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Full-Text Articles in Law
A Vaccine Approach To The Reverse Payment Illness, Scott Bergeson
A Vaccine Approach To The Reverse Payment Illness, Scott Bergeson
Richmond Journal of Law & Technology
Big Brand Name develops and files a patent for a drug that kills bacteria in an innovative way. The drug is groundbreaking and potentially marketable, so Big Brand Name incurs the enormous cost (estimated at $868 million) and time of drug discovery research and safety determinations of clinical trials to bring the drug to market. Small Generic Company wants to sell the same drug but must wait until Big Brand Name’s patent expires or, in the alternative, Small Generic Company can file an Abbreviated New Drug Application (“ANDA”) with the FDA and allege Big Brand Name’s patent is invalid or …
Will The Federal Circuit’S Eli Lilly V. Teva Decision Lead To Efforts To Abuse The Modification Provision Of The Hatch-Waxman Act?, Claire K. Comfort
Will The Federal Circuit’S Eli Lilly V. Teva Decision Lead To Efforts To Abuse The Modification Provision Of The Hatch-Waxman Act?, Claire K. Comfort
Richmond Journal of Law & Technology
The Hatch-Waxman Act provides a mandatory thirty-month stay on the Food and Drug Administration’s (FDA) approval of an Abbreviated New Drug Application (ANDA) when a patent infringement suit is filed. The Act includes a provision for a district court to shorten or extend the Act’s thirty-month stay on FDA approval if “either party to the action failed to reasonably cooperate in expediting the action”