Clarinex Patent Fight Nothing To Sneeze At
Lurking in a federal court in New Jersey is a lawsuit brought by a generic company that could change some assumptions about Schering-Plough and its cherished status as a big drugmaker with few near-term patent problems.
At issue is the Clarinex allergy med, which was a $799 million seller last year and is increasingly important as Vytorin sales decline. The drug has patent protection until 2020, according to Schering-Plough. But in its patent challenge, Orchid Pharmaceuticals charges that Clarinex doesn’t have anywhere near the patent protection Schering-Plough claims.
The fight centers on Schering-Plough’s assertion that the formulation for its Clarinex RediTabs is covered by existing patents and that those patents were filed properly. Orchid argues otherwise, but has been prevented from selling a generic by an automatic 30-month waiting period that was triggered by Schering-Plough’s patent infringement lawsuit, which was filed in September 2006.
Not surprisingly, Orchid is seeking an order that forces Schering-Plough to delete its patent listing. Meanwhile, the Indian generic drugmaker indicates in an April 15 court filing that it’s ready to start selling a generic Clarinex. “In short, the 30-month stay is the only remaining barrier to the availability of generic desloratadine orally disintegrating tablets to the public.”
Orchid and its attorneys at Latham & Watkins maintain the 30-month stay ends in March 2009, which would allow the FDA to approve its version at that time. A Schering-Plough spokesman disagrees but won’t say when the stay ends, suggesting some legal maneuvering lies just ahead. The real issue, though, is if the court orders the patent to be delisted even sooner, maybe anytime over the next few weeks or months.
Could this be the making of an at-risk launch? You know, that’s when a generic drugmaker goes ahead and sells its copycat version even as litigation with the brand-name drugmaker continues. Orchid hasn’t tipped its hand, but unless Schering-Plough can prove its filings exists and are legit, perhaps its top line will be in for another hit.
Hat tip to Shearlings Got Plowed
Prescription Access Litigation (PAL) Project » Blog Archive » What’s a “Goober Grape” drug? Just ask Schering-Plough & Merck…
[...] Combination drugs like these are intended to serve one purpose: to increase the manufacturers’ market share, particularly in the face of impending generic competition. Schering-Plough has been down a road like this already with Claritin — when Claritin was set to go generic, they introduced Clarinex. Clarinex (desloratidine) is simply a metabolite of Claritin (loratidine) — in a nutshell, Clarinex is what Claritin becomes in your liver. As one blogger put it, “if you’ve taken Claritin, you’ve taken Clarinex.” Thankfully, doctors and patients weren’t really fooled, and sales of Clarinex were never very impressive. I stand corrected! According to this item on Pharmalot, 2007 sales of Clarinex were $799 million! (See “Clarinex Patent Fight Nothing To Sneeze At“) [...]
the condor
UPDATED!
McCarter & English, LLP has filed Schering’s Response in the above case, tonight — May 1, 2008. I’ve got the goods on it — and, to cut to the chase, here: I remain unconvinced that Schering has a case.
IMO, Orchid sure seems to have a good one.
So, I think Orchid is going to be able to launch in mid- to late-2008.
Take a look:
http://shearlingsplowed.blogspot.com/2008/05/hmmm-does-ashley-work-for-mccarter-and.html