Exubera Insulin Litigation

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Novo-Nordisk A/S v. Pfizer, Inc.
Memorandum & Order   (December 14, 2006)


Judge Denies Novo-Nordisk’s Request To Halt
Pfizer’s Exubera Inhaled Insulin Sales

Home > Exubera Litigation  >  Pages 12 - 13 of 13

training sales persons and doctors for future prescribing of the product.7 If Pfizer has infringed the patent, as stated above, Novo is still years away from having AERx reach the market, and will suffer no loss in revenue for AERx in this regard. Also, if Pfizer is shown to have infringed and is later enjoined, Pfizer will have already opened the market to this new type of therapy. The balance of hardships strongly favors Pfizer.

PUBLIC INTEREST

                   “[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

________________________________

7Pfizer has hired approximately 4200 pharmacists and certified diabetes educators to aid in training prospective patients. (Pl.’s Mem. in Supp. of its Mot. for Prelim. Inj. at 12-13.) Exubera has already been launched to 5,300 physicians, and, “contingent on supply, Pfizer expects to launch Exubera to an additional 10,000 [physicians] in January 2007, 10,000 more in February, and a remaining 46,000 physicians in March 2007.” (Pfizer Inc.’s Mem. in Opp’n at 42.)

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“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.. (Id.)

                   At oral argument, Novo proposed a preliminary injunction wherein any “patient who can’t for medical reasons inject insulin or have a diagnosis of their doctor that they’re needle phobic and won’t inject insulin” would be allowed to use Exubera. (Id. at 174.) This proposal would of course substantially defeat Pfizer’s present marketing plan.8 It may or may not be affordable for Pfizer to produce a limited, and perhaps not cost-effective, run of a new drug for only a select few patients with serious phobia problems. Furthermore, such a preliminary order does not do much to alleviate Novo’s concern that those who use Exubera and are later forced to stop after trial will be harmed, it only limits the class of those at risk to the very people who most need this new form of therapy in the first place. Therefore the Court finds that the public interest weights in favor of a denial of the motion for a preliminary injunction.



CONCLUSION

                   For the reasons stated above, the Court denies the motion for a preliminary injunction. The parties are directed to submit to the Court by February 1, 2007 a proposed schedule for the future proceeding of this litigation.



Dated:   New York, New York
            December 15, 2006
                                                      /s/  Leonard Sand
                                         ___________________________
                                                U.S.D.J.

________________________________

8See supra note 7.

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