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Best Mode: A Plea To Repair Or Sacrifice This Broken Requirement Of United States Patent Law, Steven B. Walmsley
Best Mode: A Plea To Repair Or Sacrifice This Broken Requirement Of United States Patent Law, Steven B. Walmsley
Michigan Telecommunications & Technology Law Review
An inventor's obligation to disclose the best mode of her invention is strong consideration in the U.S. patent bargain, but the courts paradoxically define the scope of that obligation, thus rendering the enforcement of U.S. patents unreasonably unpredictable. If an inventor cannot reasonably foresee the scope of her obligation to disclose invention details, then she is subjected to the costs and risks of either overcompliance or undercompliance with the best mode requirement. The scope of the best mode requirement should either be reliably defined by an en banc ruling of the Court of Appeals for the Federal Circuit, or the …
Key Disclosure Issues For Life Sciences Companies: Fda Product Approval, Clinical Test Results, And Government Inspections, William O. Fisher
Key Disclosure Issues For Life Sciences Companies: Fda Product Approval, Clinical Test Results, And Government Inspections, William O. Fisher
Michigan Telecommunications & Technology Law Review
The government, particularly the Food and Drug Administration ("FDA"), heavily regulates the life sciences industry. FDA actions can have an extraordinary influence on the fortunes of biotechnology companies. Timely FDA approval of a drug or medical device can permit a company to exploit an inviting market window. FDA product approval is, in turn, tied to clinical test results which demonstrate "efficacy" and safety. Delayed approval, unfavorable test results, or the denial of an FDA application may ruin a company. Beyond the FDA product approval process and related testing lie FDA inspections and the possibility that the government will investigate charges …