Germeshausen Center Newsletters Archive - Spring 2010 Calculating Patent Term Adjustments Post-Wyeth - Gregory Finch

Calculating Patent Term Adjustments Post-Wyeth - Gregory Finch

The Kenneth J. Germeshausen Center, created in 1985 through the generosity of Kenneth J. and Pauline Germeshausen, is the umbrella organization for Pierce Law's intellectual property specializations. Today the Germeshausen Center is a driving force in the study of international and national intellectual property law and the transfer of technology. It acts as a resource to business as well as scientific, legal and governmental interests in patent, trademark, trade secret, licensing, copyright, computer law and related fields.

The Center bears the name of its benefactor Kenneth J. Germeshausen, one of New England's pioneering inventors and professor of electrical engineering at Massachusetts Institute of Technology. Germeshausen was also co-founder of the international high technology firm of EG&G.

Calculating Patent Term Adjustments Post-Wyeth by Gregory Finch

Gregory Finch (J.D./LL.M. IP '11) holds a B.A. in biology from the College of Charleston.  Prior to law school he worked as a technician in an analytical chemistry lab.  Greg plans to practice patent law upon graduation.

The Federal Circuit's recent holding in Wyeth v. Kappos clarifies how patent term adjustments are calculated under 35 U.S.C. § 154(b). The Patent and Trademark Office's (PTO) prior interpretation of the statute broadly construed the “overlap limitations stated in 154(b)(2)(A) paragraph 2 to effectively eliminate term adjustments prior to three years of application pendency. [i] In upholding summary judgment for Wyeth, the court stated that the language of 154(b) is “intolerant of the PTO's suggested interpretation. [ii] The Federal Circuit's acceptance of Wyeth's interpretation resulted in nearly an additional year to the term of Wyeth's patent. While the new interpretation of 154(b) will add to the term adjustments of future patents, many patentees are questioning how the PTO will handle prior term miscalculations.

Patent Term Adjustments and Periods of Overlap

When the effective terms of a patent were changed in 1994 from 17 years from issuance to 20 years from filing, a method of compensating patentees for PTO-caused delays during prosecution likewise followed. [iii] Under the old law, PTO-caused delays were irrelevant to patent terms because protection attached from the date of issuance. The change in law presented the potential problem of patent term reduction as a result of PTO delays. The American Inventors Protection Act amended 35 U.S.C. § 154(b) to address this problem. The Act provides three specific “guarantees. [iv] Section 154(b)(1)(A) (“A-adjustments) guarantees prompt office responses, granting a one day extension for “each day after the end of the period specified in clause (i), (ii), (iii), or (iv). [v] Subsection (B) (“B-adjustments) provides a guarantee of no more than 3-year application pendency, with a one day extension for every day delayed. [vi] Subsection (C) (“C-adjustments) guarantees adjustments for delays due to interferences, secretary orders, and appeals. [vii] All subsections, however, are only applicable to PTO-caused delay, i.e. no fault of the patentee. The statutory language, therefore, guarantees at least 17 years of patent protection assuming no applicant-caused delays.

The general limitation in § 154(b)(2)(A) paragraph 2 restricts term adjustment when any periods of delay “overlap. [viii] The statute states that “[t]o the extent that periods of delay attributable to grounds specified in paragraph (1) overlap, the period of any adjustment granted under this subsection shall not exceed the actual number of days the issuance of the patent was delayed. [ix] The PTO and Wyeth had very different views as to how this limitation applies to periods of delay prior to the subsection (B) three year pendency mark.

Difference of Interpretation

Section 154(b)(3) allows the PTO to establish procedures for determining patent term adjustment. Under this authority, the PTO enacted 37 C.F.R. § 1.703(f) in 2000. This rule defines “periods of adjustment as “the number of days, if any, in the period beginning on the day after the date that is three years after the date on which the application was filed . . . . [x] The PTO's implementation of 1.703(f) effectively eliminated A-adjustments prior to the subsection B three year pendency mark. [xi] Under this interpretation, “if a patent entitled to twenty days of A-adjustments issues twenty days after the three year mark, it is still only entitled to a 20 day extension. [xii] Wyeth's interpretation, and that of the D.C. district court, suggests that the same patent would be entitled to a 40 day extension (20 days of A-adjustment and 20 days of B-adjustment) assuming that the violations occurred on different days.

This fundamental difference in interpretation led the PTO to believe that Wyeth was only entitled to 462 days of term adjustment, while Wyeth argued that it should be entitled to 756 days. [xiii] The Federal Circuit made it clear that no overlap happens unless violations occur at the same time. Therefore, if an A delay occurs on one day and a B delay occurs on a different day, the patentee would be entitled to two days of extension. Furthermore, before the three year mark it is impossible for an A delay and B delay to overlap. Wyeth was granted the additional 294 days to its patent in light of this interpretation. [xiv]

Calculating Future Adjustments and Recalculating Prior Adjustments

The PTO calculates patent term adjustments electronically through information recorded in the Patent Application Locating and Monitoring (PALM) system. The PTO is reprogramming its system to reflect the overlap clarifications provided by Wyeth. The new system has been in place since March 2, 2010, and applies to patents granted on or after that date. If a patentee feels that the adjustments are incorrect, the patentee must file a request for reconsideration under 37 C.F.R. 1.705(d) within two months of the date the patent issued. [xv]

The question that many patentees have in light of the Wyeth decision, however, is whether the PTO will recalculate potentially miscalculated prior adjustments. To address this concern, the PTO has implemented an optional procedure under which patentees can request recalculation of term adjustments. The PTO is providing a “Request for Recalculation of Patent Term Adjustment in View of Wyeth form (PTO/SB/131) for patentees to make such a request. This form eliminates the need to file a request under 37 C.F.R. 1.705(d) and the associated fee. In order for a patentee to obtain a recalculation under this form, the patent must be granted prior to March 2, 2010 and the form must be completed within 180 days of the date the patent was granted or within two months of the date of an adjustment decision calculated under the pre-Wyeth standard. [xvi] Under this form, the PTO is limiting its review of previously miscalculated term adjustments to patents issued within the last six months.

PTO's (old) Interpretation diagram
 

Conclusion

            The Wyeth decision will certainly add to the amount of A-adjustments granted to future patentees under 35 U.S.C. 154(b)(2)(A). The PTO's review of previously miscalculated adjustments is rather limited and is subject to the patentee requesting reconsideration. The additional A-adjustments under the post-Wyeth standard are likely to be of great value to many patentees. 

 


*Gregory Finch, J.D. 2011, holds a B.A. in biology from the College of Charleston.  Prior to law school he worked as a technician in an analytical chemistry lab.  Greg plans to practice patent law upon graduation.

[i] 35 U.S.C. § 154(b)(2)(A) (1999).

[ii] Wyeth v. Kappos, 591 F.3d 1364, 1372 (Fed. Cir. 2010).

[iii] Id. at 1366 (citing Pub.L. No. 103-465, § 532, 108 Stat. 4809, 4984 (1994)).

[iv] Id. at 1367 (citing 35 U.S.C. § 154(b)(2)(A)-(C) (1999)).

[v] Id. at 1366-67.

[vi] Id.

[vii] Id.

[viii] Id. at 1367.

[ix] 35 U.S.C. § 154(b)(2)(A) (1999).

[x] Wyeth, 591 F.3d at 1367 (citing 37 C.F.R. § 1.703(b) (2000)).

[xi] Id. at 1367-68.

[xii] Id. at 1368.

[xiii] Id.

[xiv] Id. at 1368, 1370.

[xv] Interim Procedure for Patentees to Request a Recalculation of the Patent Term Adjustment to Comply with the Federal Circuit Decision in Wyeth v. Kappos Regarding the Overlapping Delay Provision of 35 U.S.C. 154(b)(2)(A), 75 Fed. Reg. 5043 (Feb. 1, 2010), available at http://www.uspto.gov/patents/announce/pta_wyeth.pdf.

[xvi] Id. at 12.

 

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