CPLRG™ 0019 - Boehringer Ingelheim International GmbH v. Barr Laboratories, Inc - Jan. 25, 2010

Boehringer Ingelheim International GmbH v. Barr Laboratories, Inc. 592 F.3d 1340, 2010 U.S. App. LEXIS 1624 (Fed. Cir. 2010) (LINN & Prost; DYK, dissenting-in-part)


MAJOR ISSUES: Double patenting; retroactive terminal disclaimer after first patent expired; Section 121 safe harbor; examiner restriction requirement in grandparent application; divisional of divisional application

Double patenting problems rarely arise–except when they really matter, for example, when even a short period of additional term for coverage by a second patent of a valuable pharmaceutical product is at stake. On double patenting and terminal disclaimers, see Chisum on Patents 9.03, 9.04, Chisum Patent Digest 1740. On restriction requirements, see Chisum on Patents 12.01, Chisum Patent Law Digest 1750, 3250.

1. PARKINSON’S DISEASE DRUG; THREE APPLICATIONS AND PATENTS. In this case, a third patent claimed, inter alia, benzothiazole compounds, including a tetrahydrobenzthiazole compound, pramipexole. Pramipexole was the active ingredient in the patent owner’s FDA-approved drug for treating Parkinson’s disease. U.S. Pat. No. 4,886,812.  USPatNo4886812

2. A district court held the third patent invalid for obviousness-type double patenting in view of a second patent. The third (child) patent was based on a divisional application from the second (parent) patent, which was, in turn, a divisional application of a first (grandparent) application. The second patent claimed methods of treating diseases, including Parkinson, using benzothiazole compounds. U.S. Pat. No. 4,843,086.  USPatNo4843086

3. The patent owner did not appeal the district court ruling that the third patent’s claims were obvious in view of the second patent’s. However, on appeal, the patent owner argued that the double patenting invalidation was avoided either by a terminal disclaimer that the patent owner had filed on the last day of trial or by Section 121’s safe harbor provision.

4. TERMINAL DISCLAIMER FILED AFTER REFERENCE PATENT EXPIRED. The Federal Circuit held that the terminal disclaimer was not effective to overcome obviousness-type double patenting because it was filed after the reference patent (that is the second, parent patent) had expired. This was so even though the patent owner had properly obtained a Section 156 extension of the third patent’s term for 1564 days. After the third patent expired, the patent owner improperly purported to enjoy the full rights to exclude of the third patent. The rights under a Section 156 extension are more limited.

5. SECTION 121 SAFE HARBOR; RESTRICTION REQUIREMENT IN GRANDPARENT; PROTECTION OF CLAIMS IN DIVISION OR A DIVISION. The Federal Circuit held that Section 121’s safe harbor provision protected the third patent from double patenting invalidation because an examiner had entered a restriction requirement during examination of the first (grandparent application). The restriction identified ten independent and distinct inventions. The third patent met the “as a result of” requirement of Section 121 even though it was based on a “division of a division” and even though the examiner of the second application had not issued a restriction or required that the invention claimed by the third patent be divided. The third patent met the consonance requirement for Section 121 even though its claims covered multiple inventions that had been identified as independent and distinct in the grandparent application restriction requirement. This was because the third patent’s claims were not for the invention that the patent owner had elected for the grandparent patent.

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