The U.S. District Court for the Southern District of New York has denied a motion for a preliminary injunction that would have blocked further sales of its inhalable insulin medication, Exubera, in the U.S. based on public interest.
Danish drug company Novo Nordisk A/S filed a claim for patent infringement against Pfizer, alleging that Pfizer’s new diabetes drug Exubera infringes on patents held by Novo. Novo also filed a motion for a preliminary injunction seeking to enjoin Pfizer from making, using, selling, offering to sell, and/or importing Exubera into the United States. The motion for a preliminary injunction focuses solely on Pfizer’s alleged infringement of U.S. Patent No. 5,884,620.

The ’620 patent claims a system for the efficient and reproducible inhalation of aerosolized insulin through the lungs and into the bloodstream to manage the blood sugar levels of diabetics. Claim 1 of the ’620 patent provides for a:

[M]ethod of administering insulin to a human patient by inhalation and comprises: (a) exhaling a determined volume of air; (b) aerosolizing an insulin formulation; (c) inhaling the aerosolized formulation with a determined volume of air; and (d) repeating (a), (b), and (c) a plurality of times wherein the determined volume of air exhaled in (a) is substantially the same for each step (a) and the determined volume of air in (c) is substantially the same for each step (c).

Novo argues that before the ’620 patent, no one knew that repetition of a breathing technique would lead to consistent insulin dispersal in the bloodstream via the lungs, and that Exubera is dependant on their patented method.

It is noteworthy that Novo is currently in the process of creating its own inhalable insulin system in conjunction with the ’620 patent, called AERx, which is currently in clinical trials and estimated to hit the market in 2011.

The FDA approved instructions for Exubera are:

[i] Push the “blue button” on the Exubera device and “watch the insulin cloud fill the chamber”;
[ii] Breathe out normally;
[iii] In one breath, slowly and deeply breathe the insulin cloud in through your mouth; and
[iv] Breathe out normally.

Novo asserts these instructions infringe on the method of breathing covered by the ’620. Novo’s position is that the words “breathe out normally” in the above instruction infringes on its patented method of assuring uniform predetermined quantities of inhalable insulin

To get a preliminary injunction, one must prove the likelihood of success on the merits considering both patent validity and infringement. If the non-movant “raises a substantial question concerning either infringement or validity, i.e. asserts an infringement or invalidity defense that the patentee cannot prove lacks substantial merit” the preliminary injunction will not issue.

Novo contends that the ’620 patent is entitled to a presumption of validity and furthermore satisfies a long-felt need for an alternative method of insulin delivery. Although, Novo conceded that if Exubera’s instructions did not direct the user to “breathe out normally” at the outset of the insulin treatment session, Exubera would not infringe on the ’620 patent’s mandate to use a determined volume of air during the breathing method.

Pfizer contends that Exubera does not infringe upon the ’620 patent because the patent does not cover Exubera’s breathing instructions and, in the alternative, if the ’620 patent does cover Exubera it is invalid because it is anticipated by the prior art.

Pfizer argues that under Novo’s construction of “determined volume of air,” anytime a patient is instructed to inhale and exhale in a certain manner, this results in the patient inhaling or exhaling a determined volume inhalation and this would cover prior art breathing techniques such as the sort used for the treatment of asthma. Pfizer also argues that if Novo’s definition of “determined volume of air” covers Exubera, then the ’620 patent is anticipated by prior art in the field of inhalable insulin and is obvious to those with an ordinary level of skill in the field.

In the end, it was public interest that prevailed in this case

“[I]n a patent infringement case, although there exists a public interest in protecting rights secured by valid patents, the focus of the district court’s public interest analysis should be whether there exists some critical public interest that would be injured by the grant of preliminary relief” Hybritech, Inc., 849 F.2d at 1457. Enjoining the release of a new and less invasive treatment for diabetes would quite obviously be contrary to the public interest, particularly in the interval between now and trial. Pfizer contends that Exubera will allow diabetics who are currently not coping well with their diabetes or afraid to begin injecting insulin to try and control their disease in a new manner. There is a strong public interest favoring such a device. Novo argues in its briefs that it is against the public interest to start patients on a new diabetes treatment plan, only to later enjoin that method. However, at oral argument, Novo conceded that there was no medical risk in switching back from inhalable insulin to injectable insulin. (Prelim. Inj. Hr’g. 165.) While it may take a former Exubera user “some period” to adjust to a new method, without any medical harm this is clearly a risk worth taking in favor of the public interest.

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