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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 1 - 3 of 17
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
NOVO NORDISK, A/S,
Plaintiff
- v. -
PFIZER, INC.,
Defendant.
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06 CV 5819 (LBS)
Memorandum and Order
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SAND, J.
On August 1, 2006 plaintiff, Novo Nordisk A/S (Novo), filed a claim for patent infringement against defendant Pfizer Inc, alleging that Pfizer’s new diabetes drug Exubera infringes on five 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 one of the five patents at issue in the complaint, U.S. Patent No. 5,884,620 (the ‘’620 patent”). For the reasons set forth below, the motion for a preliminary injunction is denied.
JURISDICTION AND FACTUAL BACKGROUND
Novo’s claim for patent infringement is brought pursuant to 35 U.S.C. §§ 271 and 281. The Court possesses subject matter jurisdiction over these claims pursuant to 28 U.S.C. §§1331 and 1338. Novo is a pharmaceutical company engaged primarily in selling diabetes products. Novo is a corporation organized and existing under the laws of
the Kingdom of Denmark with its principal place of business in Bagsvaerd, Denmark. (Compl. ¶ 6.) Pfizer is a corporation organized and existing under the laws of the state of Delaware with its principal place of business in the Southern District of New York. (Id. ¶ 7.)
The ’620 patent was issued to Aradigm Corporation on March 23, 1999, for an
invention entitled “Inhaled Insulin Dosage Control Delivery Enhanced by Controlling
Total Inhaled Volume.” (Compl. ¶ 9.) Novo has acquired all rights, title, and interest to
the ’620 patent. (Compl. ¶ 28.)
Diabetes, a disease characterized by persistently high blood glucose levels, affects
approximately 21 million Americans, with 1.5 million new diagnoses a year. (Pl.’s Mem.
in Supp. of its Mot. for Prelim. Inj. at 7.) Approximately one-third of diabetics treat their
disease through careful regulation of their glucose level by taking insulin. (Id.)
Traditionally, insulin is administered by injection or other invasive procedures at least
once per day to those diabetics who require insulin. (Id.) Many diabetics are averse to
the use of needles for insulin administration, which leads to non-compliance with
prescribed treatment or health damaging delay in seeking insulin therapy. (Id. at 8.) Due
to this aversion, many pharmaceutical companies have been researching alternatives to
the injection of insulin. (Id.)
Research has found that insulin can be introduced into the bloodstream if it is
delivered into the lungs of a patient.1 (Id. at 8.) Insulin dosing must be precise; extremes
in blood sugar levels which could result from ingestion of inappropriate quantities of
insulin can lead to loss of consciousness and even death. (Id.) Consistent reproduction
of insulin delivery for absorption of determined quantities of insulin into the bloodstream
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1 The extent to which this research qualifies as prior art for the ’620 patent is the subject of dispute.
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has proven to be the biggest hurdle in perfecting an inhalable insulin product. (Id.)
Novo’s patents at issue purport to solve the problems encountered with previous attempts
to create a breathable insulin system. The ’620 patent, in conjunction with the other four
patents at issue in the complaint, proposes 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. Id. Claim 1 of the ’620 patent registers 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).
(Id. at 9-10.) 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. (Prelim. Inj. Hr’g Tr. 7,
Dec. 4, 2006.) 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. (Pl.’s Mem. in Supp. of its Mot. for Prelim. Inj. at 10.) AERx’s arrival on the
market is estimated to occur in 2011. (Prelim. Inj. Hr’g Tr. 26.)
On December 27, 2004, Pfizer submitted to the Food and Drug Administration
(“FDA”) a New Drug Application (“NDA”) for Exubera. (Compl. ¶ 14.) The NDA
provides for the use of Exubera in the treatment of adult diabetes and hyperglycemia.
(Compl. ¶ 15.) On January 27, 2006 the FDA approved the NDA. (Compl. ¶ 16.)
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Exubera is the first FDA-approved device to administer insulin via the lungs of diabetics.
(Pfizer Inc.’s Mem. in Opp’n at 1.) 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;
[iv] Breathe out normally
(Id. at 7.) Pfizer originally intended to sell Exubera in the United States beginning in
September 2006, (Compl. ¶ 17), but has delayed the launch of the drug until March 2007.
(Prelim. Inj. Hr’g Tr. 60.) 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. (See Prelim. Inj. Hr’g Tr. 41) (“[I]f you
breathe in normally and breathe out normally, that’s a determined volume of air. So
Pfizer’s instruction is exhaling a determined volume of air because we know where the
exhale started from; it started from the end of normal inhalation.”)
STANDARD FOR A PRELIMINARY INJUNCTION
Under 35 U.S.C. § 283, this Court may grant an injunction to a patentee alleging
infringement. As with non-patent cases, a preliminary injunction is a “drastic and
extraordinary remedy that is not to be routinely granted.” Nat’l Steel Car, Ltd. v.
Canadian Pac. Ry., Ltd., 357 F.3d 1319, 1324 (Fed. Cir. 2004). As the moving party,
Novo is entitled to a preliminary injunction if it can show a “(1) reasonable likelihood of
success on the merits; (2) irreparable harm; (3) that the balance of hardships tips in its
favor; and (4) the impact of the injunction on the public interest.” Jack Guttman, Inc. v.
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