CAFC: Terminal Disclaimer Not Valid When Underlying Patent Expired

Boehringer Ingelheim Int'l v. Barr Laboratories, Inc., No. 2009-1032 (Fed. Cir., January 25, 2010)

Boehringer is the record owner of the '812 patent, which stemmed from a divisional application and was the third in a chain of related patents, all of which shared a common specification.  After the '812 patent issued, Boehringer received a patent term extension of 1,564 days which extended the expiration date from December 12, 2006 to March 25, 2011.

During litigation, defendant Mylan asserted that the '812 patet was invalid for obviousness-type double patenting over an earlier, expired, patent ('086 patent).  In response, and on the last day of trial, Boehringer filed a terminal disclaimer of the '812 patent in the USPTO which disclaimed the term of the patent "which would extend beyond 1,564 days after the full statutory term of the '086 patent . . . so that, by virtue of this disclaimer, the '812 patent will expire on October 8, 010."

The district court oncluded that the terminal disclaimer was ineffective to overcome the obviousness-type double patenting rejection because the disclaimer was filed fter the '086 patent had expired, and that the safe harbor provision of 35 U.S.C. § 121 precluded the use of the '086 patent as an invalidating reference.

Boehringer raised two issues on appeal.  The first issue was whether its "retroactive" terminal disclaimer is effective to overcome invalidity based on obviousness-type double patenting.  The Federal Circuit concluded that it was not:

[A] patentee may file a disclaimer after issuance of the challenged patent or during litigation, even after a finding that the challenged patent is invalid for obviousness-type double patenting. See, e.g., Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1375 (Fed. Cir. 2005) (noting that there is no “prohibition on post-issuance terminal disclaimers” and that “[a] terminal disclaimer can indeed supplant a finding of invalidity for double patenting”). The question here is whether a retroactive terminal disclaimer—i.e., a terminal disclaimer that is filed after the expiration date of an earlier commonly owned patent—is effective to overcome obviousness-type double patenting.

[W]hen the claims of a patent are obvious in light of the claims of an earlier commonly owned patent, the patentee can have no right to exclude others from practicing the invention encompassed by the later patent after the date of the expiration of the earlier patent. But when a patentee does not terminally disclaim the later patent before the expiration of the earlier related patent, the later patent purports to remain in force even after the date on which the patentee no longer has any right to exclude others from practicing the claimed subject matter. By permitting the later patent to remain in force beyond the date of the earlier patent’s expiration, the patentee wrongly purports to inform the public that it is precluded from making, using, selling, offering for sale, or importing the claimed invention during a period after the expiration of the earlier patent.

[B]y 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. The patentee cannot undo this unjustified timewise extension by retroactively disclaiming the term of the later patent because it has already enjoyed rights that it seeks to disclaim. Permitting such a retroactive terminal disclaimer would be inconsistent with “[t]he fundamental reason” for obviousness-type double patenting, namely, “to prevent unjustified timewise extension of the right to exclude.” . . . We therefore hold that a terminal disclaimer filed after the expiration of the earlier patent over which claims have been found obvious cannot cure obviousness-type double patenting.

On the second issue, Boehringer argued that the safe-harbor provision of 35 U.S.C. § 121 shields the ’812 patent from invalidity on the basis of double patenting in view of the ’086 patent.  Section 121 provides in relevant part:

A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application . . .

Here, Mylan argued that section 121 was not applicable, since the '812 patent was a "divisional of a divisional."  The Fed. Cir. rejected this argument:

We [] reject Mylan’s argument that § 121 is inapplicable solely because the ’812 patent issued from an application that was a divisional of a divisional and hold that, assuming all other requirements of § 121 are met, the safe-harbor provision may apply to a divisional of a divisional of the application in which a restriction requirement was entered. We note that this holding is fully consistent with the purpose of § 121—namely, to prevent a patentee who divides an application in which a restriction requirement has been made from risking invalidity due to double patenting.

WIth regard to the "as a result of" requirement, the court added:

Boehringer finally argues that when an examiner issues a restriction requirement identifying more than two independent and distinct inventions, the choice of how to prosecute non-elected inventions is up to the applicant and is constrained neither by the terms of an examiner’s restriction requirement nor by the language of § 121. According to Boehringer, so long as consonance is met, it makes no difference in terms of compliance with the “as a result of” requirement 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.

We agree with Boehringer. The restriction requirement entered in the ’947 application required only an election in that application of a subset of the ten identified inventions. It also had the effect of obligating Boehringer to file one or more divisional applications if it wanted patent protection for the non-elected subject matter. Boehringer did so not by filing separate divisional applications on each of the inventions grouped by the examiner in the restriction requirement, but instead, by filing two successive divisionals to different combinations of the inventions identified in the restriction requirement. In doing so, Boehringer neither violated the examiner’s restriction requirement nor risked loss of the safe harbor of § 121.

The Fed. Cir. concluded that Boehringer’s terminal disclaimer did not overcome obviousness-type double patenting with respect to the ’086 patent, but that the safe-harbor provision of § 121 was applicable.  Accordingly, the court reversed the district court’s judgment of invalidity and remand for further proceedings.


DYK DISSENT: 

In effect, it appears that the majority is dispensing with the requirement that the restriction requirement be followed at all in any later divisional applications, so long as the original application in which the restriction requirement was imposed complies with the restriction . . . the majority cites language from our case law for the proposition that section 121 is satisfied if later divisional applications are limited to the “non-elected invention or inventions” of the parent application. This suggests to the majority that separate inventions may be combined in a single later application. But our decisions do not in fact countenance this. In my view, the majority’s decision is inconsistent with our case law.