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Articles 361 - 383 of 383
Full-Text Articles in Intellectual Property Law
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 …
Why Pharmaceutical Firms Support Patent Trolls: The Disparate Impact Of Ebay V. Mercexchange On Innovation, Jeremiah S. Helm
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 …
Merck V. Integra: Bailing Water Without Plugging The Hole, Benjamin G. Jackson
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.
Supporting Innovation In Targeted Treatments: Licenses Of Right To Nih-Funded Research Tools, Tanuja V. Garde
Supporting Innovation In Targeted Treatments: Licenses Of Right To Nih-Funded Research Tools, Tanuja V. Garde
Michigan Telecommunications & Technology Law Review
Support for new drug development has taken some interesting turns in current patent law jurisprudence. Beginning with the severe curtailment of scope of the common law experimental use doctrine in Madey v. Duke University, and culminating with the recent Supreme Court decision in Merck KGaA v. Integra Lifesciences I, Ltd., broadening the scope of the statutory research exemption, the freedom to conduct experimental research using another's patented inventions becomes dependent in part on the purpose of the research. That the patent at issue in Merck was characterized by the Federal Circuit as being directed to a research tool raised the …
"As The Federal Circuit Turns": The Supreme Court's Consideration Of Merck V. Integra And The Safe Harbor Provision, 4 J. Marshall Rev. Intell. Prop. L. 368 (2005), Blair M. Jacobs, Christina A. Ondrick
"As The Federal Circuit Turns": The Supreme Court's Consideration Of Merck V. Integra And The Safe Harbor Provision, 4 J. Marshall Rev. Intell. Prop. L. 368 (2005), Blair M. Jacobs, Christina A. Ondrick
UIC Review of Intellectual Property Law
The Hatch-Waxman Act was enacted to balance the competing interests in the pharmaceutical marketplace between brand name and generic drug manufacturers. In the twenty years since its inception, the safe harbor provision contained in § 271(e)(1), has been interpreted to provide broad protection to those involved in research activities. However, in 2003, the Federal Circuit narrowly interpreted the safe harbor provision in a move that could potentially frustrate future research and improvements on patented technologies. Merck v. Integra is currently before the United States Supreme Court, who has the challenge of unraveling the competing interests involved. In order to encourage …
Note: Exclusive Licensing Of Dna Diagnostics: Is There A Negative Effect On Quantity And Quality Of Healthcare Delivery That Compels Nih Rulemaking?, Edward Weck
William Mitchell Law Review
This comment surveys the costs of deoxyribonucleic acid (DNA) diagnostic tests and argues in favor of non-exclusive licensing as a means to provide broad access to affordable DNA diagnostic testing. Part II provides background information on genetic testing, patenting genes as applied to genetic testing, the Bayh-Dole Act, and technology transfer. In addition, Part II summarizes academic commentary regarding the implications of exclusive licensing for biotechnology. Scholars propose a number of solutions, including expanding the experimental use exception. Part III details proposed rulemaking for DNA diagnostics. Part IV reviews anecdotal examples of genetic testing for breast cancer, hereditary hemochromatosis, and …
Regulating The Regulators: The Impact Of Fda Regulation On Corporations' First Amendment Rights, 39 J. Marshall L. Rev. 95 (2005), Lisa M. Fealk-Stickler
Regulating The Regulators: The Impact Of Fda Regulation On Corporations' First Amendment Rights, 39 J. Marshall L. Rev. 95 (2005), Lisa M. Fealk-Stickler
UIC Law Review
No abstract provided.
Public Use Or Experimental Use: Are Clinical Trials Susceptible To Another Attack Similar To That In Smithkline Beecham Corp. V. Apotex Corp., 39 J. Marshall L. Rev. 149 (2005), Nimalka Wickramasekera
Public Use Or Experimental Use: Are Clinical Trials Susceptible To Another Attack Similar To That In Smithkline Beecham Corp. V. Apotex Corp., 39 J. Marshall L. Rev. 149 (2005), Nimalka Wickramasekera
UIC Law Review
No abstract provided.
Staying Within The Negotiated Framework: Abiding By The Non-Discrimination Clause In Trips Article 27, Kevin J. Nowak
Staying Within The Negotiated Framework: Abiding By The Non-Discrimination Clause In Trips Article 27, Kevin J. Nowak
Michigan Journal of International Law
This Note argues that the Panel in Canada-Generic Medicines correctly decided that the non-discrimination clause in Article 27 applies to the exceptions of Articles 30 and 31. Because Article 27 is the guiding force of Section 5, any exceptions to the rights granted under Section 5 must comply with the requirements set forth in Article 27. Although extreme applications of the non-discrimination clause could be limiting upon some exceptions, Articles 30 and 31 were not placed into TRIPs as complete escape clauses from the framework of Section 5. Additionally, the application of the non-discrimination clause to Articles 30 and 31 …
The Experimental Purpose Doctrine And Biomedical Research, Tao Huang
The Experimental Purpose Doctrine And Biomedical Research, Tao Huang
Michigan Telecommunications & Technology Law Review
The experimental use doctrine is a common law rule in patent law that until a few years ago excused accused infringers who made and used patented products or processes on the basis of an experimental, educational, or nonprofit purpose when there was de minimis economic injury to the patent owner and de minimis economic gain to the infringer. While the application of the experimental purpose doctrine was always narrow, two recent Federal Circuit decisions indicate that there is not much left under its aegis. In Madey v. Duke University, the Federal Circuit strictly limited the application of the experimental purpose …
The Effectiveness Of International Enforcement Of Intellectual Property Rights, 37 J. Marshall L. Rev. 985 (2004), Allison Cychosz
The Effectiveness Of International Enforcement Of Intellectual Property Rights, 37 J. Marshall L. Rev. 985 (2004), Allison Cychosz
UIC Law Review
No abstract provided.
Sustainable Agriculture, Patent Rights, And Plant Innovation, Mark D. Janis
Sustainable Agriculture, Patent Rights, And Plant Innovation, Mark D. Janis
Indiana Journal of Global Legal Studies
No abstract provided.
Computer-Aided Drug Design Using Patented Compounds: Infringement In Cyberspace?, 34 J. Marshall L. Rev. 1001 (2001), Ted L. Field
Computer-Aided Drug Design Using Patented Compounds: Infringement In Cyberspace?, 34 J. Marshall L. Rev. 1001 (2001), Ted L. Field
UIC Law Review
No abstract provided.
Pharmaceutical Patent Protection: More Generic Favored Legislation May Cause Pioneer Drug Companies To Pull The Plug On Innovation, Mandy Wilson
Kentucky Law Journal
No abstract provided.
Licensed To Steal: Has Sovereign Immunity Gone Too Far, 32 J. Marshall L. Rev. 779 (1999), Sulaiman M. Qazi
Licensed To Steal: Has Sovereign Immunity Gone Too Far, 32 J. Marshall L. Rev. 779 (1999), Sulaiman M. Qazi
UIC Law Review
No abstract provided.
It's A Wonderful Genome: The Written-Description Requirement Protects The Human Genome From Overly-Broad Patents, 32 J. Marshall L. Rev. 805 (1999), Emanuel Vacchiano
It's A Wonderful Genome: The Written-Description Requirement Protects The Human Genome From Overly-Broad Patents, 32 J. Marshall L. Rev. 805 (1999), Emanuel Vacchiano
UIC Law Review
No abstract provided.
Deleting The Bolar Amendment To The Hatch-Waxman Act: Harmonizing Pharmaceutical Patent Protection In A Global Village, 32 J. Marshall L. Rev. 751 (1999), Ned Milenkovich
Deleting The Bolar Amendment To The Hatch-Waxman Act: Harmonizing Pharmaceutical Patent Protection In A Global Village, 32 J. Marshall L. Rev. 751 (1999), Ned Milenkovich
UIC Law Review
No abstract provided.
A Definite And Permanent Idea - Invention In The Pharmaceutical And Chemical Sciences And The Determination Of Conception In Patent Law, 28 J. Marshall L. Rev. 687 (1995), Jackie Hutter
UIC Law Review
No abstract provided.
The Patentability And Patent Term Extension Of Lifesaving Drugs: A Deadly Mistake, Jonathan L. Mezrich
The Patentability And Patent Term Extension Of Lifesaving Drugs: A Deadly Mistake, Jonathan L. Mezrich
Journal of Law and Health
The pharmaceutical business is dominated largely by two types of entities: large, research-intensive corporations, and the smaller "generic" drug "knock-off" artists. because the former organizations have to put so much of their budget into research and development (R&D), a form of investment which is often akin to pouring money into a hole, the 17-year exclusive monopoly of a patient is often the only way such a company can remain profitable. However, because of a concern for public safety, all substances prepared for human consumption must be put through extensive testing by the FDA. This testing could take a long period …
Elimination Of Process: Will The Biotechnology Patent Protection Act Revive Process Patents, 24 J. Marshall L. Rev. 263 (1990), Kerin Kelly
UIC Law Review
No abstract provided.
The Supreme Court's Opinion In The Inwood Case: Declination Of Duty, Kenneth B. Germain
The Supreme Court's Opinion In The Inwood Case: Declination Of Duty, Kenneth B. Germain
Kentucky Law Journal
No abstract provided.