In re Lipitor Antitrust Litig.
| Decision Date | 05 September 2013 |
| Docket Number | Master Docket No. 3:12-cv-2389 (PGS),MDL No. 2332 |
| Parties | IN RE LIPITOR ANTITRUST LITIGATION This Document Relates to: All Direct Purchaser Class Actions |
| Court | U.S. District Court — District of New Jersey |
NOT FOR PUBLICATION
This matter is before the Court on the Direct Purchaser Class Plaintiffs' motion for leave to amend the consolidated class action complaint (ECF No. 435) and a motion to dismiss all Direct Purchaser Complaints brought by Pfizer, Inc., Pfizer Ireland Pharmaceuticals, Warner-Lambert Co., and Warner-Lambert Company, LLC. (ECF No. 246).
This matter arises out of Defendant Pfizer's1 sale of a pharmaceutical product under the brand name Lipitor, and out of the sale by Ranbaxy2 of a generic version of Lipitor. The Judicial Panel on Multidistrict Litigation transferred several related actions to this Court for coordinatedand consolidated pretrial proceedings, pursuant to 28 U.S.C. § 1407. Presently pending before the Court are several motions to dismiss the Plaintiffs' various Complaints. This opinion addresses two motions: the Motion to Dismiss the Direct Purchaser Plaintiffs'3 Claims (Dkt. No. 246) filed by Pfizer pursuant to Fed. R. Civ. P. 12(b)(6), and the Motion for Leave to Amend the Consolidated Class Action Complaint (Dkt. Entry No. 435) filed by the Direct Purchaser Class Plaintiffs. The Court has considered the briefs of the parties, and oral argument held on July 24, 2013.
On motions to dismiss, the Court accepts as true the plaintiff's material allegations and construes them in the light most favorable to the plaintiff. Baldwin v. Univ. of Pittsburgh Med. Ctr., 636 F.3d 69, 73-4 (3d Cir. 2011) (citing Alston v. Countrywide Fin. Corp., 585 F.3d 753, 758 (3d Cir. 2009)). A court may also properly look at public records, including judicial proceedings, the relevant patents and the patents' prosecution histories. See, e.g., Jean Alexander Cosmetics, Inc. v. L'Oreal USA, Inc., 458 F.3d. 244, 256 n.5 (3d Cir. 2006) (citing S. Cross Overseas Agencies, Inc. v. Wah Kwong Shipping Group Ltd., 181 F.3d 410, 426 (3d Cir. 1999)); Pension Benefit Guar. Corp. v. White Consol. Indus., Inc., 998 F.2d 1192, 1196-97 (3dCir. 1993). Thus, the following facts are taken from the various Direct Purchaser Complaints and from related public records.
This matter arises from actions brought by purchasers of a pharmaceutical product sold by Pfizer under the brand name Lipitor. Plaintiffs assert that Pfizer violated federal antitrust laws by using patents for or related to Lipitor to block generic competition for the product, and by paying Ranbaxy to settle infringement litigation and stay off the market until an agreed-upon entry date.
Lipitor belongs to a class of drugs called statins, which lower cholesterol by inhibiting a liver enzyme called 3-hydroxy 3-methylglutrayl-coenzyme A reductase ("HMG-CoA reductase"). HMG-CoA reductase controls the rate of the metabolic production of cholesterol; inhibiting HMG-CoA reductase inhibits the production of cholesterol. High cholesterol is thought to be associated with coronary heart disease and atherosclerosis. The active ingredient in Lipitor is called atorvastatin calcium.
Pfizer has obtained the following seven patents covering different aspects of the Lipitor product: U.S. Patent No. 4,681,893 (the "'893 patent"); U.S. Patent No. 5,273,995 (); U.S. Patent No. 6,126,971 (the "'971 patent"); U.S. Patent No. 5,686,104 (the "'104 patent"); U.S. Patent No. 6,087,511 (the "'511 patent"); U.S. Patent No. 6,274,740 (the "'740 patent"); and U.S. Patent No. 5,969,156 (the "'156 patent"). See, e.g., Compl. ¶¶ 3, 7-8, 88-89, 179-80, 186-87, 193-95, 323, 326.
Plaintiffs' claims are largely based on allegations concerning the prosecution history of one particular Lipitor Patent - the '995 patent - as well as its relationship to the '893 patent. Compl. ¶¶ 197-281; Walgreen Compl. ¶¶ 160-215; Meijer Compl. ¶¶ 156-211. The prosecutionof the '995 patent was preceded by the issuance of the '893 patent - the original Lipitor patent -to Pfizer in 1987. Compl. ¶ 70. Plaintiffs' claims involve an allegation that Pfizer fraudulently obtained the '995 patent after the issuance of the '893 patent by avoiding the prior art contained in the '893 patent.
The '995 patent issued on December 28, 1993. Id. ¶ 159. Three years later, on December 17, 1996, the FDA approved atorvastatin calcium - "Lipitor" - for the treatment of hypercholesterolemia and mixed dislipidemia. Id. ¶ 178. Pfizer listed both the '893 and '995 patents and three other patents (the '971 and '104 patents, covering certain formulations of atorvastatin calcium, and the '156 patent, for its crystalline form) in the FDA publication "Approved Drug Products with Therapeutic Equivalence Evaluations" (the "Orange Book").4 Id. ¶¶ 179, 192-196. Pfizer also held two patents claiming the process for making Lipitor (the '511 and '740 patents). Id. ¶ 195.
The '893 patent expired on March 24, 2010. The '995 patent expired on June 28, 2011. Id. Compl. ¶ 180. The remaining patents listed in the Orange Book have not yet expired. Compl. ¶ 322.
Isomers are chemical compounds that have the same molecular formula (i.e., the same type and number of atoms), but different structural formulas (i.e., different arrangements of those atoms in space). See Pfizer Inc. v. Ranbaxy Labs. Ltd., 405 F. Supp. 2d 495, 502 (D.Del. 2005), aff'd in part, 457 F.3d 1284 (Fed. Cir. 2006). Enantiomers are isomers that are mirror images of each other with respect to how their atoms are arranged in space.5 The two enantiomers in any given enantiomeric pair can be distinguished from one another, and the percentage of each particular enantiomer in a mixture can be ascertained. A mixture with equal amounts of two opposite enantiomers present is called a racemic mixture or racemate.
Pairs of enantiomers share many chemical and physical properties, such as identical melting points, solubility, and colors. However, other properties, such as biological properties, may differ. Enzymes, including HMG-CoA reductase, typically display a preference for interacting with one enantiomer over the other. It is common for one enantiomer (the "active" enantiomer) of an enantiomeric pair to have all or most of the biological activity when interacting with an enzyme, while the other enantiomer (the "inactive" enantiomer) has little or no biological activity.
The active ingredient in Lipitor is atorvastatin calcium. Compl. ¶ 178. Atorvastatin is the active enantiomer in the compound, referred to as the "r-trans" enantiomer. Its corresponding inactive enantiomer is referred to as the "s-trans" enantiomer. Because of the structural makeup of atorvastatin, these are two of its four possible enantiomers. Atorvastatin calcium is the particular salt form of the active enantiomer used in Lipitor. Id.
Pfizer filed a patent application in 1986 for a large group of compounds and pharmaceutical compositions useful in lowering cholesterol. This application led to the issuance of the '893 patent on July 21, 1987. Complaint ¶ 88. Pfizer claimed that the disclosed compounds were useful to lower cholesterol "by virtue of their ability to inhibit the biosynthesis of cholesterol through inhibition" of the HMG-CoA reductase enzyme. The class of compounds covered by the '893 patent is referred to therein as Structural Formula I. Included among the many compounds within the Structural Formula I family was the racemic compound comprised of atorvastatin and its corresponding inactive enantiomer and "pharmaceutically acceptable salt[s]" thereof. Id. ¶¶76-77, 87, 89, 184.
Exactly two years after issuance of the '893 patent, on July 21, 1989, Pfizer submitted a patent application seeking additional patent protection for just the isolated active enantiomer of atorvastatin, which as stated above is one of the compounds disclosed by the '893 patent. The new patent application claimed atorvastatin calcium, i.e., the active R-trans isomer of atorvastatin in calcium salt form - which is the active ingredient in Lipitor. Id. ¶¶ 110-11. The specification disclosed that the R-trans isomer displays "unexpected and surprising inhibition of cholesterol biosynthesis." Id. ¶ 110.
Plaintiffs allege that this patent application was a direct result of prodding by senior management at Pfizer. After the '893 patent issued, Pfizer internally designated atorvastatin as a "lead compound" for further investigation. Id. ¶ 90. Shortly thereafter, senior management at Pfizer asked Roth, the '893 patent inventor, if there was anything about the active enantiomer that would entitle it to an additional period of patent protection. Id. ¶ 92-93. Having worked with atorvastatin for years, Roth wasn't aware of any surprising characteristics which wouldwarrant further patent protection. Id. So Don Maxwell, the vice president of discovery research, told Roth to go through the old lab books to see if there was some data that showed something surprising. Roth was instructed to provide any surprising data to Pfizer's patent attorney. Id.
Plaintiffs claim that in developing Lipitor, Pfizer used several tests6 to assess and compare the inherent differences among the compounds that would eventually be covered by the '893 patent. The tests measured the ability of the compounds to decrease the production of cholesterol. Id. ¶¶ 112, n.9, 127, 130. Plaintiffs claim that the tests, as well as internal Pfizer research memos confirmed that the R-trans enantiomer was about twice as active as the racemate (i.e., the compound with equal parts s-trans and r-trans enantiomers). Id. ¶¶ 114, 123, 125, 127, 129, 130, 132, 167. Plaintiffs claim that this was a result that was expected both based on the state of the knowledge in the field, as...
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