Patent Term Adjustment and Double Patenting

04 March 2014 PharmaPatents Blog

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:

  1. There must be a common inventor or owner or a joint research agreement linking the cited patent/application and the patent application at issue.
  2. The subject matter claimed in the application at issue must be obvious in view of the subject matter claimed in the cited patent/application, or vice versa.
  3. There must not have been a Restriction Requirement that resulted in the subject matter at issue being pursued in separate patent applications.

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.”

  • First, “the patent principally underlying the double patenting rejection need not be prior art.” This means that the asserted patent/application may have been filed earlier, simultaneously with, or after the application at issue.
  • Second, the claims at issue are not evaluated in view of the specification of the cited patent/application, although the specification may be consulted to determine the meaning of the cited claims, and “may be considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent.” See MPEP § 804.

The Impact of OTDP on Patent Term and Patent Term Adjustment

If 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 Adjustment

Examiners 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:

  • Postpone filing a Terminal Disclaimer for as long as possible. If the claims face other rejections and are subject to further amendments, filing a Terminal Disclaimer may be premature, since OTDP depends on the claim language. If there is a chance that the claims will be amended in a way that would distinguish them from the other claims, consider delaying filing a Terminal Disclaimer until the claim language is finalized.
  • Consolidate applications. If there are OTDP rejections between two copending applications and one has accrued significant Patent Term Adjustment (PTA), consider whether it might be possible to consolidate the applications by presenting both claim sets in a single application. This strategy may be most suitable for applications that share the same priority date and have substantially similar disclosures, such as applications that stem from a common parent application. If the applications are being examined by the same examiner, he or she may agree to let you move the claims from one application into the other (ideally retaining the application with the longest term), particularly if it can be done in a way that gives the examiner full credit for his or her work.
  • Sacrifice an application. If there are OTDP rejections between two copending applications and one has accrued significant PTA but it is not possible to consolidate them, consider sacrificing the application with the shorter term. In other words, consider whether the patent protection offered by the application with the shorter term is worth sacrificing the longer term of the other application. This will vary from case to case, but it can be an important factor to consider.

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.

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