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Articles 1 - 6 of 6
Full-Text Articles in Food and Drug Law
Eviscerating Patent Scope, Shahrokh Falati
Eviscerating Patent Scope, Shahrokh Falati
Articles & Chapters
The scope of patent claims directed to inventions in the field of pharmaceuticals and biotechnology has been stumped by the Court of Appeals for the Federal Circuit’s recent jurisprudence on 35 U.S.C. § 112. Specifically, the application of a heightened test for enablement of claims to a genus of compounds with functional limitations or a genus of therapeutic antibodies, coupled with an increasingly broader application of the written description doctrine, has resulted in considerable uncertainty in the biopharmaceutical industry. The Federal Circuit’s shift in interpreting 35 U.S.C. § 112 contravenes the statute and Supreme Court precedent by splitting the singular …
We Built It And They Did Not Come: Using Governance Theory In The Fight For Food Justice In Low-Income Communities Of Color, Deborah N. Archer, Tamara Belinfanti
We Built It And They Did Not Come: Using Governance Theory In The Fight For Food Justice In Low-Income Communities Of Color, Deborah N. Archer, Tamara Belinfanti
Articles & Chapters
Food deserts and food insecurity have received considerable attention from various stakeholders, such as state and local governments, community organizations, and private sector institutions. These stakeholders have sought to overcome food insecurity by turning food deserts into oases by providing “access” to fresh, healthy food. However, many of their solutions—building supermarkets and sponsoring farmers markets—have missed the mark. Residents of food deserts did not flock to grocery stores to purchase fruits andvegetables. As a result, many stakeholders blame the residents of food deserts for their own predicament, lamenting, to paraphrase Field of Dreams, “we built it but they did not …
23andme, The Food And Drug Administration, And The Future Of Genetic Testing, Patricia Zettler, Jacob S. Sherkow, Henry Greely
23andme, The Food And Drug Administration, And The Future Of Genetic Testing, Patricia Zettler, Jacob S. Sherkow, Henry Greely
Other Publications
On November 22, 2013, the US Food and Drug Administration (FDA) effectively halted health-related direct-to-consumer genetic testing in the United States by sending a warning letter to 23andMe, the leading company in the field, directing it to stop providing such testing. The FDA acted as the era of widespread, clinical use of DNA sequencing rapidly approaches. The agency’s action will contribute to changes in which genetic tests are offered to patients and how testing is provided.
The Future Of Gene Patents And The Implications For Medicine, Jacob S. Sherkow, Henry Greely
The Future Of Gene Patents And The Implications For Medicine, Jacob S. Sherkow, Henry Greely
Other Publications
The Supreme Court decision in Myriad Genetics struck down the patenting of human genomic DNA. What will this mean for genetic testing and medicine, more broadly?
The Meningitis Outbreak: Don't Expect Miracles From The Fda, Joanne Doroshow
The Meningitis Outbreak: Don't Expect Miracles From The Fda, Joanne Doroshow
Other Publications
The good news for states is drug industry immunity only kicks in if the drugs in question are FDA-approved. And thanks to the first-rate influence-peddling and lobbying prowess of compounding pharmacists, the tainted steroid shots at issue today are free and clear of FDA regulation.
Three Statutory Regimes At Impasse: Reverse Payments In Pay-For-Delay Settlement Agreements Between Brand-Name And Generic Drug Companies, Rudolph J.R. Peritz
Three Statutory Regimes At Impasse: Reverse Payments In Pay-For-Delay Settlement Agreements Between Brand-Name And Generic Drug Companies, Rudolph J.R. Peritz
Articles & Chapters
No abstract provided.