true not only of NPE licenses but even of licenses from product-producing companies and universities. …
Ending Patent Exceptionalism & Structuring The Rule Of Reason: The Supreme Court Opens The Door For Both, Robin C. Feldman
Ending Patent Exceptionalism & Structuring The Rule Of Reason: The Supreme Court Opens The Door For Both, Robin C. Feldman
Robin C Feldman
A patent gives one an opportunity to exploit an idea. It is not intended as a universal pass for exploiting the legal system. Nevertheless, a notion I would call patent exceptionalism has been allowing patent holders to exercise free rein. It is a dangerous approach that fails to distinguish between deploying the right and deploying the system. This article describes patent exceptionalism and explains how the Supreme Court decision in FTC v. Actavis moves away from it.
The article also explains how the appeal of patent exceptionalism intertwines with antitrust. To put it bluntly, patent exceptionalism is alluring because it …
Patent Trolling--Why Bio & Pharmaceuticals Are At Risk, Robin C. Feldman, W. Nicholson Price Ii
Patent Trolling--Why Bio & Pharmaceuticals Are At Risk, Robin C. Feldman, W. Nicholson Price Ii
Robin C Feldman
Patent trolls — also known variously as non-practicing entities, patent assertion entities, and patent monetizers — are a top priority on legislative and regulatory reform agendas. In the modern debates, however, the biopharmaceutical industry goes conspicuously unmentioned. Although biopharmaceuticals are paradigmatically centered on patents, conventional wisdom holds that biopharmaceuticals are largely unthreatened by trolls. This article shows that the conventional wisdom is wrong, both theoretically and descriptively. In particular, the article presents a ground-breaking study of the life science holdings of 5 major universities to determine if these might be attractive to monetizers.
This was deliberately a light, rather than …
Transparency, Robin C. Feldman
Transparency, Robin C. Feldman
Robin C Feldman
The United States patent regime is a quintessential notice system. Implicit in its design is the concept that one attempting to license a patent can identify those who hold the requisite rights and the territory that the patent holders claim as their own. As the system has evolved, however, it bears little resemblance to the idealized form.
Little scholarship has addressed problems related to notice within the modern patent system, largely because these problems have sprung up so recently. In the last five to seven years, an entire Hobbit’s world has been created under the foliage. Moreover, historic scholarly discussions …
Patent Demands & Startup Companies: The View From The Venture Capital Community, Robin C. Feldman
Patent Demands & Startup Companies: The View From The Venture Capital Community, Robin C. Feldman
Robin C Feldman
This paper presents a study of patent demands against venture-backed startups, conducted through members of the National Venture Capital Association and their portfolio companies. The results of surveying 200 venture capitalists and their portfolio companies provide strong indications of the impact that patent demands are having on the venture-backed community. Both the companies and the venture capitalists overwhelming believe that patent demands have a negative impact on the venture-backed community, with all or most of those assertions coming from entities whose core activity involves licensing or litigating patents. These impacts are described in terms of the specific costs expended by …
Whose Body Is It Anyway? Human Cells And The Strange Effects Of Property And Intellectual Property Law, Robin C. Feldman
Whose Body Is It Anyway? Human Cells And The Strange Effects Of Property And Intellectual Property Law, Robin C. Feldman
Robin C Feldman
Whatever else I might own in this world, it would seem intuitively obvious that I own the cells of my body. Where else could the notion of ownership begin, other than with the components of the tangible corpus that all would recognize as "me?" The law, however, does not view the issue so neatly and clearly, particularly when cells are no long in your body. As so often happens in law, we have reached this point, not by design, but by the piecemeal development of disparate notions that, when gathered together, form a strange and disconcerting picture.
This article examines …
The Intellectual Property Landscape For Ips Cells, Robin C. Feldman
The Intellectual Property Landscape For Ips Cells, Robin C. Feldman
Robin C Feldman
Beginning in 2006, induced pluripotent stem cells have raised the tantalizing possibility that stem cell research could move forward without the significant moral and ethical dilemmas that have paralyzed the field. These cells, known as iPS cells, originate from adult somatic cells, but function in a manner that is almost equivalent to embryonic stem cells. If iPS cell research lives up to its promise, stem cell research, diagnostics, and treatment could be accomplished without destroying or in any way interfering with human embryos or their development.
While we may be entering a historic moment in stem cell research, we are …