Source: http://www.jptos.org/news/220/80.html
Timestamp: 2019-04-26 05:58:38+00:00

Document:
Procedural History Novartis AG, Novartis Vaccines and Diagnostics, Inc., and Novartis Corporation (collectively, Novartis) filed suits that challenged the determinations by the Patent and Trademark Office of how much time to add, under 35 U.S.C. § 154(b), to the otherwise-applicable term of various Novartis patents. Of the eighteen patents before us, the district court dismissed Novartis’s claims regarding fifteen as untimely asserted. For the other three, the court rejected the PTO’s construction of the statutory provision that governs patent term adjustment here.
PTA Interplay between § 154(b)(3) and § 154(b)(4) In 35 U.S.C. § 154(b)(3) & § 154(b)(4), Congress provided administrative and judicial remedies for applicants who are dissatisfied with the PTO Director’s determination of a patent term adjustment. First, under § 154(b)(3)(B)(ii), an applicant must have “one opportunity to request reconsideration of any patent term adjustment determination made by the Director.” Second, under § 154(b)(4)(A), in the version applicable here (before recent revisions), “[a]n applicant dissatisfied with a determination made by the Director under paragraph (3) shall have remedy by a civil action against the Director filed in the United States District Court for the District of Columbia within 180 days after the grant of the patent.” Id. The PTO has interpreted the 180-day statute of limitations to apply to all patent term adjustment determinations, including those made under § 154(b)(1)(B)(i).
No Distinction between the two Provisions Subparagraph (b)(3)(A) broadly declares that “[t]he Director shall prescribe regulations establishing procedures for the application for and determination of patent term adjustments under [(b)].” That breadth of application is reinforced by the breadth of at least clause (b)(3)(B)(ii) and subparagraph (b)(3)(D), both of which plainly cover the final adjustment announced at issuance, not just a provisional adjustment announced at allowance.
No taking under 5th Amend. It is sufficient for us to say that the Fifth Amendment does not “compensate the owner for the consequences of his own neglect” in preserving its rights. United States v. Locke, 471 U.S. 84, 107 (1985). For the patents as to which it did not timely file suit under § 154(b)(4), it was only Novartis’s failure to comply with reasonable filing deadlines that prevented it from securing any patent term adjustment authorized by Wyeth. Novartis thus cannot challenge the application of the timing rule as an uncompensated taking.
This construction is supported by the statutory purpose and other aspects of the statutory structure. The evident policy behind the three enumerated exclusions is that certain delays are not attributable to the PTO— delays not “due to the failure of” the PTO to move the process along, § 154(b)(1)(B)—and so should not count against the three years before adjustments begin. That focus on PTO responsibility or its absence does not distinguish continued examinations according to when they were initiated.
Prosecution ends at allowance The language of “examination” used in § 154(b)(1)(B) reflects that underlying principle. An “examination” presumptively ends at allowance, when prosecution is closed and there is no further examination on the merits in the absence of a special reopening.
Reopening Prosecution after Allowance addressed seperately in PTA The PTO identifies several circumstances in which affirmative action is taken to resume examination after allowance, perhaps based on new information submitted by applicants in fulfillment of their continuing duty to disclose information material to patentability […] But such circumstances are exceptional, and an appropriate adjustment can be made when they occur. For none of the three applications at issue does the PTO identify any “continued examination of the application” that occurred after the notice of allowance was mailed. The possible existence of these exceptional cases does not support a general rule excluding time between allowance and issuance.
Id. at *15 (internal citations omitted).
For the foregoing reasons, we affirm the dismissal of Novartis’s claims with respect to fifteen patents as un- timely, partly reverse the judgment as to patent term adjustment for the ’155, ’518, and ’631 patents, and re- mand for redetermination of the proper adjustments in accordance with this opinion.
Image Attribution Statement: unknown (Back of the 500 Swiss Francs banknote), "Fountain of Youth," available as a public domain image as a piece of currency under Art. 5 of the Swiss Copyright Act, http://commons.wikimedia.org/wiki/File:CHF500_5_back_horizontal.jpg (last visited Jan. 16, 2014).

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