The concept of inhaled insulin has been around for multiple decades. The technology behind the delivery systems is rather different, and so is the formulation they deliver. I doubt Novo gets much out of this. They are in a weak competitive position now, so the risk/reward of the legal approach is probably worth it to them. If it works on PFE they can club Lilly/Alkermes, MannKind, Kos, and whoever else. But if they can win an injunction, that's worth the $12 million they paid for the ARDM patents right there. ARDM probably didn't want to devote the resources needed to fight this battle by itself, so it makes sense that they sold 'em to Novo, which has those resources. I might try to dig around in the patent literature, but gut feel is that this is a relatively cheap and desperate move by Novo.
>>Novo Nordisk years away from releasing inhaled insulin
Wednesday August 2, 11:33 am ET
By Aaron Smith, CNNMoney.com staff writer
Novo Nordisk has sued Pfizer, alleging that the new product Exubera violates patents on inhalable insulin for diabetics.
"We're trying to protect our intellectual property," said Novo Nordisk general counsel Jim Shehan. "We've been a leader in diabetes for 80 years. For us to keep that leadership position it's essential that our intellectual property rights are respected."
Shehan said that Pfizer's Exubera violates five Novo Nordisk patents involving inhaled insulin, and that the first of his company's patents was filed in 1993. The company filed the suit on Tuesday in federal court in Manhattan, where Pfizer is based.
Pfizer, the biggest drug maker in the world, plans to release Exubera, the first form of inhalable insulin, in the U.S. in September. This product, believed by some analysts to be a potential billion-dollar blockbuster, would allow diabetics to inhale dry powdered insulin through a dispenser. Diabetics have difficulty or are unable to produce insulin naturally, and injected insulin has been the standard treatment since the 1920s.
Danish drugmaker Novo Nordisk, the leading supplier of insulin worldwide, is conducting late-stage tests with AERx, a formed of inhaled insulin that uses aerosol. Novo Nordisk developed the product with Aradigm Corp.
But Pfizer is years ahead of the competition. If Novo Nordisk's tests, which involve 2,000 patients, are successful, then the drug maker would probably file its application to the Food and Drug Administration in 2009.
Pfizer Bryant Haskins released this statement in response to the lawsuit: "Pfizer has not had an opportunity to review the Novo Nordisk complaint, but we are confident in the innovation behind the development of this important new medicine."
The U.S. drug market for diabetes is at least $12 billion and growing, fueled by aging baby boomers suffering from bad health and obesity, known by health care providers as "diabesity."
In diabetes, the pancreas fails to produce enough insulin, which converts sugar into energy. The American Diabetes Association says that 20.8 million Americans are diabetic, while another 41 million are at risk.<<
Edit: Here's two patents, the first Aradigm's, the second InHale's. Note ARDM got it theirs issued first, but InHale filed first.
patft.uspto.gov
patft.uspto.gov
Cheers, Tuck |
