Boehringer Ingelheim Intern. v. Barr Laboratories

• Decision Date: 25 January 2010
• Docket Number: No. 2009-1032.,2009-1032.
• Citation: 592 F.3d 1340
• Parties: BOEHRINGER INGELHEIM INTERNATIONAL GMBH and Boehringer Ingelheim Pharmaceuticals, Inc., Plaintiffs-Appellants, v. BARR LABORATORIES, INC. and Barr Pharmaceuticals, Inc., Defendants, and Mylan Pharmaceuticals, Inc., Defendant-Appellee.
• Court: U.S. Court of Appeals — Federal Circuit

592 F.3d 1340

BOEHRINGER INGELHEIM INTERNATIONAL GMBH and Boehringer Ingelheim Pharmaceuticals, Inc., Plaintiffs-Appellants, v. BARR LABORATORIES, INC. and Barr Pharmaceuticals, Inc., Defendants, and Mylan Pharmaceuticals, Inc., Defendant-Appellee.

No. 2009-1032.

United States Court of Appeals, Federal Circuit.

January 25, 2010.

Bruce M. Wexler, Paul, Hastings, Janofsky & Walker LLP, of New York, NY, argued for plaintiffs-appellants. With him on the brief were Joseph M. O'Malley, Jr., Eric W. Dittmann and Angela C. Ni; and Stephen B. Kinnaird, of Washington, DC.

Shannon M. Bloodworth, Perkins Coie LLP, of Washington, DC, argued for defendant-appellee. With her on the brief was David J. Harth, of Madison, WI. Of counsel was Sarah C. Walkenhorst, Perkins Coie LLP, of Madison, WI.

Before LINN, DYK, and PROST, Circuit Judges.

Opinion for the court filed by Circuit Judge LINN. Opinion dissenting-in-part filed by Circuit Judge DYK.

LINN, Circuit Judge.

This is a patent infringement case involving the effectiveness of a terminal disclaimer to overcome obviousness-type double patenting and the safe-harbor provision of 35 U.S.C. § 121. Boehringer Ingelheim International GmbH and Boehringer Ingelheim Pharmaceuticals, Inc. (collectively "Boehringer") appeal from a final judgment that Boehringer's U.S. Patent No. 4,886,812 (the "'812 patent") is invalid for obviousness-type double patenting. Boehringer Ingelheim Int'l GmbH v. Barr Labs., Inc., No. 05-CV-700 (D.Del. Sept 18, 2008); Boehringer Ingelheim Int'l GmbH v. Barr Labs., Inc., 562 F.Supp.2d. 619 (D.Del.2008). Because the district court incorrectly concluded that the safe-harbor provision of 35 U.S.C. § 121 is inapplicable in this case, we reverse and remand.

I. BACKGROUND

Boehringer is the record owner of the '812 patent, which claims certain tetrahydrobenzthiazole compounds. Boehringer, 562 F.Supp.2d at 623; '812 patent [57], col.23 l.67-col.26 l.22. One of the claimed tetrahydrobenzthiazole compounds is 2-Amino-6-dimethylamino-4,5,6,7-tetrahy-drobenzthiazole, known more commonly as pramipexole. Boehringer, 562 F.Supp.2d at 623; '812 patent col.25 ll.19-21 (claim 7). Boehringer manufactures, markets, and sells pharmaceutical tablets containing pramipexole under the brand name Mirapex. Boehringer, 562 F.Supp.2d at 624. On July 1, 1997, the United States Food and Drug Administration ("FDA") approved Boehringer's New Drug Application ("NDA") for Mirapex, for the treatment of "signs and symptoms of idiopathic Parkinson's disease." Id.; J.A. 947, 1017-18.

The '812 patent is the third in a chain of related patents, all of which share a common specification. The first application in the chain is U.S. Patent Application No. 06/810,947 (the "'947 application"), filed December 19, 1985. '812 patent [62]; Boehringer, 562 F.Supp.2d at 625. The '947 application originally contained fifteen claims. Boehringer, 562 F.Supp.2d at 625. During prosecution of the '947 application, the examiner issued a restriction requirement listing ten groups of claims related to what the examiner considered to be independent and distinct inventions:

I. Claims 1-8 (at least part of each), drawn to benzothiazole compounds and a pharmaceutical composition, classified in Class 548, subclasses 161, 163 and 164.

II. Claims 1-5 and 8-10 (at least part of each), drawn to pyrrolidinyl-substituted benzothiazole compounds and a pharmaceutical composition, classified in Class 514, subclass 367.

III. Claims 1-4 and 8 (at least part of each), drawn to piperidinyl-substituted benzothiazole compounds and a pharmaceutical composition, classified in Class 546, subclass 192.

IV. Claims 1-4 and 8 (at least part of each), drawn to hexamethylimino substituted benzothiazole compounds and a pharmaceutical composition, classified in Class 540, subclass 603.

V. Claims 1-4 and 8, drawn (at least part of each) [to] morpholinyl-substituted benzothiazole compounds and a pharmaceutical composition, classified in Class 544, subclass 135.

VI. Claim 14, drawn to a method of preparing benzothiazole compounds using a thiourea reactant.

VII. Claim 15, drawn to a method of preparing benzothiazole compounds using a disulfide reactant classified based on type of compound formed.

VIII. Claims 9 and 10, drawn to a method of lowering blood pressure or heart rate classified based on type of compound used.

IX. Claims 11 and 12, drawn to a method for treating Parkinsonism, classified based on type of compound used.

X. Claim 13, drawn to a method for treating schizophrenia, classified based on type of compound used.

U.S. Patent Appl. Serial No. 06/810,947, Office Action, at 2-3 (Sept. 4, 1986) ("Office Action"). Although the restriction requirement stated that each of the ten groups was a distinct invention, the examiner allowed the applicant to elect "either (A) one of the compound groups I-V and one of the utility groups VIII-X (composition and utility to be limited to elected compound type for examination) or (B) one of the process groups VI and VII." Id. at 4.

In response to the restriction requirement, the applicants elected to prosecute claims directed to the invention of Group II (pyrrolidinyl-substituted benzothiazole compounds) and to the invention of Group IX (a method for treating Parkinsonism using those compounds). Boehringer, 562 F.Supp.2d at 625. The applicants amended the claims of the '947 application accordingly, and U.S. Patent No. 4,731,374 (the "'374 patent") issued from the application on March 15, 1988. Id.

While the '947 application was pending, the applicants filed U.S. Patent Application No. 07/124,197 (the "'197 application") as a divisional of the '947 application. Id. A different examiner was assigned to the '197 application. Id. at 625 n. 2. The '197 application originally contained all of the claims of the original '947 application, but, following a rejection, the applicants amended the '197 application so that it claimed various methods of using tetrahydrobenzthiazole compounds to treat certain medical conditions. Id. at 625. The method-of-use claims of the '197 application encompassed the examiner's demarcated inventions of Groups VIII and X of the restriction requirement, as well as that of Group IX directed to the use of compounds other than the compound of Group II elected in the '947 parent. Id.; see also Br. for Plaintiffs-Appellants 12, 14-17 (noting that "new claims 16 through 55 [of the '197 application] claimed the methods of use set forth in Groups VIII-X"). Thus, none of the claims of the '197 application covered subject matter elected in the '947 parent. The respective claims of the '197 and '947 applications were therefore divided as between applications along the lines of demarcation drawn by the examiner in the restriction requirement. These new claims were ultimately allowed, and U.S. Patent No. 4,843,086 (the "'086 patent") issued from the application on June 27, 1989. Boehringer, 562 F.Supp.2d at 626. The '086 patent expired on June 27, 2006.

On October 12, 1988, during the pendency of the '197 application, the applicants filed U.S. Patent Application No. 07/256,671 (the "'671 application"), which was the application from which the '812 patent issued. Id. The '671 application was filed as a division of the second application in the chain — the '197 application. It was not filed as a division of the first application — the '947 application. In fact, at the time that the '671 application was filed, the '374 patent had already issued from the '947 application, so no further divisionals from the '947 application were permitted. See '374 patent [45]; 35 U.S.C. § 120. Like the '197 application, the '671 application originally contained all of the claims of the original '947 application, but it was later amended to include only compound claims other than those directed to the pyrrolidinyl-substituted benzothiazoles previously claimed in the '374 patent. Boehringer, 562 F.Supp.2d at 626. No restriction requirement was made in the '197 application. As Boehringer acknowledges, the amended claims encompass Groups I, III, IV, and V of the restriction requirement made in the grandparent '947 application and do not cross the examiner's lines of demarcation with either the claims of the grandparent '947 application or those of the parent '197 application. See Br. for Plaintiffs-Appellants at 16-17. The '812 patent issued from the '671 application on December 12, 1989 — approximately six months after the issuance of the '086 patent. Boehringer, 562 F.Supp.2d at 626.

After the issuance of the '812 patent and after the FDA approved Boehringer's NDA for Mirapex, Boehringer applied for a patent term extension for the '812 patent under 35 U.S.C. § 156. Id. at 629. Boehringer's application stated that claims 1, 2, 3, 4, 7, 8, 9, and 10 of the '812 patent read on Mirapex. Claims 5 and 6 of the '812 patent were not listed in the application. The United States Patent and Trademark Office ("Patent Office" or "PTO") granted the application and extended the term of the '812 patent by 1,564 days, "with all rights pertaining thereto as provided by 35 U.S.C. § 156(b)." J.A. 1030. The '812 patent's original expiration date was December 12, 2006. The consequence of the 1,564-day extension was to extend Boehringer's rights in the '812 patent under § 156 until March 25, 2011.

On October 26, 2005, Mylan Pharmaceuticals, Inc. ("Mylan") notified Boehringer that it had submitted an Abbreviated New Drug Application ("ANDA") for generic pramipexole. Boehringer, 562 F.Supp.2d at 624. In response, Boehringer brought a patent infringement action against Mylan, and the action was consolidated with Boehringer's previously filed patent infringement action against an earlier ANDA filer, Barr Laboratories, Inc. ("Barr").¹ Id. Specifically, Boehringer alleged that, by filing an ANDA, Mylan infringed claims 5, 7, 9, and 10 of the '812 patent. Id. at 623. As a defense, Mylan argued that the asserted claims of the '812...