Teva trounces patent on AstraZeneca's Symbicort, opening up U.K. copycat launch

September 3, 2014 | By Carly Helfand

Ring up another win for Teva ($TEVA) in its fight to roll out a generic of AstraZeneca's Symbicort in Europe--and another loss for aging respiratory blockbusters trying to hoard their market share. The English High Court has sided with Teva in a patent case, invalidating one of AZ's IP shields on the drug.

The British pharma's patent covering Symbicort's Single inhaler Maintenance and Reliever Therapy (SMART) indication is obvious, the court ruled, rejecting the AstraZeneca's ($AZN) proposed amendments to the patent. With Symbicort's key patents already expired, that's one more roadblock out of the way for Teva and its DuoResp Spiromax, the generic it's working to roll out across the continent.

"Our DuoResp Spiromax product brings effective treatment to the patient in a device that is intuitive and easy to use," Teva Global Specialty Medicines President and CEO Rob Koremans said in a statement. "Yesterday's judgment is a big step in enabling us to make a difference to people's lives in the U.K. and all across Europe."

This isn't the first Symbicort patent win for Teva, the Israeli generics giant noted in a Wednesday announcement. The company has previously squashed a pair of patents and their national equivalents before the European Patent Office and the Norwegian court.

Teva will have to continue to take its product market by market if it hopes to challenge Symbicort's European presence. Novartis ($NVS) has so far done just that with its AirFluSal Forspiro, a generic of GlaxoSmithKline's ($GSK) market-leading Advair that now boasts approval in handful of EU countries including Denmark, Germany and Belgium. Cipla, too, is squaring off against Advair one market at a time with its own copy, a product it's currently launching in Germany and Sweden.

And if Advair's sales decline is any indication, things don't look too bright for Symbicort. In the first half of 2014, worldwide sales of GSK's one-time $8-billion-a-year seller slipped 14%, with "increasing competition" from Europe taking its toll, the company said in a regulatory filing.

On top of that, AstraZeneca will have to deal with payer headaches in the U.S. Its removal from CVS' preferred formulary--which applies to 24 million of the PBM's 37 million covered lives--will no doubt erode Symbicort's market share, Leerink Partners analyst Seamus Fernandez wrote in a recent note to clients. "At a minimum, we would expect AZN to lose several percentage points of TRx share from this change in 2015," he said.