Intellectual Property Law Commons^™

Compulsory Licensing Of Patented Pharmaceutical Inventions: Evaluating The Options, Jerome H. Reichman

Faculty Scholarship

In this Comment, the author traces the relevant legislative history pertaining to compulsory licensing of patented pharmaceuticals from the TRIPS Agreement of 1994 to the 2003 waiver to, and later proposed amendment of, article 31, which enables poor countries to obtain needed medicines from other countries that possess manufacturing capacity. The Comment then evaluates recent, controversial uses of the relevant legislative machinery as viewed from different critical perspectives. The Comment shows how developing countries seeking access to esential medicines can collaborate in ways that would avoid undermining incentives to innovation and other social costs attributed to compulsory licensing. It ends …

Rethinking The Role Of Clinical Trial Data In International Intellectual Property Law: The Case For A Public Goods Approach, Jerome H. Reichman

Faculty Scholarship

This article is a later version of the author's presentation at the Eleventh Annual Honorable Helen Wilson Nies Memorial Lecture March 26, 2008. Clinical trials are currently used to test drugs; however, the risk and cost of clinical trials are increasing so drastically that the clinical trials may become unsustainable. This article evaluates the legal and economic trends of intellectual property protection for pharmaceutical clinical trial data. The protection of clinical trials has become an alternative to patents as market exclusivity encourages the development and testing of unpatentable pharmaceuticals. This author argues that clinical trials should be treated as a …

An Intellectual Property Food Fight: Why Copyright Law Should Embrace Culinary Innovation, J. Austin Broussard

Vanderbilt Journal of Entertainment & Technology Law

In the United States, dining has become an increasingly popular form of leisure and entertainment, generating an estimated $537 billion in 2007. However, dining represents only one aspect of the modern food economy; cooking and dining are regularly featured in newspapers and magazines, while celebrity chefs tout their own brands on television. Eating has been transformed from a mere perfunctory activity into big business. Increasing competition for the attention and money of restaurant patrons has prompted chefs of grande cuisine to differentiate their menus by creating unique dishes. The time and labor that chefs sink into this form of innovation …

Putting The Brakes On Drugs: The Impact Of Ksr V. Teleflex On Pharmaceutical Patenting Strategies, Diane C. Renbarger

Georgia Law Review

In its 2007 KSR v. Teleflex decision, the Supreme Court permitted KSR International Co. to manufacture an adjustable gas pedal in spite of a competitor's patent. The ruling struck down the Federal Circuit's test to determine whether a patent is obvious and thereby invalid. Since the decision, there has been speculation about how much, if at all, the Supreme Court's decision changed patent validity standards,and particularly about how the decision will influence pharmaceutical patenting. This Note examines the impact KSRv. Teleflex may have on the pharmaceutical industry. Pharmaceutical patenting laws and early court decisions applying the reasoning of KSR v. …

Pharma's Nonobvious Problem, Rebecca S. Eisenberg

Articles

This Article considers the effect of the recent decision of the U.S. Supreme Court in KSR International Co. v. Teleflex, Inc. on the nonobviousness standard for patentability as applied to pharmaceutical patents. By calling for an expansive and flexible analysis and disapproving of the use of rigid formulas in evaluating an invention for obviousness, KSR may appear to make it easier for generic competitors to challenge the validity of drug patents. But an examination of the Federal Circuit's nonobviousness jurisprudence in the context of such challenges reveals that the Federal Circuit has been employing all along the sort of flexible …

A Healthy Solution For Patients And Patents: How India's Legal Victory Against A Pharmaceutical Giant Reconciles Human Rights With Intellectual Property Rights, Sara B. Myers

Vanderbilt Journal of Entertainment & Technology Law

The Swiss drug company Novartis challenged India's status as the "Pharmacy of the Developing World" when it initiated a lawsuit against the Indian government on February 15, 2007. In 2005, India updated its Patents Act to comply with the World Trade Organization's (WTO) intellectual property requirements. Before 2005, India only granted patents to processes, not products, which facilitated the development of the country's booming generic drug industry. On January 25, 2006, India's Office of the Controller General of Patents, Designs and Trademarks denied Novartis's patent application for its cancer-fighting drug Glivec on the grounds that it was not substantially different …

Common Ground: The Case For Collaboration Between Anti-Poverty Advocates And Public Interest Intellectual Property Advocates, Deborah J. Cantrell

Publications

This article examines the previously unappreciated common ground between scholars and advocates who work to eliminate poverty, and scholars and advocates who work on intellectual property issues in the public interest. The article first illustrates how scholars and advocates working on poverty and on public interest intellectual property have relied on rights talk to frame their social movements. Under the conventional narrative, the framing has accentuated differences between the movements. As the Article explains, the two movements share core principles and should recognize shared interests and goals. By developing a new model of how to view public interest movements, the …

That’S A Fine Chablis You’Re Not Drinking: The Proper Place For Geographical Indications In Trademark Law, Justin Hughes, Lynne Beresford, Annette Kur, Kenneth Plevan, Susan Scafidi

Articles

No abstract provided.

The Negative Effect Of Pharmaceutical Patents On South African Industry, Chenxi Jiao

Cardozo Public Law, Policy & Ethics Journal

The note argues that the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has disproportionately favored developed economies, stifling the growth of local pharmaceutical industries in developing countries like South Africa. While TRIPS aimed to balance societal benefits with short-term costs, its strict patent protections have hindered the development of generic drug manufacturing and technology transfer in these regions. The analysis highlights that strong intellectual property rights alone do not drive foreign investment or industrial growth, as market size, infrastructure, and economic stability play more critical roles. The note advocates for a reformed approach to intellectual …

Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz

Michigan Telecommunications & Technology Law Review

Before a new drug can be marketed, the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed at restoring such incentives have been implemented or advocated. This Article challenges the central argument that drug regulation and drug innovation are necessarily at odds with one another. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate does not fully capture the role that regulation plays in …

The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg

Michigan Telecommunications & Technology Law Review

This Article reexamines the role of FDA regulation in motivating investment in biopharmaceutical innovation. I begin by challenging the standard story that it is the patent system that makes drug development profitable, and drug regulation that makes it costly, by showing how patents add to costs and how drug regulation works in tandem with patents to protect profits. I then compare FDA-administered exclusive rights to patents as a means of fortifying drug development incentives, suggesting ways that FDA-administered rights might be preferable both from the perspective of policy makers and from the perspective of firms. In the remainder of the …

Diversifying Without Discriminating: Complying With The Mandates Of The Trips Agreement, Graeme B. Dinwoodie, Rochelle C. Dreyfuss

Michigan Telecommunications & Technology Law Review

Since the Patent Act was revised in 1952, patent law has expanded to cover an array of novel endeavors--new fields of technology (notably computer science and business methods) as well as the activities of researchers engaged in fundamental scientific discovery. These changes have been accompanied by shifts in the organizational structure of the technological community, with smaller firms and universities emerging as important players in the patent system, and by new marketplace expectations arising from consumer demand for interoperable technology and converging functionality. As a result of these developments, structural flaws in the legal order have become evident. Although the …

Restoring The Genetic Commons: A Common Sense Approach To Biotechnology Patents In The Wake Of Ksr V. Teleflex , Anna Bartow Laakmann

Michigan Telecommunications & Technology Law Review

In this Article, I argue that a new approach to biotechnology patenting is necessary to fully realize the tremendous potential of recent advances in our understanding of the human genome. Part I places the gene patenting debate in context by highlighting the key landmarks that have shaped the biotechnology industry and outlining the products and stakeholders that comprise the industry. Part II describes the current state of the law on biotechnology patents, summarizing the Federal Circuit's application of the various doctrines that collectively define the patent landscape's parameters. In this Part, I explain how the Federal Circuit's jurisprudence is tied …

The Patent End Game: Evaluating Generic Entry Into A Blockbuster Pharmaceutical Market In The Absence Of Fda Incentives, Jeremiah Helm

Michigan Telecommunications & Technology Law Review

Generic drugs play an important role in the American system of health care. Most anticipate that the entry of these drugs into the market will lower prices and thereby increase treatment options for consumers. To stimulate generic entry, the Food and Drug Administration currently offers a period of marketing exclusivity to the first firm that gains approval for a generic version of a branded drug. During this 180-day period, only two firms can sell versions of the drug: the original, branded drug maker and the first approved generic firm. After the period of exclusivity expires, other generic firms are free …

Outsourcing Drug Investigations To India: A Comment On U.S., Indian, And International Regulation Of Clinical Trials In Cross-Border Pharmaceutical Research, James Cekola

Northwestern Journal of International Law & Business

The traditional research and development model of large pharmaceutical companies is arguably unsustainable in current times. For example, estimated research and development costs increased as much as twelve percent over the last year while pharmaceutical sales grew only seven percent over the same period. Current estimates put the price to develop a new drug and bring it to market between $800 million and $1.5 billion per drug. These costs are increasing, driving large pharmaceutical companies to find more cost-effective research and development models. One cost-saving initiative is to globalize the system. In particular, companies have increasingly outsourced the required investigational …

To Achieve Closure Of The Hatch-Waxman Act's Loopholes, Legislative Action Is Unnecessary; Generic Manufacturers Are Able To Hold Their Own, Yana Pechersky

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Knowledge Commons: The Case Of The Biopharmaceutical Industry, Arti K. Rai

Faculty Scholarship

No abstract provided.

A Complete Property Right Amendment, John H. Ryskamp

ExpressO

The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.

Why Pharmaceutical Firms Support Patent Trolls: The Disparate Impact Of Ebay V. Mercexchange On Innovation, Jeremiah S. Helm

Michigan Telecommunications & Technology Law Review

Before the unanimous decision in eBay v. MercExchange, patent holders were almost always granted an injunction against an infringer. In fact, the Federal Circuit, in deciding eBay, noted that, upon a finding of infringement, an injunction would issue unless there were extraordinary circumstances. The Court, in a brief opinion, disagreed with the Federal Circuit and explained that the injunction issue in a patent case must be analyzed under the traditional four-factor test.[...] Is the four-factor test fairer or better than the Federal Circuit's near-automatic injunction rule? It is certainly more difficult to administer a factor test as compared to a …

On The Legal Consequence Of Sauces: Should Thomas Keller's Recipes Be Per Se Copyrightable, Christopher J. Buccafusco

ExpressO

This article is devoted to copyright protection for one of the restaurant industry’s most valuable assets – original recipes. The two most recent appellate courts to consider the issue have been hostile to the notion that recipes are copyrightable, but given the enormous amount of money at stake, litigation in this area is likely about to expand. The article begins by critiquing the courts’ conclusions. Following an analogy to musical composition, I argue that recipes are simply the means of fixation for culinary works of authorship, i.e, dishes. Next, based on interviews with some of America’s leading chefs, including Thomas …

Why It Is Time To Eliminate Genomic Patents, Together With Natural Extracts Doctrine That Have Supported Such Patents, Allen K. Yu

ExpressO

The constitutional purpose of intellectual property is to “promote the progress of science and useful arts.” Given the utilitarian basis of patents, it is critical that policies and laws must be continually adjusted to reflect the needs of new technologies. When the law tries to shield itself from rather than confront the realities of underlying technologies, patents end up actually subverting rather than promote technological progress. This paper explores why the natural extracts doctrine belongs to the class of doctrines that subvert progress. The doctrine, established over a century ago to enable the patenting of purified compounds for use as …

Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp

ExpressO

This brief comment suggests where the anti-eminent domain movement might be heading next.

Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson

ExpressO

This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …

Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson

ExpressO

This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …

Merck V. Integra: Bailing Water Without Plugging The Hole, Benjamin G. Jackson

Brigham Young University Journal of Public Law

No abstract provided.

Has The Supreme Court Incorrectly Expanded § 271(E)(1) To Risk A Regulatory Taking?, 5 J. Marshall Rev. Intell. Prop. L. 216 (2006), Tara Stuart

UIC Review of Intellectual Property Law

The U.S.S.C. expanded the scope of the Hatch-Waxman Act’s safe harbor provision in Merck III to include protection for infringing use of any type of invention as long as a researcher intended to perform research reasonably relevant to FDA approval. This broad interpretation is inconsistent with the legislative intent of the Hatch-Waxman Act, and the policies of the U.S. patent system. Many patent owners may unnecessarily experience such a reduction in their property rights as to constitute a regulatory taking. The proposed narrow interpretation would rectify the constitutional problems and inconsistencies in infringement exemptions. Section 271(e)(1) should apply only to …

Suppression Of Innovation Or Collaborative Efficiencies?: An Antitrust Analysis Of A Research & Development Collaboration That Led To The Shelving Of A Promising Drug, 5 J. Marshall Rev. Intell. Prop. L. 348 (2006), Saami Zain

UIC Review of Intellectual Property Law

This article discusses antitrust issues present in research and development collaborations between competitors. In particular, it illustrates that, although often very beneficial, these collaborations may have the potential for considerable harm via suppression of innovation. The article examines a recent case involving a collaboration to develop drugs, which arguably resulted in the suppression of a promising drug.

Paying For Delay: Pharmaceutical Patent Settlement As A Regulatory Design Problem, C. Scott Hemphill

Center for Contract and Economic Organization

Over the past decade, drug makers have settled patent litigation by making large payments to potential rivals who, in turn, abandon suits that (if successful) would increase competition. Because such "pay-for-delay" settlements postpone the possibility of competitive entry, they have attracted the attention of antitrust enforcement authorities, courts, and commentators. Pay-for-delay settlements not only constitute a problem of immense practical importance in antitrust enforcement, but also pose a general dilemma about the proper balance between innovation and consumer access.

This Article examines the pay-for-delay dilemma as a problem in regulatory design. A full analysis of the relevant industry-specific regulatory statute, …

Merck V. Integra And Its Aftermath: A Safe Harbor For The Commercial Use Of Biotechnology Research Tools?, Brendan M. O'Malley

Cardozo Arts & Entertainment Law Journal

No abstract provided.

A Mathematical Approach To Benefit-Detriment Analysis As A Solution To Compulsory Licensing Of Pharmaceuticals Under The Trips Agreement, Vishal Gupta

Cardozo Journal of International and Comparative Law

The note proposes a mathematical approach to benefit-detriment analysis as a solution to the challenges posed by compulsory licensing of pharmaceuticals under the TRIPS Agreement. The core argument is that a socio-economic framework, comparing the monetary detriment to pharmaceutical companies (D) with the aggregate societal benefit (H x C), where H is the average health benefit per person and C is the number of affected citizens, can provide a balanced and objective method to determine when compulsory licenses should be granted. This approach aims to address the "Paragraph 6 problem" and improve access to essential medicines in developing countries while …