Double Patenting: The § 121 Safe Harbor Protects Patents Descending from Divisional Applications, but not from Continuation Applications Exclusively

Amgen Inc. v. F. Hoffmann-La Roche Ltd, Nos. 2009-1020, -1096 (Fed. Cir. Sept. 15, 2009):

In the 80-page decision, the Court addressed many issues. Instead of covering the entire opinion, we choose to focus on a couple of notable holdings.

Notable Holdings:

The 35 U.S.C. § 121 safe harbor protects patents descending from divisional applications, but not from continuation applications exclusively. Slip op. at 18.

An accused infringer cannot show patentable indistinctiveness by relying on evidence up to the filing date of the secondary application; rather, it must rely on evidence up to the filing date of the first application because of the priority claim under 35 U.S.C. § 120. Slip op. at 23.

Comments:

Section 121, entitled “Divisional applications,” provides in its third sentence:
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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.
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35 U.S.C. § 121.

The Court’s holding that the § 121 safe harbor does not protect patents descending from continuation applications exclusively is consistent with its earlier decisions that § 121 protects patents which issued directly from continuation applications that descended from divisional applications that were filed as a result of restriction requirements. Slip op. at 18.

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Regarding patentable indistinctiveness, the Court rejected Roche’s interpretation of Takeda Pharmaceutical Co. v. Doll, 561 F.3d 1372 (Fed. Cir. 2009), that both the patentee and the accused infringer can show patentable indistinctiveness by relying on evidence up to the filing date of the secondary application. Because of 35 U.S.C. § 120, the Court held that only the patentee may do so, but not the accused infringer.

However, if the patentee pursues that course, the accused infringer will be free to rely on subsequent developments in the art up to the filing dates of the second application to prove that any alternative processes put forth by the patentee do not render the claims of both applications patentably distinct. Slip op. at 25.