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Clarifying the Interplay of Patent Term Adjustment and Obviousness-Type Double Patenting: In Re Cellect

Clarifying the Interplay of Patent Term Adjustment and Obviousness-Type Double Patenting: In Re Cellect

Clarifying the Interplay of Patent Term Adjustment and Obviousness-Type Double Patenting: In Re Cellect

Patent practitioners of all stripes should take heed of the recent decision by the U.S. Federal Circuit in In re Cellect. The decision has direct implications for strategies in patent portfolio management, patent prosecution, patent litigation, and transactions involving patent assets.

The Long and Short of In re Cellect

In re Cellect involves the interplay among the doctrine of obviousness-type double patenting (ODP), patent term adjustment (PTA), and terminal disclaimers. Patent applicants commonly file a series of applications based on a single original application in the United States. This can lead to issuance of multiple patents in a single patent “family.”

If the claims of one application (or the patent issuing from that application) are not patentably distinct from claims of another in the same family, they may be invalid under ODP. This is intended to prevent inventors from obtaining what is effectively an unjustified time-wise extension by tweaking their claim language slightly in subsequent continuation applications. 

The simplest way to avoid an ODP issue is to file a terminal disclaimer, relinquishing the patent term to avoid this time-wise extension. Importantly, however, this can only be done before the earlier-expiring patent has expired.

Relatedly, the U.S. Patent and Trademark Office (USPTO) can award PTA, which lengthens a patent’s term, to compensate for delays incurred at the USPTO. This can result in certain members of a patent family having a later expiration date than others.

Until recently, it was unclear whether the award of PTA could open up a patent to an ODP problem by making it expire later than one of its family members. Some district courts had held that it could not, while others had held the opposite view. In re Cellect resolved this split of authority, finding that a PTA award could open up a patent to an ODP challenge.

Specifically, the Federal Circuit held that for purposes of an ODP analysis, the correct expiration date of the challenged patent is the date after PTA has been applied.

Implications of In re Cellect

In re Cellect is significant for patent prosecution, patent litigation, and transactional diligence involving patent portfolios, especially in the life sciences sector, where ODP issues more often arise.

For patentees, this decision serves as a reminder to carefully coordinate portfolio management and related patent prosecution issues within a given patent family, including decisions regarding claiming strategy in continuation applications, preventive use of terminal disclaimers, and pursuit of PTA.  It also should remind patentees developing an enforcement strategy to audit existing patent families to identify and consider whether they can cure any PTA-induced ODP issues through terminal disclaimer.

For patent defendants, this decision resolves the district court split and clarifies that ODP is available as an invalidity defense in some circumstances where PTA prolongs the life of an asserted patent.

Jeremy has represented numerous parties in patent litigation spanning a variety of fields, from automotive to biotechnology to medical devices to optics. He has extensive experience representing clients in life sciences patent litigation, especially in cases brought under the Hatch Waxman Act.

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