Author: Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 90
Book Description
Patent-term Extension and the Pharmaceutical Industry
Author: Patent Term Extension and Pharmaceutical Innovation
Author: United States. Congress. House. Committee on Science and Technology. Subcommittee on Investigations and OversightPublisher:
ISBN:
Category : Drugs
Languages : en
Pages : 308
Book Description
Patent-term extension and the pharmaceutical industry
Author: Pharmaceutical Patent Issues
Author: Orrin G. HatchPublisher: DIANE Publishing
ISBN: 9780788187759
Category :
Languages : en
Pages : 304
Book Description
Witnesses: Michael Kantor, U.S. Trade Rep.; William Brock, former U.S. Trade Rep.; Gerald Mossinghoff, Pharmaceutical Research & Mfrs. of Amer.; Charles Cooper, Shaw, Pittman, Potts & Trowbridge; James Firman, Generic Drug Equity Coalition, & pres., Nat. Council of the Aging; Judith Simpson, United Patients' Assoc. for Pulmonary Hypertension; Robert Gunter, Nat. Pharm. Alliance, & Novo-Pharm; John Klein, Generic Pharm. Ind. Assoc.; Bruce Downey, Barr Labs.; Eran Broshy, Boston Consulting Group; David Beier, Genentech, for the Biotech. Industry Org.; Henry Grabowski, Duke Univ.; Daniel Perry, Alliance for Aging Research; & Dixie Horning, Gray Panthers.
Patent-term Extension and the Pharmaceutical Industry
Author: Pharmaceutical Patent Issues
Author: United States. Congress. Senate. Committee on the JudiciaryPublisher:
ISBN:
Category : Law
Languages : en
Pages : 300
Book Description
Drug Price Competition and Patent Term Restoration Act of 1984
Author: United States. Congress. Senate. Committee on Labor and Human ResourcesPublisher:
ISBN:
Category : Administrative procedure
Languages : en
Pages : 474
Book Description
Patent-term extension and the pharmaceutical industry
Author: états-Unis. Technology assessment (Office).Publisher:
ISBN:
Category :
Languages : en
Pages : 74
Book Description
The Generic Challenge
Author: Martin A. VoetPublisher: BrownWalker Press
ISBN: 1627347461
Category : Law
Languages : en
Pages : 240
Book Description
This Sixth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject.
Pharmaceutical Patent Term Extensions
Author: Publisher:
ISBN:
Category :
Languages : en
Pages : 0
Book Description
The pharmaceutical industry appears to place a high value on patents and drug companies frequently obtain patent protection and enforce patent rights. Patents permit the owner to exclude others from making, using, importing, or selling the patented invention. Patents are issued by the U.S. Patent and Trademark Office (USPTO), generally for a term of 20 years from the date of filing. However, certain circumstances permit extensions to the term of the patent, including delays in the initial administrative process at the USPTO. More significantly, the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the "Hatch-Waxman" Act, permits limited extensions to compensate for market time lost during the drug approval process undertaken by the Food and Drug Administration (FDA). Independent of the patent term, the FDA may provide market exclusivity to pharmaceuticals meeting specific conditions under the Hatch-Waxman Act, the Orphan Drug Act, and the Best Pharmaceuticals for Children Act.