In Re Rosuvastatin Calcium Patent Litigation
| Decision Date | 01 July 2010 |
| Docket Number | MDL No. 08-1949-JJF.,07-807-JJF-LPS,08-426-JJF-LPS.,07-810-JJF-LPS,07-806-JJF-LPS,Civil Action No. 07-805-JJF-LPS,08-359-JJF-LPS,07-808-JJF-LPS,07-811-JJF-LPS,07-809-JJF-LPS |
| Citation | 719 F.Supp.2d 388 |
| Parties | In re ROSUVASTATIN CALCIUM PATENT LITIGATION, AstraZeneca Pharmaceuticals LP, AstraZeneca UK Limited, IPR Pharmaceuticals Inc., and Shionogi Seiyaku Kabushiki Kaisha, Plaintiffs, v. Mylan Pharmaceuticals Inc., Defendant. AstraZeneca Pharmaceuticals LP, AstraZeneca UK Limited, IPR Pharmaceuticals Inc., and Shionogi Seiyaku Kabushiki Kaisha, Plaintiffs, v. Sun Pharmaceutical Industries Ltd., Defendant. AstraZeneca Pharmaceuticals LP, AstraZeneca UK Limited, IPR Pharmaceuticals Inc., and Shionogi Seiyaku Kabushiki Kaisha, Plaintiffs, v. Sandoz Inc., Defendant. AstraZeneca Pharmaceuticals LP, AstraZeneca UK Limited, IPR Pharmaceuticals Inc., and Shionogi Seiyaku Kabushiki Kaisha, Plaintiffs, v. Par Pharmaceuticals Inc., Defendant. AstraZeneca Pharmaceuticals LP, AstraZeneca UK Limited, IPR Pharmaceuticals Inc., and Shionogi Seiyaku Kabushiki Kaisha, Plaintiffs, v. Apotex Corp., Defendants. AstraZeneca Pharmaceuticals LP, AstraZeneca UK Limited, IPR Pharmaceuticals Inc., and Shionogi Seiyaku Kabushiki Kaisha, Plaintiffs, v. Aurobindo Pharma Ltd. and Aurobindo Pharma USA Inc., Defendants. AstraZeneca Pharmaceuticals LP, AstraZeneca UK Limited, IPR Pharmaceuticals Inc., and Shionogi Seiyaku Kabushiki Kaisha, Plaintiffs, v. Cobalt Pharmaceuticals Inc. and Cobalt Laboratories Inc., Defendants. AstraZeneca Pharmaceuticals LP, AstraZeneca UK Limited, IPR Pharmaceuticals Inc., and Shionogi Seiyaku Kabushiki Kaisha, Plaintiffs, v. Aurobindo Pharma Ltd. and Aurobindo Pharma USA Inc., Defendants. AstraZeneca Pharmaceuticals LP, AstraZeneca UK Limited, IPR Pharmaceuticals Inc., and Shionogi Seiyaku Kabushiki Kaisha, Plaintiffs, v. Teva Pharmaceuticals USA, Defendant. |
| Court | U.S. District Court — District of Delaware |
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Ford F. Farabow, Esquire; Charles E. Lipsey, Esquire; Kenneth M. Frankel, Esquire and York M. Faulkner, Esquire of Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., Washington, D.C. Richard D. Kirk, Esquire and Stephen B. Brauerman, Esquire of Bayard, P.A., Wilmington, DE, for Defendant Aurobindo Pharma Ltd.
Richard A. Kaplan, Esquire; Ralph J. Gabric, Esquire; Jeffry M. Nichols, Esquire and Jason W. Schigelone, Esquire of Brinks Hofer Gilson & Lione, Chicago, IL, Joseph H. Huston, Jr., Esquire of Stevens & Lee, APC, Wilmington, DE, for Defendant Teva Pharmaceuticals USA, Inc.
William A. Rakoczy, Esquire; Paul J. Molino, Esquire; Deanne M. Mazzochi, Esquire; Joseph T. Jaros, Esquire; Tara M. Raghavan, Esquire and Eric R. Hunt, Esquire of Rakoczy Molino Mazzochi Siwik LLP, Chicago, IL, Mary B. Matterer, Esquire of Morris James LLP, Wilmington, DE, for Defendant Mylan Pharmaceuticals, Inc.
Henry J. Renk, Esquire of Fitzpatrick, Cella, Harper & Scinto, New York, NY, Mary W. Bourke, Esquire of Connolly Bove Lodge & Hutz LLP, Wilmington, DE, for Plaintiffs.
Thomas A. Stevens, Esquire of AstraZeneca Pharmaceuticals LP, Wilmington, DE, for Plaintiffs, AstraZeneca Pharmaceuticals LP, AstraZeneca UK Limited, and IPR Pharmaceuticals.
William R. Zimmerman, Esquire and Steven A. Maddox, Esquire of Knobbe, Martens, Olson & Bear, LLP, Washington, D.C. Payson Le Meilleur, Esquire of Knobbe, Martens, Olson & Bear, LLP, Irvine, CA, for Defendants, Cobalt Pharmaceuticals, Inc. and Cobalt Laboratories, Inc.
Charles B. Klein, Esquire; John K. Hsu, Esquire; Adam S. Nadelhaft, Esquire and Mark A. Smith, Esquire of Winston & Strawn LLP, Washington, D.C. Kevin G. Abrams, Esquire and John M. Seaman, Esquire of Abrams & Bayliss LLP, Wilmington, DE, for Defendant Sun Pharmaceutical Industries, Ltd.
Daniel G. Brown, Esquire of Wilson, Sonsini, Goodrich & Rosati, New York, NY, Dutch D. Chung, Esquire of Wilson, Sonsini, Goodrich & Rosati, Washington, D.C., Frederick L. Cottrell, III, Esquire and Steven J. Fineman, Esquire of Richards, Layton & Finger, P.A., Wilmington, DE, for Defendant Par Pharmaceuticals, Inc.
Robert B. Breisblatt, Esquire; Craig M. Kuchii, Esquire; Jeremy C. Daniel, Esquire; Stephen P. Benson, Esquire and Brian J. Sodikoff, Esquire of Katten Muchin Roseman LLP, Chicago, IL, Richard L. Horwitz, Esquire and David E. Moore, Esquire of Potter Anderson & Corroon LLP, Wilmington, DE, for Defendant Apotex Corp.
Thomas P. Heneghan, Esquire; Jeffrey S. Ward, Esquire; Edward J. Pardon, Esquire and Shane A. Brunner, Esquire of Merchant & Gould, Madison, WI.
AstraZeneca Pharmaceuticals LP, AstraZeneca UK Limited, IPR Pharmaceuticals Inc. and Shionogi Seiyaku Kabushiki Kaisha (collectively, “Plaintiffs”) brought this action against several different generic drug manufacturers, Mylan Pharmaceuticals Inc., Sun Pharmaceutical Industries, Ltd., Par Pharmaceutical, Inc., Apotex Corp., Aurobindo Pharma Ltd., Cobalt Pharmaceuticals Inc., Cobalt Laboratories Inc., Teva Pharmaceuticals USA, Inc. (collectively, “Defendants”) 1 alleging infringement of U.S. Patent No. RE 37,314 (the “'314 patent”), covering rosuvastatin and its salts, based on Defendants' submission of an Abbreviated New Drug Application (“ANDA”) to the Food and Drug Administration (“FDA”) for approval to engage in the commercial manufacture, use, or sale in the United States of rosuvastatin calcium tablets. With the exception of Apotex Corp., Defendants admit that they have infringed claims 6 and 8 of the ' 314 patent by submitting its ANDA under 35 U.S.C. § 271(e)(2)(A). However, Defendants contend that claims 6 and 8 of the ' 314 patent are invalid and unenforceable. In addition, Defendants have challenged the standing of Plaintiff AstraZeneca Pharmaceuticals LP to sue for infringement and have filed motions to dismiss based on this issue. As for Defendant Apotex Corp., Apotex Corp. contends that it did not engage in an infringing act in the first instance, because it did not “submit” the ANDA within the meaning of Section 271(e)(2)(A).
With the exception of Defendant Apotex Corp., no Defendant contests that the Court has subject matter jurisdiction over this action pursuant to 28 U.S.C. §§ 1331 and 1338, as arising under the patent laws of the United States, Title 35 of the United States Code and the Abbreviated New Drug Application provisions of the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355(j). Personal jurisdiction and venue are also uncontested.
The Court held a Bench Trial on the issues of invalidity and unenforceability from February 22, 2010, through March 3, 2010, and reserved decision on the standing issue for resolution post-trial. Briefing on the various post-trial issues was not completed until June 4, 2010. 2 This Memorandum Opinion constitutes the Court's findings of fact and conclusions of law on the issues of standing, invalidity and unenforceability.
Plaintiff AstraZeneca Pharmaceuticals LP is a Delaware corporation with its principal place of business in Wilmington, Delaware. Plaintiff AstraZeneca UK Limited is a corporation existing under the laws of the United Kingdom with its principal place of business in London, England. Plaintiff IPR Pharmaceuticals Inc. is a wholly owned subsidiary of AstraZeneca UK, existing under the laws of the Commonwealth of Puerto Rico with a principal place of business in Canovanas, Puerto Rico. Plaintiff Shionogi Seiyaku Kabushiki Kaisha is a Japanese corporation with a principal place of business in Osaka Japan. Plaintiffs are engaged in the business of research, development, manufacturing and/or selling pharmaceutical products world-wide.
Defendant Apotex Corp. is a Delaware corporation with its principal place of business in Weston, Florida. Defendant Aurobindo Pharma Limited is a corporation existing under the laws of India with its principal place of business in Andhra Pradesh, India. Defendant Cobalt Pharmaceuticals Inc. is a Canadian corporation with its principal place of business in Ontario, Canada. Defendant Cobalt Laboratories Inc. is a Delaware corporation with its principal place of business in Bonita Springs, Florida. Defendant Mylan Pharmaceuticals Inc. is a West Virginia corporation with its principal place of business in Morgantown, West Virginia. Defendant Par Pharmaceutical, Inc. is a Delaware corporation with its principal place of business in Woodcliff Lake, New Jersey. Defendant Sun Pharmaceutical Industries Ltd. is a corporation existing under the laws of India with its principal place of business in Maharashtra, India. Defendant Teva Pharmaceuticals USA, Inc. is a Delaware corporation with its principal place of business in North Wales, Pennsylvania. Defendants are engaged in the business of making, selling and/or distributing generic drugs in the United States.
The '314 patent is a reissue of U.S. Patent No. 5,260,440 (the “'440 patent”), which pertains to rosuvastatin and its salts, which are compounds useful in the treatment of hypercholesterolemia, hyperlipoproteinemia and atherosclerosis. (PTX-682 at 1:26-28; PTX-1054 at 1:32-34.) The invention secured in the 314 patent is known as rosuvastatin calcium and marketed and sold by the AstraZeneca-affiliated Plaintiffs under the name CRESTOR ® as a result of a licensing agreement between Shionogi and the AstraZeneca-affiliated Plaintiffs.
Claims 6 and 8 of the '314 patent are at issue in this litigation. Claim 6 is an independent claim directed to
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AstraZeneca UK Ltd. v. Aurobindo Pharma Ltd. (In re Rosuvastatin Calcium Patent Litig.)
...art to the PTO because of the “chaos” and “confusion” that ensued after Kitamura resigned in July 1992. AstraZeneca Pharms. LP v. Mylan Pharms. Inc., 719 F.Supp.2d 388, 400 (D.Del.2010). Kitamura, however, had already filed the '440 application—with its overlap with Sandoz—when she left Shi......
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...rejected Cobalt's defense that the '314 patent was invalid and unenforceable. See In re Rosuvastatin Calcium Patent Litigation, 719 F.Supp.2d 388, 410 (D.Del.2010) (hereinafter the “2010 calcium litigation”). On August 10, 2010, the 2010 calcium litigation defendants filed their notices of ......
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Astrazeneca Pharms. LP v. Apotex Corp.
...calcium until the '314 patent expires in 2016. Appellees have separately appealed that decision. In re Rosuvastatin Calcium Patent Litig., 719 F.Supp.2d 388 (D.Del.2010), appeal docketed, Nos. 10–1460 to –1473 (Fed.Cir. Aug. 13, 2010). While the '314 infringement matter remained pending bef......
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McDowell v. United States
...harm must be in the zone of interests protected by the statute or constitutional provision at issue." In re Rosuvastatin Calcium Patent Litig., 719 F. Supp. 2d 388, 398 (D. Del. 2010) (citing Valley Forge Christian College v. Americans United for Separation of Church & State, 454 U.S. 464, ......
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Court Refuses To Dismiss Entity That Worked On Development Of The ANDA Product
...Op. at 9. The court agreed with the reasoning of the second line of cases, including In re Rosuvastatin Calcium Patent Litigation, 719 F. Supp. 2d 388 (D. Del. 2010), which found that active participation in preparing the ANDA rendered the defendant a "submitter" under § 271(e)(2), stating ......
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Responding to the Complaint
...Medtronic that SSI failed to show that Synthes, Inc. had standing to bring this suit.”). 20. In re Rosuvastatin Calcium Patent Litig., 719 F. Supp. 2d 388, 398–99 (D. Del. 2010). 21. Rite-Hite Corp. v. Kelley Co., Inc., 56 F.3d 1538, 1553 (Fed. Cir. 1995) (en banc) (“The grant of a bare lic......
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Responding to the Complaint
...Medtronic that SSI failed to show that Synthes, Inc. had standing to bring this suit.”). 19. In re Rosuvastatin Calcium Patent Litig., 719 F. Supp. 2d 388, 398–99 (D. Del. 2010). 20. Rite-Hite Corp. v. Kelley Co., 56 F.3d 1538, 1553 (Fed. Cir. 1995) (en banc) (“The grant of a bare license t......
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...the ANDA are deemed to have “submit[ted]” the ANDA, regardless of whether they are the 4. In re Rosuvastatin Calcium Patent Litig., 719 F. Supp. 2d 388, 399 (D. Del. 2010). 5. Pfizer Inc. v. Elan Pharm. Res. Corp., 812 F. Supp. 1352, 1374 (D. Del. 1993). In In re Rosuvastatin Calcium Patent......
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Pretrial Preparation
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