Open Access. Powered by Scholars. Published by Universities.®
- Institution
- Keyword
-
- Patent law (3)
- Food and Drug Administration (2)
- Hatch-Waxman Act (2)
- Pharmaceuticals (2)
- Access to information (1)
-
- Colleges and universities (1)
- Disclosure (1)
- Drug trials (1)
- Drugs (1)
- Empirical studies (1)
- Follow-on patents (1)
- Freedom of Information Act (1)
- Freedom of information (1)
- Information (1)
- Information technology services (1)
- Ksr international co. v. teleflex inc. (1)
- Licenses (1)
- Pharmaceutical industry (1)
- Secrecy (1)
- Trade secrets (1)
Articles 1 - 4 of 4
Full-Text Articles in Food and Drug 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 …
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 …
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 …