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ALZA’s Lawsuit Against Mylan Over the Fentanyl Patch

Posted in Duragesic / Fentanyl

It will be interesting to scour the documents from the ALZA v. Mylan lawsuit to see if either company took positions that are inconsistent with their positions in the numerous fentanyl lawsuits both companies are facing.  Here’s a copy of ALZA’s lawsuit it filed in January of 2002 against Mylan.

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Plaintiffs Alza Corporation (“Alza”) and Janssen Pharmaceutica, Inc. (“Janssen”) (collectively, “Plaintiffs”), by their attorneys, for their complaint against Mylan Laboratories, Inc. (“Mylan Laboratories”), Mylan Technologies, Inc. (“Mylan Technologies”), and Mylan Pharmaceuticals, Inc. (“Mylan Pharmaceuticals”) (collectively, “Defendants” or “Mylan”) allege as follows:

The Parties

1. Alza is a corporation organized and existing under the laws of the State of Delaware and has its principal place of business at 1900 Charleston Road, Mountain View, California.

2. Janssen is a corporation organized and existing under the laws of the State of Pennsylvania and has its principal place of business at 1125 Trenton-Harbourton Road, Titusville, New Jersey.

3. Upon information and belief, Mylan Laboratories is a corporation organized and existing under the laws of the State of Pennsylvania and has its principal place of business at 130 Seventh Street, 1030 Century Building, Pittsburgh, Pennsylvania.

4. Upon information and belief, Mylan Technologies is a corporation organized and existing under the laws of the State of West Virginia and has its principal place of business at 110 Lake Street, Saint Albans, Vermont. Upon information and belief, Mylan Technologies is wholly owned and controlled by Mylan Laboratories.

5. Upon information and belief, Mylan Pharmaceuticals is a corporation organized and existing under the laws of the State of West Virginia and has its principal place of business at 781 Chestnut Ridge Road, Morgantown, West Virginia. Upon information and belief, Mylan Pharmaceuticals is wholly owned and controlled by Mylan Laboratories.

Jurisdiction And Venue

6. This action is based upon the Patent Law of the United States, Title 35 of the United States Code, for infringement of United States Patent No. 4,588,580 (“the '580 patent”), Reexamination Certificate No. B1 4,588,580 (“the '580 B1 Reexamination Certificate”), and Reexamination Certificate No. B2 4,588,580 (“the '580 B2 Reexamination Certificate”). This Court has jurisdiction over the subject matter of this action pursuant to 28 U.S.C. §§ 1331, 1338(a) and 1400(b).

7. Mylan Laboratories, Mylan Technologies and Mylan Pharmaceuticals are subject to personal jurisdiction in this judicial district.

8. Venue is proper in this judicial district pursuant to 28 U.S.C. §§ 1391 and 1400(b).

Count I: Patent Infringement

9. Plaintiffs reallege paragraphs 1 through 8 above as if fully set forth herein.

10. On May 13, 1986, the United States Patent and Trademark Office (“the PTO”) issued the '580 patent, entitled “Transdermal Administration of Fentanyl and Device Therefor.” A true and correct copy of the '580 patent is attached as Exhibit A.

11. On January 3, 1989, the PTO issued the '580 B1 Reexamination Certificate, entitled “Transdermal Administration of Fentanyl and Device Therefor.” A true and correct copy of the '580 B1 Reexamination Certificate is attached as Exhibit B.

12. On February 16, 1999, the PTO issued the '580 B2 Reexamination Certificate, entitled “Transdermal Administration of Fentanyl and Device Therefor.” A true and correct copy of the '580 B2 Reexamination Certificate is attached as Exhibit C.

13. Alza holds title to the '580 patent, the '580 B1 Reexamination Certificate, and the '580 B2 Reexamination Certificate (collectively, “the '580 patent family”).

14. The United States Food & Drug Administration (“FDA”) has approved a New Drug Application under § 505(a) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355(a), for a fentanyl transdermal system sold by plaintiffs under the trade name Duragesic.

15. Pursuant to 21 U.S.C. § 355(b)(1), the '580 patent is identified in the FDA publication entitled “Approved Drug Products with Therapeutic Equivalence Evaluations” (the “Orange Book”), as covering Duragesic.

16. Janssen is the exclusive United States distributor of Duragesic.

17. Upon information and belief, on or before December 4, 2001, Mylan submitted an Abbreviated New Drug Application (“ANDA”) No. 76-258 to the FDA under § 505(j) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355(j), (“Mylan ANDA”) seeking FDA approval to engage in the commercial manufacture, use, offer for sale and sale of a generic version of Duragesic fentanyl transdermal patches (“generic fentanyl transdermal patches”).

18. On or about December 11, 2001, Alza received a letter dated December 6, 2001 stating that Mylan had filed the Mylan ANDA seeking approval to manufacture, use and sell generic fentanyl transdermal patches before the expiration of the '580 patent family (“Mylan's first ANDA certification letter”).

19. In mid-January 2002, both Alza and Janssen received substantially identical letters dated January 7, 2002 stating that Mylan had filed the Mylan ANDA seeking approval to manufacture, use and sell fentanyl transdermal patches before the expiration of the '580 patent family (“Mylan's second ANDA certification letter”).

20. Mylan's first ANDA certification letter and Mylan's second ANDA certification letter are identical in substantive text.

21. Upon information and belief, the Mylan ANDA was filed in the name of Mylan Technologies, but was also filed for the benefit of Mylan Pharmaceuticals and Mylan Laboratories.

22. Upon information and belief, Mylan's first ANDA certification letter and Mylan's second ANDA certification letter were prepared at, signed at and sent from the Mylan Pharmaceuticals offices in West Virginia.

23. Upon information and belief, the factual and legal statement purportedly supporting the paragraph IV certification was prepared and signed by Shelly Monteleone, Esquire, an employee of Mylan Pharmaceuticals located at the Mylan Pharmaceuticals offices in West Virginia.

24. Upon information and belief, the officers and directors of Mylan Laboratories and/or Mylan Pharmaceuticals directed the preparation and filing of the Mylan ANDA with the FDA.

25. Mylan's first ANDA certification letter and second ANDA certification letter both state that the Mylan ANDA certifies, pursuant to 21 U.S.C. § 355(b)(2)(A)(iv), that the manufacture, use or sale of fentanyl transdermal patches will not infringe the '580 patent family, and that the '580 patent family is invalid (“paragraph IV certification”).

26. Mylan Technologies is liable for the infringement of the '580 patent family under 35 U.S.C. § 271(e)(2)(A) by filing the Mylan ANDA which, upon information and belief, includes the paragraph IV certification.

27. Mylan Laboratories is liable for the infringement of the '580 patent family because, upon information and belief, Mylan Laboratories caused or participated in, contributed to, aided, abetted, directed and induced the submission of the Mylan ANDA and its paragraph IV certification to the FDA

28. Mylan Pharmaceuticals is liable for the infringement of the '580 patent family because, upon information and belief, Mylan Pharmaceuticals caused or participated in, contributed to, aided, abetted, directed and induced the submission of the Mylan ANDA and its paragraph IV certification to the FDA.

29. Mylan had actual and constructive notice of the '580 patent family prior to filing the Mylan ANDA. Mylan's infringement of the '580 patent family has been, and continues to be, willful.

30. Alza and Janssen will be irreparably harmed if Mylan is not enjoined from infringing or actively inducing or contributing to infringement of the '580 patent family. Alza and Janssen do not have an adequate remedy at law.

Prayer For Relief

WHEREFORE, Alza and Janssen pray for:

A. A judgment providing that the effective date of any FDA approval for the making, using, selling, offering for sale, or importing of fentanyl transdermal patches described in ANDA No. 76-258 by Mylan Laboratories, Inc., Mylan Technologies, Inc., and Mylan Pharmaceuticals, Inc. be no earlier than the date on which the '580 patent family expires;

B. A judgment declaring that the making, using, selling, offering to sell, or importing of the fentanyl transdermal patches described in ANDA No. 76-258 would constitute infringement of the '580 patent family, or inducing or contributing to such conduct, by Mylan Laboratories, Inc., Mylan Technologies, Inc., and Mylan Pharmaceuticals, Inc. pursuant to 35 U.S.C. § 271(a), (b) and (c);

C. A judgment permanently enjoining Mylan Laboratories, Inc., Mylan Technologies, Inc., and Mylan Pharmaceuticals, Inc., and each of their officers, agents, servants and employees, and those persons in active concert or participation with any of them, from making, using, selling, offering to sell, or importing the fentanyl transdermal patches described in ANDA No. 76-258 or any product that infringes or induces or contributes to the infringement of the '580 patent family;

D. Attorneys' fees in this action pursuant to 35 U.S.C. § 285;

E. Costs and expenses in this action; and

F. Such further and other relief as this Court determines to be just and proper.

Dated: January 25, 2002