Cellectis Patent Surrendered by Operation of Inter Partes Reexamination Pendency
Last week, the litigation between Cellectis S.A. and Precision Biosciences Inc., (E.D. N.C) No: 5.08-CV-00119-H was stayed pending the outcome of inter partes patent reexamination proceedings involving the patents at issue in the litigation, namely, U.S. Patents 6,610,545 and 7,309,605. In the decision to stay the case, the same familiar factors were analyzed. Of particular interest is the court’s discussion of the “undue prejudice” factor.
In discussing the undue prejudice factor, the court noted that both of the patents at issue will expire in May of 2012. By pointing this out, the court surmised that should the case be stayed, any improper shifting of market share (due to infringement) would be transient at best in view of the relatively imminent patent expiration. Thus, the court found that the balance of equities favored staying the case. With regard to patent expiration, the court explained:
[I]t is uncertain whether the PTO’s reexamination will be completed before the patents expire and highly unlikely that any appeal of the PTO’s decision will be resolved prior to the expiration of the patents.
In pointing out this fact, the court unknowingly emphasized a sad reality for Cellectis. By amending the ‘605 Patent, Cellectis has effectively surrendered this patent by operation of USPTO pendency.
On November 17, 2009, the only independent claim of the ‘605 patent (claim 1) was amended to recite first “chromosomal DNA” and “providing an isolated, viable cell . . .” On July 7, 2010, in response to an Action Closing Prosecution (ACP) of June 17, 2010, the independent claim was again amended to recite a further step of “repairing a double stranded break…” new claims 19-21 were also added in July. These features and new claims have been argued as distinguishing with respect to the submitted art of the inter partes patent reexamination. (In the ‘545 Patent, one of the independent claims, claim 7 was amended)
With appeal briefing, and BPAI processing still to come it is a practical certainty that there will not be a BPAI decision in this case prior to expiration of the ‘605 and ‘545 patents in the Spring of 2012. Importantly, upon expiration, any pending claim amendments are considered withdrawn (37 CFR 1.530 (j)) since such claim changes cannot be added by reexamination certificate thereafter. Thus, at the time of expiration, amended claims revert to unamended form, and any newly added claims simply go away…..seemingly, along with the ‘605 Patent.
Even assuming the BPAI somehow sided with Cellectis prior to expiration, the certain CAFC appeal by the third party would doom any opportunity to publish a reexamination certificate in time to actually issue the amended claims. (this calculation does not even account for the three month delay from the Notice of Intent to Issue a Reexamination Certificate (NIRC) to physical printing of the certificate).
At the time of expiration, a patent is construed more narrowly, yet one would assume the briefing will be based upon the amended claims.
Certainly, the USPTO has taken steps to speed up the processing of inter partes reexamination. Still, as this case demonstrates, there is a great deal of work still to be done. In the most recent BPAI data from the inter partes reexamination dashboard, the average BPAI pendency is shown as less than 10 months from the time of initial appeal docketing (shown in green as opposed yellow (bad) or red (really bad)). Disappointingly, the same 10 month metric is used with respect to run-of-the-mill, patent application appeals, yet patent reexaminations are supposed to be accorded special dispatch? (application BPAI pendency for July here). As pointed out by others in emails to me last week, including Hal Wegner and Paul Morgan, a 10-month benchmark is not at all encouraging.