[PDF] Price Regulation Under Patents eBook

Author : Neel U. Sukhatme
Publisher :
Page : 68 pages
File Size : 33,66 MB
Release : 2014
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ISBN :

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Patents are limited-term monopolies awarded to inventors to incentivize innovation. But there is another monopoly that has been largely overlooked at the heart of patent law: the monopoly of the U.S. Patent and Trademark Office (PTO) over the granting of patents. The present Article addresses this topic by introducing the broader notion of a regulatory monopoly, where a single governmental actor has the power to set prices in a regulatory area.The Article explains how regulatory monopolists like the PTO could enhance social welfare via differential pricing -- by charging regulated entities differing fees based on their willingness and ability to pay. In particular, the Article shows how the PTO could increase its revenues and promote innovation by charging different patent “prices” for inventions in different industries. Such pricing could also be used to tailor effective patent term across industries, an emergent goal for many patent scholars.The Article then applies the author's recent empirical research to generate potential differential patent price structures. This research takes advantage of a natural experiment -- a change in patent term rules due to enactment of the TRIPS agreement in 1995 -- to measure the relative importance of patent protection across different industries. The Article concludes by discussing how recent patent reform (the America Invents Act of 2011) provides a legal basis for the PTO to conduct differential pricing.

Author : Ramsi Woodcock
Publisher :
Page : 0 pages
File Size : 40,17 MB
Release : 2020
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In limiting the patent term to twenty years, Congress sought to use competition to make patented products available to the public at low prices once inventors have reaped the fruits of the exclusivity provided by the patent grant. But competition has in practice proven an unreliable method of achieving low prices for off-patent products. Patentholders reap supra-competitive profits, and consumers pay supra-competitive prices, long after expiration of the patent term. That is because, as antitrust scholars recognized decades ago, the primary effect of competition is not to drive down prices but to stimulate innovation. Congress should stop relying on competition alone to drive down off-patent prices and instead give the U.S. Patent and Trademark Office authority directly to set the prices of off-patent products equal to marginal cost.

Author : Jean O. Lanjouw
Publisher :
Page : 0 pages
File Size : 47,99 MB
Release : 2007
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We consider how patent rights and price regulation affect whether new drugs are marketed in a country, and how quickly. The analysis covers a large sample of 68 countries at all income levels and includes all drug launches over the period 1982-2002. It uses newly compiled information on legal and regulatory policy, and is the first systematic analysis of the determinants of drug launch in poor countries. Price control tends to discourage rapid product entry, while the results for patents are mixed. There is evidence that local capacity to innovate matters and that international pricing externalities may play a role.

Author : Philip B. Kurland
Publisher : University of Chicago Press
Page : 310 pages
File Size : 14,41 MB
Release : 1975-10
Category : Law
ISBN : 9780226464046

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The papers in this collection are drawn from the annual The Supreme Court Review, which, since its inception in 1960, has been regarded by such legal scholars as Robert F. Drinnan, S. J., as "An indispensable, universally quoted work of the highest scholarship regarding the world's most influential tribunal." Now some of the most important contributions to the Review have been brought together in paperback editions that focus on issues that are becoming increasingly relevant to the ordinary citizen's daily life.

Author : Vicente Ortun
Publisher :
Page : 0 pages
File Size : 22,85 MB
Release : 2015
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The trade-off between property rights/price regulation and innovation depends on country characteristics and drug industry specificities. Access to drugs and innovation can be reconciled by seven ways that, among others, include: public health strengthening in the countries with the largest access problems (those among the poor with the weakest institutions); public and private aid to make attractive R&D on neglected diseases; price discrimination with market segmentation; to require patent owners to choose either protection in the rich countries or protection in the poor countries (but not both). Regarding price regulation, after a review of theoretical arguments and empirical evidence, seven strategies to reconcile health and industrial considerations are outlined, including: mitigation of the medical profession dependence on the pharmaceutical industry; consideration of a drug as an input of a production process; split drug authorization from public funding decisions; establish an efficiency minimum for all health production inputs; and stop the European R&D hemorrhagia.

Author : Jean Olson Lanjouw
Publisher :
Page : 74 pages
File Size : 39,68 MB
Release : 2005
Category : Drug accessibility
ISBN :

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Efforts to strengthen the global patent system for pharmaceuticals continue to be controversial, and what will likely be a similarly fraught international debate over price controls has begun. The outcome of international negotiations and the resulting policy decisions made by each country will have many ramifications - influencing the size of future investment in medical research, the availability of the resulting therapies, how the financial burdens are distributed across countries, and finally the health of consumers. This paper considers how legal and regulatory policies affect whether new drugs are marketed in a country, and how quickly. Less than one-half of the new pharmaceutical molecules that are marketed worldwide are sold in any given country, and those that are sold are often available to consumers in one country only six or seven years after those in another. Both price regulation and intellectual property rights influence these outcomes. The analysis covers a large sample of 68 countries at all income levels and includes all drug launches over the period 1982-2002. It uses newly compiled information on legal and regulatory policy, and is the first systematic analysis of the determinants of drug launch in poor countries.

Author : Rafal Sikorski
Publisher : Kluwer Law International B.V.
Page : 474 pages
File Size : 48,16 MB
Release : 2021-02-16
Category : Law
ISBN : 9403524146

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Patents as an Incentive for Innovation Edited by Rafal Sikorski & Zaneta Zemla-Pacud Patents are a reward for human inventiveness. A well-functioning patent system must provide incentives for innovation, safeguard dynamic competition and protect the public interest – a balancing act fraught with difficulty in the ‘connected’ global world. This ground-breaking book is the first to deeply analyse how patent law today performs its function of stimulating innovation in the crucial sectors of healthcare, agriculture, artificial intelligence and communications technology. Patent specialists, practitioners and scholars from various jurisdictions thoroughly describe how patent rights can be deployed to incentivize investments in researching and developing socially critical innovations without sacrificing the public’s interest in sharing the benefits that are produced. Among the emerging issues of patent rights investigated are the following: protectability and morality of according private rights over material derived from the human body; licensing on fair, reasonable and non-discriminatory (FRAND) terms; the supplementary protection certificate (SPC) manufacturing waiver; patent eligibility of artificial intelligence-related inventions; excessive enforcement of patents by patent assertion entities; enforcement of second medical use innovations; the so-called farmer’s privilege, the farm-save seed exemption, and breeders’ rights; international trade regulations and their influence on patent systems; human enhancement technologies and the consequences of patenting them; specifics of patent protection for biologic medicines; challenges posed by artificial intelligence for the disclosure requirement in patent law; and standard essential patent licensing, particularly in the context of the 5G standard. Perspectives taken into consideration by the authors include protectability criteria, length and scope of the granted protection, mechanisms for dealing with the friction between generalized application and specialized concerns, and rights enforcement. These aspects are analysed on the domestic, international and global levels. The COVID-19 pandemic has highlighted the urgent need to strike the right balance between innovation and access in healthcare and other technologies, a need rooted in patent law. Because the problems discussed – and solutions offered – in this collection of expert essays are of tremendous practical and cultural significance, the book will be of immeasurable value to practitioners, policymakers and researchers in patent law and other fields of intellectual property law.

Author : Adam Mossoff
Publisher :
Page : 0 pages
File Size : 49,64 MB
Release : 2023
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The patent system is at the center of heated policy debates about drug prices, as some scholars and policy organizations claim that patents are a principal cause of rising drug prices. They propose price controls be imposed on drug patents to lower drug prices, and they claim federal agencies are authorized to do so by two federal statutes: § 1498 and the march-in power in § 203 of the Bayh-Dole Act. These price-control theories of § 1498 and the Bayh-Dole Act allege that Congress has already authorized federal agencies to break patents by imposing price controls on sales of patented products in the marketplace. This Article explains that these statutes do not authorize agencies to impose price controls on drug patents, as evidenced by their plain text and by longstanding judicial and agency interpretations of these two statutes. The price-control theories of § 1498 and the Bayh-Dole Act contradict the text and function of both statutes. Section 1498 is an eminent domain statute, applying only when a patent is “used by and for the United States.” This is not the case of a private company authorized by the government to sell a patented drug at a lower price than the drug innovator who owns the patent. Section 203 in the Bayh-Dole Act specifies only four delimited conditions when an agency may “march in” and license a patent without authorization by a patent owner. All address circumstances when a product is not available at all in the marketplace; price is not a specified condition. In sum, neither § 1498 nor the Bayh-Dole Act authorize a federal agency to impose price controls in private transactions in the marketplace between companies and consumers. There is a significant body of scholarship and policy work-product advancing the price-control theories of § 1498 and the Bayh-Dole Act, but these are policy arguments masquerading as statutory construction. It is time to lay these statutory myths to rest and to have a forthright policy debate.