sanofi-aventis deutschland v. rea

7/29/2019 Sanofi-Aventis Deutschland v. Rea

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FILEDUNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF VIRGINIA

SANOFI-AVENTIS DEUTSCHLANDGMBH,Plaintiff,

v.

HON. TERESA STANEK REAActingUnder SecretaryofCommerce forIntellectual Property and Director of theUnited States Patent and Trademark OfficeOffice of the General CounselUnited States Patent and Trademark OfficeP.O. Box 1450, Arlington, VA 22313600 Dulany Street, Alexandria, VA 22314,

Defendant.

2013 MAR 18 P 1:08CLERK US DISTRICT COURT

ALEXANDRIA. VIRGINIA

Civil Action No . MMM-CMil

C O M P L A I N T

PlaintiffSanofi-Aventis Deutschland GmbH ("Plaintiff or"Sanofi"), for its Complaintagainst Defendant, the Honorable Teresa Stanek Rea ("Defendant" or "the Director"), in herofficial capacity as the Acting Under Secretary ofCommerce for Intellectual Property andDirector ofthe United States Patent and Trademark Office ("USPTO"), respectfully states asfollows:

N A T U R E O F T H E A C TIO N

1. This isan action by Sanofi, the assignee and owner ofUnited States PatentNo. 8,267,870 ("the '870 Patent"), seeking review ofthe determination by Defendant ofthepatent term adjustment calculation. Specifically, this isanaction bySanofi under 35 U.S.C. 154(b)(4)(A) seeking a judgment that the patent term adjustment for the '870Patent bechanged from 193 days to 2022 days.

2. This action arises under 35 U.S.C. 154 and the Administrative Procedure Act,1


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5 U.S.C. 701-706.T H E P AR TIE S

3. PlaintiffSanofiis a corporation organized andexistingunderthe lawsofGermany, with itsprincipal place ofbusiness located at Industriepark Hoechst, Bldg. K607,Frankfurt AmMain, Germany D-65926.

4. The Director istheUnder Secretary ofCommerce for Intellectual Property andDirectorof theUSPTO, and is suedhere in his official capacity. TheDirectoris the headof theUSPTO andis responsible forall duties required bylawwith respect to the granting and issuingofpatents. As such, theDirector is designated by statute astheofficial responsible fordetermining theperiodof patenttermadjustments under35 U.S.C. 154.

JURISDICTION AND VENUE5. This Court has jurisdiction to hear this action and is authorized to issue the

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

6. Venue is proper in this district pursuant to 35U.S.C. 154(b)(4)(A).7. This Complaint is being timely filed inaccordance with 35 U.S.C. 154(b)(4)(A).

B A C K G R O U N D

T he ' 87 0 P a te n t

8. Dominique M.Freeman, Dirk Boecker, Don Alden, Matt Schumann, and MikeBeadman are the inventors named on the '870Patent. A true and correct copy of the '870Patentis at tached hereto as Exhibi t A.

9. PlaintiffSanofi is the assignee ofall right, titleandinterest inthe '870 Patent, asevidenced by the face of the '870 Patent.


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10. The '870 Patent issued from U.S. Patent Application No. 10/452,815 ("the '815application"), and filed onMay 30,2003 (the "FilingDate").

11. On February 24,2006, the USPTO mailed a Non-Final Action for the'815application (the "FirstNon-Final Office Action"). Sanofi responded to theFirst Non-FinalOffice Action on August 24,2006.

12. OnDecember 5, 2006 theUSPTO mailed a Final Rejection forthe '815application (the "First Final Rejection").

13. On June 4,2007, Sanofi filed a Request for Continued Examination for the ' 815application.

14. OnAugust 23,2007, the USPTO mailed a non-final rejection for the '815application ("Second Non-Final Office Action"). Sanofi responded to the Second Non-FinalOffice Action onFebruary 22,2008. Sanofi supplemented its response with an InformationDisclosure Statement("IDS") on April 11,2008

15. On June 9,2008, the USPTO mailed a Final Rejection for the '815 application(the "Second Final Rejection"). Sanofi responded to the Second Final Rejection onNovember 3,2008 and filed a second Request for Continued Examination for the '815 application. Sanofisupplemented its responsewith an IDS on November 7,2008.

16. On December 23,2008, the USPTO mailed a non-final rejection for the '815application ("Third Non-Final Office Action"). Sanofi responded to the Third Non-Final OfficeAction onJanuary 23,2009. Sanofi supplemented its response with an IDS onMarch 27,2009.

17. On April 17, 2009, the USPTO mailed a Final Rejection for the '815 application(the "Third Final Rejection"). Sanofi filed aNotice ofAppeal for the '815 application onOctober 19, 2009.


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18. On June 1,2010, the USPTO mailed a Final Rejection for the '815 application(the "Fourth Final Rejection"). Sanofi filed a Request forContinued Examination for the '815application on November 2, 2010.

19. OnFebruary 8, 2011, theUSPTO mailed a non-final rejection forthe'815application ("Fourth Non-Final Office Action"). Sanofi responded to theFourth Non-FinalOffice Action on August 8,2011. Sanofi supplemented its response with an IDS on January 9,2012.

20. On March 21,2012, the USPTO mailed a Notice ofAllowance for the '815application.

21. On May 18,2012, Sanofi filed anamendment after Notice ofAllowance under 1.312. The USPTO responded on May 24,2012.

22. On May 31,2012, Sanofi paid the issue fee for the '815 application, satisfying alloutstanding requirements for issuance of a patent.

23. On August 29, 2012, the USPTOmailed an issue notification for the '870 Patent.Included in the Issue Notification was aDetermination ofPatent Term Adjustment in which theUSPTO indicated that the patent term adjustment for the '815 application was 193 days.

24. On September 18, 2012, the'815 application issued as the '870 Patent, reflectinga PTA of 193days.

25. OnNovember 19, 2012, Sanofi filed a petition under 35 U.S.C. 154(b) and 37C.F.R. 1.705(d) with the USPTO for reconsideration ofthe Patent Term Adjustment accordedby the Director to the '870 Patent in view ofthe recent decision in Exelixis, Inc. v. Koppos, No.l:12-cv-0096,2012 U.S. Dist. LEXIS 157762 (E.D. Va. Nov. 1, 2012).


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Patent Term Guarantee

26. ThePatent TermGuarantee Actof 1999, a part of theAmerican InventorsProtection Act ("AIPA"), amended 35 U.S.C. 154(b) to address concerns that delays by theUSPTO during the prosecution ofpatent applications could result ina shortening of the effectivelife of the resulting patentsto less than seventeen years.

27. Amended 35U.S.C. 154(b) broadened the universe of cognizable administrativedelays by the USPTO that could retroactively yield anextension of the patent term tocompensate for such prosecution delays ("Patent Term Adjustment" or "PTA").

28. Patent Term Adjustment applies to original utility patent applications (includingcontinuations, divisionals, and continuations-in-part) filed onor after May 29, 2000.

29. Incalculating PTA, Defendant must take into account USPTO delays under 35U.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 under 35U.S.C. 154(b)(2)(C).

30. Under35 U.S.C. 154(b)(1)(A), an applicant is entitled to PTAfor theUSPTO'sfailure tocarry out certain acts during processing and examination within defined deadlines ("ADelay").

31. Under 35U .S.C. 154(b)(1)(B), an applicant is entitledto additional PTAattributable to the USPTO's "failure ... to issue a patent within 3years after the actual Filing Dateofthe application in the United States," but not including "any time consumed by ContinuedExamination ofthe application requested by the applicant under section 132(b)" ("B Delay").

32. 35 U.S.C. 154(b)(2)(A) provides that "to the extent that periods ofdelayattributable to grounds specified in paragraph [154(b)(1)] overlap, the period ofany adjustmentgranted under this subsection shall not exceed the actual number of days the issuance ofthe


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patent was delayed."33. On January 7,2010, the Court ofAppeals 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 ofADelay and BDelay isto aggregate ADelay and BDelay except to the extent that suchaggregation would amount to counting the same calendar days twice.

34. Section 154(b)(2)(C)(i) of35 U.S.C. also directs that "the period ofadjustment ofthe term ofapatent under paragraph [154(b)(1)] shall be reduced by aperiod equal to the periodoftime during which the applicant failed to engage in reasonable efforts to conclude prosecutionof the application" ("C Reduction").

35. On November 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 awardsarising from the failure ofthe PTO to grant apatent within three (3) years ofthe filing date(known as "B delays") are not necessarily reduced by the filing ofaRequest for Continuation ifthe 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 thepatent is issued, whether or not an RCE was filed. Id.

36. Under 35U.S.C. 154(b)(4)(A), "anapplicant dissatisfied with a determinationmade by the Director under paragraph (3) shall have remedy by a civil action against the Directorfiled in the United States District Court for the Eastern District ofVirginia within 180 days afterthe grant of the patent. Chapter 7of title 5 shall apply to such action."


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Defendant's Abrogation of th e Patent Term Guarantee37. Defendant has improperly calculated PTA in amanner that deprives Sanofi ofB

Delay due to an incorrect interpretation ofthe effect ofthe Continued Examination procedureunder 35 U.S.C. 132(b) within the context of35 U.S.C. 154(b)(1)(B).

38. Defendant has inappropriately promulgated and relied upon 37 C.F.R. 1.703(b)(1) to support its flawed interpretation of35 U.S.C. 154(b)(1)(B) that BDelaypermanently ceases to accrue upon the filing ofa Request for Continued Examination ("RCE")by an applicant.

39. Instead, 35 U.S.C. 154(b)(l)(B)(i)merely requires the exclusion of"any timeconsumed by Continued Examination of the application requested by the applicant under 35U.S.C. 132(b)" when calculating whether the USPTO has satisfied the three-year pendencyguarantee.

40. When properly construed, ifthe USPTO fails to meet this three-year pendencyguarantee, the applicant is entitled to the full remedy afforded by 35 U.S.C. 154(b)(1)(B): "theterm ofthe patent shall be extended 1day for each day after the end of that 3-year period untilthe patent is issued," subject only to the specific limitations set forth in 35 U.S.C. 154(b)(2).

41. None of the limitations included within 35 U.S.C. 154(b)(2) reduce orotherwiseaffect the PTA remedy in 35 U.S.C. 154(b)(1)(B) on the basis oftime consumed byexamination after filing of an RCE.

42. The USPTO also promulgated regulations pursuant to 35 U.S.C. 154(b)(2)(C)specifying applicant actions that will result ina reduction of the additional patent term availableunder 154(b)(1)(B). These regulations, set forth at 37 C.P.R. 1.704, likewise do not include anyreduction or limitation based upon time consumed by examination after the filing ofan RCE.


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43. The plain language of 35 U.S.C. 154(b)(1)(B) dictates that ifanRCE is not filed"within 3years after the actual filing date of the application in the United States" (which filingdate, here, is May 30,2003), the filing ofthe RCE has no effect on the accrual ofBDelay forthat patent. Under such circumstances, the applicant is entitled toBDelay from the day after thethree-year pendency period through the date of issuance ofthe patent, the explicit remedy setforth 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. 1:12-cv-0096, 2012 U.S. Dist. LEXIS 157762 (E.D.Va. Nov. 1,2012).

44. To the extent that 37 C.P.R. 1.703(b)(1) conflicts with the straightforward andunambiguous language of35 U.S.C. 154(b)(1)(B), this subsection ofthe regulation is invalid.The Proper Calculation o f PTA for the ' 870 Patent

45. Under 35 U.S.C. 154(b)(1)(A), Sanofi is entitled to an adjustment ofthe term ofthe '870Patent for a period of678 days. This ADelay is attributable to the USPTO's failure tomail an action under 35 U.S.C. 132 not later than 14 months after the Filing Date, and theUSPTO's failure to file aNotice ofAllowance not later than 4months after the reply to theFourth Non-Final Office Action was filed. This period consists ofthe 574-day period from July31, 2004 (day after the date that is fourteen months after the Filing Date ofMay 30,2003) untilFebruary 24,2006 (the mailing date ofthe FirstNon-Final Office Action), and the 104-dayperiod from December 9,2011 (day after the date that is four months after the date onwhich thereply to the Fourth Non-Final Office Action was filed) until March 21,2012 (the date the NoticeofAllowance wasmailed).

46. Under 35 U.S.C. 154(b)(1)(B), Sanofi is entitled to an additional adjustment ofthe term ofthe '870 Patent for aperiod of2303 days. This Bdelay consists ofthe period from

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May 31,2006 (day after the date that is three years after the Filing Date ofMay 30,2003)through September 18,2012 (the issue date ofthe '870 Patent).

47. Pursuant to 35 U.S.C. 154(b)(2)(A), there is a 104 day overlap ofADelay andB Delay.

48. Under 35 U.S.C. 154(b)(2)(C), 224-days ofdelay is attributable to Sanofi. ThisC Reduction is:

the 92-day period from May 25,2006 (day after the date that is three months afterthe First Non-Final Office Action) through August 24, 2006 (the date that theReply to the First Non-Final Office Action was filed),

the 91 -day period from March 6,2007 (day after the date that is three monthsfrom themailing date ofthe First Final Rejection) through June 4,2007 (the datethat the Reply to the First Final Rejection was filed),

the 91 -day period from November 24,2007 (day after the date that is threemonths from themailing date ofthe SecondNon-Final Office Action) throughFebruary 22, 2008 (the date that the Reply to the Second Non-Final Rejection wasfiled),

the 55-day period from September 10, 2008 (day after the date that is threemonths from the mailing date ofthe Second Final Rejection) through November3,2008 (date the reply to the Second Final Rejection was filed),

the 94-day period from July 18, 2009 (day after the date that is three months fromthemailing date ofthe Third Final Rejection) through October 19,2009 (date theNoticeof Appeal was filed),

the 62-day period from September 2,2010 (day after the date that is three months


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from the mailing date ofthe Fourth Final Rejection) through November 2, 2010(date the reply to the Fourth Final Rejection was filed,

the 92-day period from May 9,2011 (day after the date that is three months fromthe mailing date ofthe Fourth Non-Final Office Action) through August 8,2011(date the reply to the Fourth Non-Final Office Action was filed),

the 49-day period from February 22,2008 (date the reply to the Second Non-FinalOffice Action was filed) through April 11, 2008 (date the supplemental reply(IDS) was filed),

the 4-day period from November 3, 2008 (date the reply to the Second FinalRejection was filed) through November 7, 2008 (date the supplemental reply(IDS)was filed),

the 63-day period from January 23,2009 (date the reply to the Third Non-FinalOffice Action was filed) throughMarch 27, 2009 (date the supplemental reply(IDS) was filed),

the 154-day period from August 8,2011 (date the reply to the Fourth Non-FinalRejection was filed) through January 9, 2012 (date the supplemental reply (IDS)was filed), and

the 7-day period from May 18,2012 (date the amendment under 1.312 wasfiled) through May 24,2012 (date the USPTO responded to the amendment).

49. Accordingly, the correct PTA for the'870 Patent is 2023 days: the sum ofthe 678days ofADelay and the 2303 days ofBDelay, minus the 104 days ofADelay and BDelayoverlap, and minus 854 days ofApplicant Delay.

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CLAIMS FOR RELIEFCOUNT 1: U.S. PATENTNO. 8,267,870

50. Sanofi incorporates by reference the allegations in paragraph 1-46 above, as iffully set forth herein.

51. The USPTO's calculation ofBDelay for the '870 Patent was based upon aflawedinterpretation of35 U.S.C. 154(b)(1)(B) that wrongly excluded all otherwise compensableUSPTO delay thataccrued after Sanofi filed theRCE.

52. Sanofi filed the RCE during prosecution more than three years after the actualfiling dateof theapplication in theUnited States.

53. Sanofi's filing of the RCE did not limit or otherwise affect the accrual ofBDelayfo r th e '870 Patent.

54. The USPTO's erroneous interpretation of 35 U.S.C. 154(b)(1)(B) resulted in anincorrect calculation ofBDelay for the '870 Patent that deprived Sanofi of the appropriate PTAfor this patent.

55. Sanofi is entitled to additional patent term for the '870 Patent such that the 193days ofPTA granted by the USPTO should be changed to 2023 days.

P R A Y E R FOR RELIEF

WHEREFORE, Sanofi respectfully prays that this Court:1. Issue an Order changing the period ofpatent term adjustment for the '870 Patent

term from 193 days to no less than 2023 days and requiring Defendant to correct the term ofthe'870Patent 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 '870 Patent iffurther errors are identified and found in

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

Respectfully submitted,

Dated: March 18,2013

Sumedha Ahuja (VA Bar. No. 83581)Goodwin Procter LLP901 NewYork Avenue, N.W.Washington, DC 20001Tel.: 202.346.4035Fax.: 202.346.4444

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sanofi-aventis deutschland v. rea

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