Interim Patent Extensions PDF Download

Author: United States. Congress. House. Committee on the Judiciary. Subcommittee on Intellectual Property and Judicial Administration
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 44

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Author: United States. Congress. House. Committee on the Judiciary. Subcommittee on Intellectual Property and Judicial Administration
Publisher:
ISBN:
Category : Patent extensions
Languages : en
Pages : 37

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Author:
Publisher:
ISBN:
Category : Patent extensions
Languages : en
Pages : 22

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This report surveys the law on extensions and adjustments of patents in nine jurisdictions: Australia, Canada, the European Union, France, Germany, Israel, Japan, South Korea, and the United Kingdom. All of the surveyed jurisdictions provide for a standard patent term of twenty years, and all of them except Canada provide for extensions of protection for certain products that are subject to regulatory approval before they can be marketed. For the European Union and France, Germany, and the United Kingdom, supplementary protection certificates (SPCs) are available that extend the protections of patents for medicinal and plant protection products to cover the period needed for regulatory approval of the product, typically to a maximum of five years. Australia similarly provides for extensions of patent protections for pharmaceutical substances to account for the period needed for regulatory approval up to five years. Israel permits the term of basic pharmaceutical patents to be extended for a period equal to the time between submission and granting of the marketing license application, up to five years. Israel also permits extension of related patents held in the United States, Italy, Britain, Germany, Spain, and France where there is patent extension or SPC in the country of origin. Japan allows an extension of the duration of a patent right by up to five years when the patented invention is subject to certain regulatory approval processes that take a considerable time to complete, including those for agrochemicals and pharmaceuticals. South Korea likewise allows for the extension of patent terms for up to five years with respect to medicines and agricultural chemicals to account for the period of product registration. In addition, South Korea provides for adjustment of patent terms due to delayed patent registrations. While Canada currently does not have legislation providing for extensions of patent protection, it is currently negotiating a trade agreement with the European Union that in draft form provides for patent term extensions of two to five years for qualifying pharmaceutical products.

Author:
Publisher:
ISBN:
Category : Trademarks
Languages : en
Pages : 1138

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Author:
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 24

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Author: United States. Patent and Trademark Office
Publisher:
ISBN:
Category : Patents
Languages : en
Pages : 1530

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Author:
Publisher:
ISBN:
Category : Patent laws and legislation
Languages : en
Pages : 520

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Author: Commerce Department
Publisher: Government Printing Office
ISBN: 9780160911804
Category : Law
Languages : en
Pages : 880

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The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the United States Federal Government.

Author: Donald O. Beers
Publisher: Wolters Kluwer
ISBN: 1454836091
Category : Law
Languages : en
Pages : 2154

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Completely updated, the new Eighth Edition of Generic and Innovator Drugs: A Guide to FDA Approval Requirements provides indispensable and practical insights into the FDA approval process. Youand’ll find comprehensive coverage of: Abbreviated new drug applications 505(b)(2) new drug applications Delaying approval of competing products FDA approval of biologic drugs No other book can cover the drug approval process as thoroughly, answering important questions like these: What is required to extend the patent of an FDA-approved product? When must a generic manufacturer notify the innovator manufacturer when submitting an ANDA or 505(b)(2) application? When does the FDA delay approvals because of patent claims, and when does it ignore patents? How can one challenge an FDA exclusivity decision? When can a manufacturer safely sell a drug without prior FDA approval? In what circumstances can a generic manufacturer obtain FDA permission to file an ANDA for a variant of an existing drug? When will the FDA waive or reduce prescription drug user fees? How can a company or an individual avoid debarment? What steps are necessary to comply with the FDAand’s Fraud Policy? When and how can a drug company take advantage of FDA accelerated approval procedures? What are the labeling requirements for exporting approved drugs? How have the changes made by the FDA Safety and Innovation Act, including the Prescription Drug User Fee Act, the Generic Drug User Fee Amendments and the Biosimilars User Fee Act, and the Generating Antibiotic Incentives Now Act affected the overall statutory scheme? Generic and Innovator Drugs: A Guide to FDA Approval Requirements, Eighth Edition provides step-by-step guidance of the approval process and expert interpretation of: The Hatch-Waxman Act (Drug Price Competition and Patent Restoration Act) The Medicare Prescription Drug, Improvement, and Modernization Act The Food and Drug Administration Modernization Act The FDA Export Reform and Enhancement Act The Biologics Price Competition and Innovation Act And more! AUTHOR NOTE Donald O. Beersand’ contributions to this publication were completed before he rejoined the Food and Drug Administration. He has had no part in writing and revising this Eighth Edition.

Author:
Publisher: DIANE Publishing
ISBN: 1428951938
Category :
Languages : en
Pages : 129

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