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Safe-Harbor Provision of 35 U.S.C. § 121 Applies to a Divisional of a Divisional—Even One Filed Voluntarily, Claiming Several Nonelected Inventions

January 25, 2010

Decision icon Decision

Judges: Linn (author), Dyk (dissenting-in-part), Prost

[Appealed from: D. Del., Judge Farnan]

In Boehringer Ingelheim International GmbH v. Barr Laboratories, Inc., No. 09-1032 (Fed. Cir. Jan. 25, 2010), the Federal Circuit reversed the district court’s finding of invalidity, holding that (1) a retroactive terminal disclaimer cannot overcome obviousness-type double patenting; (2) the safe-harbor provision of 35 U.S.C. § 121 properly applies to a divisional of a divisional of the application in which a restriction requirement was entered, even where the subsequent divisional application was filed voluntarily; and (3) the safe-harbor provision of 35 U.S.C. § 121 applies to a divisional application that claims more than one of the nonelected inventions from the original application.

Boehringer Ingelheim International GmbH (“Boehringer”) manufactures and sells MIRAPEX®, an FDA-approved drug for the treatment of signs and symptoms of idiopathic Parkinson’s disease.  Boehringer brought suit against two ANDA filers for infringing U.S. Patent No. 4,886,812 (“the ’812 patent”) by attempting to obtain FDA approval for generic versions of the drug. 

The ’812 patent belongs to a chain of related patents that share common specifications.  The original patent—U.S. Patent No. 4,731,374 (“the ’374 patent”)—issued after the PTO required the applicants to elect one of at least five independent and distinct inventions claimed in the application.  After making an election, the applicants filed a divisional application which claimed more than one of the nonelected inventions.  This divisional later issued as U.S. Patent No. 4,843,086 (“the ’086 patent”).  Before the ’086 patent issued, the applicants voluntarily filed a second divisional application based on the previous divisional application.  The second divisional application issued as the ’812 patent.  A patent term extension added 1,564 days to the ’812 patent’s term.

At the time of trial, both the ’374 and ’086 patents had expired.  In an attempt to avoid invalidity due to obviousness-type double patenting, Boehringer filed a terminal disclaimer on the last day of trial.  The district court concluded that Boehringer’s terminal disclaimer was ineffective to overcome obviousness-type double patenting because the disclaimer was filed after the ’086 patent had expired.  The district court also held that the safe-harbor provision of § 121 did not apply to the ’812 patent because (1) the provision does not apply to a divisional of a divisional of an application that required restriction, and (2) the second divisional was not “a result of” the original restriction requirement.  Based on these holdings, the district court went on to find the ’812 patent invalid.

The Federal Circuit began its analysis by holding that a terminal disclaimer cannot overcome obviousness-type double patenting when the disclaimer is filed after the expiration of the original patent.  The Court reasoned that by failing to terminally disclaim a later patent prior to the expiration of an earlier related patent, a patentee enjoys an unjustified advantage—a purported time extension of the right to exclude from the date of the expiration of the earlier patent.  Boehringer argued that it did not enjoy any unjustified advantage because it had properly obtained a term extension of the ’812 patent that would have kept it in force.  The Court was not persuaded, however, responding that since the rights of a patentee during a term extension are limited in ways that do not normally apply to granted patents, the ’812 patent had enjoyed an unjustified extension of its term.  Accordingly, the Court found Boehringer’s terminal disclaimer ineffective.

Next, the Court held that the safe-harbor provision of 35 U.S.C. § 121 may apply to a divisional of a divisional of the application in which a restriction requirement was entered.  Section 121 provides a safe harbor against double patenting rejections for divisional applications filed as a result of a restriction requirement.  The Court pointed to previous holdings in Symbol Technologies, Inc. v. Opticon, Inc., 935 F.2d 1569 (Fed. Cir. 1991), and Amgen Inc. v. F. Hoffman-La Roche Ltd, 580 F.3d 1340 (Fed. Cir. 2009), where it held that § 121 applies to continuing applications deriving from a divisional application filed as a result of a restriction requirement.  Similarly, the Court found that the safe-harbor provision applies equally to a divisional of a divisional application filed as a result of a restriction requirement.

The Court also held that the “as a result of” requirement of § 121 is met when an application simply traces its lineage to an application that elicited a restriction requirement.  Here, the fact that the applicants voluntarily filed the second divisional application did not affect the applicability of the safe-harbor provision.  The Court reasoned that but for the original restriction requirement, the applicants would have been free to pursue all of the claims in the ’812 patent.  The Court agreed that “it makes no difference . . . whether the applicant responds to the examiner’s restriction requirement by filing one or more divisional applications from the original application, or instead files a single divisional application followed by successive additional divisionals.”  Slip op. at 22.

Finally, the Court held that the language of § 121 does not require a divisional—or a divisional of a divisional—to be restricted to only one of the examiner’s demarcated inventions in order to preserve the right to rely on the safe-harbor provision of § 121.  The application must only trace its lineage back to the application in which a restriction requirement was entered and claim some subset of the nonelected subject matter.  According to the Court, § 121 is not concerned with any overlap in nonelected inventions prosecuted within any particular divisional application or in how any such applications are filed.

Although Boehringer’s terminal disclaimer remained ineffective, the Federal Circuit reversed the district court’s judgment of invalidity and remanded the case for further proceedings consistent with its interpretation of 35 U.S.C. § 121. 

Judge Dyk dissented-in-part, arguing that the Court’s construction of 35 U.S.C. § 121 significantly expanded the statute’s coverage.  Judge Dyk’s dissent focused on the purpose of the statute and reasoned that it is not enough that the original divisional application was filed as a result of the restriction requirement; the subsequent contested patent application itself must have been the result of a restriction requirement as well.  Judge Dyk also opined that § 121 was never intended to apply to a divisional that elects more than one independent and distinct invention as identified by the examiner.

Summary authored by Armon B. Shahdadi, Esq.