Friday, January 29, 2010

Teva won the battle of world's top-selling Brain Cancer Drug patent

History:

Schering-Plough Corporation merged with Merck & Co on November 4,2009. Schering-Plough had licensed the Temodar patent (see full text here) from Cancer Research Technology Ltd. (CRT) of the U.K. and began selling Temodar in 1999. The drug Temodar approved to treat brain tumors, had worldwide sales of $781 million for the first nine months of 2009, the last period reported by Schering-Plough.

In 2007, Barr Pharmaceuticals, which is now owned by Teva, filed for FDA approval to sell a generic version of Temodar. This triggered a patent infringement lawsuit by Schering-Plough and Cancer Research Technology in federal court in Delaware, which went to trial earlier this year.

Who has claimed?

Barr claimed that the patent was unenforceable partly because Cancer Research Technology unreasonably delayed the patent-review process by filing and withdrawing numerous applications, and requesting extensions of time to respond to questions by the U.S. Patent and Trademark Office. Cancer Research Technology countered that the patent examiners required additional data to support the patent.

Court ruling decision:

Israel-based Teva Pharmaceutical Industries Ltd the world’s largest generic drug maker has won its patent litigation against Merck & Co. Inc. Over brain tumor treatment drug Temodar. The US District Court ruled in favor of Teva. Now Teva is waiting for the US Food and Drug Administration (FDA) to give final marketing approval for the company's generic version of Temodar which is world's top-selling brain cancer drug.

As the first company to file an Abbreviated New Drug Application (ANDA) with paragraph IV certification for Temodar, Teva is eligible to receive 180-day marketing exclusivity for its generic version of the drug. Teva is seeking to market 5, 20, 100, 140, 180, and 250 milligram capsule dosages of generic drug .Now Teva Pharmaceutical Industries Ltd. (TEVA) can sell a copycat version before the U.S. patent expires in 2014.

Response:

Merck spokesman said that "We are disappointed with the ruling and continue to believe the patent is valid and enforceable, and we will continue to defend our intellectual property,"

Sources: orange book blog, Google news

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