Hatch-Waxman Amendments: Contemporary Decisions (Intellectual Property Law Series) LandMark Publications

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Published: May 21st 2012

Kindle Edition

1024 pages


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Hatch-Waxman Amendments: Contemporary Decisions (Intellectual Property Law Series)  by  LandMark Publications

Hatch-Waxman Amendments: Contemporary Decisions (Intellectual Property Law Series) by LandMark Publications
May 21st 2012 | Kindle Edition | PDF, EPUB, FB2, DjVu, audiobook, mp3, ZIP | 1024 pages | ISBN: | 3.73 Mb

This casebook contain 52 decisions that interpret and apply the provisions of the Hatch-Waxman Amendments. The selection of decisions spans from 2007 through the date of publication.The FDA regulates the manufacture, sale, and labeling ofMoreThis casebook contain 52 decisions that interpret and apply the provisions of the Hatch-Waxman Amendments. The selection of decisions spans from 2007 through the date of publication.The FDA regulates the manufacture, sale, and labeling of prescription drugs under a complex statutory scheme.

To begin at the beginning: When a brand manufacturer wishes to market a novel drug, it must submit a new drug application (NDA) to the FDA for approval. The NDA must include, among other things, a statement of the drugs components, scientific data showing that the drug is safe and effective, and proposed labeling describing the uses for which the drug may be marketed.

The FDA may approve a brand-name drug for multiple methods of use—either to treat different conditions or to treat the same condition in different ways. Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, (2012)Once the FDA has approved a brand manufacturers drug, another company may seek permission to market a generic version pursuant to legislation known as the Hatch-Waxman Amendments. See Drug Price Competition and Patent Term Restoration Act of 1984, 98 Stat.

1585. Those amendments allow a generic competitor to file an abbreviated new drug application (ANDA) piggy-backing on the brands NDA. Rather than providing independent evidence of safety and efficacy, the typical ANDA shows that the generic drug has the same active ingredients as, and is biologically equivalent to, the brand-name drug. As we have previously recognized, this process is designed to speed the introduction of low-cost generic drugs to market.

[Citations Omitted.] See Eli Lilly & Co. v. Medtronic, Inc., 496 U. S. 661, 676 (1990). Ibid.



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