Source: http://www.aippi.org/enews/2010/edition12/Patent%20Term%20Extensions%20in%20Light%20of%20Wyeth%20v.%20Kappos.html
Timestamp: 2017-06-26 17:29:53
Document Index: 530236651

Matched Legal Cases: ['§154', '§154', '§154', '§254', '§154', '§154']

Patent Term Extensions in Light of Wyeth v. Kappos
No. 12May 2010
Joshua Goldberg,The Nath Law Group, USA On January 7, 2010, the Court of Appeals for the Federal Circuit decided the case of Wyeth v. Kappos, handing down a significant decision affecting patent term adjustment in favor of patentees. Specifically, the Federal Circuit found that the USPTO´s calculation of Patent Term Adjustment (PTA) was improper, denying Wyeth a portion of the patent term to which it was entitled under 35 U.S.C. §154 (b). Ultimately, as a result of the Federal Circuit´s decision, the post-Wyeth landscape will lead not only to additional PTA for prospective patentees, but also very likely to a flurry of additional patent term adjustments for patents that issued previously.
After announcing that it would not challenge the Federal Circuit´s decision, the USPTO instituted an interim procedure for requesting recalculation of patent term based on the Wyeth decision. The interim procedure, which is provided free of charge, may be utilized for any patent issued prior to March 2, 2010 so long as the request for reconsideration is submitted within 180 days of the day the patent was granted. Further, the request for reconsideration may only be filed if the sole basis for requesting the recalculation is premised on the USPTO´s pre-Wyeth interpretation of 35 U.S.C. §154(b).
Unfortunately for patentees whose patents issued more than 180 days ago, the likelihood that any additional PTA can still be recouped is uncertain at best. 35 U.S.C. §154(b)(4) provides a civil remedy to applicants dissatisfied with a PTA determination made by the Director so long as the civil action is filed in D.C. District Court within 180 days from the issue date of the patent.
One potential avenue for recovering PTA beyond the 180 day window is to request a Certificate of Correction based on the statutory language of 35 U.S.C. §254, which states, “Whenever a mistake in a patent, incurred through the fault of the Patent and Trademark Office, is clearly disclosed by the records of the Office, the Director may issue a certificate of correction stating the fact and nature of such mistake, under seal, without charge, to be recorded in the records of patents.” Further, several patentees of patents that issued more than 180 days before their respective statutory periods ended have already filed suit against the USPTO to reclaim portions of PTA that were miscalculated pre-Wyeth, under the doctrine of equitable tolling. Because the plaintiffs must demonstrate not only that they acted with due diligence but also that the circumstances are “rare and exceptional,” the likelihood of success for an argument relying on the doctrine of equitable tolling will likely depend on several factors. Specifically, it is possible that the court will not consider patentees to have acted with due diligence if they did not at least pursue all of their opportunities for requesting reconsideration and filing for appeal under 35 U.S.C. 154(b)(3)
and (b)(4).
Although several questions still remain as to just how many patentees will recover additional patent term adjustment following Wyeth, it is almost assuredly certain that future patentees will be entitled to a greater patent term based on the Federal Circuit´s interpretation of the statutory language in 35 U.S.C. §154(b). Further, even though the USPTO has promised that it will reconfigure its software to correctly calculate PTA post-Wyeth, patentees should be encouraged to consult with their respective patent counsel to confirm that they have been awarded the correct amount of PTA. Lastly, for patentees whose patents have already exceeded the 180 day statutory window to file a civil action as set forth under 35 U.S.C. §154(b)(4), it is very likely that the Federal Circuit will soon weigh in on whether the Wyeth PTA calculation can be applied retroactively.