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Partner Barry Negrin was interviewed by Pharmawire.com for its September 25, 2009 article entitled “Vivus’s Qnexa has strong patent although drug composed of two generic compounds.”

Qnexa is a weight loss drug that combines two compounds, phentermine and topiramate – both off-patent – into one drug. Phase III trials have been completed and the company plans to file an NDA before the end of this year. The article notes that the Qnexa patent is unlikely to face obviousness challenges in the future, despite the fact that the obesity pill is composed of two generic components.  

Negrin, a patent attorney, noted that it was not necessarily obvious to combine phentermine with another compound when the Qnexa patent was filed and agreed that the FDA’s warning against combining phentermine with another compound could strengthen Vivus’s patent position.

In addition, Negrin noted that the Qnexa patent would survive the “main test for obviousness” – whether two known elements, when combined, produce unexpected results.  If this combination does provide unexpected results, then it is not obvious. Because phentermine and topiramate have synergistic effects, and not just additive effects, the combination has unexpected results and would survive an obviousness attack.

“[Vivus] is in pretty good shape,” Negrin said, after analyzing the Qnexa ‘818 patent. In addition to the ‘818 patent, Vivus has additional pending patents that could cover different doses of Qnexa that could provide this compound with additional protection against generic competition, he added.

To read the article, please click here.