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March 7, 2008

CIP Not A Divisional

Teva's ANDA for a generic version of Pfizer's Celebrex, an arthritis treatment, predictably met with infringement assertion: 5,466,823; 5,563,165; and 5,760,068. Teva lost, and appealed, whereupon the CAFC found double patenting in the '068. Safe harbor for divisionals under 35 U.S.C. § 121 applies only to divisionals, not CIPs, which '068 was.

Pfizer v. Teva Pharmaceuticals (CAFC 07-1271)

The district court found '068 in a safe harbor under § 121.

The district court held that the safe-harbor provision of 35 U.S.C. § 121 prevented the '165 patent from serving as prior art with respect to the '068 patent. This was so because both the '165 patent and the '068 patent derived from applications filed in response to the restriction requirement made in the common parent application. Because it found that the '165 patent was not prior art, the district court held that the '068 patent was not invalid on grounds of double patenting.

Case law requires continuity.

The third sentence of section 121 provides a safe harbor to patents that issue on applications filed as a result of a restriction requirement:

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.

35 U.S.C. § 121 (2000). In addition to the express requirements of section 121, we have also construed the statute to require consonance: the applicant must maintain the line of demarcation between the independent and distinct inventions that prompted the restriction requirement. Gerber Garment Tech. v. Lectra Sys., Inc., 916 F.2d 683, 688 (Fed. Cir. 1990). This consonance requirement prevents an applicant from amending the claims in the divisional application in a way that would violate the originally imposed restriction requirement and thereby impermissibly extend the patent term as to that subject matter. Id.

Teva rightly contended that §121 was strictly for divisionals; because '068 was a CIP, §121 didn't apply.

Although both are types of continuing applications, divisionals and CIPs differ significantly in at least one respect: a divisional application contains an identical disclosure to its parent application, but a CIP introduces new matter. A CIP is "just what its name implies. It partly continues subject matter disclosed in a prior application, but it adds new subject matter not disclosed in the prior application." Univ. of W. Va. Bd. of Trs. v. Vanvoorhies, 278 F.3d 1288, 1297 (Fed. Cir. 2002); see also Manual of Patent Examining Procedure ("MPEP") § 201.08 (8th ed., Rev. 5, 2006) ("A continuation-in-part is an application filed during the lifetime of an earlier nonprovisional application, repeating some substantial portion or all of the earlier nonprovisional application and adding matter not disclosed in the said earlier nonprovisional application.") (emphasis in original). A divisional application is defined as "[a] later application for an independent or distinct invention, carved out of a pending application and disclosing and claiming only subject matter disclosed in the earlier or parent application . . . ." MPEP § 201.06. A divisional application "is often filed as a result of a restriction requirement made by the examiner." Id.

Of course, Pfizer pooh-poohed that: "although the '068 is termed a CIP, it is in effect a divisional for purposes of section 121." The CAFC disagreed.

That safe harbor, by its literal terms, protects only "divisional application[s]" (or the original application) and patents issued on such applications.

The safe harbor for divisionals, and for divisionals solely, was crafted in the 1952 Patent Act.

Prior to the 1952 Patent Act, no protection was afforded to patent applications filed as a result of a restriction requirement--referred to at the time as a "requirement for division"--and such applications were often rejected or held invalid on double patenting grounds. See Studiengesellschaft Kohle mbH v. N. Petrochemical Co., 784 F.2d 351, 358 (Fed. Cir. 1986) ("SGK") (Newman, J., concurring); In re Eisler, 203 F.2d 726 (CCPA 1953)... Pursuant to this practice, a patent applicant could appeal an examiner's requirement for division, United States ex rel. Steinmetz v. Allen, 192 U.S. 543 (1904), and "his failure to litigate the question was at his peril." Kauffman, 152 F.2d at 993.

The inequity of this practice was well known by 1952... The purpose of section 121 was to eliminate this inequity and thereby allow applicants to reasonably rely on restriction requirements. See SGK, 784 F.2d at 358 (Newman, J., concurring). Given the protection of section 121, applicants would no longer need to appeal a restriction requirement because they would no longer be penalized for acquiescing in an improper restriction requirement. See id. at 359. The enactment of section 121, therefore, brought clarity and fairness to the interaction between restriction and double patenting.

There is no suggestion, however, in the legislative history of section 121 that the safe-harbor provision was, or needed to be, directed at anything but divisional applications... The difference between divisional applications and CIPs, moreover, was well known at the time that Congress enacted the 1952 Patent Act... If the drafters wanted to include CIPs within the protection afforded by section 121, they could have easily done so.

We conclude 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.

So '068 is nailed for double patenting.

Obviousness-type double patenting is a judicially created doctrine that "prohibit[s] a party from obtaining an extension of the right to exclude through claims in a later patent that are not patentably distinct from claims in a commonly owned earlier patent." Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 967 (Fed. Cir. 2001). We have identified two steps in an obviousness-type double patenting analysis. First, "a court construes the claim[s] in the earlier patent and the claim[s] in the later patent and determines the differences." Id. at 968. Second, it determines whether those differences render the claims patentably distinct. Id. "A later patent claim is not patentably distinct from an earlier patent claim if the later claim is obvious over, or anticipated by, the earlier claim." Id. We have also held that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use." Geneva, 349 F.3d at 1385-86.

The asserted claims of the '068 are... not patentably distinct over the claims of the '165 patent... Accordingly, the '068 patent is invalid for obviousness-type double patenting.

Teva's other invalidity seeds: inequitable conduct and best mode violation, which found stony ground at district court, were likewise dismissed by the CAFC.

Reversed-in-part. Teva won a battle but lost the war.

Posted by Patent Hawk at March 7, 2008 2:56 PM | Prior Art