USPTO: Proposed Changes to Terminal Disclaimer Practice in Joint Research Agreement Situations

February 1, 2021 – Article

The USPTO proposes to modify the rules of practice when certain types of patent applicants and patentees may obtain or enforce a second patent for an invention that is similar (i.e., patentably indistinct) to a first patent. Generally, an application for a second patent covering a similar invention would be rejected. The proposed rule change is limited to the situation where owners of the first and second patents or patent applications are different but have an agreement to conduct research together (i.e., a joint research agreement or JRA). The proposed rule change would increase the ability to file a terminal disclaimer (TD) that ties the rights of a second patent to the first patent. The proposed rule change intends to expand when a TD can be filed in the JRA situation by eliminating the requirement that the second patent or patent application be filed later than the first patent or patent application. The USPTO also proposes to amend the rules to explicitly state existing practices in the rules regarding when certain affidavits and declarations, as well as TDs, may be filed.

Comments must be received by March 22, 2021 to ensure consideration.

Double patenting analysis is not limited to situations in which the reference patents or applications, whose claims form the basis for the nonstatutory double patenting (NSDP) rejection, are prior art as defined in 35 U.S.C. 102. The reference may have an effectively filed date that is before, the same as, or after the effective filing date of a claimed invention in an application under examination or patent under reexamination (i.e., the subject patent application or patent). Thus, the reference need not be ‘‘prior art’’ to the claimed invention in the subject application or patent for its claims to be relied upon in a NSDP rejection.

The Cooperative Research and Technology Enhancement Act of 2004 (CREATE Act) was passed to promote cooperative research between universities, the public sector, and private enterprises. The CREATE Act provides that subject matter developed by another person and a claimed invention shall be treated as owned by the same person if (1) the claimed invention was made by or on behalf of parties to a JRA that was in effect on or before the date the claimed invention was made; (2) the claimed invention was made as a result of activities undertaken within the scope of the JRA; and (3) the application for the claimed invention discloses the names of the parties to the JRA.

Consistent with the legislative history, the NSDP doctrine was expanded to include rejections based on patents or applications that were disqualified as prior art under pre-AIA 35 U.S.C. 103(c). A prior art exception, similar to the prior art exclusion in the CREATE Act, was enacted in 35 U.S.C. 102(b)(2)(C) and 102(c) by AIA. Consistent with this prior art exception, the NSDP doctrine was further revised to include rejections based on patents or applications that were excepted as prior art under 35 U.S.C. 102(b)(2)(C) and 102(c).

Under the current practice, a NSDP rejection generally may be obviated by filing a TD. Under current USPTO regulations, two types of terminal disclaimers may be used. The first type is filed pursuant to 37 CFR 1.321(c) and must include a provision that the subject patent or any patent issuing from it shall be enforceable only for and during the time period that the subject patent or any patent issuing from it is commonly owned with the reference that is the basis of the NSDP rejection. The second type is filed pursuant to 37 CFR 1.321(d) and must include a provision that the subject patent or any patent issuing from it shall be enforceable only for and during such period that the subject patent or any patent issuing from it and the reference are not separately enforced. The second type obviates NSDP based on a noncommonly owned reference that is disqualified or excepted as prior art as a result of activities undertaken within the scope of a JRA.

Currently, 37 CFR 1.321(d) limits the ability of parties to a JRA to file a terminal disclaimer to overcome a NSDP rejection to instances where the reference application or patent had previously been applied as prior art or was available as prior art against the subject application or patent and the reference application publication or patent had been excepted or disqualified respectively as prior art under 37 CFR 1.104(c)(4)(ii) or (c)(5)(ii). 37 CFR 1.321(d) does not provide for the filing of such a TD where the reference is not prior art under 35 U.S.C. 102(a)(2) or pre-AIA 35 U.S.C. 102(e) and therefore cannot be excepted or disqualified as prior art as set forth in 37 CFR 1.104(c)(4)(ii) or (c)(5)(ii). For example, a reference is not prior art where the effective filing date of the claimed invention in the subject application or patent is the same as or before the effectively filed date of the reference. Because of this limitation, the USPTO has granted a number of petitions requesting a waiver of the prior art requirement in 37 CFR 1.321(d). Another example where the reference is not prior art under 35 U.S.C. 102(a)(2) or pre-AIA 35 U.S.C. 102(e) is where the inventive entities are the same for the reference and the subject application or patent.

In 2014, the Federal Circuit Court clarified for patents subject to the 20-year patent term that a first patent that expires before a second patent to a common owner or inventor may be used as a reference in a NSDP rejection, regardless of whether the first patent is prior art to the second patent. Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014). Following Gilead, applicants that received a NSDP rejection based on an application or a patent under a JRA that was not earlier filed than the application under examination have filed petitions under 37 CFR 1.183 seeking waiver of the requirement in current 37 CFR 1.321(d) that the reference in a terminal disclaimer be prior art in order to file a terminal disclaimer under 37 CFR 1.321(d). In the last two years, the USPTO has granted the majority of the filed petitions.   

Under the proposed rules, a proper TD will be accepted without the need for such a petition. The USPTO proposes to revise 37 CFR 1.321(d) to permit a TD filed by a party to a JRA to obviate NSDP even where the patent application or patent referenced in the TD is not prior art under 35 U.S.C. 102 with respect to the subject application or patent in which the TD is filed. This change would accommodate the two non-prior art circumstances in which a reference would not qualify as prior art under 35 U.S.C. 102(a)(2) or pre-AIA 35 U.S.C. 102(e). This change, permitting a party to a JRA to file a TD even where the reference is not prior art, is consistent with the purpose of the CREATE Act. This change does not obviate the requirement in pre-AIA 35 U.S.C. 103(c) or in 35 U.S.C. 102(c) that the claimed invention of the application or patent in which the TD is filed was made as a result of activities undertaken within the scope of the JRA. Also, the revised rule permits acceptance of a TD even when a NSDP rejection has not been made.  Such preemptive terminal disclaimers avoid delays in examination. Under the current practice, an affidavit or declaration of attribution or prior public disclosure under the AIA is not filed until after the rejection.