Zocor Generic Exclusivity dispute continues on appeal in the US

Copyright Monday, May 29, 2006 Duncan Bucknell Company

This is one for those in the pharmaceutical industry and an interest in the USA. It has potentially enormous implications for strategy in this industry in the US, and about zero application otherwise.

The FDA has appealed summary judgment at first instance (Ranbaxy v Leavitt, 30 April 2006 - Federal District court for the District of Columbia) which held that it should have re-listed Merck’s Zocor (simvastatin) patents in the Orange Book in response to citizen’s petitions filed by Ivax (now part of Teva) and Ranbaxy in 2005. Ivax and Ranbaxy had filed paragraph IV certifications in 2000 and 2001 and Merck had declined to sue within the allowed 45 day period. Thus, under the Hatch-Waxman legislation, Ivax and Ranbaxy were to be granted a 180 day generic exclusivity. However, this opportunity was taken away when the FDA granted Merck’s unusual request (in 2003) that the relevant patents be delisted.

Comment

Why did Merck request delisting?

It’s interesting to contemplate why Merck sought to have the patents de-listed in the first place. Conventional wisdom holds that the generic exclusivity also assists the innovator company in the situation where multiple generic players are preparing to launch. (This must almost certainly be the case here as Zocor is the world’s second biggest selling drug (behind Pfizer’s Lipitor)). The thinking goes that the 180 generic exclusivity provides the innovator company with an extra six months of limited competition.

Perhaps Merck has licensed an authorised generic which will not be selling under the original New Drug Application (NDA).

An interesting twist

In an interesting twist, a law firm which made no mention of acting on behalf of a client also wrote to the FDA requesting delisting of the relevant patents. While some might say that this firm may have been acting for Merck, a more plausible suggestion is that it acted on behalf of a competitor generic company that stands to be out of the market during the 180 day period.

Ivax (Teva)’s generic simvastatin about to be approved

A press release on Teva’s website states that it expects to gain FDA approval for its generic simvastatin product on 23 June 2006. Consequently, the parties have agreed to an expedited appeal schedule.

Greater certainty

It’s a good thing that the decision has been appealed as the higher the court which decides on this issue, the greater the certainty for all in the future.

Background

(I apologise, as I have assumed a lot of knowledge in the above.) If you want to know more about the Orange Book, paragraph IV certifications, the Hatch-Waxman legislation, etc, then the best place to start is the judgment, above. Please also click on any of the links in this article, or simply send me an email.

Click here for Aaron Barkoff’s excellent write up on this case.