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Is Merck's Singulair Patent a Fraud? Suit Lays Out Timeline of Omissions

Patent litigation is usually dull stuff, but the case filed by several wholesale pharmacies against Merck over its Singulair patent is a doozy. It describes in detail how Merck allegedly defrauded the Patent and Trademark Office by failing to mention in its application for the patent that the idea for Singulair did not spring from its labs but from four previously published articles.

The result, the pharmacies allege, is that Merck was wrongly given a monopoly on Singulair when the method of its creation was well-known, and that pharmacies and generic maker such as Teva and Mylan were denied the right to make generic versions of the drug.

Merck claims its patents are valid and enforceable. Merck earns about $3 billion a year from the drug.

The suit says:
Merck deliberately engaged in inequitable and fraudulent conduct in its statements and submissions to the PTO.
Patents cannot be issued if the invention is the subject of "prior art," meaning that everyone already knows how to make the stuff. That's why you can't get a patent on the wheel or fire, but you could get one on a cure for HIV.

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.

Teva just lost another ruling in its patent challenge of Singulair; it is not clear how that ruling would be affected if it emerged that the original patent was based on a fraud. Here's Merck's statement on the Teva ruling.