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 9 - 11 of 13

Novo contends that introduction of Exubera, which absent injunctive relief will be the first inhalable insulin product to reach the American public, will tarnish Novo’s reputation and result in a loss of its hard fought market share. (Pl.’s Mem. in Supp. of its Mot. for Prelim. Inj. at 21.) Novo asserts that the marketing of Exubera prior to launch of Novo’s AERx will further harm Novo’s status and market position. (Id. at 23.) Pfizer argues that any future loss Novo may suffer should it release AERx is highly speculative because AERx is more than four years away from reaching the market. (Pfizer Inc.’s Mem. in Opp’n at 36.) Assuming that AERx does eventually reach the market in 2011 other major pharmaceutical makers actively working on developing an inhalable insulin product may have preceded Novo’s entry into the market. (Id. at 1.) Thus, regardless of whether or not Pfizer is enjoined, Novo’s claim to preserving a role as a unique innovator in diabetes treatment will not go unchallenged.

                   Novo’s attempts to show irreparable harm in the future for both its current market standing and for the future sales of AERx fail as, paradoxically, they are readily determinable for the purposes of monetary damages and at the same time speculative.

                   Should Novo prevail at trial, money damages will be readily available. Pfizer is the largest pharmaceutical company in the world, and will be providing Exubera on a prescription only basis. (Pfizer Inc.’s Mem. in Opp’n at 42.) Novo too keeps records of its prescription sales, so any drop in sales is quantifiable. (Id.) The amount of Exubera users will be easy to track, and any decline in Novo’s sales due to the alleged infringement will be readily ascertainable. As the Court has noted, Novo’s alleged reputation as an innovator in diabetes treatment will not be preserved by obtaining a preliminary injunction. It is uncontested that other pharmaceutical companies are further

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along in developing a marketable inhalable insulin product than Novo; even assuming Novo successfully enjoins Exubera its status as an innovator will be harmed.

                   Novo proceeds under the assumption that it will suffer a drop in sales during interim between now and a trial on the merits. Pfizer states that it is currently planning on marketing Exubera only to diabetics suffering from a form of diabetes, those with Type 2 diabetes “uncontrolled by 2 oral agents”5 for which Novo currently does not offer treatment. (Id. at 8-9.) Thus Pfizer asserts that its present intent is to reach a market entirely different than that which Novo now reaches or seeks to reach. While it is possible that Pfizer could expand the scope of its intended users going forward, or that doctors would prescribe Exubera on their own for other types of diabetics during the interim prior to a trial on the merits, Novo’s market share will not be affected by Exubera. As stated above, AERx is years away from its launch date; at that time, other companies may have taken over the field, newer products may become available, or all inhalable insulin products could fail to find acceptance in the market place.

                   Patents provide the right to exclude others from using one’s invention and money damages are not always an adequate remedy for infringement. Hybritech, Inc., 849 F.2d at 1457. In this case, however, Novo has only shown that the future market harms it may suffer between now and trial are compensable by money damages except to the somewhat amorphous claim to a role as the premier pharmaceutical company in the treatment of diabetes, a claim that for the reasons stated above the Court does not find persuasive. The harms Novo may suffer between now and trial are compensable by money damages because of the availability of prescription records to quantify the harm,

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5Other forms of diabetes are not treated with insulin, or are treated with other forms of insulin which Pfizer does not plan to market.

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the lack of any Novo product on the market in the immediate future, and Pfizer’s ability to pay a large damages award. Therefore the Court finds this prong to weigh in favor of Pfizer.

BALANCE OF HARDSHIPS

                   When balancing hardships the Court “must balance the harm that will occur to the moving party from the denial of the preliminary injunction with the harm that the nonmoving party will incur if the injunction is granted” Hybritech, Inc., 849 F.2d at 1457.

                   The Court agrees with Pfizer’s view that diabetes is not a single product field; there are various courses of treatment available with various insulin therapies. (Pfizer Inc.’s Mem. in Opp’n at 44.) Ignoring the fact that the success of Exubera, or later AERx, is not guaranteed and that Pfizer does not intend to market Exubera to a class of diabetics currently served by Novo’s products, Novo argues that it should not be faced with a loss of significant sales of insulin based diabetes treatments to Pfizer as many of its customers who do not accept injecting insulin will switch to the less invasive inhalable insulin option that Exubera provides. (Pl.’s Mem. in Supp. of its Mot. for Prelim. Inj. at 24.) Even if Pfizer’s marketing plans change before trial, the balance of hardships would still favor Pfizer.

                   Pfizer has invested huge sums of money in this product, all of which would be unfairly frozen pending this litigation should Pfizer later show it did not infringe the patents at issue.6 The money invested includes development costs for the product and

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6The exact amount is under seal.

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