Boehringer Ingelheim Int’l v. Barr Labs and Mylan Pharma (Fed. Cir. 2010)
This decision holds a terminal disclaimer cannot be effective if filed after the expiration date of the earlier patent. The decision expands scope of the safe-harbor created by 35 USC 121 against double patenting allegations. Here, the court held that a divisional-of-a-divisional still qualifies for the safe harbor so long as the later-filed applications do not violate the Examiner's original grouping suggestions.
(Opinion by Judge Linn and Joined by Judge Prost) Boehringer owns several patents listed in the FDA’s Orange Book as covering the drug Mirapex (pramipexole) used to treat symptoms of Parkinson’s disease. Boehringer filed this lawsuit after the defendant generic-drug manufacturers submitted abbreviated new drug applications (ANDAs) to the FDA as part of their efforts to begin making generic versions of the Mirapex.
The Mirapex patent family began with a 1985 patent application. That family has branched-out into more than fifty world-wide patents, including three US patents. Interestingly, the patent that issued from the original application (the “earlier patent”) is not listed in the Orange Book while a later issued patent is listed. By the time of this lawsuit, the Mirapex patents had passed their ordinary 17–year term of enforceability. However, the term of the later issued patent had been extended by over 4–years based on FDA delay under 35 USC 156.
Late-Filed Terminal Disclaimer : Despite their similarity, Boehringer had not filed a terminal disclaimer in the latest-filed US application. On the last day of trial, Boehringer decided to go ahead and file a terminal disclaimer. In spite of that action, the district court still held Boehringer’s asserted patent invalid under the judicially created doctrine of obviousness-type double patenting. In its opinion, the district court rejected the terminal disclaimer as inoperative because it was filed after the original patent had expired.
On appeal, the Federal Circuit agreed that a terminal disclaimer is not effective if filed after the expiration of the earlier patent.
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. 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.
Safe harbor of Section 121: Section 121 of the Patent Act provides a safe-harbor for family–member patents that issue after a restriction requirement:
A patent issuing on an application with respect to which a requirement for restriction … 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…
On appeal, the Federal Circuit first held that Section 121 can apply to protect “a divisional of a divisional” as in this case. Here, the court agreed that the later application was filed “as a result of” a restriction requirement because the restriction requirement in the original application was the original cause of the multiple US patent filings. The court did indicate that this safe-harbor would have been lost if the later-filed application violated the claim groupings of the restriction requirement.
In a prior decision, the court held that Section 121 applies to protect patents against double patenting rejections. See Geneva Pharms, 349 F.3d 1373, 1378 (Fed. Cir. 2003) (“Section 121 intervenes to prevent a nonstatutory double patenting rejection”).
Thus, because of the protection of Section 121, Boehringer did not need to file a terminal disclaimer.
In dissent, Judge Dyk argued that Section 121 should not apply here because the applicant had not strictly following the groupings in the original restriction requirement. Notably, the original restriction requirement divided the claims into ten groups — each group representing a separate invention while the later application was filed with claims from four of the groups.