IP Law Daily Biologic autoimmune treatment claims unpatentable for obviousness-type double patenting
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Tuesday, January 23, 2018

Biologic autoimmune treatment claims unpatentable for obviousness-type double patenting

By Thomas Long, J.D.

Seven claims of a patent directed to certain chimeric antibodies used in biologic drugs to treat autoimmune diseases were unpatentable under the doctrine of obviousness-type double patenting, the U.S. Court of Appeals for the Federal Circuit has held. The court affirmed a decision of the Patent Trial and Appeal Board rejecting the claims and finding that they were not protected by the safe-harbor provision of 35 U.S.C. §121 for divisional applications filed as a result of a restriction requirement. The patent owner could not retroactively bring its challenged patent within the scope of the safe-harbor provision by filing an amendment in a reexamination proceeding. The application resulting in issuance of the challenged patent was not a divisional application because it claimed matter not present in the original application (In re Janssen Biotech, Inc., January 23, 2018, Prost, S.).

Janssen Biotech, Inc., and New York University (collectively, "Janssen") held U.S. Patent No. 6,284,471 ("the ’471 patent"), titled "Anti-TNFa antibodies and assays employing anti-TNFa antibodies." The seven claims at issue disclosed methods of making and using chimeric antibodies in immunoassays and immuno-therapeutic approaches. In an ex parte reexamination proceeding, the USPTO’s examiner rejected the claims on double patenting grounds over three patents, including U.S. Patent No. 5,656,272 ("the ’272 patent") and U.S. Patent No. 5,698,195 ("the ’195 patent"), the reference patents in this appeal. The Board affirmed the rejection, and Janssen appealed.

The judicially created doctrine of obviousness-type double patenting prohibits an inventor from extending the right to exclude through claims in a later-expiring patent that are not patentably distinct from the claims of the inventor’s earlier-expiring patent. The doctrine applies when two patents that claim the same invention have different expiration dates. A later claim is not patentably distinct if it is obvious over or anticipated by the earlier claim.

The Section 121 safe harbor protects certain patents and patent applications from double patenting rejections/invalidations when the USPTO has issued a restriction requirement. A restriction requirement may be issued when an application claims two or more independent and distinct inventions; the applicant will be required to choose one of the inventions for prosecution and can file one or more divisional applications claiming the non-elected inventions. Section 121 is intended to protect an applicant from losing rights when an application is divided. The safe harbor only applies when: (1) the divisional application was filed "as a result" of the restriction requirement and (2) the divisional application did not contain claims drawn to the invention chosen for prosecution in the parent application (referred to as the "consonance" requirement).

Prosecution history. Resolution of Janssen’s Section 121 defense in this case depended on an interpretation of the prosecution history of the ’471 patent and the patent’s relationship to a prior abandoned application, No. 08/013,413 ("the ’413 application"). On October 27, 1993, an examiner issued a five-way restriction requirement in the ’413 application. The relevant restrictions were Group I, drawn to antibodies, pharmaceutical compositions, and assay methods; and Group IV, drawn to methods for treating an animal by administering a pharmaceutical composition containing an antibody. Rather than filing a response to the restriction, Janssen abandoned the application and stated that it was filing a continuation-in-part (CIP) application. Janssen then filed application No. 08/192,093 ("the ’093 application"), on which the ’471 patent was issued, and application No. 08/192,102 ("the ’102 application"), on which the ’272 patent was issued. In the ’093 application, Janssen disclosed and claimed subject matter not only from the ’413 application but also from another abandoned application, No. 08/010,406 ("the ’406 application"). The ’413 application related to antibodies specific to human tumor necrosis factor (TNF) alpha. The ’406 application related to immunoreceptor molecules that were specific for TNF alpha or beta.

Janssen later filed an amendment in the ’093 application, cancelling claims drawn to the non-elected treatment-method invention (Group IV) pursuant to the restriction requirement set forth in the ’413 application. The amendment did not, however, limit the claimed subject matter to only subject matter claimed and dis-closed in the ’413 application. The examiner mailed an office action requiring Janssen to elect between species I (which included chimeric antibodies and immunoreceptors that comprise the epitope binding region of an antibody) and species II (which included immunoreceptor molecules comprising TNF receptors p55 or p75). The claims directed to species II were originally disclosed and claimed only in the ’406 application and not in the ’413 application. Janssen elected species I.

The examiner next issued an office action in the ’093 application provisionally rejecting claims on obviousness-type double patenting grounds over yet another application, No. 08/324,799 ("’799 application"). Janssen then filed a preliminary amendment in the ’102 application, cancelling all of the pending claims and replacing them with seven new claims directed to a method of treating Crohn’s disease. Janssen also filed a preliminary amendment in the ’799 application, replacing all of the pending claims with seven new claims directed to methods of treatment of rheumatoid arthritis.

Following the examiner’s double patenting rejection in the ’093 application, Janssen cancelled and amended claims in that application, including limiting claim 1 to TNF alpha. The examiner issued another office action maintaining these rejections and Janssen appealed. Janssen then filed another amendment cancelling and amending claims. Janssen argued that the double patenting rejection over the ’799 application should be withdrawn because all of the claims in that application had been cancelled and replaced by seven new claims directed to methods of treatment of rheumatoid arthritis. When Janssen asserted the Section 121 safe harbor, the examiner withdrew the double patenting rejection in the ’093 application but continued to reject the claims on other grounds. The ’093 application eventually issued as the ’471 patent on September 4, 2001, with 9 claims. Claims 1, 3, and 5–6 are directed to a chimeric antibody specific for TNF alpha. Claims 2 and 4 are directed to immunoassay methods for detecting human TNF. Claims 8 and 9 are directed to polypeptides of particular amino acid sequences that bind to hTNF alpha.

Reexamination. In 2013, in response to a third-party request, the USPTO instituted reexamination of the ’471 patent on double patenting grounds over three patents, including the ’272 and ’195 patents. During the reexamination, Janssen cancelled claims 8 and 9 and requested that the ’471 patent be amended to delete the benefit claim to the ’406 application. Janssen also requested that the specification, abstract, and drawings of the ’471 patent be conformed to the ’413 application and that the ’093 application be designated as a divisional of that application. The USPTO entered the amendments for the "purpose of reexamination" but did not confirm the status of the ’471 patent as a divisional. The examiner ultimately maintained the double patenting rejections on the basis that the safe harbor did not apply. According to the examiner, although Janssen had never received issued claims in the ’471 patent on the subject matter originating from the ’406 application, more than 32 issued patents "reached through the ’471 patent for benefit of a prior filing date" and the "patentability of those claims … cannot be determined without reopening examination of those patents in view of the deletion of the subject matter in the ’471 patent." The examiner found the claims unpatentable, and the Board affirmed.

Section 121 safe harbor. Addressing the question de novo, the Federal Circuit held that the Section 121 safe harbor did not apply to the ’471 patent and did not protect it from invalidation based on the ’272 and ’195 reference patents. The issue was whether, several years after a challenged patent issued on a CIP application, a patent owner can retroactively bring the challenged patent within the scope of the safe harbor by amending the CIP application during a reexamination proceeding to redesignate it as a divisional application. The court concluded that Janssen could not do this. The ’471 patent issued on a CIP application, and that CIP application could not retroactively become, for the purposes of Section 121, a divisional application. The CIP application could not be a divisional of the original application because it contained new matter that was not present in the original application, the court explained.

Double patenting. Turning to the question of whether the double-patenting rejection was proper, the court applied the "one-way test," in which the question was whether the application’s claims were obvious over the reference patents’ claims. Under this test, the court affirmed the Board’s decision. The court held that circumstances were not present that would warrant applying the "two-way test," in which "the examiner also asks whether the patent claims are obvious over the application claims." Those unusual circumstances occurred only "when the applicants filed first for a basic invention and later for an improvement, but, through no fault of the applicants, the PTO decided the applications in reverse order of filing, rejecting the basic application although it would have been allowed if the applications had been decided in the order of their filing." In this case, Janssen took, or failed to take, several actions that caused the ’471 patent to issue after the ’272 and ’195 reference patents. Therefore, the USPTO was not "solely responsible" for any alleged delay associated with the ’471 claims.

The case is No. 2017-1257.

Attorneys: William C. Rooklidge (Gibson Dunn & Crutcher LLP) for Janssen Biotech, Inc., and New York Unviersity. Frances Lynch for the USPTO.

Companies: Janssen Biotech, Inc.; New York University

MainStory: TopStory Patent FedCirNews

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