Download e-book for kindle: Generic Drug Entry Prior To Patent Expiration: An FTC Study by Federal Trade Commission, United States Federal Trade

By Federal Trade Commission, United States Federal Trade Commission

This learn tested even if the behavior that the FTC challenged, which was once definite antitrust activities opposed to brand-name and standard drug businesses, represented remoted situations or is extra normal, and even if the 180-day exclusivity and the 30-month remain provisions of the Hatch- Waxman Amendments are vulnerable to ideas to hold up or deter buyer entry to commonplace possible choices to model- identify drug items. The research focuses exclusively at the approaches used to facilitate prevalent drug marketplace access ahead of expiration of the patent(s) that defend model- identify drug product.

Show description

Read Online or Download Generic Drug Entry Prior To Patent Expiration: An FTC Study PDF

Similar graphics & design books

Download e-book for kindle: Fonts and Encodings: From Unicode to Advanced Typography by Yannis Haralambous

This reference is an engaging and entire advisor to utilizing fonts and typography on the net and throughout quite a few working platforms and alertness software program. Fonts & Encodings exhibits you the way to take complete benefit of the exceptional variety of typographic techniques on hand, with complicated fabric that covers every thing from designing glyphs to constructing software program that creates and strategies fonts.

Get Fonts & Encodings PDF

This reference is an interesting and entire consultant to utilizing fonts and typography on the internet and throughout numerous working platforms and alertness software program. Fonts & Encodings indicates you ways to take complete good thing about the brilliant variety of typographic techniques to be had, with complex fabric that covers every little thing from designing glyphs to constructing software program that creates and techniques fonts.

Read e-book online Generic Drug Entry Prior To Patent Expiration: An FTC Study PDF

This learn tested no matter if the behavior that the FTC challenged, which used to be yes antitrust activities opposed to brand-name and widely used drug businesses, represented remoted cases or is extra regular, and even if the 180-day exclusivity and the 30-month remain provisions of the Hatch- Waxman Amendments are liable to concepts to hold up or deter customer entry to primary choices to model- identify drug items.

Read e-book online Preserving digital materials PDF

This booklet offers a single-volume advent to the rules, techniques and practices at present utilized through librarians and checklist keepers to the maintenance of electronic info. additionally incorporated are case reports of perform from the library, list retaining, audiovisual archiving, facts archiving and geospatial groups.

Additional resources for Generic Drug Entry Prior To Patent Expiration: An FTC Study

Example text

The FTC’s action regarding Hytrin involved two drug products (Hytrin capsules and Hytrin tablets). 34 Box 3-1 Summary of the Commission’s Action in the Abbott/Geneva Matter In May 2000, the Commission issued a complaint and consent order against Abbott Laboratories and Geneva Pharmaceuticals, Inc. S. market, potentially costing consumers hundreds of millions of dollars a year. Hytrin is used to treat hypertension and benign prostatic hyperplasia (BPH or enlarged prostate) - chronic conditions that affect millions of Americans each year.

The Federal Circuit upheld the non-infringement holding, but reversed on the invalidity holding. This has not been counted in the rate at which the Federal Circuit reversed decisions of invalidity and non-infringement for drug products included in this study because the non-infringement decision was affirmed and generic entry occurred prior to patent expiration. 18 This rate does not include Federal Circuit overrules of summary judgement or collateral estoppel decisions. 19 For those drug products in which both the first and second generic applicant were sued, approximately 50 percent of the suits were pursued in different district courts.

Thus, the brand payment was in the form of a royalty on the brand-name drug company’s drug product. Interim Agreements In addition to the 20 final settlements, 4 interim settlements with the first generic applicant were produced. The interim settlements did not resolve the underlying patent litigation, but were contingent upon the outcome of the litigation. 11 The FTC’s actions relating to 2 of those agreements, involving Hytrin tablets and capsules, are described in Box 3-1. No settlements similar to the interim settlements challenged by the Commission were executed after April, 1999 (shortly after the FTC’s investigations in this area became public) and the end of the period covered by this study.

Download PDF sample

Rated 4.54 of 5 – based on 30 votes

About the Author

admin