Mylan Again Calls For An End To Authorized Generics During 180-Day Exclusivity Period

Main Category: Pharmacy / Pharmacist
Article Date: 14 Jun 2009 - 1:00 PDT

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Mylan Inc.'s (NASDAQ: MYL) Chief Operating Officer Heather Bresch today testified before the U.S. House of Representatives Judiciary Subcommittee on Courts and Competition Policy concerning patent litigation settlements between branded pharmaceutical companies and generic pharmaceutical companies. During her testimony, Bresch conveyed Mylan's position that the launch of an authorized generic by brand companies during a generic company's 180-day exclusivity period undermines competition and delays timely access to high quality, affordable generic medications for patients, taxpayers, the government and businesses.

The committee's hearing, "Pay to Delay: Are Patent Settlements That Delay Generic Drug Market Entry Anticompetitive?," was called to gather information about the effects of settlements.

Bresch commented: "When it comes to settlements, Congress need look no further than the use and abuse of authorized generics by brand manufacturers. The increase in the number of patent litigation settlements in recent years is directly related to the increased use of authorized generics during the 180-day market exclusivity period. This tactic upsets the natural balance of incentives that Congress intended with its 1984 Hatch-Waxman legislation."

Bresch continued: "Congress has an opportunity to act now to ensure that timely access to affordable generics is offered to patients by restoring the true 180-day exclusivity period. This is even more profound and critical today as Congress deliberates on a regulatory pathway for life-saving generic biologics, treatments that can cost hundreds of thousands of dollars per patient per year."

A complete version of Bresch's written testimony for the subcommittee hearing can be found here.

Source
Mylan Inc.