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Changes in Hatch-Waxman Act debated.

WASHINGTON -- Provisions in the House and Senate Medicare bills (HR1 and S1) could aid the industry by encouraging generic drug makers to challenge patents held by brand-name pharmaceutical firms.

The 1984 Hatch-Waxman Act allows the first generics company to successfully challenge a brand patent 180 days to market its generic product without generic competition.

The new provisions initiate the six-month period when the generic product is ready for sale (rather than when the patent is successfully challenged), thus making it easier for generic drug manufacturers to secure exclusivity.

Another governmental action designed to speed generic drugs to market took effect last month.

New regulations by the Food and Drug Administration limit the number of automatic 30-month stays on loss of patent protection that brand pharmaceutical firms can obtain when challenging the availability of a generic drug. Patents filed before August 18 (the implementation date) are subject to the old rule, but those filed after that day fall under the new regulations.

Only one 30-month stay is now permitted for each generic application. In addition, brand firms must demonstrate that their new patent applications have not been filed merely to extend marketing protection on established products.

Specifically, the law will only allow submission of patents that claim the active ingredient, formulation and composition, and method of use (i.e., injectable, tablet, etc.).

"The final rule balances innovator drug companies' need for intellectual property protections and the desire to have equivalent generic drugs approved and marketed--a balance intended by the 1984 Hatch-Waxman Act," says the FDA.

According to the agency, consumers should save approximately $35 billion over 10 years as a result of the change. Pharmaceutical Research and Manufacturers of America, which represents the brand industry, asserts multiple 30-month stays have delayed a mere handful of generic drug applications.

But the FDA says it has found multiple stays had been issued for products with significantly high dollar value.

Ironically, notes the FDA, generic drug companies that have sometimes camped out in its parking lot in an attempt to become the first to submit an application may--because of security concerns--have unwittingly prompted the agency to eliminate such competition.

The FDA recently announced it no longer matters which generics company is physically first in line when it opens its doors at 7 a.m. Instead, any company that files on the first eligible day is considered first.

In the past, notes Gary Buehler, head of the FDA's office of generic drugs, company representatives established spots in the parking lot--sometimes a week in advance--in order to obtain the 180-day right to have the only generic version of a certain drug on the market.

Decisions in the judicial arena have also benefited the industry.

Last month a federal appeals court rejected Schering-Plough Corp.'s contention that patents on a chemical created in the body as a side effect of using Claritin should prohibit generic versions of the allergy treatment, also known as loratadine. The decision paves the way for generics companies to bring their versions of Claritin to the market before the end of the year.

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Title Annotation:Generic Drugs
Publication:Chain Drug Review
Geographic Code:1USA
Date:Sep 29, 2003
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