Zocor Generic Exclusivity dispute continues on appeal in the US
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
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.
Why did Merck
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
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.
(Teva)’s generic simvastatin about to be approved
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.
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.
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.
for Aaron Barkoff’s excellent write up on this case.