CAFC says reissued patent can’t sail into safe harbor

| July 8, 2015

G.D. Searle LLC et al. v. Lupin Pharmaceuticals, Inc., et al.

June 23, 2015

Before: Prost, Bryson, and Hughes. Opinion by Bryson

The CAFC strictly construes the “safe harbor” provision of 35 USC § 121 and casts doubt on whether there are any circumstances in which reissue can be used to correct failure to file a divisional application.

In Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008), the CAFC held the relevant claims of the ‘068 patent invalid for obviousness-type double patenting over the ‘165 patent. The CAFC held that the “safe harbor” provision of 35 USC § 121 was inapplicable to the ‘068 patent because the “safe harbor” provision is limited to divisional patents filed as the result of a restriction requirement. The ‘068 patent issued based on a CIP application, not a divisional.

Pfizer subsequently filed ‘319 application, seeking reissue of the ‘068 patent. The error asserted in the reissue declaration was that the application that resulted in the ‘068 application was filed as a CIP, rather than as a divisional application. The relationship between the ‘068 patent and its related applications, as well as the two infringement suits, is somewhat convoluted, and consequently is summarized below in a flow chart:











In a preliminary amendment in the reissue application, Pfizer made the following amendments, assertedly to conform the ’068 patent to a divisional of the ’594 application:

(1) deleted portions of the ’068 patent specification that were new matter, i.e., not present in the ’594 application
(2) designated the ’113 application as a divisional of the ’594 application and removed the priority claim to the ’629 application
(3) amended claim 1 to be a method claim supported by the disclosure of the ’594 application
(4) canceled claims 2-12 and 18, which required the new matter for support
(5) added new method claims 19-23, which recited the use of the method disclosed in claim 1

The Examiner rejected the preliminary amendment on the ground that the “error” identified in the reissue declaration was not correctable under 35 USC § 251. Pfizer filed an additional reissue declaration listing various technical errors relating to the claimed chemical structures, which it alleged rendered the ‘068 patent claims indefinite, and therefore eligible for correction via reissue.

The examiner found that the technical errors provided a proper basis for reissue under section 251, and allowed Pfizer to correct those technical errors; as well as to designate the ’113 application as a divisional of the ’594 application and to delete subject matter not present in the ’594 application. The’319 application subsequently issued as the RE ’048 patent, on which Pfizer based a new infringement suit against five generic drug manufacturers.

The defendants moved for summary judgment, which the district court granted in part, because:

(1) the error originally asserted in the reissue declaration was not an error correctable by reissue
(2) the safe harbor provision of section 121 was not applicable to RE ‘048 patent
(3) the relevant claims of the RE ‘048 patent were invalid for obviousness-type double patenting over the ‘165 patent

The parties addressed two issues on appeal — (1) whether the PTO was authorized to reissue the ‘068 patent under section 251 and (2) assuming the reissue was authorized, whether the RE ‘048 patent was protected by the safe harbor provision of section 121 — but the CAFC decided the appeal on the second issue only. It held that the test for application of the safe harbor provision is a strict one, for public policy reasons, and was not applicable to the RE ‘048 patent.

The safe harbor provision of section 121 provides as follows:

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.

The CAFC set forth a variety of reasons for affirming the district court.
First, the ‘165 patent (the patent on which the invalidity determination was based) issued from a divisional of the ‘594 application. Based on the language of section 121, the safe harbor provision would apply to the patent that issued directly from the ‘594 application (the ‘829 patent) or a patent issuing from a divisional of the ‘594 application. The RE ‘048 patent was neither of these.

Second, the CAFC also considered the definition of a divisional application. According to the MPEP, a divisional application is one that is carved out of an earlier-filed application and claims only subject matter disclosed in the earlier application. An application that discloses and claims new matter cannot retroactively be converted to a divisional by deleting the new matter.

Third, as a matter of fairness to the public, Pfizer cannot retroactively relinquish the new matter in the ‘113 application after having had years of benefit from claims directed to the new matter.

Fourth, the ‘113 application was a national stage of a PCT application that was identified as a CIP of the ‘594 application. Pfizer obtained foreign patents based on the PCT application. The scope of the PCT application cannot be altered without calling into question the scope of the foreign patents; but because it contained new matter, the PCT application could not be a division of the ‘594 application.

Fifth, the lack of unity in the ‘113 application was separate from the restriction requirement in the ‘594 application. The RE ‘048 patent therefore did not result from a restriction requirement in the ‘594 application or carried forward from the ‘594 application, contrary to the conditions for safe harbor set forth in section 121.

Take aways:
• A CIP application cannot be converted into a divisional application.
• The test for application of the “safe harbor” provision of 35 USC § 121 is a strict one, so the language of the “safe harbor” provision is strictly construed.
• Patentees should not expect to be able to use a reissue application to remedy a failure to file a divisional application.

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