Wyeth Raises The Stakes: Ships A Generic Protonix
4 CommentsBy Ed Silverman // January 29th, 2008 // 5:28 pm
The war between the big drugmaker and Teva Pharmaceuticals just took an interesting turn. Wyeth has launched its own generic version of the heartburn med, five weeks after Teva’s surprise decision to sell a copycat before a nasty patent lawsuit had played out. The move comes two days before the expiration of an extended standstill agreement, which meant the Israeli generic maker agreed not to make additional shipments.
You may recall that, last September, a federal Judge in New Jersey denied a motion by Wyeth and its partner, Altana Pharma, to halt sales of Teva’s generic version, which the FDA approved the previous month. While Teva is not disputing it infringed the patent, the company argued the patent itself is not valid. Wyeth, which still expects a trial to begin in the second half of this year, already filed an appeal over the denied injunction.
“Compound patents, like that infringed by Teva, represent the foundation of pharmaceutical innovation, a critical underpinning in bringing important new medicines to patients,” Bernie Poussot, Wyeth’s ceo, says in a statement. “We believe the Protonix compound patent is strong and we will vigorously pursue our litigation against Teva and other infringing generics. Going forward, we will continue to seek an injunction against any infringement of this patent, as well as monetary damages, including lost profits, from Teva.”
The Protonix patent is set to expire in July 2010, though Wyeth could extend the date to 2011 if it seeks a pediatric use for the drug. Protonix had sales of $1.4 billion during the first nine months of 2007. Meanwhile, Wyeth is examining every aspect of its business to cut costs to offset the impact of a generic launch of Protonix, along with the delay of new drug approvals. The drugmaker recently disclosed plans to cut up to 10 percent of its workforce.
Outside the Box
It is about time. Given that the majority of any remaining branded sales following patent expiry are from a loyal group of customers who, for what ever reason, want to stick with the brand, it makes perfect sense for the owner of the brand to launch the generic. They can gain market position as a result of being the owner of the product and can keep a large share of the volume they would have otherwise lost (which presumably keeps the margin on the remaining branded sales even higher). All ways round this is a win for Wyeth and a loss for Teva.
I am convinced that patent owners are only just beginning to scratch the potential for EOPL planning (even though they all talk a good story). This is one strategy that has to make sense (as I am sure does launching a generic prior to patent expiry with a view to killing the generic market before the generic manufacturers can get in).
Nathan
This is a unique case — the “composition of matter” patent does not expire till 2010. This is not a case of Wyeth trying to extend the patent life by getting a patent on some slight variant of the active ingredient or some other sneaky approach. This the original patent. I agree with Bernard when he says “Compound patents represent the foundation of pharmaceutical innovation”. If the patents aren’t enforced, what hope does the industry have?
Does anyone know what the basis for Teva’s challenge is? What do they think is invalid about Wyeth’s patent?
PIV
My understanding is that the litigation is based on an obviousness argument. Both Teva and Sun have stipulated to infringement of the patent if it’s upheld as valid.
Sun just announced that it’s going ahead with an at-risk launch as well. It’s pretty clear that Teva and SUn are both confident they will prevail if the case goes to trial or it’s unlikely they would have launched at-risk.
Aftab
Generic launch by innovator before expiry of product patent is surprising. If it is strategic to launch a generic version of an enforced product (eg protonix), then it may threat to generic companies. Innovators may try to capture generic market after taking the benefit of first entry. It seems to be a better option, if product patent is about to expire within 1-2 year and there a chances of litigation. So this decision may have taken on the basis of loss over benefit. Anyway consumers are in benefit.