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Articles 1 - 10 of 10
Full-Text Articles in Intellectual Property Law
Patently Obvious: A Dual Standard Solution To The Diverging Needs Of The Information Technology And Pharmaceutical Patent Industries, Andrew Moody
Golden Gate University Law Review
This Comment proposes the use of a specifically tailored obviousness standard as a new solution to the IT and pharmaceutical patent industries' divergent needs. Part I summarizes the obviousness standard's history in patent law. Part II illustrates how the IT and pharmaceutical industries have divergent needs. Part III describes why using a single standard for the obviousness inquiry is inadequate to meet the needs of both the IT and pharmaceutical industries. Part IV illustrates why the obviousness standard needs to be specifically tailored for the IT and pharmaceutical industries. Finally, Part V concludes that a dual standard for obviousness is …
A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski
A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski
Michael J. Malinowski
This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.
How Many Patents Does It Take To Make A Drug - Follow-On Pharmaceutical Patents And University Licensing, Lisa Larrimore Ouellette
How Many Patents Does It Take To Make A Drug - Follow-On Pharmaceutical Patents And University Licensing, Lisa Larrimore Ouellette
Michigan Telecommunications & Technology Law Review
As described by Professors Dan Burk and Mark Lemley, drugs are[...] special because of the low number of patents per product: "In some industries, such as chemistry and pharmaceuticals, a single patent normally covers a single product. Much conventional wisdom in the patent system is built on the unstated assumption of such a one-to-one correspondence." Although many have repeated this one-patent, one-drug assumption, there has been little empirical analysis of how many patents actually protect each drug. In fact, most small-molecule drugs are protected by multiple patents. The average was nearly 3.5 patents per drug in 2005, with over five …
It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü
It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü
Michigan Telecommunications & Technology Law Review
Although [drug] manufacturers bear the cost of research data generation, it is oftentimes a worthwhile investment that also confers significant commercial advantages. Consequently, they have argued that research data should be considered a trade secret and kept confidential. The FDA's longstanding position has been to accept this proposition. Even when Congress appeared to mandate disclosure or weaken the underlying rationale for secrecy, the FDA has continued to treat research data as confidential. A strong argument against a default posture of confidentiality is that research data disclosure would promote broad public interests by eliminating the societal costs brought about by keeping …
Special 301 Of The Trade Act Of 1974 And Global Access To Medicine, Sean Flynn
Special 301 Of The Trade Act Of 1974 And Global Access To Medicine, Sean Flynn
Articles in Law Reviews & Other Academic Journals
Since its inception in 1988, the United States Trade Representative’s “Special 301” adjudication of foreign intellectual property law standards has been used to promote policies restricting access to affordable medications around the world. President-elect Obama released a platform promising to “break the stranglehold that a few big drug and insurance companies have on these life-saving drugs” and pledged support for “the rights of sovereign nations to access quality-assured, low-cost generic medication to meet their pressing public health needs.” The 2009 and 2010 Special 301 reports, however, indicate that the Obama Administration has not yet implemented this pledge into administration trade …
We Can Work It Out: Co-Op Compulsory Licensing As The Way Forward In Improving Access To Anti-Retroviral Drugs, Horace E. Anderson
We Can Work It Out: Co-Op Compulsory Licensing As The Way Forward In Improving Access To Anti-Retroviral Drugs, Horace E. Anderson
Elisabeth Haub School of Law Faculty Publications
This Article explores the social and developmental underpinnings of the access problem and describes the legal framework that provides the backdrop for the Waiver's licensing scheme. Part III examines the various lenses, humanitarian, economic, and political, through which the underutilization problem may be viewed and explained. Part IV sets out the structural heart of the Waiver scheme's deficiencies: the notion of the “compulsory” license itself. Part V posits a co-op scheme of licensing that aligns the concerns, goals, and incentives of IP owners, importers, exporters, and consumers. Finally, the Article relates the proposed scheme to more general trends in thinking …
Emerging Law Addressing Climate Change And Water, Prof. Elizabeth Burleson
Emerging Law Addressing Climate Change And Water, Prof. Elizabeth Burleson
Prof. Elizabeth Burleson
The World Economic Forum recognizes that while restrictions on energy affect water systems and vice versa, energy and water policy are rarely coordinated. The International Panel on Climate Change predicts that wet places will become wetter and dry places will become dryer. Transboundary water, energy and climate coordination can occur through international consensus building.
Deadly Delay / Postponed Pills, 10 J. Marshall Rev. Intell. Prop. L. 254 (2010), Christopher R. Walker
Deadly Delay / Postponed Pills, 10 J. Marshall Rev. Intell. Prop. L. 254 (2010), Christopher R. Walker
UIC Review of Intellectual Property Law
Since 1984, generic pharmaceuticals have continued to grow, and are an important element in our national struggle to increase affordable health care options in the United States. The Hatch-Waxman Act has played a pivotal role in helping to create a regulatory environment that fosters the development of generic pharmaceuticals, thereby increasing access to lower-cost alternatives to more expensive drugs. An important part of balancing the interests of the generic manufacturers against those of the primary pharmaceutical makers is the thirty-month stay provision of the Hatch-Waxman Act. This comment begins by taking a look at the history of the Hatch-Waxman Act …
Misplaced Fears In The Legislative Battle Over Affordable Biotech Drugs, David E. Adelman, Christopher M. Holman
Misplaced Fears In The Legislative Battle Over Affordable Biotech Drugs, David E. Adelman, Christopher M. Holman
Faculty Works
Much like tort reform, the debate over recently enacted legislation on biotech drugs — and particularly regulatory supplements to patent protection — has taken on a significance that dwarfs its impact on prescription drug expenditures. Under the Health Care Reform legislation, Congress enacted two major reforms: First, creation of an abbreviated Food and Drug Administration (FDA) approval process for follow-on biologics (FOBs), which are the analogues of generics for biotech drugs. Second, establishment of a twelve-year “data exclusivity” period in which clinical testing data collected by brand-name innovators cannot be used by producers of FOBs to satisfy FDA testing requirements. …
Unofficial Legislative History Of The Biologics Price Competition And Innovation Act 2009, An, Erika Lietzan, Krista Hessler Carver, Jeffrey Elikan
Unofficial Legislative History Of The Biologics Price Competition And Innovation Act 2009, An, Erika Lietzan, Krista Hessler Carver, Jeffrey Elikan
Faculty Publications
On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act of 2009 (BPCIA) which created a regulatory pathway for, and scheme for litigation of patent issues relating to, “biosimilar” biological products. This article discusses the history of the BPCIA and explains its provisions. Section I provides background and a history of the regulation of drugs and biological products in the United States. Section II describes the growing interest in biosimilar approval from the early 2000s through September 2006, when the legislative debate began in earnest. Section III describes the legislative and stakeholder process from …