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This treatise is the only reference available with a detailed, practitioner-oriented treatment of pharmaceutical patent law from the perspective of both patent law and food and drug laws. It tracks legal developments within the Patent and Trademark Office, the Food and Drug Administration (FDA), Congress, the courts, the Federal Trade Commission, the Department of Justice, and the World Trade Organization. The book examines how these agencies and organizations interact with each other and determines how they impact strategies within a practitioner’s core area of expertise. Core topics covered include antitrust implications of patent settlements, the experimental use privilege, international aspects of the field, follow-on biologics, the substance and procedure of pharmaceutical patent acquisition, FDA marketing approval procedures for innovative and generic drugs, FDA’s Orange Book, patent term extension standards, FDA marketing exclusivities, the scope of patent rights, patent infringement procedures under the Hatch-Waxman Act, and defenses to — and remedies for — patent infringement.
Pharmaceutical Patent Law, Second Edition takes on the complicated tasks of tracking legal developments within the Patent and Trademark Office, the Federal Drug Administration (FDA), Congress, the courts, the Federal Trade Commission (FTC), the Department of Justice, and the World Trade Organization; examining how these agencies and organizations interact with each other; and determining how they impact strategies within a practitioner’s core area of expertise. This treatise is the only reference available with a detailed, practitioner-oriented treatment from the perspective of both patent law and food and drug laws.
Pharmaceutical Patent Law provides complete coverage of advanced topics, including the antitrust implications of patent settlements, the experimental use privilege, and international aspects of the field. Core topics covered include follow-on biologics; the substance and procedure of pharmaceutical patent acquisition; FDA marketing approval procedures for innovative and generic drugs, as well as FDA marketing exclusivities; the FDA’s Orange Book; and patent term extension standards.
The 2014 Cumulative Supplement covers the following significant developments: Supreme Court decisions pertaining to claim definiteness, inducement of infringement, the award of attorney’s fees, and patentable subject matter; the Court of Appeals’ decisions regarding obviousness and double patenting; the Food and Drug Administration’s drafted guidance indicating a more generous interpretation of new chemical entity exclusivity, granting five years of regulatory exclusivity to combination therapies where the therapy includes at least one new drug substance; and Canada’s “promise of the patent” doctrine and international agreements.
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