AstraZeneca And Teva Square Off Over Pulmicort
5 CommentsBy Ed Silverman // November 19th, 2008 // 11:50 am
Nothing more enjoyable than a little brinkmanship between brand-name and generic drugmakers. The latest round began this morning, when Teva Pharmaceuticals disclosed that the FDA approved its generic version of AstraZeneca’s Pulmicort Respules asthma med.
This amounts to what is known as an ‘at risk’ launch, because AstraZeneca already filed a patent-infringement lawsuit against Teva and a trial is scheduled to begin January 12. Perhaps Teva execs have concluded they can win the case, because having launched a generic means Teva would have to pay AstraZeneca triple damages if it loses.
For its part, AstraZeneca obviously anticipated Teva’s latest move, because the brand-name drugmaker just announced a deal with Par Pharmaceuticals to ship a so-called authorized generic version of its own drug - and shipments begin today.
Teva threw Wyeth into a fit last year with the same maneuver over the Protonix heartburn med by shipping a generic before patent litigation was resolved. Wyeth was forced to scramble to launch its own authorized generic, but not before sales were lost (back story). And Merck may soon face the same challenge from Teva over its Singulair asthma med (another back story).
Nathan
I hope that Teva gets slammed one of these days… What they are doing just isn’t right. Wyeth laid off thousands of employees simply because Teva decided to do an “at risk” launch of Protonix. While I don’t think this drug represents quite as big of a percentage of Astra’s income as Protonix did, it continues down a very bad road.
I know it’s beginning to sound trite these days, but the erosion of patent rights truly stifles innovation. We can’t operate a business with the uncertainty that these kind of “at risk” launches bring. This is driving more and more research into biologics — which can’t be infringed upon so easily.
Michael
Teva is more in the business of pharmaceutical patent prospecting than it is in the business of manufacturing and selling generic drugs. Of course, one could say that the two activities are one in the same . . . somehow, I doubt that the current market effects were contemplated by the drafters of the 1984 act.
Random Walk
Can Astrazeneca buy up bank deposits, become a bank holding company, and get in line for TARP money that will bail them out from generic competition?
malcolm ross
Like the comment about Teva being in the business of pharmaceutical prospecting rather than manufacturing or selling drugs. Look at their production capacity and sales volumes.
I think it is more like the innovators who are in the business of manufacturing fools gold by extending products life cycle with dubious patent protection.
But maybe I am biased?
Bingo
Nathan,
Do you know anything about the patents in question or is your reaction just based on your pro-innovator bias?
At-risk launches are relatively rare in Paragraph IV cases and tend to indicate a strong case on the generic side.
There are lots of bad patents in place and the only way to get around them is to challenge them.
Do you think companies would continue to innovate if they could extend exclusivity indefinitely through bogus patents? Why would they bother? Generic competition is a spur to innovation, threatening as that might be.
Michael, your assertion is laughable. Teva’s Copaxone is subject to paragraph IV challenge by Sandoz. US sales of Copaxone are over $1 billion a year and are a significant contributor to Teva’s bottom line.