Wednesday, January 17, 2007

Generic Pharma responds to FTC study on Hatch-Waxman

from PRNewswire: In response to a study released Jan. 17 by the Federal Trade Commission (FTC), the Generic Pharmaceutical Association (GPhA) said patent settlements between brand and generic pharmaceutical companies can benefit consumers by bringing affordable medicines to market sooner. The FTC study and patent settlements were the topic of a Senate Judiciary Committee hearing today.

The release also stated:

Absent a settlement, patent litigation is an all or nothing proposition. Taking a complex patent challenge all the way to a court decision necessarily means that the generic company risks being kept off the market entirely until patent expiration, which would ultimately harm the consumer. Limiting a generic company's ability to settle patent disputes would lead to fewer patent challenges and, in the end, delay market entry with a substantial loss in savings for consumers, Kathleen Jaeger noted.

Moreover, Congress already has established an effective system to ensure federal review of patent settlements through revisions to the Hatch-Waxman Act that were included in the Medicare Modernization Act of 2003. Under that law, settlement agreements between generic and brand companies must be filed with the FTC and the Department of Justice. FTC reviews each agreement and can propose amendments or challenge settlements.

[This comes under the general heading of issues in the Hatch-Waxman Act.]


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