ROUND OF LAWSUITS MAY THREATEN GENERIC ZOLOFT LAUNCHES
Multiple patent infringement lawsuits filed in federal court by Teva Pharmaceutical against competitors gearing up to market their own generic versions of Zoloft could jeopardize their efforts, legal sources say.
"Basically, Teva has put its generic competitors in the position of launching their versions of Zoloft at risk, even after they've waited out Teva's 180-day exclusivity period," drug patent attorney David Harper said. "It looks like a page out of the pharma playbook."
In separate complaints filed in the U.S. District Court for the District of New Jersey between Jan. 12 and 17, Teva charges several generic firms with infringing on four of its patents related to crystalline forms of sertraline hydrochloride and how they are manufactured. The patents cover crystalline versions (called polymorphs) of the active ingredient and certain preparation and process methods related to its production.
Generic firms holding tentatively approved abbreviated new drug applications (ANDAs) include Apotex, Sandoz, Genpharm, Pliva, Andrx, Sun Pharma, Lupin, Roxane and Mutual Pharma. They were set to launch sertraline hydrochloride tablets in multiple doses ranging between 10 and 200 mg early next month until they were hit with patent infringement lawsuits filed by Teva.
According to the complaint, Teva had requested data and product samples from the generic firms named in the suits and it resorted to legal action after it received no responses.
Teva representatives did not respond to requests for comment.
The lawsuits come weeks before Teva's 180-day marketing exclusivity period expires Feb. 6, prompting questions about the timing of the patent litigation.
"Teva admits in its complaint that it does not really know whether the patents are infringed. Instead, it notes that Teva sought information on the methods used by the competitors for producing their generic versions of Zoloft and filed suit when their information requests went unanswered," Harper explained.