Boehringer Ingelheim Int'l GmbH v. Barr Labs., Inc.

Boehringer Ingelheim Int'l GmbH v. Barr Labs., Inc.

Opinion

 [*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.

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-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 [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:

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