Ortho-Mcneil Pharmaceutical v. Mylan Laboratories

• Decision Date: 31 March 2003
• Docket Number: No. CIV.A. 102CV32.,CIV.A. 102CV32.
• Citation: 267 F.Supp.2d 533
• Court: U.S. District Court — Northern District of West Virginia
• Parties: ORTHO-MCNEIL PHARMACEUTICAL, INC., Johnson & Johnson Pharmaceutical Research & Development, LLC, and Daiichi Pharmaceutical Co., Ltd., Plaintiffs, v. MYLAN LABORATORIES, INC. and MYLAN PHARMACEUTICALS, INC., Defendants.

267 F.Supp.2d 533

ORTHO-MCNEIL PHARMACEUTICAL, INC., Johnson & Johnson Pharmaceutical Research & Development, LLC, and Daiichi Pharmaceutical Co., Ltd., Plaintiffs, v. MYLAN LABORATORIES, INC. and MYLAN PHARMACEUTICALS, INC., Defendants.

No. CIV.A. 102CV32.

United States District Court, N.D. West Virginia.

March 31, 2003.

Chad A. Cicconi, Esquire, Thorp, Reed & Armstrong, Wheeling, Counsel for Plaintiffs Ortho-McNeil Pharmaceutical, Inc. Johnson & Johnson Pharmaceutical Research & Development, LLC Daiichi Pharmaceutical Company, Ltd.

Edward L. Pencoske, Esquire, G. Daniel Carney, Esquire, Thorp, Reed & Armstrong, Pittsburgh, PA, Counsel for Plaintiff Ortho-McNeil Pharmaceutical, Inc.

Vicki Margolis, Esquire, Jeffrey B. Elikan, Esquire, George F. Pappas, Esquire, Ryan M. Walsh, Esquire, Jeffrey A. Dunn, Esquire, Venable, Baetjer, Howard & Civiletti, LLP, Washington, DC, Counsel for Plaintiffs Ortho-McNeil Pharmaceutical, Inc. Johnson & Johnson Pharmaceutical Research & Development, LLC.

Mary Ellen R. Himes, Esquire, Venable, Baetjer, Howard & Civiletti, LLP, Baltimore, MD, Counsel for Plaintiff Ortho-McNeil Pharmaceutical, Inc.

Steven P. Berman, Esquire, Johnson & Johnson, New Brunswick, NJ, Counsel for Plaintiffs Ortho-McNeil Pharmaceutical, Inc. Johnson & Johnson Pharmaceutical Research & Development, LLC.

Mary Jane Saunders, Esquire, Eugene Purvis, Jr., Esquire, Justin E. Pierce, Esquire, Venable, Baetjer and Howard, LLP, Vienna, VA, Counsel for Plaintiffs Ortho-McNeil Pharmaceutical, Inc. Johnson & Johnson Pharmaceutical, Research & Development, LLC.

Frank E. Simmerman, Jr., Esquire, Simmerman Law Office, PLLC, Clarksburg, Counsel for Plaintiffs Ortho-McNeil Pharmaceutical, Inc. Johnson & Johnson Pharmaceutical, Research & Development, LLC.

Richard W. Gallagher, Esquire, Robinson & McElwee, Clarksburg, Counsel for

Plaintiff Daiichi Pharmaceutical Company, Ltd.

Robert A. Bourque, Esquire, Jeremy S. Pitcock, Esquire, Noah M. Leibowitz, Esquire, Jordan N. Malz, Esquire, Henry B. Gutman, Esquire, Amy E. Semet, Esquire, Simpson, Thacher & Bartlett, New York, NY, Counsel for Plaintiff Daiichi Pharmaceutical Company, Ltd.

Mary H. Sanders, Esquire, Huddleston, Bolen, Beatty, Porter & Copen, Charleston, Counsel for Plaintiff Daiichi Pharmaceutical Company Ltd.

David B. Thomas, Esquire, George G. Guthrie, Esquire, Allen Buthrie & McHugh, Charleston, Counsel for Defendants American Safety Razor Company Megas Beauty Care, Inc.

William J. Witte, Esquire, Riley, McNulty, Hewitt & Sweitzer, Pittsburgh, PA, Counsel for Defendants BBA U.S. Holdings, Inc., BBA Nonwovens Simpsonville, Inc.

William J. Witte, Esquire, Riley, McNulty, Hewitt & Sweitzer, Pittsburgh, PA, John H. Tinney, Esquire, The Tinney Law Firm, PLLC, Charleston, Sheri E. Hametz, Esquire, James E. Brandt, Esquire, Blair Connelly, Esquire, Latham & Watkins, LLP, New York, NY, Counsel for Defendants International Paper Company.

Mark Boland, Esquire, W. Mack Webner, Esquire, Sheldon I. Landsman, Esquire, Brett Smith Sylvester, Esquire, Paul Joseph Wilson, Esquire, Brian Hannon, Esquire, Michael R. Dzwonczyk, Esquire, J. Warren Lytle, Jr., Sughrue Mion, PLLC, Washington, DC, Counsel for Plaintiff Daiichi Pharmaceutical Company, Ltd.

E.J. Strassburger, Esquire, Harry F. Kunselman, Esquire, Strass, McKenna, Gutnick & Potter, Pittsburgh, PA, Counsel for Plaintiff Daiichi Pharmaceutical Company Ltd.

Jeffrey E. Ostrow, Esquire, Harrison J. Frahn, Esquire, Simpson Thacher & Bartlett, Palo Alto, CA, Counsel for Plaintiff Daiichi Pharmaceutical Company.

Gordon H. Copland, Esquire, Megan D. Dortenzo, Esquire, Steptoe & Johnson, Clarksburg, Michael T. Smith, Esquire, Steptoe & Johnson, Martinsburg, Gordon W. Schmidt, Esquire, Doepken, Keevican & Weiss, PC, Pittsburgh, PA, Thomas w. Kirby, Esquire, Gregory R. Lyons, Esquire, Christopher L. Hale, Esquire, John B. Wyss, Esquire, Wiley, Rein & Fielding, E. Anthony Figg, Esquire, Joseph A. Hynds, Esquire, Mark I. Bowditch, Esquire, Glen Karta, Esquire, Martin M. Zoltick, Esquire, Rothwell, Figg, Ernst & Manbeck, James H. Wallace, Jr., Esquire, Wiley Rein & Fielding, LLC, Washington, D.C., Terry L. Schnell, Esquire, William P. Smith, Esquire, Roberta R. Wilson, Esquire, DKW Law Group, PC, Pittsburgh, PA, Counsel for Defendants Mylan Laboratories, Inc. Mylan Pharmaceuticals, Inc. Mylan Laboratories, Inc.

ORDER

KEELEY, District Judge.

This matter comes before the Court on the Defendants' Motion for Summary Judgment on the Basis of Anticipation under 35 U.S.C. § 102(a) and (b). The motion is fully briefed, the Court has heard oral argument, and the issues presented are ripe for review. For the following reasons, the Defendants' motion is DENIED.

BACKGROUND.

Plaintiffs Daiichi Pharmaceutical Company, Ltd. (Daiichi), Ortho-McNeil Pharmaceutical, Inc. (Ortho), and Johnson & Johnson Research & Development, LLC (J & J) are brand-name pharmaceutical manufacturers who produce an antimicrobial pharmaceutical marketed under the name "Levaquin." Levaquin is a "pioneer" drug registered with the United States Food and Drug Administration. Levaquin's active ingredient is a chemical compound conventionally known as levofloxacin. Levofloxacin is protected by United States Patent No. 5,053,407 (the '407 patent), which is held by Daiichi and licensed to Ortho and J & J. The '407 patent was issued in 1991 and expires in 2010.

Defendants Mylan Laboratories, Inc. and Mylan Pharmaceuticals, Inc. (together, Mylan), have filed an Abbreviated New Drug Application ("ANDA") seeking to produce a generic version of Levaquin. Before they can do so, though, they too must obtain approval from the FDA to market the generic drug. The Hatch-Waxman Amendments to the Drug Price Competition and Patent Term Restoration Act of 1984, 21 U.S.C. § 355, create an expedited generic drug approval process for brand-name drugs that are protected by patents. To begin the process, the generic manufacturer must file an ANDA, which incorporates the testing and efficacy data previously submitted by the manufacturer of the pioneer drug with the original new drug application. 28 U.S.C. § 355(j)(2). Because the pioneer drug is protected by a patent, the ANDA applicant must make one of the following certifications with respect to each patent at issue:

(I) that such patent information has not been filed;

(II) that such patent has expired,

(III) the date on which such patent will expire; or

(IV) 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 ....

21 U.S.C. § 355(b)(2)(A).

If an applicant makes the fourth statement (a "Paragraph IV certification"), it must give notice of the ANDA filing to the pioneer drug patent holder along with a detailed statement of the factual and legal basis for the Paragraph IV certification. 21 U.S.C. § 355(j)(2)(B)(i)-(ii). To prevent the ANDA from being approved, the patent owner must sue the applicant for patent infringement within 45 days of its receipt of the notice. 21 U.S.C. § 355(j)(2)(B)(iii); 35 U.S.C. § 271(e)(2) (making and ANDA filing an act of patent infringement). If suit is filed, the FDA may not approve the ANDA for 30 months, unless, prior to the end of the 30-month period, a court determines that the patent is "invalid or not mfringed." 21 U.S.C. § 355(j)(5)(B)(iii)(I); Mylan Pharm., Inc. v. Shalala, 81 F.Supp 2d 30, 32-33 (D.D.C. 2000).

To begin marketing its generic levofloxacin tablets, Mylan filed an ANDA with a paragraph IV certification stating that the '407 patent is invalid. The plaintiffs then promptly filed the present patent infringement suit to protect their rights under the '407 patent.

Mylan now moves for summary judgment on the limited ground that the patented invention is invalid because it was anticipated in the prior art, pursuant to 35 U.S.C. § 102(a) and/or (b).

Background of the Invention.¹

The enantiomeric chemical compound at issue in this case is levofloxacin. An enantiomer is one of a pair of isomers² that are non-superimposeable mirror images of each other. This mirror image structure is often likened to the relative structures of a person's right and left hands, and chemists normally refer to each enantiomer as either the dextro (Latin dexter, or right-handed) or levo (Latin laevus, or lefthanded) enantiomer.

The right/left nomenclature also stems from the fact that enantiomers are "optically active." That is, an enantiomer will rotate a plane of polarized light³ clockwise (dextrorotatory) or counterclockwise (levorotatory). This ability to rotate light is an inherent property of the enantiomer. Moreover, a given pair of enantiomers will always rotate polarized light in equal and opposite directions. For example, if the dextrorotatory enantiomer rotates polarized light 90 to the right (clockwise), then the levorotatory enantiomer will rotate the polarized light 90 to the left (counterclockwise).

Because enantiomers have identical chemical formulae, chemists distinguish between the chemical names of enantiomeric pairs by preceding each with a symbol that reflects the direction the enantiomer rotates polarized light: "(+)" for dextrorotatory enantiomers, and "(-)" for levorotatory enantiomers.

Chemists also distinguish between enantiomers by designating an enantiomer as either "R" or "S" based upon the arrangement of certain atoms at the enantiomer's "chiral center."⁴ Where one enantiomer is an "R," the other will be an "S."

Still another way that chemists distinguish between enantiomers is by the way the compound is drawn. Because each enantiomer has the same chemical formula and bonding sequence, but different spatial orientations, drawings of each enantiomer will be very similar. Chemists can designate spatial arrangements through the use of special symbols indicating the direction of a bond between particular atoms. As drawn on a sheet of paper, a bond within the plane of the paper...