MannKind holds patents protecting the design and formulation of Technosphere, however, the device appears to infringe the following patents held by Novo Nordisk. Novo has sued Pfizer for patent infringement of these patents in reference to Exubera.
• US 6,250,298 Gonda, et al. June 26, 2001. Method of use of monomeric insulin as a means for improving the reproducibility of inhaled insulin.
• US 6,024,090. Gonda et al. February 15, 2000. Method of treating a diabetic patient by aerosolized administration of insulin lispro. Claim 1. A method of treating a diabetic patient, comprising: (a) aerosolizing a formulation comprising monomeric insulin and a carrier to make an aerosol;
• US 5,743,250. Gonda, et al et al. April 28, 1998. Insulin delivery enhanced by coached breathing. Claim 1. A method of enhancing the rate at which insulin migrates into a patient's circulatory system, comprising: aerosolizing a formulation; inhaling the aerosolized formulation into lungs of a patient and allowing particles of insulin to deposit on lung tissue; inhaling maximally followed by exhaling the forced vital capacity of the lungs.
Novo Nordisk, filed a patent infrignment lawsuit against Pfizer on August 1, 2006, claiming patent infringement. The lawsuit seeks both compensatory damages and injunctive relief. Novo sought a preliminary injunction preventing the release of Pfizer's planned September 2006 launch of the diabetes drug. A federal judge, however, delayed any decision on Novo Nordisk's request for injunctive relief until at least December 4, 2006 when a court hearing is scheduled in the case. Pfizer's answer contends that Novo wants to deny diabetics access to Exubera because it's the only FDA approved inhaled insulin and interfere with the company's pharmaceutical business.
From Wikipedia: On December 14, 2006 a federal judge denied Novo Nordisk's request for a preliminary injunction to halt sales of Pfizer's inhaled insulin. The patent lawsuit, however, has not been dismissed, and Pfizer's legal defenses are preserved. The pharmaceutical companies are still litigating in court over their respective inhaled insulin patent claims, a process that could take some time to resolve.
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