Generic drugmaker Teva Pharmaceutical Industries has halted sales of its new antibiotic product clarithromycin in the USA after another legal salvo from the drug’s originator Abbott Laboratories.
Teva launched a generic version of Abbott’s Biaxin XL product last Friday, after a federal court of appeal overturned a preliminary injunction blocking its introduction.
But Abbott swiftly responded by requesting that the judge in an ongoing patent infringement case between the two companies, who is most familiar with the case, impose another block on sales of Teva’s copycat version.
Teva said in a statement that it had decided to withdraw its product from sale pending the outcome of a hearing with the judge scheduled to take place tomorrow. The patent infringement lawsuit is not due to come to trial until March 2007, but if the initial hearing goes in its favour Teva may elect to re-launch its product and take the risk of losing the case and having to pay damages.
Analysts at A G Edwards cited by Reuters said the decision to halt the sale was sensible, as any short-term gain from sales of the generic could be heavily outweighed by damages if the patent infringement case does not go Teva’s way. Launching with an injunction still in place would make the Israeli firm liable for triple damages if its patent suit is unsuccessful, but only one-time damages if there has been an initial court decision saying its product dos not infringe Abbott’s patents.
At the moment Teva is the only company in the running to launch a generic version of the product.
The Israeli group has already obtained approval from the US Food and Drug Administration to market 250mg and 500mg doses of immediate-release Biaxin as well as a 500mg version of the extended-release form Biaxin XL, but had been prevented from launching the latter until the patent infringement litigation was resolved.
Biaxin is used to treat upper and lower respiratory and skin infections, and generates annual revenues of around $1.2 billion for Abbott, with around $305 million coming from the US market. The US drugmaker maintains that it has patent protection on the Biaxin XL formulation, which makes up the lion’s share of Abbott’s Biaxin revenues, out to 2017.