The March 3, 2014 edition of BNA’s Patent, Trademark & Copyright Journal® — Daily Update included an interesting article by Qing (Becky) Lin about “Strategies for Minimizing Patent Term Loss Due to Double Patenting.” I agree with most of Ms. Lin’s suggestions, and wanted to point out a few creative ways to minimize the impact of obviousness-type double patenting (OTDP) when Patent Term Adjustment (PTA) is at stake.
The USPTO’s Manual of Patent Examination and Procedure (MPEP) explains obviousness-type double patenting (also referred to as nonstatutory double patenting) this way:
A rejection based on nonstatutory double patenting is based on a judicially created doctrine grounded in public policy so as to prevent the unjustified or improper timewise extension of the right to exclude granted by a patent.
Section 804 of the MPEP includes a complex flow chart illustrating when an OTDP rejection should be raised, but there are three basic requirements:
As the Federal Circuit explained in Otsuka Pharmaceutical Co. v. Sandoz, Inc., an OTDP situation “is analogous to [a failure to meet] the non-obviousness requirement of 35 U.S.C. § 103 . . . . [but] [i]mportant differences remain.”
The Impact of OTDP on Patent Term and Patent Term AdjustmentIf an OTDP rejection cannot be overcome on the merits (e.g., by establishing that the claims are patentably distinct), it usually is possible to remove an OTDP rejection by filing a Terminal Disclaimer.
A Terminal Disclaimer must disclaim the term of any patent granted on the application at issue that would extend beyond the term of cited application or patent. Importantly, a Terminal Disclaimer takes precedence over any Patent Term Adjustment that the application at issue may have accrued due to USPTO delays in prosecution, but does not prevent the extended rights of a patent that has obtained a Patent Term Extension under 35 USC § 156 (e.g., for regulatory review of a drug product) from enduring beyond the term of the cited patent/application.
(A Terminal Disclaimer also must provide that any patent granted on the application at issue “shall be enforceable only for and during such period that said patent is commonly owned” with the cited patent/application.)
Strategies For Preserving Patent Term and Patent Term AdjustmentExaminers often encourage applicants to electronically file Terminal Disclaimers so they can be approved right away, but just because filing a Terminal Disclaimer can be a quick and easy way to overcome a rejection doesn’t mean it should be done. Before agreeing to potentially shorten a patent’s term, applicants may want to consider the following:
Learn More OTDP Strategies
If you would like to learn more about OTDP and strategies for avoiding, overcoming, or minimizing the impact of OTDP issues, mark your calendar for Thursday, May 8, 2014, when Kimberly Prior (Johnson & Johnson) and I will be discussing obviousness-type double patenting for an AIPLA On-Line CLE webinar.