Thursday, August 20, 2009

Merck beats Teva on Singulair in D NJ

As had been predicted, Merck beat Teva on Singulair in D NJ in Trenton before Judge Garrett Brown, who previously had been involved in the Florida Prepaid Postsecondary case.

Text at Bloomberg suggested Merck prevailed by presentation of secondary considerations to rebut a prima facie case of obviousness:

Merck “put forth sufficient evidence of the failed attempts of others to develop a leukotriene antagonist,” Brown said in his opinion.

In spite of the legal victory, Merck plans to cut 16,000 jobs:

Schering-Plough shareholders approved Merck’s $46.7 billion takeover offer this month.

Schering-Plough has said it plans to file for approval of seven drugs, which may each generate more than $1 billion in peak annual sales. Merck plans to eliminate 16,000 positions as part of the merger and to help stem the generic losses.

In a story by Ransdell Pierson , Reuters mis-reported the location of the trial: Teva had challenged the validity of patent '473 during a trial in February before Judge Garrett Brown in Newark federal court in New Jersey.

***In passing, there have been allegations of inequitable conduct relating to US Patent 5,565,473 directed to montelukast.
These are described in a blog post by Jim Edwards:

The suit claims that Dr. Robert Young of the Merck Frosst Center for Therapeutic Research wrote two articles about the processes behind Singulair before its application to the PTO was made. It alleges that Merck attorney Gabriel Lopez reviewed the articles and then decided to omit them in his filing for Merck.

Young also presented his work to Merck scientists, the suit claims:

A primary inventor named in the ‘473 patent has conceded in deposition testimony that key insights behind the purported invention in the ‘473 patent first occurred to Merck scientists either during that presentation or shortly thereafter.

A third article was mentioned in Merck’s patent but a copy was not provided to the PTO examiner, and a fourth abstract also was not disclosed, the suit claims.

Thus Merck’s 2007 suit against Teva to prevent it from making a generic Singulair is a sham, the suit says. Roxane Labs was also prevented from producing a generic.


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