Wyeth and Elan Pharma International, Ltd. v. Under Sec. of Commerce for Intellectual Property

United States Court of Appeals for the Federal Circuit
2009-1120
WYETH
and ELAN PHARMA INTERNATIONAL LIMITED,
Plaintiffs-Appellees,
v.
David J. Kappos, UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL
PROPERTY and DIRECTOR OF THE UNITED STATES PATENT
AND TRADEMARK OFFICE,
Defendant-Appellant.
Patricia A. Carson, Kaye Scholer LLP, of New York, New York, argued for plaintiffs-
appellees. With her on the brief were Richard G. Greco; and David O. Bickart, of
Washington, DC. Of counsel were Thomas E. Malone, Elan Pharmaceuticals, of South
San Francisco, California; and Reem F. Jishi, Wyeth, of Madison, New Jersey.
Christine N. Kohl, Attorney, Appellate Staff, Civil Division, United States Department
of Justice, of Washington, DC, argued for defendant-appellant. On the brief were Tony
West, Assistant Attorney General, Channing D. Phillips, Acting United States Attorney, and
Scott R. McIntosh and Abby C. Wright, Attorneys. Of counsel on the brief were James A.
Toupin, General Counsel, and Raymond T. Chen, Deputy General Counsel and Solicitor,
United States Patent and Trademark Office, of Arlington, Virginia.
William G. James, II, Kenyon & Kenyon LLP, of Washington, DC, for amicus curiae
Hospira, Inc. With him on the brief was Richard W. Ward.
Jeffrey B. Elikan, Covington & Burling LLP, of Washington, DC, for amicus curiae
Pharmaceutical Research and Manufacturers of America, et al. With him on the brief were
E. Edward Bruce and James P. Sullivan.
Appealed from: United States District Court for the District of Columbia
Judge James Robertson
United States Court of Appeals for the Federal Circuit
2009-1120
WYETH
and ELAN PHARMA INTERNATIONAL LIMITED,
Plaintiffs-Appellees,
v.
David J. Kappos, UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL
PROPERTY and DIRECTOR OF THE UNITED STATES PATENT
AND TRADEMARK OFFICE,
Defendant-Appellant.
Appeal from the United States District Court for the District of Columbia in case no. 07-
CV-1492, Judge James Robertson.
___________________________
DECIDED: January 7, 2010
___________________________
Before RADER, PLAGER, and MOORE, Circuit Judges.
RADER, Circuit Judge.
I.
On summary judgment, the United States District Court for the District of
Columbia held that plaintiffs Wyeth and Elan Pharma International Ltd. (collectively,
“Wyeth”) were entitled to extended patent term adjustments under 35 U.S.C. § 154(b)
due to the Patent and Trademark Office’s (the “PTO’s”) delay in prosecuting their patent
applications. Because section 154(b) expressly permits this legal relief, this court
affirms.
II.
In 1994, the law changed the effective term of a patent from seventeen years
commencing from issuance to twenty years from filing. See Pub. L. No. 103-465, § 532,
108 Stat. 4809, 4984 (1994). With the change came new ways of compensating
patentees for PTO-caused delays during prosecution. Under the previous seventeen-
year regime, PTO-caused delays could not affect patent terms because the term
commenced upon issuance after any delays during patent acquisition. Under the
twenty-year term, however, those delays consumed the effective term of a patent.
In 1999, the American Inventors Protection Act amended 35 U.S.C. § 154(b) to
address this new problem. The new Act promised patent applicants a full patent term
adjustment for any delay during prosecution caused by the PTO. This promise took the
form of three distinct “guarantees” in 35 U.S.C. § 154(b)(1):
(A) Guarantee of prompt Patent and Trademark Office responses.--
Subject to the limitations under paragraph (2), if the issue of an original
patent is delayed due to the failure of the Patent and Trademark Office to
[meet deadlines specified in clauses (i)-(iv)] . . .
the term of the patent shall be extended 1 day for each day after the end
of the period specified in clause (i), (ii), (iii), or (iv), as the case may be,
until the action described in such clause is taken.
(B) Guarantee of no more than 3-year application pendency.--Subject to
the limitations under paragraph (2), if the issue of an original patent is
delayed due to the failure of the United States Patent and Trademark
Office to issue a patent within 3 years after the actual filing date of the
application in the United States . . .
the term of the patent shall be extended 1 day for each day after the end
of that 3-year period until the patent is issued.
(C) Guarantee or adjustments for delays due to interferences, secrecy
orders, and appeals.--Subject to the limitations under paragraph (2) . . .
the term of the patent shall be extended 1 day for each day of the
pendency of the proceeding, order, or review, as the case may be.
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(emphases added). To summarize, paragraph A (the “A guarantee” or “A clause”)
promises “prompt [PTO] responses” by extending the term of the patent one day for
each day the PTO does not meet certain examination deadlines in subdivisions (i)-(iv).
Id. § 154(b)(1)(A). One of these deadlines, for instance, requires a first response to a
filed application within fourteen months. See id. § 154(b)(1)(A)(i). Paragraph B (the “B
guarantee” or “B clause”) extends the term of the patent one day for each day issuance
is delayed due to the PTO’s failure “to issue a patent within 3 years after the actual filing
date of the application in the United States.” Id. § 154(b)(1)(B). Last, paragraph C
allows for adjustments relating to delays resulting from interference proceedings,
secrecy orders, and appeals. Id. § 154(b)(1)(C). At issue in this case are the A and B
guarantees.
Both the A and B clauses are expressly subject to paragraph 2’s “In general”
limitation:
In general. To 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.
Id. § 154(b)(2)(A) (emphasis added). In other words, this limitation restricts the period
of adjustment when any of the “periods of delay” “overlap.” This case asks this court to
interpret and enforce the guarantees in the face of an “overlap” and “periods of delay”
under section 154(b)(2)(A).
Section 154(b)(3) of the statute directs the PTO to “prescribe regulations
establishing procedures for the application for and determination of patent term
adjustments under this subsection.” Id. § 154(b)(3) (emphasis added). Under the guise
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of that authority, the PTO promulgated 37 C.F.R. § 1.703(f) in 2000: “To the extent that
periods of adjustment attributable to the [guarantees] overlap, the period of adjustment
granted under this section shall not exceed the actual number of days the issuance of
the patent was delayed.” (emphasis added). Other than adding the term “periods of
adjustment,” this language repeated the text of section 154(b)(2)(A). The regulations
later defined “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 . . . .” 37 C.F.R. § 1.703(b) (2000). The regulation supplied no
explanation about implementation or application of these rules.
In 2004, the PTO amended the regulation to replace “periods of adjustment” with
“periods of delay.” 69 Fed. Reg. 21706 (2004). The PTO contended that this
substitution clarified the regulation:
The language of former § 1.703(f) misled applicants into believing that
[periods of A-delay] and [periods of B-delay] were overlapping only if the
[period of A-delay] occurred more than three years after the actual filing
date of the application. If an application is entitled to a [B-]adjustment . . .
the entire period during which the application was pending before the
[PTO] . . ., and not just the period beginning three years after the actual
filing date of the application; is the period of delay under 35 U.S.C.
154(b)(1)(B) in determining whether periods of delay overlap under 35
U.S.C. 154(b)(2)(A).
Id. (emphasis added). Thus, the “period of delay,” according to the PTO’s new
definition, caused the B guarantee to start with the filing of the application, not three
years later. Under that interpretation, “overlap” between A adjustments and B
adjustments can arise and begin during the pendency of the patent application. For
example, if a patent entitled to twenty days of A adjustments issues twenty days after
the three year mark, then it is only entitled to a total of twenty days of adjustment. In
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other words, the entire period of A delay “overlaps” with the entire period of B delay.
Using this framework, the PTO uses either the greater of the A delay or B delay to
determine the appropriate adjustment but never combines the two.
Wyeth and Elan Pharma are the owners of U.S. Patent Nos. 7,179,892 (the “’892
patent”) and 7,189,819 (the “’819 patent”)—inventions that treat Alzheimer’s disease.
During the prosecution of each of their respective applications, the PTO undisputedly
caused delays that gave the applicants entitlement to both A and B guarantees.
For the ’892 patent, the PTO calculated 610 days of A delay and 345 days of B
delay. Of the 610 days of A delay, 51 occurred more than three years after the
application was filed. During the prosecution, the applicant caused 148 days of delay.
Thus, under section 154(b)(2)(C), any adjustment must be reduced by that amount.
See 35 U.S.C. 154(b)(2)(C). Under its greater-of-A-or-B rubric, the PTO calculated the
total adjustment at 462 days—i.e., 610 (the greater of A or B) - 148 (applicant delay).
According to Wyeth, however, the “period of delay” for purposes of the B clause could
not have started until three years after the application’s filing date. For that reason, the
only possible “overlap” was any A delay occurring after the three-year mark. Because
only 51 days of A delay occurred after the three year mark for the ’892 patent, the
adjustment, according to Wyeth, should have been 756 days—i.e., 610 (A delay) + 345
(B delay) - 51 (“overlap”) - 148 (applicant delay).
For the ’819 patent, the PTO calculated 336 days of A delay and 827 days of B
delay. Of the 336 days of A delay, 106 occurred after the three-year mark. In this case,
the applicant caused 335 days of delay. The greater-of-A-or-B rubric yields an
adjustment period of 492 days—i.e., 827 (the greater of A or B) - 335 (applicant delay).
2009-1120 5
Wyeth contends the adjustment period should have been 722 days—i.e., 336 (A delay)
+ 827 (B delay) - 106 (“overlap”) - 335 (applicant delay).
After filing petitions for reconsideration of the adjustments with the PTO, Wyeth
filed the instant action in the District Court for the District of Columbia seeking an order
directing the PTO to grant an adjustment per Wyeth’s interpretation. Both parties filed
motions for summary judgment. Citing section 154(b)(3) as evidence of a delegation of
authority to draft regulations, the PTO sought Chevron deference for its interpretation.
See Chevron U.S.A., Inc. v. Natural Resources Def. Council, Inc., 467 U.S. 837 (1984).
The district court sided with Wyeth, finding first that the PTO “does not have the
authority to issue substantive rules, only procedural regulations regarding the conduct of
proceedings before the agency.” Wyeth v. Dudas, 580 F. Supp. 2d 138, 141 (D.D.C.
2008) (citing Merck & Co. v. Kessler, 80 F.3d 1543, 1549-50 (Fed. Cir. 1996)). The
district court further found that even if Chevron was applicable, it would have rejected
the PTO’s interpretation as contrary to the plain language of the statute. As the district
court put it: “The problem with the PTO’s interpretation is that it considers the
application delayed under [the B guarantee] during the period before it has been
delayed.” Id. at 142 (emphasis in original).
III.
This court reviews a grant of summary judgment without deference. Johns
Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1353 (Fed. Cir. 1998). Summary
judgment is only appropriate if the court determines that there “is no genuine issue as to
any material fact and that the moving party is entitled to a judgment as a matter of law.”
Fed. R. Civ. P. 56(c). Because both parties in the instant case perceive no genuine
2009-1120 6
issues of material fact, this court need only decide the question of law decided by the
district court. “That question is one of statutory interpretation, one that an appellate
court can independently determine without deference to the trial court's interpretation.”
Glaxo Operations UK Limited v. Quigg, 894 F.2d. 392, 395 (Fed. Cir. 1990) (citing
Madison Galleries, Ltd. v. United States, 870 F.2d 627, 629 (Fed. Cir. 1989)).
“As always, the ‘starting point in every case involving construction of a statute is
the language itself.’” United States v. Hohri, 482 U.S. 64, 68 (1987) (quoting Kelly v.
Robinson, 479 U.S. 36, 43 (1986)). When the terms of a statute are unambiguous,
“judicial inquiry is complete, except ‘in rare and exceptional circumstances.’” Rubin v.
United States, 449 U.S. 424, 430 (1981) (quoting TVA v. Hill, 437 U.S. 153, 187 n.33
(1978)). “Absent a clearly expressed legislative intention to the contrary, [the statute’s
plain] language must ordinarily be regarded as conclusive.” Consumer Prod. Safety
Comm'n v. GTE Sylvania, Inc., 447 U.S. 102, 108 (1980).
This court detects no ambiguity in the terms “periods of delay” and “overlap.”
Each term has an evident meaning within the context of section 154(b). The limitation
in section 154(b) only arises when “periods of delay” resulting from violations of the
three guarantees “overlap.” 35 U.S.C. § 154(b)(2)(A). Significantly, the A and B
guarantees expressly designate when and for what period they each respectively apply.
Thus, this court can easily detect any overlap by examining the delay periods covered
by the A and B guarantees.
A violation of the A guarantee—delays in meeting examination deadlines—
begins with a “failure of the [PTO]” to meet one of the deadlines specified in
subparagraphs (i)–(iv). Id. § 154(b)(1)(A). It ends when “the action described . . . is
2009-1120 7
taken.” Id. The “period of delay” for purposes of the A clause therefore runs from the
date the PTO misses the specified deadline to the date (past the deadline) of response
to the underlying action.
Correspondingly, a violation of the B guarantee—the one at the heart of the issue
in this case—begins when the PTO fails “to issue a patent within 3 years after the actual
filing date of the application in the United States . . . .” Id. § 154(b)(1)(B). It ends when
“the patent is issued.” Id. The “period of delay” under the express language of the B
clause therefore runs from the three-year mark after filing until the application issues.
Reading this framework into section 154(b)’s limitation provision makes it clear
that no “overlap” happens unless the violations occur at the same time. Each “period of
delay” has its own discrete time span whose boundaries are defined in section
154(b)(1). That is, each has a start and an end. Before the three-year mark, no
“overlap” can transpire between the A delay and the B delay because the B delay has
yet to begin or take any effect. If an A delay occurs on one day and a B delay occurs on
a different day, those two days do not “overlap” under section 154(b)(2).
Under the PTO’s strained interpretation, B delay can occur anytime after the
application is filed. To the contrary, the language of section 154(b) does not even
permit B delay to start running until three years after the application is filed. The PTO’s
position cannot be reconciled with the language of the statute. Thus, returning to the
district court’s decision, this time with affirming approval: “The problem with the PTO’s
interpretation is that it considers the application delayed under [the B guarantee] during
the period before it has delayed.” Wyeth, 580 F. Supp. 2d at 142 (emphasis in original).
2009-1120 8
The PTO defends its interpretation by arguing that A delays during the first three
years of prosecution ultimately lead to B delays after the three-year mark from filing.
Put differently, it would be double counting if A and B delays were both used to adjust
because A delays “cause” B delays. In that vein, the PTO highlights various scenarios
where a hypothetical patentee appears to receive some type of windfall adjustment
under the statute despite being in a similar position as other applicants who receive no
similar adjustment. Indeed, the statute requires as much. Nonetheless, this court
perceives potential perverse results as well under the PTO’s suggested interpretations.
Under certain scenarios, both the PTO’s interpretation and the statute itself result in
some imbalanced treatment of similarly-situated patentees.
For example, the language of section 154(b) presents a slight imbalance in the
following hypothetical: suppose Applicant 1 receives a patent 3 years and 30 days after
filing an application. In prosecuting the application, Applicant 1 incurred 30 days of A
delay before the three-year mark. In the same hypothetical situation, suppose Applicant
2 also receives a patent 3 years and 30 days after filing an application but incurred no A
delay during prosecution. Notably, both patents issued the same amount of time from
filing—3 years and 30 days. Nonetheless, Applicant 1 would receive a 60 day
adjustment whereas Applicant 2 would only receive a 30 day adjustment meaning
Applicant 1’s effective term would be 30 days longer than Applicant 2.
By the same token, under the PTO’s counter-statutory interpretation, suppose
Applicant 1 incurs 400 days of A delay before the three-year mark with the application
issuing exactly three years after filing. Suppose Applicant 2 also incurs 400 days of A
delay before the three-year mark, but in addition incurs a one-year delay by the PTO
2009-1120 9
after the three-year mark. Despite the fact each applicant incurred the same A delay,
under the PTO’s interpretation, Applicant 1’s effective term would be a full year greater
than Applicant 2’s effective term. Simply put, the additional B delay incurred by
Applicant 2 produces a shorter effective term.
Regardless of the potential of the statute to produce slightly different
consequences for applicants in similar situations, this court does not take upon itself the
role of correcting all statutory inequities, even if it could. In the end, the law has put a
policy in effect that this court must enforce, not criticize or correct. See Harbison v. Bell,
129 S. Ct. 1481, 1493-94 (2009) (Thomas, J., concurring) (quoting Eldred v. Ashcroft,
537 U.S. 186, 222 (2003) (“Even if the proper interpretation of a statute upholds a ‘very
bad policy,’ it ‘is not within our province to second-guess’ the ‘wisdom of Congress’
action’ by picking and choosing our preferred interpretation from among a range of
potentially plausible, but likely inaccurate, interpretations of a statute.”)).
The PTO also passingly refers to the second clause of section 154(b)(2)(A) for
support: “the period of any adjustment granted under this subsection shall not exceed
the actual number of days the issuance of the patent was delayed.” 35 U.S.C.
§ 154(b)(2)(A). While the PTO’s argument on this point is unclear, that language does
not provide any support for its interpretation. Significantly, the second clause of section
154(b)(2)(A) only takes effect upon satisfaction of the first clause. See id.§ 154(b)(2)(A) (“To the extent that periods of delay attributable to grounds specified in
paragraph (1) overlap . . . .”) (emphasis added). Viewed in this light, a “delay” must
refer consistently to the violation of either the A or B guarantees. “[T]he actual number
2009-1120 10
of days the issuance of the patent was delayed” therefore refers to each day covered by
a “period of delay” in the first clause with no such day counted twice.
This court has also examined the legislative history of the 1999 Act but finds
nothing to rescue the PTO’s cause. In the first place, only a “most extraordinary
showing of contrary intentions” by Congress justifies a departure from the plain
language of a statute. Garcia v. United States, 469 U.S. 70, 75 (1984). Far from
intentions contrary to the meaning of section 154(b), the legislative history generally
supports the interpretation required by the statutory language itself. The AIPA’s
section-by-section analysis states:
Accordingly, subtitle D removes the 10-year caps from the existing
provisions, adds a new provision to compensate applicants fully for
USPTO-caused administrative delays, and, for good measure, includes a
new provision guaranteeing diligent applicants at least a 17-year term by
extending the term of any patent not granted within three years of filing.
Thus, no patent applicant diligently seeking to obtain a patent will receive
a term of less than the 17 years as provided under the pre-GATT
standard; in fact, most will receive considerably more.
H.R. Rep. No. 106-464, at 125 (1994) (emphases added). From this, it is apparent that
the statutory language should provide a minimum seventeen-year term for most
patents. The outcome suggested by the language itself effectuates this goal by
ensuring such a minimum term unless the applicant caused delays.
The PTO urges this court to read that passage in view of the 25-month average
patent pendency at that time—that is, most patents received more than a seventeen-
year term because of the shorter prosecution periods. Even taking that context into
account, this court notes that the PTO’s interpretation effectively creates a seventeen-
year term cap where B delays are greater than A delays. In other words, any A delay
before the three-year mark causes PTO delays in issuance beyond the three-year
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mark—thereby violating the B guarantee. Together, these effects, under the PTO’s
desire to aggregate A and B delays, reduce the effective term of the patent towards
seventeen years. The passage from the House report does not expressly preclude that
type of effective cap, but the context suggests a very different goal of supplying
adequate protection that will often be “considerably more” than the PTO’s effective cap.
In any event, the House report does not produce any “extraordinary showing of contrary
intentions.” Moreover, if the Act intended to create a seventeen-year cap, it could have
easily done so with just a few words.
The PTO next highlights the belated addition of the B guarantee into section
154(b) for support. Before enactment of AIPA, section 154(b) only provided extensions
for the category that now fall under C adjustments. See 35 U.S.C. § 154(b)(1)-(2)
(1996). The earlier versions of AIPA added only A delays. See S. 507, 105th Cong.,
143 Cong. Rec. S2678, S2696-97 (Mar. 20, 1997). Not long afterwards, B adjustments
appeared in drafts of section 154(b). See H.R. 400, 105th Cong., 143 Cong. Rec.
H1629, H1651 (April 17, 1997). According to the PTO, this legislative history suggests
that Congress did not intend to give patentees already eligible for A adjustments
additional compensation where the A delay occurred during the first three years of
prosecution. Even if these ambiguous timing observations suggested some kind of
substantive difference in the meaning of section 154(b), they would be wholly irrelevant
to interpretation of the law itself. Such opaque timing observations hardly amount to a
“most extraordinary showing of contrary intentions,” especially when the language of the
statute trumpets its meaning by itself. See Harbison, 129 S. Ct. at 1494 (Thomas, J.,
concurring) (“And Congress’ silence certainly does not empower us to go even farther
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and incorporate such an assumption into the text of these provisions.”). In sum,
legislative history—always a very dull instrument for extracting the essence of statutory
meaning—provides no reason to depart from the language of section 154(b).
Last, the PTO contends that its interpretation is entitled to deference under either
Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984)
or Skidmore v. Swift & Co., 323 U.S. 134 (1944). Because the language of the statute
itself controls this case and sets an unambiguous rule for overlapping extensions, this
court detects no reason to afford special deference to the PTO’s interpretation. See
Smith v. City of Jackson, Miss., 544 U.S. 228, 267 (2005) (quoting Pub. Employees Ret.
Sys. of Ohio v. Betts, 492 U.S. 158, 171 (1989)) (“Of course, it is elementary that ‘no
deference is due to agency interpretations at odds with the plain language of the statute
itself.’”) .
IV.
This court therefore affirms the judgment of the district court. Section 154(b)’s
language is clear, unambiguous, and intolerant of the PTO’s suggested interpretation.
For that reason, this court accords no deference to the PTO’s greater-of-A-or-B rubric.
AFFIRMED
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