Review of Patent Settlements between Brand and generic: Mylan and FTC representative testified in front of Judiciary Subcommittee

The U.S. House of Representatives Judiciary Subcommittee on Courts and Competition Policy concerning patent is hearing various generic and innovator companies as well as regulatory authorities views on "Pay to Delay: Are Patent Settlements That Delay Generic Drug Market Entry Anticompetitive?," . The initiative is aimed to collect information about the effects of settlements and to address various contentious issue.

Mylan Opposed Authorized Generics During 180-Day Exclusivity Period

Various generic players are constantly opposing launch of authorized generics by innovator to affect sale of First Para IV filer generic player during 180 days exclusivity period. In the past, the authorized generic launch by innovator has hugely dented the sale forecast of generic player. The authorized generic launch of blockbuster molecules like Paroxetine (Paxil), Fexofenadine (Allegra), Pantoprazole (Protonix) and Alendronate Sodium (Fosamax) has affected the sale of First Para IV filer generic player.

Also, generic player Mylan's Chief Operating Officer (COO) Mrs Heather Bresch 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 (As reported by Mylan in a press release Here )

Further, Mrs 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.

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 at Here (as announced by Mylan in a press release)

Federal Trade Commision representative Opposed pay for delay tactics

Testifying today on behalf of the Federal Trade Commission before the U.S. House Judiciary Committee’s Subcommittee on Courts and Competition Policy, Bureau of Competition Director Richard A. Feinstein said that anticompetitive patent settlements in the U.S. pharmaceutical industry delay consumer access to lower-cost generic drugs, and impose “enormous costs” on consumers; employers; federal, state and local governments; and our nation’s health care system. The testimony stated that congressional action to prohibit these “pay-for-delay” settlements between brand-name drug manufacturers and their generic competitors is “both appropriate and timely,” and would help contain spiraling health care costs.

(Source:FTC press release Here )