Boehringer Ingelheim Int'l. v. Barr Laboratories, Inc.: Federal Circuit Reverses and Remands District Court Ruling in Obviousness-type Double Patenting Case

Boehringer Ingelheim Int'l. v. Barr Laboratories, Inc., No. 2009-1032 (Fed. Cir. 2010).

Opinion

The Federal Circuit reversed and remanded the District Court for the District of Delaware, which had ruled that U.S. Patent No. 4,866,812, owned by the appellant Boehringer, was invalid because Boehringer’s terminal disclaimer did not overcome obviousness-type double patenting with respect to an earlier expired patent, and because the safe harbor provision of § 121 of the Patent Act does not protect the current patent.

The District Court had ruled that the terminal disclaimer filed by Boehringer on the last day of the trial was inoperative because it was filed after the original patent, U.S. Patent No. 4,843,086, had expired. The court also concluded that the safe harbor provision of § 121 did not apply to the ‘812 patent because it was not filed as a result of any restrictions in the ‘086 patent but rather due to a restriction in another patent, U.S. Patent No. 4,731,374. On appeal, the Federal Circuit agreed with the District Court on the issue of the terminal disclaimer, but found that the safe harbor provision did apply.

271 Patent Blog and Patently-O Blog provide brief overviews of the case. Patent Docs gives a more detailed analysis of the case as well as a short summary of the dissenting opinion. IPWatchdog talks about the practical nature of the decision and criticizes the dissent’s narrow interpretation of the safe harbor provision.

The present suit covers two patent infringement actions brought by Boehringer against Mylan Pharmaceuticals and Barr Laboratories. The ‘812 patent is the third patent in a chain of related patents which covers the use of tetrahydrobenzthiazole compounds for the treatment of idiopathic Parkinson’s disease. The District Court found that the patent had violated the double patenting restrictions of 35 U.S.C. § 101. In order to bypass this problem, Boehringer had filed a terminal disclaimer which “sought to disclaim the approximately six months of the ’812 patent’s original term that extended beyond the term of the ’086 patent” and to apply the extension they had on the ‘812 patent to this shortened original term. However, the court concluded that Boehringer’s terminal disclaimer was ineffective because it was filed after the ‘086 patent had expired. Upon review, the Circuit Court agreed and held that retroactively filed terminal disclaimers that allow the later patent to remain in effect for a period after the expiration of the previous patent should not be allowed because it wrongly gives the public the impression that the earlier patent remains in force even after it has expired.

The District Court also found that the safe harbor provision of § 121 does not shield the ‘812 patent from invalidity from the earlier ‘086 patent. Upon review, the Circuit Court addressed this issue in two parts: (1) whether § 121 applies to patents that are considered divisional applications of another divisional application and (2) whether the “as a result of” requirement of § 121 applies in this case and is satisfied here. The court held that the safe harbor provision can apply to patents that are a divisional of a divisional application because § 121 refers broadly to a “divisional application” and does not expressly limit itself to divisional applications that directly stem from the original patent. Furthermore, the court found that the purpose of the safe harbor provision would be undermined if its application was restricted to divisional of the original patent. The court then held that the “as a result of” requirement of § 121 applies and is satisfied by both the ‘086 and ‘812 patents. Boehringer claimed that both patents trace their lineage back to the ‘374 patent, which had claimed a subset of the non-elected subject matter from its first patent application, U.S. Patent Application No. 06/810,947. The Patent and Trademark Office had placed a restriction requirement on the ‘947 application, which is why Boehringer has sought protection of its claims under several separate patents. The Circuit Court agreed with this, ruling that the safe harbor provision did apply to the ‘812 patent and reversed the lower court’s decision.

This decision broadens the application of the safe harbor provision in a straightforward and practical way. It also affirms the District Court’s judgment on the ineffectiveness of retroactive terminal disclaimers.