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"Obvious To Try": A Proper Patentability Standard In The Pharmaceutical Arts?, Andrew V. Trask
"Obvious To Try": A Proper Patentability Standard In The Pharmaceutical Arts?, Andrew V. Trask
Fordham Law Review
Pharmaceutical research often entails making small modifications to candidate drug molecules--modifications that might be deemed “obvious to try”--and then studying the largely unpredictable, yet critical, resulting biological effects. Recognizing this characteristic unpredictability, the U.S. Court of Appeals for the Federal Circuit has traditionally upheld the patentability of obvious-to-try pharmaceutical inventions. This approach has been challenged, however, by the U.S. Supreme Court's 2007 decision in KSR International Co. v. Teleflex Inc. This Note reviews the history of the obvious-to-try test and considers the Federal Circuit's post-KSR inconsistency regarding obviousness in the pharmaceutical arts. This Note argues that KSR does not permit …
Should Preemption Apply In A Pharmaceutical Context? An Analysis Of The Preemption Debate And What Regulatory Compliance Statutes Contribute To The Discussion, Jennifer A. Surprenant
Should Preemption Apply In A Pharmaceutical Context? An Analysis Of The Preemption Debate And What Regulatory Compliance Statutes Contribute To The Discussion, Jennifer A. Surprenant
Fordham Law Review
Should the Food and Drug Administration (FDA)’s determination that a product is safe negate a private litigant’s cause of action under state law in all circumstances, unless the FDA determines that the manufacturer withheld relevant information regarding the safety of the product? This Note concludes that such federal preemption is proper because the FDA is fully capable of making a determination regarding the adequacy of the information disclosed by a pharmaceutical manufacturer without state interference. Additionally, such interference on the state level hinders the FDA’s objectives and effective functioning. Thus, determinations about the adequacy of the information provided to the …
Settlements Between Brand And Generic Pharmaceutical Companies: A Reasonable Antitrust Analysis Of Reverse Payments, Anne-Marie C. Yvon, Ph.D.
Settlements Between Brand And Generic Pharmaceutical Companies: A Reasonable Antitrust Analysis Of Reverse Payments, Anne-Marie C. Yvon, Ph.D.
Fordham Law Review
No abstract provided.
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Fordham Law Review
No abstract provided.