Boehringer Ingelheim International GMBH v. Barr Laboratories, Inc. (Fed. Cir. 2010) (denial of en banc rehearing)
In January 2010, the Federal Circuit expanded the scope of the safe-harbor created by 35 USC 121 against double patenting allegations. Namely, 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.
Now, the court has denied generic drugmaker Mylan request for rehearing en banc. Mylan had presented two questions:
1. Whether a divisional of a divisional patent application is a "result of a restriction requirement imposed on an original application, entitling a patentee to invoke 35 U.S.C. § 121's safe harbor from invalidity due to double patenting, where the second divisional was filed voluntarily for strategic reasons and was not mandated by the original restriction requirement."
2. Whether a divisional application is "consonant" with a restriction requirement, entitling a patentee to invoke the safe harbor of 35 U.S.C. § 121, where the divisional disregards the lines drawn by the examiner in imposing the restriction requirement.
Judges Gajarsa and Dyk dissented from the en banc denial. In the dissent, Judge Gajarsa wrote:
Because the majority's decision improperly expands the statutory safe-harbor provision of 35 U.S.C. § 121 beyond Congress's intended scope, I respectfully dissent from the court's denial of Mylan's petition for rehearing en banc. While the Supreme Court has not construed § 121, the majority's expansive opinion is inconsistent with our longstanding precedent, and will work a major change in our jurisprudence.
The purpose of § 121 is to prevent the inequity that resulted from an examiner's improper restriction requirement (separating out supposedly patentably distinct inventions that were in fact the same or not patentably distinct), whereby a patentee's compliance with an examiner's incorrect restriction would result in the original application being used as a reference against the later divisional application and a rejection on double patenting grounds. See Pfizer, Inc. v. Teva Pharms. USA Inc., 518 F.3d 1353, 1361 (Fed. Cir. 2008); Studiengesellschaft Kohle mbH v. N. Petrochem. Co., 784 F.2d 351, 359 (Fed. Cir. 1986) (Newman, J., concurring). Thus, § 121 "effects a form of estoppel" against the PTO, "that shields the applicant from having to prove the correctness of the restriction requirement in order to preserve the validity of the second patent." Studiengesellschaft, 784 F.2d at 361. In our past decisions, we have limited § 121 in accordance with its language and clear purpose to situations in which the patent applicant has been forced to divide his application by action of the PTO. We have interpreted the statute to include a requirement of consonance, requiring that the later application or applications follow the original examiner's restriction requirement, and we have interpreted the statute to include a requirement that the later application or application be filed "as a result of" the original PTO restriction.
In addressing § 121, the majority opinion commits two legal errors. First, it significantly undermines this court's "consonance" precedence by permitting a patentee to ignore the examiner's demarcation of independent and distinct inventions in subsequent divisional applications. Second, it engages in an impermissible and expansive reading of § 121's "as a result of" language. Either error in isolation would be worthy of en banc review; coupled together, the errors threaten to significantly broaden § 121's safe-harbor provision in clear defiance of this court's "strict test for application of § 121." Geneva Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1382 (Fed. Cir. 2003).