Abbott Laboratories v. Torpharm, Inc.

• Citation: 156 F.Supp.2d 738
• Decision Date: 30 March 2001
• Docket Number: No. 97 C 7515.,97 C 7515.
• Parties: ABBOTT LABORATORIES, Plaintiff, v. TORPHARM, INC.; Apotex, Inc.; Apotex Corp., Defendants.
• Court: U.S. District Court — Northern District of Illinois

156 F.Supp.2d 738

ABBOTT LABORATORIES, Plaintiff, v. TORPHARM, INC.; Apotex, Inc.; Apotex Corp., Defendants.

No. 97 C 7515.

United States District Court, N.D. Illinois, Eastern Division.

March 30, 2001.

Thomas David Brooks, Sperling, Slater & Spitz, P.C., Chicago, IL, Daniel E. Reidy, James R. Daly, Robert C. Micheletto, Jones, Day, Reavis & Pogue, Chicago, IL, for plaintiff. Hugh L. Moore, Richard Philip Beem, Scott B. Feder, Keith D. Parr, Paul J. Molino, William Andrew Rakoczy, Deanne M. Mazzochi, Lord, Bissell & Brook, Chicago, IL, for defendants.

OPINION AND ORDER

NORGLE, District Judge.

Before the court is Plaintiff's motion for summary judgment. For the following reasons, the motion is granted.

I. BACKGROUND

This patent infringement case arises from Defendants' (hereinafter "Torpharm") attempt to gain approval from the Food and Drug Administration ("FDA") to market the generic equivalent of DEPAKOTE®¹, an anti-seizure medication produced by Abbott.

A very brief discussion of the intersection between patent and drug laws places this dispute in context. With what is commonly known as the Hatch-Waxman Act, Congress set up an expedited process for FDA approval of generic equivalents of previously approved drugs. See Bayer AG v. Elan Pharmaceutical Research Corp., 212 F.3d 1241, 1244-45 (Fed.Cir.2000); Glaxo v. Novopharm, Ltd., 110 F.3d 1562, 1567-70 (Fed.Cir.1997); Jeffrey I.D. Lewis, Declaratory Judgments of Patent Infringement: What They Forgot About Drug Applications, 7 Fed. Cir. B.J. 35 (1997). The Hatch-Waxman Act allows generic drug manufacturers to gain FDA approval of generic drugs pursuant to an abbreviated new drug application ("ANDA"), which is substantially less expensive and time consuming than getting FDA approval for a brand new, or pioneer, drug. 21 U.S.C. § 355(j); 21 C.F.R. § 314.94; Bayer AG, 212 F.3d at 1244-45. As part of the ANDA, the generic manufacturer must submit one of four certifications concerning patents that may pertain to the previously approved drug: (1) that such patent information has not been filed (a "Paragraph I" certification); (2) that such patent has expired (a "Paragraph II" certification); (3) the date on which such patent will expire (a "Paragraph III" certification); or (4) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted (a "Paragraph IV" certification). 21 U.S.C. §§ 355(j)(2)(A)(vii)(I)-(IV); Bayer AG, 212 F.3d at 1244-45.

A Paragraph IV certification is an invitation to a patent infringement suit. Bayer AG, 212 F.3d at 1244-45. Paragraph IV certification requires the ANDA applicant to give notice of the certification to the patentee. 21 U.S.C. § 355(j)(2)(B)(i); Bayer AG, 212 F.3d at 1244-45. The patentee then has forty-five days to file a patent infringement action under 35 U.S.C. § 271(e)(2)(A). Bayer AG, 212 F.3d at 1244-45. If the patentee fails to file the infringement suit, the ANDA is approved immediately after meeting the applicable scientific and regulatory requirements. Id. Such is the case here. Torpharm is seeking FDA approval to market the generic equivalent of DEPAKOTE, and submitted an ANDA with a Paragraph IV certification. Abbott responded with this suit.

DEPAKOTE's active ingredient is divalproex sodium. Abbott owns two patents for sodium hydrogen divalproate oligomers, # 4,988,731 (the '731 patent), and # 5,212,326 (the '326 patent). Abbott asserts that both the '731 patent and the '326 patent cover divalproex sodium, including DEPAKOTE and Torpharm's proposed generic equivalent. Abbott moves for summary judgment, arguing that there is no genuine dispute of material fact that Torpharm's proposed product infringes the '731 and '326 patents. Torpharm asserts that the patents do not cover its proposed product and are invalid.

II. DISCUSSION

A. Standards for Summary Judgment:

Summary judgment is permissible when "there is no genuine issue as to any material fact and ... the moving party is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(c). The nonmoving party cannot rest on the pleadings alone, but must identify specific facts, see Cornfield v. Consolidated High School District No. 230, 991 F.2d 1316, 1320 (7th Cir.1993), that raise more than a mere scintilla of evidence to show a genuine triable issue of material fact. See Murphy v. ITT Educational Services, Inc., 176 F.3d 934, 936 (7th Cir.1999); see also Shank v. William R. Hague, Inc., 192 F.3d 675, 682 (7th Cir.1999) (stating that a party opposing summary judgment must present "what evidence it has that would convince a trier of fact to accept its version of events"). In deciding a motion for summary judgment, the court can only consider evidence that would be admissible at trial under the Federal Rules of Evidence. See Bombard v. Fort Wayne Newspapers, Inc., 92 F.3d 560, 562 (7th Cir.1996). The court views the record and all reasonable inferences drawn therefrom in the light most favorable to the party opposing summary judgment. See Fed.R.Civ.P. 56(c); see also, Perdomo v. Browner, 67 F.3d 140, 144 (7th Cir.1995). "In the light most favorable" simply means that summary judgment is not appropriate if the court must make "a choice of inferences." See United States v. Diebold, Inc., 369 U.S. 654, 655, 82 S.Ct. 993, 8 L.Ed.2d 176 (1962); see also, First Nat'l. Bank of Arizona v. Cities Service Co., 391 U.S. 253, 280, 88 S.Ct. 1575, 20 L.Ed.2d 569 (1968); Wolf v. Buss (America) Inc., 77 F.3d 914, 922 (7th Cir.1996). The choice between reasonable inferences from facts is a jury function. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).

B. Infringement Analysis:

"A patent is a government grant of rights to the patentee." Markman v. Westview Instruments, Inc., 52 F.3d 967, 978 (Fed.Cir.1995) aff'd 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). The patentee's right is one of exclusion—for a limited time, the patentee has the right to exclude others from making, using, or selling the claimed invention. Id.

Patent infringement analysis is a two step process. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1581-82 (Fed.Cir.1996). The court first must construe, or interpret, the meaning of the patent claims. Id. The second question is whether the defendant has infringed on the patentee's rights. Id. Claim construction is a question of law, while infringement is a question of fact. Id. It is the patentee's burden to prove infringement. Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1566-68 (Fed.Cir.1997).

1. Claim Construction:

A short word is necessary here on the legal effect of a decision by Judge Zagel of the Northern District of Illinois in a similar case. This case is not the first time that Abbott has litigated an infringement issue related to DEPAKOTE. In 1997, Judge Zagel granted summary judgment in favor of Abbott, finding that a proposed generic form of DEPAKOTE infringed the '731 and '326 patents. See Abbott Labs. v. Alra Labs., Inc., No. 92 C 5806, 1997 WL 667796 (N.D.Ill. Oct.24, 1997). Abbott argues that this court should give Judge Zagel's claim construction stare decisis effect, while Torpharm urges the court to conduct its own construction analysis.

Abbott's authority for the stare decisis argument is Markman v. Westview Instruments, Inc., 517 U.S. 370, 391, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996), where the Supreme Court noted the need for intrajurisdictional uniformity of patent claim construction. Whether Markman gives district court claim construction binding effect is a question the court need not answer. The court has reviewed Judge Zagel's claim construction and agrees with it. Thus, regardless of whether stare decisis applies, as explained below, the court adopts Judge Zagel's construction of the patents.

The '731 patent claims:

1. An oligomer having a 1:1 molar ratio of sodium valproate and valproic acid of the unit formula, (CH₃CH₂CH₂)₂ CHCO₂ Na/(CH₃CH₂CH₂)₂CHCO₂ H, and containing about 4 such units.

2. An oral pharmaceutical dosage form for treating the symptoms of epileptic seizures or convulsions, containing as the active principal an oligomer having a 1:1 molar ratio of sodium valproate and valproic acid of the unit formula, (CH₃ CH₂CH₂)₂ CHCO₂Na/(CH₃CH₂CH₂)₂ CHCO₂ H, and containing about 4 such units.

(Pl.'s Local Rule 56.1 Ex. 1.)

The '326 patent claims:

1. An oligomer having a 1:1 molar ratio of sodium valproate and valproic acid of the unit formula, (CH₃CH₂CH₂)₂ CHCO₂ Na/(CH₃CH₂CH₂)₂CHCO₂ H, and containing about 4 to 6 such units.

2. An oral pharmaceutical dosage form for treating the symptoms of epileptic seizures or convulsions, containing as the active principal an oligomer having a 1:1 molar ratio of sodium valproate and valproic acid of the unit formula, (CH₃ CH₂CH₂)₂ CHCO₂Na/(CH₃CH₂CH₂)₂ CHCO₂ H, and containing about 4 to 6 such units.

3. An oligomer having a 1:1 molar ratio of sodium valproate and valproic acid of the unit formula, (CH₃CH₂CH₂)₂ CHCO₂ Na/(CH₃CH₂CH₂)₂CHCO₂ H, and containing about 6 such units.

4. An oral pharmaceutical dosage form for treating the symptoms of epileptic seizures or convulsions, containing as the active principal an oligomer having a 1:1 molar ratio of sodium valproate and valproic acid of the unit formula, (CH₃ CH₂CH₂)₂ CHCO₂Na/(CH₃CH₂CH₂)₂ CHCO₂ H, and containing about 6 such units.

5. An oligomer having a 1:1 molar ratio of sodium valproate and valproic acid of the unit formula, (CH₃CH₂CH₂)₂ CHCO₂ Na/(CH₃CH₂CH₂)₂CHCO₂ H, and having physical/chemical properties as follows:

a. stable, white crystalline powder:

b. melting point of 98°-100° C; and

c. an infrared spectrum having strong absorption bands at about 2957, 2872, 2932, 1685, 1555 and 1370 cm^-1.

(Pl.'s Local Rule 56.1 Ex. 2.)

The parties dispute two portions of these claims: (1) the meaning of "oligomer;" and (2) the required number of repeating units. Abbott argues that the...