In what could be termed as a setback to the Indian drug major, Dr Reddy?s Labs has reached at an out-of-court settlement with Teva Pharmaceuticals in patent litigation regarding the sales of blockbuster anti-depressant drug, Zoloft. Under the agreement, Dr Reddy?s will not sell generic Zoloft in the US other than to Teva. Also, Dr Reddy?s will provide Teva with 30-days advance notice of any import, sale or use of sertraline hydrochloride, the active pharmaceuticals ingredient (API) of Zoloft, in the US.
Early this week, Teva and Dr Reddy?s filed a joint stipulation of dismissal of their lawsuit, filed on February 1, 2007 in the district court of New Jersey, over sertraline hydrochloride. Teva has also filed patent suits against other Indian firms like Aurobindo, Matrix, Cipla, Zydus Cadila, Torrent and Lupin. A spokesperson for Dr Reddy?s refused to comment on the issue.
Teva, the world?s largest generic player, has been known to obtain a number of patents on a single API before the drugs go off patent, which results in other generic drug makers being unable to apply for approval of the drug. An industry expert says, ?Teva receives patents of even various particle sizes or crystallization forms of an API, which makes it difficult for others to get approval for the API without infringing Teva?s patents.?
For Zoloft, Teva is claimed to be the owner of right, title, and interest in US patents relating to methods of manufacturing certain crystalline forms of sertraline hydrochloride. Various crystalline forms known as ?721, ?073, ?987 and ?340 patents were issued to the company. Teva argued that the import, manufacture, use and sale by the defendants of its generic Zoloft would infringe its patents. In July 2006, Ivax Corp, a subsidiary of Teva, had launched its generic Zoloft with 180-day exclusivity.
Zoloft, the drug of Pfizer for which the patent expired in June 2006, had registered sales of $3.3 billion in 2005. So far, the US FDA has given tentative approvals to 27 players.