FTC Commissioner Testifies on Barriers to Generic Market Entry Before Senate Special Committee on Aging

          by David Harper

FTC Commissioner Jon Leibowitz testified yesterday before the Senate Special Committee on Aging, stating that there continue to be competitive problems in pharmaceutical markets.  The FTC released its prepared statement, which included discussion of:

• anticompetitive patent litigation settlements (such as reverse payment settlements) between brand pharmaceutical manufacturers and generic competitors;
• how brand companies have used the 180-day exclusivity period for the first generic paragraph IV certification filers to block generic market entry;
• anti-competitive agreements between generic companies that delay generic competition; and
• the FTC's plan to study the impact of authorized generics on pharmaceutical markets.

Commissioner Leibowitz stated that, due to its enforcement efforts, the FTC was unaware of "any pharmaceutical settlements between a brand-name manufacturer and a generic [paragraph IV certification] filer that included both a payment to the generic company and an agreement by the generic company not to market its product between 2000 and the end of fiscal year 2004."  (It is not clear whether this statement was intended to mean that no such settlements were entered into between 2000 and 2004, or to refer only to settlements where the generic company agreed not to market its product between 2000-2004.)

The Commissioner bemoaned the recent decision on reverse payments by the 11th Circuit (cert denied by the US Supreme Court) in FTC v Schering, as well as the 2nd Circuit's Tamoxifen decision, arguing that they will invite the type of collusive reverse payment agreements that FTC enforcement had been effective in reducing.  As a result, the FTC supports a legislative solution, such as S 3582 (see also this earlier Orange Book Blog post). 

The Commissioner also asserted that the 180 day exclusivity period, meant to reward generic filers that challenged weak patents, is increasingly being used as a means to prevent generic market entry via settlement agreements between brand manufacturers and first generic filers, in which the first generic filers agree to delay market entry, and thus initiation of the 180 day exclusivity period.  As a result, subsequent generic ANDA filers are unable to enter the market.

The Commissioner urged Congress to adopt legislation providing that dismissal of an action brought by a generic applicant seeking a declaratory judgment of invalidity or unenforceability of a patent covering the brand drug constitutes a forfeiture event for the 180 day exclusivity period.

RELATED READING:

• Mylan Laboratories' Statement to the Special Committee

Comments

[Dolly]

Dear Sir,
My query is not related to the instant case. I wish to know is there some site like www.fedcir.gov which gives details of the patent cases fought in courts European countries?

Your immidiate help will be highly appreciated.

Regards,
Dolly