Combination Drugs: Intellectual Property Hogs?

Today it was reported (subscription required) that BiDil, a combination drug of isorsorbide (a nitrate) and hydralazine (an alpha blocker/vasodilator), made by Nitromed, Inc., and specifically approved for use in blacks with congestive heart failure, has had underpenetration of the market due to its high price. Insurers have argued that the other generic medications (isorsorbide and hydralazine) can be administered separately for less cost, explaining the underpenetration in blacks despite significant clinical improvement in heart failure symptoms with the medication.

Now it is rumored that Nitromed may threaten intellectual property infringement if separate drugs are used instead (WSJ):

NitroMed, meanwhile, is taking a hardball stance. It says it believes insurers that encourage the prescription of the two generic drugs instead of BiDil may be bordering on patent infringement. That's because the company owns several patents covering the combination use of isosorbide and hydralazine, either as separate pills or in a single pill, for the treatment of heart failure. The company has sent letters to more than a dozen health insurance plans, including Aetna Inc., Humana Inc. and Coventry Health Care Inc., placing them on notice of this view.

"We'd much rather have the plans as our customers and we don't want to be litigants," says company spokeswoman Jane Kramer. "But if it becomes necessary to fight for our intellectual property, we will."

Aetna replied that it was "very confident that our actions do not violate any patent rights." A spokeswoman for Humana said she had not been able to find a record confirming receipt of the letter at the health plan. Coventry didn't return several requests for comment.

Give me a break! While I understand the company's concerns about lack of sales, the thought they'd come after me due to intellectual property infringement because I choose to save my patient a few bucks by using separate generic drugs will NEVER fly. Too many other examples of combination drugs are out there and if my patient is willing to take the generics more frequently to save a few buck, so be it!

Intellectual property threats like this only serve to discredit Nitromed, Inc. They might want to rethink this stance.

-Wes