This treatise offers transactional health care attorneys the essential information they need to adequately advise clients on the industry’s unique fraud and abuse risks, such as off-label marketing. It explains other violation risks surrounding compliance, as well as in the areas of antitrust and securities law. Also covered are Medicare Part D drug benefit and the methodology used for reimbursement.
2010/856 pp. Hardcover with 2014 Cumulative Supplement/Order #9510P/$540.00
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.
2014 Cumulative Supplement alone/ISBN 9781617465109/Order #2510/$265.00
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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