Pfizer Inc. v. Mylan Laboratories Inc.

Full title: PFIZER INC., Plaintiff and Counterclaim-Defendant, v. MYLAN LABORATORIES…

Court: United States District Court, W.D. Pennsylvania

Date published: Mar 16, 2007

2:02-cv-1628 (W.D. Pa. Mar. 16, 2007)

Opinion

2:02-cv-1628.

March 16, 2007

ORDER OF COURT

TERRENCE McVERRY, District Judge

AND NOW, this 16^th day of March, 2007, upon consideration of:

PFIZER'S MOTION TO AMEND THE COURT'S JUDGMENT AND ORDER (Document No. 237);

PFIZER INC.'S MEMORANDUM OF LAW IN SUPPORT OF ITS MOTION TO AMEND THE COURT'S JUDGMENT AND ORDER (Document No. 238);

DEFENDANTS' MOTION TO AMEND THE COURT'S JUDGMENT AND ORDER (Document No. 244-1);

DEFENDANTS' MEMORANDUM IN SUPPORT OF THEIR MOTION TO AMEND THE COURT'S JUDGMENT AND ORDER (Document No. 244-2);

DEFENDANTS' MEMORANDUM IN OPPOSITION TO PLAINTIFF'S MOTION TO AMEND THE COURT'S JUDGMENT AND ORDER (Document No. 245); and,

PFIZER INC.'S COMBINED OPPOSITION TO MYLAN'S MOTION TO AMEND THE COURT'S JUDGMENT AND ORDER AND REPLY IN SUPPORT OF ITS MOTION TO AMEND THE COURT'S JUDGMENT (Document No. 246),

and it appearing that the language in the Court Order of February 27, 2007, may have been in error insofar as it appeared to extend the term of the `303 patent by a period of pediatric exclusivity which was not in conformance with the mandatory language of the patent statute and further, the issue of pediatric exclusivity per se was not before the Court in this infringement action.

NOW THEREFORE, PFIZER'S MOTION TO AMEND THE COURT'S JUDGMENT AND ORDER and DEFENDANTS' MOTION TO AMEND THE COURT'S JUDGMENT AND ORDER are both GRANTED IN PART and DENIED IN PART, and it is hereby ORDERED, ADJUDGED AND DECREED that the Order and Judgment entered in this action on February 27, 2007 are amended to provide as follows:

IT IS ORDERED, ADJUDGED AND DECREED that, for the reasons set forth in the Court's findings of fact and conclusions of law, Judgment shall be entered in favor of Plaintiff Pfizer and against Defendants Mylan Laboratories, Inc. and Mylan Pharmaceuticals, Inc. (herein collectively "Mylan") on Pfizer's claims that Mylan has infringed claims 1-3 of United States Patent No. 4,879,303 (the "303 patent"); and it is further,

ORDERED, ADJUDGED AND DECREED that Judgment shall be entered in favor of Pfizer and against Mylan dismissing Mylan's counterclaims which alleged and sought declarations of noninfringement, invalidity, or unenforceability of the `303 patent; and it is further,

ORDERED, ADJUDGED AND DECREED that, pursuant to the provisions of 35 U.S.C. § 271(e)(4)(A), the effective date of any approval of Mylan's Abbreviated New Drug Application No. 76-418, seeking FDA approval of amlodipine besylate tablets, 2.5, 5 and 10 mg dosage strengths, shall be a date which is not earlier than the date of expiration of the `303 patent (March 25, 2007); and it is further, ORDERED, ADJUDGED AND DECREED that, pursuant to the provisions of 35 U.S.C. § 271(e)(4)(B), Mylan, its officers, agents, servants, employees and attorneys, and those persons in active concert or participation with Mylan are enjoined until the date of expiration of the `303 patent (March 25, 2007), from engaging in the commercial manufacture, use, offer to sell, or sale within the United States, or importation into the United States, of any product comprising the chemical compound amlodipine besylate covered by, or the sale or use of which is covered by claims 1-3 of the `303 patent.