Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Abbott Laboratories v. Sandoz

December 15, 2006

ABBOTT LABORATORIES, PLAINTIFF,
v.
SANDOZ, INC. DEFENDANT.



The opinion of the court was delivered by: Honorable David H. Coar

MEMORANDUM OPINION AND ORDER

This matter comes before this Court on the motion of plaintiff, Abbott Laboratories ("Abbott"), for a temporary restraining order (a "TRO") against defendant, Sandoz, Inc. ("Sandoz").*fn1 Abbott seeks to enjoin Sandoz from marketing a generic extended release form of the antibiotic drug, clarithromycin, that allegedly infringes Abbott's U.S. Patent Nos. 6,010,718 (the "'718 patent"), 6,551,616 (the "'616 patent") and 6,827,407 (the "'407 patent") relating to its Biaxin XL product. For purposes of this motion, however, only the '718 patent is at issue. For the reasons stated below, Abbott's motion for a TRO is DENIED.

BACKGROUND

Abbott filed a complaint against Sandoz alleging patent infringement. Sandoz manufactures and markets generic versions of branded pharmaceuticals in the United States. Abbott sought a declaratory judgment that Sandoz would infringe the '718, '616, and '407 patents. Each of these patents pertains to Abbott's branded antibiotic product, BIAXIN XL, which is an extended release formulation of clarithromycin, an erythromycin derivative.

Clarithromycin is a macrolide antibiotic used to treat bacterial infections, particularly those of the skin and upper respiratory system. Abbott held a patent on the immediate release version of clarithromycin, marketed as BIAXIN, until the patent expired on May 23, 2005. Abbott began marketing BIAXIN in the United States in approximately 1991. In 2000, Abbott was issued two formulation patents (the '616 and the '718 patents) on an extended release formulation of clarithromycin. Abbott began marketing this extended release formulation under the name BIAXIN XL in 2000. As of May 2005, Abbott estimated that BIAXIN XL accounted for approximately 70% of the sales in the BIAXIN market. Generic competitors entered the market for immediate release clarithromycin on May 24, 2005.

Abbott brought an application for a temporary restraining order against Andrx Pharmaceuticals, Inc. ("Andrx") and Teva Pharmaceuticals USA, Inc. ("Teva") in this Court. Andrx and Abbott entered a stipulated temporary restraining order on May 20, 2005. This Court held a hearing and entered a temporary restraining order against Teva on May 20, 2005. This Court then held a hearing on Abbott's motion for a preliminary injunction against Teva and ultimately issued a preliminary injunction. That preliminary injunction order was vacated by the Federal Circuit Court of Appeals. Teva and Abbott subsequently entered into a settlement agreement.

Now Sandoz seeks to bring to market a generic version of an extended release clarithromycin product that undoubtedly will cause Abbott some loss of market position. Thus, Abbott seeks to stop Sandoz's intrusion upon the market for extended release clarithromycin products.

STANDARD FOR TEMPORARY RESTRAINING ORDER

A TRO is an emergency remedy issued to maintain the status quo until a hearing can be held on an application for a preliminary injunction. Coca-Cola Co. v. Alma-Leo U.S.A., Inc., 719 F. Supp. 725, 726 (N.D. Ill. 1989). Like a preliminary injunction, a TRO is designed to minimize the hardship to the parties pending the ultimate resolution of the lawsuit. Faheem-El v. Klincar, 841 F.2d 712, 717 (7th Cir. 1988). The standards for a TRO and a preliminary injunction are functionally identical in this circuit. Bernina of America, Inc. v. Fashion Fabrics Int'l, 2001 WL 128164, at *1 (N.D.Ill. Feb. 9, 2001).

A party seeking injunctive relief, including the entry of a TRO, must make a four-part threshold showing that (1) the movant has some likelihood of success on the merits of the underlying litigation; (2) immediate irreparable harm will result if the relief is not granted; (3) the balance of the hardships weighs in the movant's favor; and (4) the impact on the public interest is in favor of the relief. Polymer Techs., Inc. v. Bridwell, 103 F.3d 970, 973 (Fed. Cir. 1996); see also Duct-O-Wire Co. v. U.S. Crane, Inc., 31 F.3d 506, 506 (7th Cir. 1994). The movant's TRO can only be granted if it can establish both of the first two factors, specifically, likelihood of success on the merits and irreparable harm. Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1350 (Fed. Cir. 2001).

DISCUSSION

A. Likelihood of Success on the Merits

In order to demonstrate a likelihood of success on the merits, the plaintiff (Abbott) must show, in light of the presumptions and burdens that will be present at any eventual trial on the merits, that it is likely to prove the defendant (Sandoz) infringed its patent, and that any of the defendant's challenges to the validity and enforcement of its asserted patents lack substantial merit. Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1350-51 (Fed. Cir. 2001). The '718 patent has already been analyzed by both this Court and the Federal Circuit Court of Appeals in another case (the "Teva case"). See Abbott Laboratories v. Andrx Pharmaceuticals, Inc., 452 F.3d 1331 (vacating Abbott Laboratories v. Andrx Pharmaceuticals, Inc., et. al., 2005 WL 1323435 (N.D.Ill. June 3, 2005)).

In the Teva Case, Abbott secured a preliminary injunction against another generic drugmaker, Teva, that was trying to come to market with its own extended release clarithromycin product. 452 F.3d at 1332. Teva conceded that its generic extended release clarithromycin product infringed upon the '718 patent. Id. at 1333. However, Teva raised the defense that Abbott's '718 patent claims 2, 4 and 6 were invalid for obviousness under 35 U.S.C. ยง 103. Id. This Court found that Teva had failed to raise a substantial question as to the validity of Abbott's claims 2, 4 and 6. Id. On appeal, the Federal Circuit vacated the Order of this Court. Id. It held that this Court erred in assessing the content of prior art, which in the Federal ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.