2004N-0087 - Request for Comment on Generic Drug Issues
FDA Comment Number : EC2
Submitter : Mr. J. Jeffrey Hawley Date & Time: 05/06/2004 07:05:25
Organization : Intellectual Property Owners Association (IPO)
Other Organization
Category :
Issue Areas/Comments
IPO is a trade association for owners of patents, trademarks, copyrights and trade secrets. IPO's membership includes 100 large and mid-size companies and 250 small businesses, universities, inventors, authors, executives, law firms and attorneys. Most members of the IPO's Board of Directors are chief intellectual property counsel in U.S. companies. IPO represents the interests of intellectual property owners in all industries and advocates effective protection for patents, trademarks, copyrights and trade secrets.

The recent changes to the Drug Price Competition and Patent Term Restoration Act of 1984 ('Hatch-Waxman Act'), signed into law in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ('MMA')(Public Law 108-173), have a significant effect on our members and their employees, as well as others in the community of patent owners. IPO, therefore, takes this opportunity to offer comments on what additional regulatory steps are warranted in light of the recent statutory changes to section 505 (a), (b) and (j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. Sec. 355 (a), (b) and (j)).

IPO Website: http://www.ipo.org