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FILED
UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF VIRGINIA

SANOFI-AVENTIS DEUTSCHLAND GMBH,

Plaintiff,

2013 MAR 11 P? 5M
CLERK US DISTRICT COURT ALEXANDRIA. VIRGINIA

HON. TERESA STANEK REA

Acting Under Secretary of Commerce for Intellectual Property and Director of the
United States Patent and Trademark Office
Office of the General Counsel

Civil Action No. // 3ci/^T

United States Patent and Trademark Office

P.O. Box 1450, Arlington, VA 22313 600 Dulany Street, Alexandria, VA 22314,
Defendant.

COMPLAINT

Plaintiff Sanofi-Aventis Deutschland GmbH ("Plaintiff or "Sanofi"), for its Complaint

against Defendant, the Honorable Teresa Stanek Rea ("Defendant" or"the Director"), in her

official capacity as the Acting Under Secretary of Commerce for Intellectual Property and
Director of the United States Patent and Trademark Office ("USPTO"), respectfully states as
follows:
NATURE OF THE ACTION

1.

This is an action by Sanofi, the assignee and owner of United States Patent

No. 8,262,614 ("the '614 Patent"), seeking review of the determination by Defendant of the
patent term adjustment calculation. Specifically, this is an action by Sanofi under 35 U.S.C. 154(b)(4)(A) seeking a judgment thatthe patent termadjustment for the '614 Patent be
changed from 692 days to 1442 days.

2.

This action arises under 35 U.S.C. 154 and the Administrative Procedure Act,
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5 U.S.C. 701-706.
THE PARTIES

3.

Plaintiff Sanofi is a corporation organized and existing under the laws of

Germany, with its principal place of business located at Industriepark Hoechst, Bldg. K607,
Frankfurt Am Main, Germany D-65926.

4.

The Directoris the Acting Under Secretary of Commerce for Intellectual Property

and Directorof the USPTO, and is sued here in her official capacity. The Directoris the head of

the USPTO and is responsible for all duties required by law with respect to the granting and
issuing of patents. As such, the Director is designated by statute as the official responsible for
determining the period of patent term adjustments under 35 U.S.C. 154.
JURISDICTION AND VENUE

5.

This Court has jurisdiction to hear this action and is authorized to issue the

requested relief sought by Sanofi pursuant to 28 U.S.C. 1331, 1338(a) and 1361; 35 U.S.C.
154(b)(4)(A) and 5 U.S.C. 701-706.

6.

Venue is properin this district pursuant to 35 U.S.C. 154(b)(4)(A).

7.

This Complaint is being timely filed in accordance with 35 U.S.C. 154(b)(4)(A).

BACKGROUND

The '614 Patent

8.

Dominique M. Freeman, Dirk Boecker, and Don Alden are the inventors named

on the '614 Patent. A true and correctcopy of the '614 Patent is attached hereto as Exhibit A.

9.

Plaintiff Sanofi is the assignee of all right, title and interest in the '614 Patent, as

evidenced by documents recorded with the USPTO.

10.

The '614 Patent issued from U.S. Patent Application No. 10/558,865 ("the '865

application"), and fulfilled the requirements under 35 U.S.C. 371 on December 19,2006 (the
"Filing Date").

11.

The national stage for the '865 application commenced under 35 U.S.C. 371(b)

on November 30,2005.

12.

On February 22,2010, the USPTO mailed a Non-Final Action for the '865

application (the "First Non-Final Office Action"). Sanofi responded to the First Non-Final
Office Action on April 28,2010.

13.

OnJuly20, 2010, the USPTO mailed a Final Rejection forthe '865 application

(the "First Final Rejection").

14.

On November 11,2010, Sanofi responded to the Final Rejection and filed a

Request for Continued Examination (the "RCE") for the '865 application.
15. On December 10, 2010, the USPTO mailed a non-final rejection for the '865

application ("Second Non-Final Office Action"). Sanofi responded to the Second Non-Final Office Action on June 10,2011. Sanofi supplemented its response to the Second Non-Final
Office Action by filing an Information Disclosure Statement on June 22,2011.

16.

OnJuly29,2011, the USPTO mailed a Final Rejection for the '865 application

(the "Second Final Rejection"). Sanofi responded to the Second Final Rejection on January 27, 2012 and filed a second Request for Continued Examination for the '865 application.
17. application.
18. On March 19,2012, Sanofi filed an amendment after Notice of Allowance under

On February 3, 2012, the USPTO mailed a Notice of Allowance for the '865

1.312. The USPTO responded on March 26,2012.

19.

On April 23, 2012, Sanofi paidthe issue fee for the '865 application, satisfying all

outstanding requirements for issuance of a patent.

20. On August 22,2012, the USPTO mailed an issue notification for the '614 Patent.

Included in the Issue Notification was a Determination of Patent Term Adjustment in which the

USPTO indicated that the patent term adjustment for the '865 application was 692 days.

21.

On September 11,2012, the '865 application issued as the '614 Patent, reflecting

a Patent Term Adjustment of 692 days.

22.

On March 11,2013, Sanofi filed a petition under 37 C.F.R. 1.183 with the

USPTO for reconsideration of the Patent Term Adjustment accorded by the Director to the '614

Patent in view of the recent decision in Exelixis, Inc. v. Kappos, No. 1:12-cv-0096,2012 U.S.
Dist. LEXIS 157762 (E.D. Va. Nov. 1,2012).
Patent Term Guarantee

23.

The Patent Term Guarantee Act of 1999, a part of the American Inventors

Protection Act ("AIPA"), amended 35 U.S.C. 154(b) to address concerns thatdelays by the

USPTO during the prosecution of patent applications could result in a shortening of theeffective
life of the resulting patents to less than seventeen years.

24.

Amended 35 U.S.C. 154(b) broadened the universe of cognizable administrative

delays by the USPTO that could retroactively yield an extension of the patent term to

compensate for such prosecution delays ("Patent Term Adjustment" or "PTA").

25.

Patent Term Adjustment applies to original utility patent applications (including

continuations, divisionals, and continuations-in-part) filed on or after May 29,2000.

26. In calculating PTA, Defendant must take into account USPTO delays under 35

U.S.C. 154(b)(1), any overlapping periods in the USPTO delays under 35 U.S.C.
154(b)(2)(A), and any applicant delays under35 U.S.C. 154(b)(2)(C).

27.

Under 35 U.S.C. 154(b)(1)(A), an applicant is entitled to PTA for the USPTO's

failure to carry out certain acts during processing and examination within defined deadlines ("A
Delay").

28.

Under 35 U.S.C. 154(b )(1)(B), an applicant is entitled to additional PTA

attributable to the USPTO's "failure ... to issue a patent within 3 years after the actual Filing Date of the application in the United States," but not including"any time consumed by

Continued Examination of the application requested by the applicantunder section 132(b)" ("B
Delay").

29.

35 U.S.C. 154(b)(2)(A) provides that "to the extentthat periods of delay

attributable to grounds specified in paragraph [154(b)(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."

30.

On January 7, 2010, the Court of Appeals for the Federal Circuit in Wyeth v.

Kappos, 591 F.3d 1364 (Fed. Cir. 2010) ("Wyeth") affirmed the District Court ruling in Wyeth v.

Dudas, 580 F. Supp. 2d 138 (D.D.C. 2008) that the correct method for calculating overlap ofA
Delay and B Delay is to aggregate A Delay and B Delay except to theextent that such
aggregation would amount to counting the same calendar days twice.

31.

Section 154(b)(2)(C)(i) of 35 U.S.C. also directs that "the period ofadjustment of

the term ofa patent under paragraph [154(b)(1)] shall be reduced by a period equal to the period

oftime during which the applicant failed to engage in reasonable efforts to conclude prosecution
of the application" ("C Reduction").

32.

OnNovember 1,2012, Exelixis, Inc. v. Kappos, No. 1:12-cv-00096,2012 U.S.

Dist. LEXIS 157762, at *8 (E.D. Va. Nov. 1, 2012) held that Patent Term Adjustment awards

arising from the failure of the PTO to grant a patent within three (3) years of the filing date (known as "B delays") are not necessarily reduced by the filing of a Request for Continuation if

the Request is filed more than three (3) years after the filing date for that patent application. Therefore, the "B delay" should be calculated from the date three years after filing to the date the
patent is issued, whether or not an RCE was filed. Id. 33. Under 35 U.S.C. 154(b)(4)(A), "an applicant dissatisfied with a determination

made by the Director under paragraph (3) shall have remedy by a civil action againstthe Director

filed in the United States District Courtfor the Eastern District of Virginia within 180 days after
the grant of the patent. Chapter 7 of title 5 shall apply to such action."
Defendant's Abrogation of the Patent Term Guarantee

34.

Defendant has improperly calculated PTA in a mannerthat deprives Sanofi of B

Delay due to an incorrect interpretation of the effect of the Continued Examination procedure
under 35 U.S.C. 132(b) within the context of 35 U.S.C. 154(b)(1)(B).

35.

Defendant has inappropriately promulgated and relied upon 37 C.F.R.

1.703(b)(1) to support its flawed interpretation of 35 U.S.C. 154(b)(1)(B) that B Delay permanently ceases to accrue upon the filing of a Request for Continued Examination ("RCE")
by an applicant.

36.

Instead, 35 U.S.C. 154(b)(l)(B)(i) merely requires the exclusion of"any time

consumed byContinued Examination of the application requested by the applicant under 35

U.S.C. 132(b)" when calculating whether the USPTO has satisfied the three-year pendency
guarantee.

37.

When properly construed, if the USPTO fails to meet this three-year pendency

guarantee, the applicant is entitled to the full remedy afforded by 35 U.S.C. 154(b)(1)(B): "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," subject only to the specific limitations set forth in 35 U.S.C. 154(b)(2). 38. None of the limitations included within 35 U.S.C. 154(b)(2) reduce or otherwise

affect the PTA remedy in 35 U.S.C. 154(b)(1)(B) on the basis of time consumed by
examination after filing of an RCE.

39.

The USPTO also promulgated regulations pursuant to 35 U.S.C. 154(b)(2)(C)

specifying applicant actions that will result in a reduction of the additional patent term available
under 35 U.S.C. 154(b)(1)(B). These regulations, set forth at 37 C.P.R. 1.704, likewise do not

include any reduction or limitation based upon time consumed by examination after the filing of
an RCE.

40.

The plain language of 35 U.S.C. 154(b)(1)(B) dictates that if an RCE is not filed

"within 3 years after the actual filing date of the application in the United States" (which filing

date, here, is December 19,2006), the filing of the RCE has no effect on the accrual of B Delay

for that patent. Under such circumstances, the applicant is entitled to B Delay from the day after the three-year pendency period through the date ofissuance ofthe patent, the explicit remedy set forth in 35 U.S.C. 154(b)(1)(B), subject only to the specific limitations set forth at 35 U.S.C.
154(b)(2). See Exelixis, Inc. v. Kappos, No. l:12-cv-0096,2012 U.S. Dist. LEXIS 157762 (E.D.
Va. Nov. 1,2012).

41.

To the extent that 37 C.P.R. 1.703(b)(1) conflicts with the straightforward and

unambiguous language of35 U.S.C. 154(b)(1)(B), this subsection of the regulation is invalid.
The Proper Calculation of PTA for the '614 Patent

42.

Under 35 U.S.C. 154(b)(1)(A), Sanofi is entitled to an adjustment of the term of

the '614 Patent for a period of 753 days. This A Delay is attributable to the USPTO's failure to

mail an action under 35 U.S.C. 132 not later than 14 months after the Filing Date, and the

USPTO's failure to issue the '614 Patent not later than 4 months after the Issue Fee was paid. This period consists of the 734-day period from February 20,2008 (day after the date that is fourteen months after the Filing Date of December 19,2006) until February 22,2010 (the mailing date of the First Non-Final Office Action), and the 19-day period from August 24,2012

(day after the date that is four months after the date on which the Issue Fee was paid) until
September 11,2012 (the date the '614 Patent issued).

43.

Under35 U.S.C. 154(b)(1)(B), Sanofi is entitled to an additional adjustment of

the term of the '614 Patent for a period of 1381 days. This B delay consists of the period from
December 1,2008 (day after the date that is three years after the national stage commenced

under 35 U.S.C. 371(b)) through September 11, 2012 (the issue date of the '614 Patent).
44.
B Delay.

Pursuant to 35 U.S.C. 154(b)(2)(A), there is a 468 day overlapof A Delayand

45.

Under 35 U.S.C. 154(b)(2)(C),224-days of delay is attributable to Sanofi. This

C Reduction is the 22-day period from October 20, 2010 (day after the date that is three months

after theFirst Final Rejection) through November 11, 2010 (the date thatthe Reply to the First
Final Rejection was filed), the 92-day period from March 10, 2011 (day after the date that is

three months from the mailing date of the Second Non-Final Rejection) through June 10,2011

(the date that the Reply to the Second Non-Final Rejection was filed), the 90-day period from October 30,2011 (day after the date that is three months from the mailing date of the Second

Final Rejection) through January 27, 2011 (the date that the Reply to the Second Final Rejection
was filed), the 12-day period from June 10, 2011 (date the reply to the First Non-Final Rejection was filed) through June 22, 2011 (date the supplemental reply to the Second Non-Final Rejection

was filed, and the 8-day period from March 19,2012 (date the amendment under 1.312 after

the Notice of Allowance) through March 26, 2012 (date the Office action or notice in response to
the amendment under 1.312 was mailed).

46.

Accordingly, the correct PTA for the '614 Patent is 1442 days: the sum of the 753

days of A Delay and the 1381 days of B Delay, minus the 468 days of A Delay and B Delay
overlap, and minus 224 days of Applicant Delay.
CLAIMS FOR RELIEF

COUNT 1: U.S. PATENT NO. 8,262,614

47.

Sanofi incorporates by reference the allegations in paragraph 1-46above, as if

fully set forth herein.

48.

The USPTO's calculation of B Delay for the '614 Patent was based upon a flawed

interpretation of 35 U.S.C. 154(b)(1)(B) that wrongly excluded all otherwise compensable

USPTO delay that accrued after Sanofi filed the RCE.

49.

Sanofi filed the RCE during prosecution more than three years afterthe actual

filing date of the application in the United States.

50.

Sanofi's filing ofthe RCE did not limit orotherwise affect the accrual ofBDelay

for the'614 Patent.

51.

The USPTO's erroneous interpretation of 35 U.S.C. 154(b)(1)(B) resulted in an

incorrect calculation ofBDelay for the '614 Patent that deprived Sanofi ofthe appropriate PTA
for this patent.

52.

Sanofi is entitled to additional patent term for the '614 Patent such that the 692

days of PTA granted by the USPTO should be changed to 1442 days.

PRAYER FOR RELIEF

WHEREFORE, Sanofi respectfully prays that this Court: 1. Issue an Order changing the period of patent term adjustment for the '614 Patent

term from 692 days to no less than 1442 days and requiring Defendant to correct the term of the
'614 Patent to reflect such additional PTA;

2.

Grant such other and further relief as the nature of the case may admit or require,

including additional patent term for the '614 Patent if further errors are identified and found in

the USPTO's patent term adjustment calculation methodology, and any such other and further
relief as may be deemed just and equitable by this Court.

Respectfully submitted,

Sumedha Ahuja (VA BfaT No. 83581)

Goodwin Procter LLP

901 New York Avenue, N.W.

Washington, DC 20001
Tel.: 202.346.4035 Fax.: 202.346.4444

Dated:

March 11,2013

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