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United States Court of Appeals for the Federal Circuit
January 25, 2010, Decided
[*1342] 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") [**2] is invalid for obviousness-type double patenting. Boehringer Ingelheim Int'l GmbH v. Barr Labs., Inc., No. 05-CV-700 (D. Del. Sept. [*1343] 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.
Boehringer is the record owner of the '812 patent, which claims certain tetrahydrobenzthiazole compounds. Boehringer, 562 F. Supp. 2d at 623; '812 patent , col.23 l.67-col.26 l.22. One of the claimed tetrahydrobenzthiazole compounds is 2-Amino-6-dimethylamino-4,5,6,7-tetrahydrobenzthiazole, 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, 526 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 [**3] 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 ; 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:
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592 F.3d 1340 *; 2010 U.S. App. LEXIS 1624 **; 93 U.S.P.Q.2D (BNA) 1417
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.
Subsequent History: Related proceeding at Mylan, Inc. v. Boehringer Ingelheim Int'l GMBH, 2010 U.S. Dist. LEXIS 27819 (W.D. Pa., Mar. 24, 2010)
Rehearing denied by, Rehearing, en banc, denied by Boehringer Ingelheim Int'l GmbH v. Barr Labs., Inc., 603 F.3d 1359, 2010 U.S. App. LEXIS 9371 (Fed. Cir., 2010)
Related proceeding at FTC v. Boehringer Ingelheim Pharms., Inc., 2012 U.S. Dist. LEXIS 138854 (D.D.C., Sept. 27, 2012)
Prior History: [**1] Appeal from the United States District Court for the District of Delaware in consolidated cases 05-CV-700 and 05-CV-854, Judge Joseph J. Farnan, Jr.
Boehringer Ingelheim Int'l GMBH v. Barr Labs., Inc., 562 F. Supp. 2d 619, 2008 U.S. Dist. LEXIS 49036 (D. Del., 2008)
Disposition: REVERSED and REMANDED.
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Patent Law, General Overview, Double Patenting, Standards & Tests, Terminal Disclaimers, US Patent & Trademark Office Proceedings, Continuation Applications, Divisionals & Restrictions