Obtaining, challenging and enforcing pharmaceutical patents under the America Invents Act

Lars H Genieser1, Clifton E McCann

  • 1Venable LLP, 575 7th Street, NW, Washington, DC 20004, USA.

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Drug Regulation01:25

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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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