106 research outputs found
The Technology is Nano: Legal Challenges are Enormous
No full textPresented on April 28, 2015 at 12:00 p.m. in the Pettit Microelectronics Building Conference Room 102 A&B.Prof. Yaniv Heled researches and writes on legal and ethical aspects of biomedical technologies, such as biologics and biosimilars, stem cells, cloning and DNA sequencing and testing. He teaches Patent Law, Intellectual Property Survey and a seminar course on Law & Emerging Technologies, which examines the interaction of law and various cutting-edge technologies and how new technologies shape legal practice. Prof. Heled earned a J.S.D. from Columbia University School of Law. His doctoral dissertation focused on the regulation of novel biomedical technologies. In addition, Heled holds an LL.M. from Columbia, where he was a Harlan Fiske Stone Scholar, and an LL.B. and undergraduate Diploma in Biology, magna cum laude, from Tel Aviv University. Prior to Georgia State Law, Heled practiced intellectual property law with Goodwin Procter LLP in New York.Runtime: 43:57 minutesThe field of nanotechnology has been perplexing various areas within the law from day one. Yet, while legal challenges
stemming from new technological developments are quite common, nanotechnology raises a unique kind of quandary.
Namely, that it is not simply one technology or even one area of technology, but rather a whole different way of doing
things. This, as one may expect, makes nanotechnology inadequate for categorization using the rather neat
classifications that exist within the law. In other words: nanotechnology simply does not fit within any one legal “box.” In this talk I will further explain this fundamental
challenge that nanotechnology poses to the law and discuss the many legal areas implicated by developments in
nanotechnology
Regulatory Competitive Shelters in the Area of Personalized Medicine
No full textMuch has been written about the ramifications of recent Supreme Court decisions in the area of patent subject matter eligibility on innovation in the area of personalized medicine. Yet, regulatory competitive shelters (RCSs) have remained largely unexplored as a mechanism for incentivizing innovation in that area, possibly in lieu of patents. Similarly, in a recent report and related guidance documents, the Food and Drug Administration (FDA) made clear its commitment to streamlining regulation in the area of personalized medicine. These documents, however, also do not address the RCSs available to personalized medicine technologies. This Article seeks to explore the existing landscape of RCSs that are currently available to personalized medicine technologies and highlight further ways in which RCSs may provide incentives for innovation in such technologies.
Published: Yaniv Heled, Regulatory Competitive Shelters in the Area of Personalized Medicine, 21 B.U. J. Sci. & Tech. L. 287 (2015)
Regulatory Competitive Shelters in the Area of Personalized Medicine
No full textMuch has been written about the ramifications of recent Supreme Court decisions in the area of patent subject matter eligibility on innovation in the area of personalized medicine. Yet, regulatory competitive shelters (RCSs) have remained largely unexplored as a mechanism for incentivizing innovation in that area, possibly in lieu of patents. Similarly, in a recent report and related guidance documents, the Food and Drug Administration (FDA) made clear its commitment to streamlining regulation in the area of personalized medicine. These documents, however, also do not address the RCSs available to personalized medicine technologies. This Article seeks to explore the existing landscape of RCSs that are currently available to personalized medicine technologies and highlight further ways in which RCSs may provide incentives for innovation in such technologies.
Published: Yaniv Heled, Regulatory Competitive Shelters in the Area of Personalized Medicine, 21 B.U. J. Sci. & Tech. L. 287 (2015)
Patents vs. Statutory Exclusivities in Biological Pharmaceuticals - Do We Really Need Both?
No full textOn March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Patient Protection and Affordable Care Act (also known as the Healthcare Bill). BPCIA sets up a framework for the approval of generic biologics and provides for up to 12.5 years of market exclusivity for FDA approved bio-pharmaceutical products. The exclusivity is intended to run in parallel and in addition to any patents that may apply to such approved bio-pharmaceutical products, which would also grant the developers of these products monopolies in the underlying technologies on which such bio-pharmaceutical products are based. This seeming “double dipping” raises questions regarding the need and justification, if any, for such parallel, double protection of this particular class of biological products. This article seeks to address these questions. Analyzing the fundamentals and underlying assumptions of the legal regimes of patents and statutory exclusivities, this article examines their applicability to the context of bio-pharmaceuticals. Based on the conclusions reached, this article then further examines the proposition that statutory exclusivity regimes could become a blueprint for “patentless” areas of technology, replacing the traditional patent regime with a new class of incentives to invent and invest in the development of new technology.
Published: Yaniv Heled, Patents vs. Statutory Exclusivities in Biological Pharmaceuticals - Do We Really Need Both?, 18 Mich. Telecomm. Tech. L. Rev. 419 (2012)
Patents vs. Statutory Exclusivities in Biological Pharmaceuticals - Do We Really Need Both?
No full textOn March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Patient Protection and Affordable Care Act (also known as the Healthcare Bill). BPCIA sets up a framework for the approval of generic biologics and provides for up to 12.5 years of market exclusivity for FDA approved bio-pharmaceutical products. The exclusivity is intended to run in parallel and in addition to any patents that may apply to such approved bio-pharmaceutical products, which would also grant the developers of these products monopolies in the underlying technologies on which such bio-pharmaceutical products are based. This seeming “double dipping” raises questions regarding the need and justification, if any, for such parallel, double protection of this particular class of biological products. This article seeks to address these questions. Analyzing the fundamentals and underlying assumptions of the legal regimes of patents and statutory exclusivities, this article examines their applicability to the context of bio-pharmaceuticals. Based on the conclusions reached, this article then further examines the proposition that statutory exclusivity regimes could become a blueprint for “patentless” areas of technology, replacing the traditional patent regime with a new class of incentives to invent and invest in the development of new technology.
Published: Yaniv Heled, Patents vs. Statutory Exclusivities in Biological Pharmaceuticals - Do We Really Need Both?, 18 Mich. Telecomm. Tech. L. Rev. 419 (2012)
Regulatory Competitive Shelters as Incentives for Innovation in Agro-biotech
No full textThis short paper is a summary of my presentation at the Michigan State Law Review 2014 Fall Symposium on “Public Domain(s): Law, Generating Knowledge, and Furthering Innovation in the Information Economy” held on October 3, 2014. The paper reviews the current role played by regulatory competitive shelters (RCSs; a.k.a. regulatory exclusivities) in the area of agrobiotech. The article also suggests that the Food and Drug Administration\u27s move to treat genetically modified animals as animal drugs under the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) may result in the application of GADPTRA\u27s RCS regime to genetically modified animals and in a Hatch-Waxmanizing of the regulation of that agrobiotechnology
Toward Effective Competition in Biologics
No full textIn a previous article—Follow-On Biologics Are Set Up to Fail—I explained why biologics markets do not and probably will not have enough competition. This is not to say that these markets lack competition altogether. Rather, the legal and commercial landscape is such that competition in biologics will remain scant and inadequate for lowering prices of biologics similarly to the price drops seen in generic drugs. This reality is not a result of one or two cardinal reasons, but many. Accordingly, if lowering the price of biologics is the goal and competition is the means by which we seek to achieve this goal, then there does not seem to be a “quick fix” to address all of the many impediments to competition that plague biologics markets. Yet, baring significant technological developments, meaningful competition in biologics markets is not going to be possible without making biologics’ manufacturing information available to follow-on manufacturers.
As recognized by several commentators, access to biologics manufacturing information is key to increasing competition in biologics markets. Without access to such information, making follow-on biologics in general and interchangeable biosimilars in particular is and will continue to be difficult and expensive, if not outright impossible. Yet, it has long been the position of the pharmaceutical industry (Industry) that biologics manufacturing information is proprietary and, thus, may not be shared. Both Congress and the FDA have subscribed to the Industry’s position and kept regulatory filings submitted by biologics manufacturers, including manufacturing information, unavailable to the public. This article examines the position that manufacturing information is proprietary and must remain confidential in light of the similar legal and commercial circumstances in the area of pesticides. The article reviews the regulatory regime established by Congress in the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) as it is administered by the Environmental Protection Agency (EPA) and then examines its applicability to the area of biologics. The article proceeds with a proposal for a similar regime to be incorporated into the pathway for approval of follow-on biologics as a means of increasing competition in biologics markets
The Biologics Price Competition and Innovation Act 10--A Stocktaking
No full textOn March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Patient Protection and Affordable Care Act (“Obamacare”). The purpose of BPCIA was to create for biologics a regime similar to that of the Drug Price Competition and Patent Term Restoration Act (Hatch–Waxman Act) and, in so doing, to open biologics markets to competition and, subsequently, lower the price of these expensive and increasingly important pharmaceuticals. Using original data, this Essay takes stock of the decade that has passed since the enactment of BPCIA. This Essay surveys the state of competition in United States biologics markets, entry of follow-on biologics into these markets, and the effects such entry has had on biologics prices.
This Essay’s main findings are that, as of March 23, 2020—exactly ten years since the signing of BPCIA into law—the FDA has approved a total of 26 follow-on biologics deemed biosimilar to 9 original products (ratio: 2.63 follow-on/original products), with only 16 of these deemed biosimilar to 7 original products (ratio: 1.78 follow- on/original products) actually available on the market. None of these follow-on products have been approved as interchangeable with their reference products, which means that substitution of the 7 original products with one of their 16 approved biosimilars cannot be done automatically. The price of these products was 10%–37% lower than the price of the original biologic, with the average price savings being 24% or 27%. All 35 approved follow-on and reference products are owned by a total of 11 pharmaceutical companies. The number of years of market exclusivity of the 9 original biologics before the approval of the first biosimilar ranged between 13.5–28.92 with an average of 18.27 years or 15.33–29.42 with an average of 19.87 years before the launch of the first competing biosimilar.
This Essay further puts forward a new method of measuring comparative levels of competition in drug markets by comparing the ratio of total approved follow-on products per total approved original products at certain critical benchmarks. Using this measurement tool, this Essay compares BPCIA’s track record with the levels of competition in small-molecule drugs before and after the Hatch– Waxman Act, showing that that BPCIA significantly underperforms in comparison and fails to instigate levels of competition that would lead to significant price drops and increase access to biologics in the United States. A short survey of the most likely reasons for BPCIA’s underperformance follows.
This Essay concludes by presenting the following question: if BPCIA’s current track record is (still) not enough to convince that it is failing to meet its goals, what more would it take to reach such a conclusion, and how much longer should policymakers wait before it is possible to surmise that BPCIA in its current form has failed to significantly increase access to biologics in the United States
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