Hatch-Waxman provisions

The study was prompted, in part, by the Commission s enforcement actions against alleged anticompetitive agreements that relied on certain Hatch-Waxman provisions." The study was designed to... 

The study did not examine how generic competition has developed under the other methods the Amendments established. Nor did the study examine whether Hatch-Waxman provisions have achieved another purpose of the Amendments to compensate brand-name companies for lost patent life due to the time needed for FDA s safety and efficacy review process. 

Infringement Exemptions for Generic Pharmaceutical Manufacturers under Hatch-Waxman Provisions... 

This study examines whether the conduct that the FTC challenged represented isolated instances or is more typical, and whether the 180-day exelusivity and the 30-month stay provisions of the Hatch-Waxman Amendments are susceptible to strategies to... 

When an applicant makes a paragraph IV certification, two additional provisions of Hatch-Waxman are implicated. These two provisions are at the heart of the FTC s study. 

This chapter deseribes the 180-day provision in the Hatch-Waxman Amendments and details how FDA s rules governing 180-day exelusivity have evolved. The ehapter examines how the 180-day exelusivity has been triggered, and it also reviews the agreements that were obtained through the study that affeet the triggering of the 180-day exclusivity. 

Relevant Provisions of the Hatch-Waxman Amendments 21 USCA 355 (a), (b) and (j)... 

A central question is Do biologies fall under the provisions of the Hatch-Waxman Act Since the Hatch-Waxman Act specifically amended the FD C Act, biologies... 

Coleman, T. S., Waxman-Hatch Exclusivity Provisions Not Related to Patent Status, Food Drug Cosmetic Law Journal 46 345-356,1991. 

In the US, the Hatch-Waxman legislation has started the wheels turning with regard to biosimilar acceptance. The legislation that the FDA utilizes as its reference point is provision 505 (b) (2), which allows for the approval of different biological therapies when compared to the originator s product. Both the EU and the US are under increased pressure to approve biosimilar products as soon as possible. The basis of this reality cannot be understated. 

Drugs Under Patent. This book [77] is a cross-referenced listing of over 2500 drugs covered in the United States under patent law and marketing exclusivity provisions of the Waxman-Hatch Act. Eight indexes provide market and patent status information by company, trade name, generic name, expiration date, dosage form, exclusivity code, patent number, and NDA number. Updated annually, this book is available commercially. 

Another regulatory provision aimed at eliminating a competitive disadvantage of European API producers refers to the European Supplementary Protection Certificate (EPC). Adopted in 1992, it prevented de facto Europe-based API producers from being qualified as bulk sources before the effective marketing exclusivity date in their home country. By extension of the Bolar Roche Provision in the Waxman-Hatch Patent Restoration Act to Europe, the situation will be remediated. 

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