Baxter International Et. Al. v. Rea

7/28/2019 Baxter International Et. Al. v. Rea

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FILED

IN THEUNITED STATESDISTRICT COURT 2013 JUN -") P 12= I8EASTERN DISTRICT OF V IRGIN IA

(Alexandria Division)BAXTER INTERNATIONAL, INC.ANDBAXTER HEALTHCARE S.A.,

Plaintiffs,vs.

HON. TERESA STANEK REA,Acting Under Secretary ofCommerce forIntellectual Property and Director of the UnitedStates Patent and Trademark Office,

Defendant .

Civil Action No.

CLERK US DISTRICT COURTALEXANDRIA. VIRGINIA

COMPLA INT

Plaintiffs Baxter International, Inc. and Baxter Healthcare S.A. (collectively"Baxter"), through their attorneys, K&L Gates LLP, brings this action against theHonorable Teresa Stanek Rea, and state as follows:

NATURE OF ACTION

1. This is an action by Baxter, the applicant and owner of United StatesPatentNos. 8,330,579 ("the '579 Patent,"), 8,333,959 ("the '959 Patent"), and 8,349,174("the '174 Patent") for review of the determination by Defendant, pursuant to 35U.S.C. 154(b)(4)(A), that: (1) the patent term adjustment for the '579 Patent be changed from1,149 days to 1,557 days; (2) the patent term adjustment for the '959 Patent be changedfrom 415 days to 1,807 days; and (3) the patent term adjustment for the '174 Patent bechanged from 1,043 days to 1,202 days.


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BACKGROUND

Patent Term Adjustments

8. The American Inventors Protection Act of 1999 ("AIPA") includedchanges to the patent laws - codified in 35 U.S.C. 154 - granting inventors additionalpatent term if certain conditions are met.

9. Under 35 U.S.C. 154(a)(2), when a patent issues, it is granted a twentyyear term from the date on which the underlying application was filed in the UnitedStates, or from certain earlier dates referenced in the application. The twenty year periodbegins to run before a patent is issued. Accordingly, any delay in the PTO's processingof an application reduces the duration of the patent term.

10. To prevent PTO delays from decreasing patent term, Congress directed thePTO to grant successful applicants adjustments of their patent terms to compensate forthree categories of processing delay by the PTO. Three guaranteed adjustments arecodified in 154(b) under sub-sections 35 U.S.C. 154(b)(1)(A), (B), and (C), and arecommonlyknown as "A" delay," "B delay," and "C delay," respectively.

11. At issue in this case is "B delay" which is based on a statutory "guaranteeof no more than 3-Year application pendency." Under this guarantee, applicants aregranted additional patent term "if the issue of an original patent is delayed due to thefailure of the [PTO] to issue a patentwithin three years after the actual filing dateof theapplication in the United States." See 35 U.S.C. 154(b)(1)(B). In calculating whetherthe PTO has met its three-year pendency guarantee or if, instead, the applicant's right topatent term adjustment is triggered, the statute excludes three categories of time: 1) timeconsumed by continued examination of the application requested by the applicant under


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35 U.S.C. 132(b); 2) time consumed by interferences, appeals, or secrecy orders; and 3)time consumed by processing delays requested by the applicant. See 35 U.S.C. 154(b)(l)(B)(i)-(iii).

12. The statute guarantees issuance of a patent from a pending patentapplication within three years after the actual filing date, not including time consumedduring that three-year period by continued examination after the filing of a request forcontinued examination ("RCE"). See 35 U.S.C. 154(b)(l)(B)(i).

13. The remedy to the applicant for the PTO's failure to meet this guarantee,requires that "the term of the patent shall be extended 1 day for each day after the end ofthat 3-year period until the patent is issued," subject to specific limits set forth at 35U.S.C. 154(b)(2). The scope of the remedy is limited only by 35 U.S.C. 154(b)(2)(A-C), which set forth certain conditions under which the period of additional patent termgranted to an applicant may be limited or reduced. Notably, these conditions do notpurport to reduce or limit patent term adjustment on the basis of time consumed byexamination after filing of an RCE.Patent Term Adjustments Of The '579 Patent

14. The '579 Patent issued on December 11, 2012 and is attached as ExhibitA .

15. Daniel Kneip, David West, David Cummings, Patrick Lee, and RandyMurphy are the inventors of the '579 Patent.

16. The Proceedings in the PTO with respect to the '579 Patent are reflectedin the administrative record. That record includes patent term adjustment historywhich


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explains the PTO's calculation of the adjustment. The worksheet for the '579 Patent isat tached as Exhibi t B.

17. The PTO admits that during prosecution of the '579 Patent, there were 913days of"A delay." (See Ex. B, row 52 (34 days) plus row 28 (879 days)).

18. The PTO has stated that during prosecution of the '579 Patent, there were0 days of "C delay." (See Ex. B).

19. The PTO has credited the '579 Patent with 447 days of "B delay." (SeeEx. B, row 79.5 (447 days))

20. The PTO, however, failed to credit the '579 Patent with the entire amountof "B delay" guaranteed to it.

21. The application that led to the '579 Patent was filed on July 5, 2007.Thus, one day of "B delay" should have been credited for every additional day ofprosecution (subject to statutory exceptions) beginning on July 6, 2010. See 35 U.S.C. 154(b)(1)(B).

22. An RCE was filed during prosecution of the '579 Patent on September 26,2011, but does not impact the calculation of "B delay" because it was filed after July 5,2010. See 35 U.S.C. 154(b)(1)(B).

23. The properly calculated "B delay" for the '579 Patent is 889 days - i.e.,one day for every day between July 6,2010 and December 11,2012.

24. The properly calculated "B delay" overlaps with 245 days of "A delay."(See Ex. B, row 52 (34 days) plus row 28 (in part - 211 days from February 1, 2011 toJuly 6,2011).


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25. The properly calculated patent term adjustment for the '579 Patent is1,557 days - i.e., 913 days ("A delay") plus 889 days ("B delay") less 245 days(overlapped delays).

26. The properly calculated patent term adjustment for the '579 Patent is 408days greater than the currently granted patent term adjustment.

27. The PTO's exclusion of the additional 408 days is contrary to 35 U.S.C. 154(b)(1). Specifically, as discussed above, the patent term adjustment statute, 35 U.S.C. 154(b)(1) provides that, once "B delay" is triggered, "the term of the patent shall beextended 1 day for each day after the end of that three-year period until the patent isissued," subject only to specific limits set forth at 35 U.S.C. 154(b)(2). Once the three-year period has ended and the "B delay" provision is triggered, the statute does not allowthe PTO to ignore days occurring after the filing of an RCE for purposes of calculating"B delay."Patent Term Adjustments Of The '959 Patent

28. The '959 Patent issued on December 18, 2012 and is attached as ExhibitC.

29. James E. Kipp and Barrett E. Rabinow are the inventors of the '959Patent .

30. The Proceedings in the PTO with respect to the '959 Patent are reflectedin the administrative record. That record includes patent term adjustment history whichexplains the PTO's calculation of the adjustment. The worksheet for the '959 Patent isattached as Exh ib i t D.


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31. The PTO admits that during prosecution of the '959 Patent, there were 596days of "A delay." (See Ex. D, row 97 (223 days) plus row 26 (373 days)).

32. The PTO has stated that during prosecution of the '959 Patent, there were0 days of "C delay." (See Ex. D).

33. The PTO has credited the '959 Patent with 260 days of "B delay." (SeeEx. D, row 143.5 (260 days))

34 . The PTO, however, failed to credit the '959 Patent with the entire amountof "B delay" guaranteed to it.

35. The application that led to the '959 Patent was filed on June 9, 2005.Thus, one day of "B delay" should have been credited for every additional day ofprosecution (subject to statutory exceptions) beginning on June 10, 2008. See 35 U.S.C. 154(b)(1)(B).

36. An RCE was filed during prosecution of the '959 Patent on February 25,2009, but does not impact the calculation of "B delay" because it was filed after June 10,2008. See 35 U.S.C. 154(b)(1)(B).

37. The properly calculated "B delay" for the '959 Patent is 1,652days - i.e.,one day for every day between June 10,2008 and December 18,2012.

38. The properly calculated "B delay" overlaps with 0 days of "A delay."(See Ex. D).

39. Additionally, the PTO has stated there were 441 days of applicant delay.(See Ex. D).


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47. The PTO has stated that during prosecution of the '174 Patent, there were0 days of "C delay." (See Ex. F).

48. The PTO has credited the '174 Patent with 375 days of "B delay." (SeeEx. F, row 82.5 (375 days)).

49 . The PTO, however, failed to credit the ' 174 Patent with the entire amountof "B delay" guaranteed to it.

50. The application that led to the '174 Patent was filed on July 23, 2008.Thus, one day of "B delay" should have been credited for every additional day ofprosecution (subject to statutory exceptions) beginning on July24, 2011. See35 U.S.C. 154(b)(1)(B).

51. An RCE was filed during prosecution of the '174 Patent on August 2,2012, but doesnot impactthe calculation of "B delay" because it was filed afterJuly 24,2011. See 35 U.S.C. 154(b)(1)(B).

52. The properly calculated "B delay" for the '174 Patent is 534 days - i.e.,one day for every day between July 24,2011 and January 8,2013.

53. The properly calculated "B delay" overlaps with 58 days of "A delay."(SeeEx.F, row35 (in part - 58days from July 24, 2011 to September19,2011).

54. Additionally, the PTO has stated there were 0 days of applicant delay.(See Ex. F).

55. The properly calculated patent term adjustment for the '174 Patent is1,202 days - i.e., lid days ("A delay") plus 534 days ("B delay") plus 0 days ("Cdelay") less58 days(overlapped delays) less0 days (applicant delay).


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56. The properly calculated patent term adjustment for the '174 Patent is 159days greater than the currently grantedpatent term adjustment.

57. ThePTO's exclusion of the additional 159 days is contrary to 35 U.S.C. 154(b)(1). Specifically, as discussed above, the patent termadjustment statute, 35U.S.C. 154(b)(1) provides that, once "B delay" is triggered, "the term of the patent shall beextended 1 day for each day after the end of that three-year period until the patent isissued," subject onlyto specific limits set forth at 35 U.S.C. 154(b)(2). Once the three-year periodhas ended and the "B delay" provision is triggered, the statute does not allowthe PTO to ignore days occurring after the filing ofan RCE for purposes of calculating"B delay."

CLA IMS FOR REL IEF

COUNT ONE('579 Patent - Patent Term Adjustment Under 35U.S.C. 154)58. Baxter incorporates the allegations of paragraphs 1 - 28 as if fully set

forth herein.

59. The currently challenged patent term adjustment for the '579 Patent, asdetermined by the Defendant under 35 U.S.C. 154(b), and listed on the face of the '579Patent, is 1,149 days. (See Ex. A at p.l). This determination was based onan improperinterpretation of 35 U.S.C. 154(b)(1)(B) that improperly excluded time consumed bycontinued examination ofthe application requested by the applicant under section 132(b).

60. The properly calculated patent term adjustment for the '579 Patent is1,557 days.

61. The PTO's incorrect calculation of the "B delay" adjustment for the '579Patent led to an incorrect calculation of the total patent term adjustment for the '579

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Patent. The PTO's calculation of the total term adjustment for the '579 Patentwas basedon an improper interpretation of35 U.S.C. 154(b)(1)(B).

62. The PTO's patent term adjustment calculation of 1,149days for the '579Patent is contrary to its statutory jurisdictionand authority, and arbitrary, capricious, anabuse ofdiscretion, or otherwise not in accordance with law.

COUNT TWO('959 Patent - Patent Term AdjustmentUnder 35U.S.C. 154)63. Baxter incorporates the allegations of paragraphs 1-13 and 29-43 as if

fully set forth herein.64. The currently challenged patent term adjustment for the '959 Patent, as

determined by the Defendant under 35 U.S.C. 154(b), and listed on the faceof the '959Patent, is 415 days. (See Ex. C at p.l). Thisdetermination was based on an improperinterpretation of 35 U.S.C. 154(b)(1)(B) that improperly excluded time consumed bycontinued examination of the application requested by theapplicant under section 132(b).


66. The PTO's incorrect calculation of the "B delay" adjustment for the '959Patent led to an incorrect calculation of the total patent term adjustment for the '959Patent. The PTO's calculation of the total term adjustment for the '959 Patent was basedon an improperinterpretationof 35 U.S.C. 154(b)(1)(B).

67. The PTO's patent term adjustment calculation of 1,807 days for the '959Patent is contrary to its statutory jurisdiction and authority, and arbitrary, capricious, anabuse ofdiscretion, or otherwise not in accordance with law.

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COUNT THREE('174 Patent - Patent Term Adjustment Under 35U.S.C. 154)68. Baxter incorporates the allegations of paragraphs 1-13 and 44-58 as if

fully set forth herein.69. The currently challenged patent term adjustment for the '174 Patent, as

determined by theDefendantunder 35 U.S.C. 154(b), and listedon the faceof the '174Patent, is 1,043 days. (See Ex. E atp.l). This determination was based on an improperinterpretation of 35 U.S.C. 154(b)(1)(B) that improperly excluded time consumed bycontinued examination of the application requested by the applicant under section 132(b).


71. The PTO's incorrect calculation of the "B delay" adjustment for the '174Patent led to an incorrect calculation of the total patent term adjustment for the '174Patent. The PTO's calculation of the total term adjustment for the '174 Patentwas basedon an improper interpretation of 35 U.S.C. 154(b)(1)(B).

72. The PTO's patent term adjustment calculation of 1,043 days for the '174Patent is contrary to its statutory jurisdiction and authority, and arbitrary, capricious, anabuse of discretion, or otherwise not in accordance with law.

WHEREFORE, Plaintiffrespectfully prays that thisCourt:A. Issue anOrder changing the period of patenttermadjustment for the '579

Patent from 1,149 days to 1,557 days, and requiring Defendant to alter the termof the'579 Patent to reflect the 1,557day patent term adjustment;

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B. Issue an Order changing the period of patent term adjustment for the '959Patent from 415 days to 1,807 days, and requiring Defendant to alter the term of the '959Patentto reflectthe 1,807 day patent termadjustment;

C. Issue anOrder changing the period ofpatent term adjustment for the ' 174Patent from 1,043 days to 1,202 days, and requiring Defendant to alter the term of the' 174 Patent to reflect the 1,202 daypatent term adjustment;

D. Grant such other and further relief as the nature of the case may admit orrequire asmay bejust and equitable.

Respectfully submitted,

Dated: June 7, 2013

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Sric C. Rusnak(VABar#65895)K&L GATES LLP1601 K Street, N.W.Washington, DC 20006Tel: 202-778-9000Fax:[email protected] BaxterInternational, Inc. andBaxterHealthcare S.A.

OfCounselRobert Barret [email protected] [email protected] W. Madison StreetChicago, IL 60602Tel: 312.372.1121Fax: 312.827.8000

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Baxter International Et. Al. v. Rea