What You Need to Know:
• Instead of filing multiple applications claiming different aspects of an invention but not sharing a single priority chain, patentees should strive to file highly comprehensive applications that consider as many features and aspects of the invention as possible. Such a strategy would allow subsequent child applications to claim priority to the same parent application without fear of invalidation of the parent application based on obviousness-type double patenting (ODP) with respect to child applications.
• Proper divisionals are now even more desirable with implications for filing strategy and restriction practice, so drafting claims designed to elicit a restriction requirement may be prudent.
• Be sure to consider ODP implications before allowing a patent claiming an obvious variant of an earlier-filed patent to issue if it does not share a priority date with the earlier-filed patent, especially if the earlier-filed patent has the longer term, for example by an award of PTA, because this will fall outside the safe harbor created by Allergan.
The State of the Law
The judicial doctrine of obviousness-type double patenting (ODP) stems from 35 U.S.C. § 101, which provides that an inventor may obtain “a patent” (i.e., a single patent) for an invention. Subsequent patents that are held by the same applicant and claim obvious variants of the same invention may be held invalid for ODP. Crucially, the ODP analysis does not require the patents to be prior art with respect to one another, and thus patents that would not raise issues of obviousness because of their publication date may be damaging references for issues of ODP. In most cases, a so-called “one way” obviousness test is performed where the later-filed claims are compared against the earlier-filed claims in an obviousness analysis.
The doctrine’s primary goal is to prevent an unjustified extension of the patent term beyond the life of a patent. This goal is based on the principle that the public should be able to act on the assumption that upon expiration of the patent it will be free to use not only the claimed invention but obvious variants as well. Accordingly, there is a Congressionally created remedy for invalidity for ODP called a “terminal disclaimer” that accomplishes Congress’ objectives without unnecessarily rendering patents invalid. Terminal disclaimers, when filed with the U.S. Patent and Trademark Office (USPTO), disclaim the portion of a patent’s term that extends beyond the lifetime of the ODP references. Terminal disclaimers require common ownership between the applications/patents in question, in order to avoid the potential for a defendant to face multiple plaintiffs asserting similar patents.
Filing a terminal disclaimer is typically only a problem when the patent owner is forced to give up a significant amount of valuable patent term in order to preserve the validity of some of its patents over other of its patents. Therefore, the most critical situations arise when patents claiming similar inventions have significantly different expiration dates. One common situation in which that is true is when one patent has received a significant patent term adjustment (PTA) and another patent owned by the same applicant has not. PTA is an extension of the patent term to compensate the applicant for certain delays incurred by the USPTO during prosecution.
The issuance of Allergan USA v. MSN Labs, 24-1061 (Fed. Cir. August 13, 2024) marked the end of an uneasy year for patent owners. The previous year, In re Cellect, LLC, 81 F.4th 1216 (Fed. Cir. 2023) held that ODP is considered after PTA is applied and thus the filing of a terminal disclaimer can erase PTA. This decision was alarming to many in the patent community because if one member of the same patent family is awarded PTA and another member of the family is not, the PTA will be lost upon filing a terminal disclaimer between the two patents. To the relief of patent holders, Allergan held that a first-filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date.
Accordingly, terminal disclaimers will generally not need to be filed to preserve the validity of a first-filed, first-issued patent over continuation applications claiming priority to that patent and, therefore, the first-filed, first-issued patent in a family will enjoy the maximum term for all patents in the family claiming obvious variants of that first patent, in regard to ODP. Allergan offers no protection for an applicant’s patents that do not share a priority date.
Strategic Implications
Intellectual property owners may wish to consider the following as they align their behavior with the incentives created by Cellect and Allergan:
• Be sure to consider ODP implications before allowing a later-filed patent claiming an obvious variant to issue if it does not share a priority date with an earlier-filed patent, especially if the earlier filed patent has the longer term, for example by an award of PTA, because this will fall outside the safe harbor created by Allergan.
• Likewise, if two parallel related applications are filed on the same day, applicants should consider the likelihood of one of them receiving PTA that could be wiped out if you have to file a terminal disclaimer over the other.
• Proper divisional applications (e.g., in response to a restriction requirement and styled as a divisional application rather than a continuation) continue to be desirable with implications for filing strategy and restriction practice, so drafting claims designed to elicit a restriction requirement may be prudent.
• Patentees should strive to file highly comprehensive applications that consider as many features and aspects of the invention as possible so that subsequent child applications can claim priority to the same application without fear of invalidation of the parent application based on ODP with respect to the children. It may be desirable to pursue the most commercially valuable subject matter in the parent application, for example, species-level claims for a clinical product in a pharmaceutical or biotechnology application. Furthermore, patentees might consider being more aggressive (e.g., by pursuing after-final prosecution and appeals) during prosecution of the first application to obtain as much PTA as possible in the event the Examiner is not timely in issuing Office Actions, since the first application will have the maximum possible patent term in the family.
• If you wish to file multiple divisional applications, consider filing each subsequent application with a full set of original claims to induce the same restriction requirement as in the parent.
• Always perform a thorough analysis of ODP rejections to see if the later claims are truly obvious over the earlier claims. Consider claim amendments to introduce patentably distinct subject matter if doing so will avoid a loss of the patent term. If only a subset of the pending claims is rejected under ODP, consider canceling the rejected claims to allow the non-rejected claims to issue, rather than filing a terminal disclaimer which will affect the patent as a whole. The claims rejected under ODP can always be pursued in a new continuation/divisional application.
