Thursday, September 17, 2009

Fed. Cir.: Section 121 "Safe Harbor" Provision Does Not Apply to Continuations

Amgen, Inc. v. F. Hoffman-La Roche, Ltd., No. 09-1020 (Sept. 15, 2009)

Amgen prosecuted a series of patent applications relating to the production of the protein erythropoietin ("EPO") using recombinant DNA technology. All of the patents stemmed from a common specification disclosed in "the '298 application."

During prosecution, the '298 application was subjected to a 7-way restriction. The applicants elected prosecution of one group of claims, which ultimately issued as a patent. Prior to issuance, Amgen prosecuted withdrawn claims as continuation applications, where a number of patents issued as "product patents" and "process patents."

During litigation, Rouche alleged at the summary judgment phase that certain patents stemming from the continuation application were invalid for obviousness-type double patenting, since later-claimed products were covered by earlier-claimed processes. The district court granted summary judgment in favor of the patentee Amgen, ruling that the later patents were shielded from double patenting by 35 U.S.C. § 121, which, in pertinent part states:

A patent issuing on an application with respect to which a requirement for restriction under this section has been made . . . shall not be used as a reference . . . 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.

In other words, § 121 shields patents that issue on applications filed as a result of a restriction requirement from double patenting invalidation.

Rouche argued that § 121 cannot shield the later patents because they issued from solely continuation applications to which § 121 is inapplicable. Roche contended that § 121 applies exclusively to divisional applications and patents issuing therefrom. Amgen countered that, although the applications were technically filed as "continuations", a court should look to an application’s substance—not its designation—to determine whether it qualifies as a divisional application under § 121’s safe harbor.

The Fed. Cir. dealt with a similar issue recently in Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008), where the court ruled that CIP's were not eligible for protection of the § 121 safe harbor:
§ 121 on its face refers to "divisional application[s]." . . . Turning to the legislative history, the court observed that a House Report also referred specifically to "divisional application[s]." Notably absent from the legislative history, in the court’s view, was a suggestion "that the safe-harbor provision was, or needed to be, directed at anything but divisional applications." From there, the court "conclude[d] that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications." Accordingly, the court decided that the § 121 safe harbor did not apply to the patent before it, which issued from a continuation-in-part application.
Noting that the application of § 121 should be "strict", the court ruled that continuation applications were also not eligible:

We recognize that, unlike a continuation-in-part application, a continuation application can satisfy the definition of a "divisional application" in MPEP § 201.06. . . . This distinction, however, does not justify departing from a strict application of the plain language of § 121, which affords its benefits to "divisional application[s]."

* * *

Amgen does not dispute that it denominated the [] applications continuations, that it checked the continuation application box on the submitted form, or that its applications met the PTO’s definition of a continuation application in MPEP § 201.07. . . . Instead, Amgen argues that, because the [] continuation applications could have been filed as divisional applications, we should treat them as such for purposes of § 121. While this argument convinced the district court to regard the [] continuation applications as divisional applications, we are not likewise convinced. We decline to construe "divisional application" in § 121 to encompass Amgen’s properly filed, properly designated continuation applications.

Interestingly, the court noted that, if Amgen filed the continuation applications originally as divisionals, and then filed continuations off of the divisional, the safe harbor provision would be left intact ("intervening continuation applications do not render a patent ineligible for § 121 protection so long as they descended from a divisional application filed as a result of a restriction requirement.").

In vacating summary judgment on the issue of double-patenting, the court added that the continuation provision of section 120 ("[an] application for patent for an invention . . . shall have the same effect . . . as though filed on the date of the prior application") would allow the patentee to rely on "post-invention" developments to show distinctiveness in combating issues of double-patenting. In other words,
[W]hen an issued patent claims a product and discloses, but does not claim, a process for making that product, the patentee, when later seeking a patent on the disclosed process, may present evidence of post-invention, alternative processes that produce the patented product, in order to show that the process and product are patentably distinct.
The 81-page opinion also dives into a multitude of different issues relating to distinctiveness, anticipation, indefiniteness, claim construction and infringement, and DOE - you can read/download the entire opinion here (link).

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