Source: https://www.scribd.com/doc/147378651/Baxter-International-et-al-v-Rea
Timestamp: 2017-04-28 12:42:55
Document Index: 625371329

Matched Legal Cases: ['art0', '§\n154', '§ 154', '§ 701', '§ 154', '§\n154', '§ 1331', '§ 154', '§701', '§ 9', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 132', '§\n154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§\n154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§\n154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154']

Baxter International et. al. v. Rea
ScribdBrowseInterestsCareer & MoneyPersonal GrowthPolitics & Current AffairsScience & TechHealth & FitnessLifestyleEntertainmentBiographies & HistoryFictionBrowse byBooksAudiobooksNews & MagazinesSheet MusicBrowse allUploadSign inJoinBaxter International et. al. v. ReaUploaded by PriorSmart0.0 (0)DownloadEmbedDescription: Official Complaint for Patent Infringement in Civil Action No. 1:13-cv-00693-CMH-JFA: Baxter International, Inc. et. al. v. Rea. Filed in U.S. District Court for the Eastern District of Virginia, t...View MoreOfficial Complaint for Patent Infringement in Civil Action No. 1:13-cv-00693-CMH-JFA: Baxter International, Inc. et. al. v. Rea. Filed in U.S. District Court for the Eastern District of Virginia, the Hon. Claude M. Hilton presiding. See http://news.priorsmart.com/-l8zS for more info.Copyright: Public DomainDownload as PDF, TXT or read online from ScribdFlag for inappropriate contentFILEDIN THE UNITED STATES DISTRICT COURT 2013 JUN -") P 12= I8
CLERK US DISTRICT COURT ALEXANDRIA. VIRGINIA
BAXTER INTERNATIONAL, INC. AND BAXTER HEALTHCARE S.A.,
HON. TERESA STANEK REA,
Acting Under Secretary of Commerce for Intellectual Property and Director of the United
States Patent and Trademark Office,
Plaintiffs Baxter International, Inc. and Baxter Healthcare S.A. (collectively
"Baxter"), through their attorneys, K&L Gates LLP, brings this action against the
Honorable Teresa Stanek Rea, and state as follows:
This is an action by Baxter, the applicant and owner of United States
Patent Nos. 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 35 U.S.C. §
154(b)(4)(A), that: (1) the patent term adjustment for the '579 Patent be changed from
1,149 days to 1,557 days; (2) the patent term adjustment for the '959 Patent be changed from 415 days to 1,807 days; and (3) the patent term adjustment for the '174 Patent be
changed from 1,043 days to 1,202 days.
This action arises under 35 U.S.C. § 154(b)(4)(A) and the Administrative
Procedure Act, 5 U.S.C. §§ 701-706.
Baxter International, Inc. is a Delaware corporation with its principal place
of business in Deerfield, Illinois. Baxter Healthcare S.A. is a Swiss corporation with its
principal place of business in Opfikon, Switzerland.
Defendant Teresa Stanek Rea is the Acting Under Secretary of Commerce
for Intellectual Property and Director of the United States Patent and Trademark Office ("PTO"), acting in his official capacity. The Director is the head of the PTO and is
responsible for supervising or performing all duties required by law with respect to the
granting and issuing of patents, and is designated by statute as the official responsible for
determining the period of patent term adjustments under 35 U.S.C. § 154(b)(3)(B), and is
the proper defendant in a suit seeking review of such determinations. See 35 U.S.C. §
154(b)(4)(A).
This Court has jurisdiction to hear this action and is authorized to issue the
reliefsought 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.
Venue is proper in this district by virtue of the Leahy-Smith America
Invents Act. Pub. L. No. 112-29, § 9,125 Stat. 316 (2011).
This Complaint is being timely filed in accordance with 35 U.S.C. §
Patent Term Adjustments 8. The American Inventors Protection Act of 1999 ("AIPA") included
changes to the patent laws - codified in 35 U.S.C. § 154 - granting inventors additional patent term if certain conditions are met.
9. Under 35 U.S.C. § 154(a)(2), when a patent issues, it is granted a twenty
year term from the date on which the underlying application was filed in the United
States, or from certain earlier dates referenced in the application. The twenty year period begins to run before a patent is issued. Accordingly, any delay in the PTO's processing
of an application reduces the duration of the patent term.
To prevent PTO delays from decreasing patent term, Congress directed the
PTO to grant successful applicants adjustments of their patent terms to compensate for
three categories of processing delay by the PTO. Three guaranteed adjustments are codified in § 154(b) under sub-sections 35 U.S.C. §§ 154(b)(1)(A), (B), and (C), and are
commonly known as "A" delay," "B delay," and "C delay," respectively. 11. At issue in this case is "B delay" which is based on a statutory "guarantee
of no more than 3-Year application pendency." Under this guarantee, applicants are
granted additional patent term "if the issue of an original patent is delayed due to the
failure of the [PTO] to issue a patent within three years after the actual filing date of the application in the United States." See 35 U.S.C. § 154(b)(1)(B). In calculating whether
the PTO has met its three-year pendency guarantee or if, instead, the applicant's right to patent term adjustment is triggered, the statute excludes three categories of time: 1) time consumed by continued examination of the application requested by the applicant under
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).
The statute guarantees issuance of a patent from a pending patent
application within three years after the actual filing date, not including time consumed
during that three-year period by continued examination after the filing of a request for
continued examination ("RCE"). See 35 U.S.C. § 154(b)(l)(B)(i).
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 of that 3-year period until the patent is issued," subject to specific limits set forth at 35
U.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 term
granted to an applicant may be limited or reduced. Notably, these conditions do not
purport to reduce or limit patent term adjustment on the basis of time consumed by
examination 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 Exhibit
Daniel Kneip, David West, David Cummings, Patrick Lee, and Randy
Murphy are the inventors of the '579 Patent.
The Proceedings in the PTO with respect to the '579 Patent are reflected
in the administrative record. That record includes patent term adjustment history which
explains the PTO's calculation of the adjustment. The worksheet for the '579 Patent is
attached as Exhibit B.
The PTO admits that during prosecution of the '579 Patent, there were 913
days 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 were
0 days of "C delay." (See Ex. B). 19. The PTO has credited the '579 Patent with 447 days of "B delay." (See
Ex. B, row 79.5 (447 days))
20. The PTO, however, failed to credit the '579 Patent with the entire amount
of "B delay" guaranteed to it.
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 of
prosecution (subject to statutory exceptions) beginning on July 6, 2010. See 35 U.S.C. § 154(b)(1)(B).
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).
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.
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 to
July 6,2011).
The properly calculated patent term adjustment for the '579 Patent is
1,557 days - i.e., 913 days ("A delay") plus 889 days ("B delay") less 245 days
(overlapped delays).
The properly calculated patent term adjustment for the '579 Patent is 408
days 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 be extended 1 day for each day after the end of that three-year period until the patent is
issued," subject only to specific limits set forth at 35 U.S.C. § 154(b)(2). Once the threeyear period has ended and the "B delay" provision is triggered, the statute does not allow the PTO to ignore days occurring after the filing of an RCE for purposes of calculating
"B delay." Patent Term Adjustments Of The '959 Patent
The '959 Patent issued on December 18, 2012 and is attached as Exhibit
James E. Kipp and Barrett E. Rabinow are the inventors of the '959
The Proceedings in the PTO with respect to the '959 Patent are reflected
explains the PTO's calculation of the adjustment. The worksheet for the '959 Patent is
attached as Exhibit D.
The PTO admits that during prosecution of the '959 Patent, there were 596
days 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 were
0 days of "C delay." (See Ex. D). 33. The PTO has credited the '959 Patent with 260 days of "B delay." (See
Ex. D, row 143.5 (260 days))
34. The PTO, however, failed to credit the '959 Patent with the entire amount
of "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 of prosecution (subject to statutory exceptions) beginning on June 10, 2008. See 35 U.S.C.
§ 154(b)(1)(B).
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).
The properly calculated "B delay" for the '959 Patent is 1,652 days - i.e.,
one day for every day between June 10,2008 and December 18,2012.
(See Ex. D).
The properly calculated "B delay" overlaps with 0 days of "A delay."
Additionally, the PTO has stated there were 441 days of applicant delay.
The properly calculated patent term adjustment for the '959 Patent is
1,807 days - i.e., 596 days ("A delay") plus 1,652 days ("B delay") plus 0 days ("C
delay") less 441 days (applicant delay). 41. The properly calculated patent term adjustment for the '959 Patent is
1,392 days greater than the currently granted patent term adjustment. 42. The PTO's exclusion of the additional 1,392 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
be extended 1 day for each day after the end of that three-year period until the patent is
issued," subject only to specific limits set forth at 35 U.S.C. § 154(b)(2). Once the threeyear period has ended and the "B delay" provision is triggered, the statute does not allow the PTO to ignore days occurring after the filing of an RCE for purposes of calculating "B delay."
Patent Term Adjustments Of The '174 Patent
The ' 174 Patent issued on January 8, 2012 and is attached as Exhibit E. John A. Bedingfield, Richard E. Kienman, and Brian C. Laumanis are the
inventors of the '174 Patent.
The Proceedings in the PTO with respect to the '174 Patent are reflected
explains the PTO's calculation of the adjustment. The worksheet for the '174 Patent is
attached as Exhibit F.
The PTO admits that during prosecution of the ' 174 Patent, there were 726
days of "A delay." (See Ex. F, row 35 (726 days)).
The PTO has stated that during prosecution of the '174 Patent, there were
0 days of "C delay." (See Ex. F).
The PTO has credited the '174 Patent with 375 days of "B delay." (See
Ex. F, row 82.5 (375 days)).
49. The PTO, however, failed to credit the ' 174 Patent with the entire amount
The application that led to the '174 Patent was filed on July 23, 2008.
prosecution (subject to statutory exceptions) beginning on July 24, 2011. See 35 U.S.C. §
154(b)(1)(B).
An RCE was filed during prosecution of the '174 Patent on August 2,
2012, but does not impact the calculation of "B delay" because it was filed after July 24,
2011. See 35 U.S.C. § 154(b)(1)(B).
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.
The properly calculated "B delay" overlaps with 58 days of "A delay."
(SeeEx. F, row 35 (in part - 58 days from July 24, 2011 to September 19,2011).
(See Ex. F).
Additionally, the PTO has stated there were 0 days of applicant delay.
The properly calculated patent term adjustment for the '174 Patent is
1,202 days - i.e., lid days ("A delay") plus 534 days ("B delay") plus 0 days ("C
delay") less 58 days (overlapped delays) less 0 days (applicant delay).
The properly calculated patent term adjustment for the '174 Patent is 159
The PTO's exclusion of the additional 159 days is contrary to 35 U.S.C. §
§ 154(b)(1) provides that, once "B delay" is triggered, "the term of the patent shall be
extended 1 day for each day after the end of that three-year period until the patent is
issued," subject only to specific limits set forth at 35 U.S.C. § 154(b)(2). Once the threeyear period has ended and the "B delay" provision is triggered, the statute does not allow
the PTO to ignore days occurring after the filing of an RCE for purposes of calculating
"B delay."
CLAIMS FOR RELIEF COUNT ONE
('579 Patent - Patent Term Adjustment Under 35 U.S.C. § 154)
Baxter incorporates the allegations of paragraphs 1 - 28 as if fully set
The currently challenged patent term adjustment for the '579 Patent, as
determined by the Defendant under 35 U.S.C. § 154(b), and listed on the face of the '579
Patent, is 1,149 days. (See Ex. A at p.l). This determination was based on an improper interpretation of 35 U.S.C. § 154(b)(1)(B) that improperly excluded time consumed by
continued examination of the application requested by the applicant under section 132(b).
1,557 days.
The PTO's incorrect calculation of the "B delay" adjustment for the '579
Patent led to an incorrect calculation of the total patent term adjustment for the '579
Patent. The PTO's calculation of the total term adjustment for the '579 Patent was based on an improper interpretation of 35 U.S.C. § 154(b)(1)(B).
The PTO's patent term adjustment calculation of 1,149 days for the '579
Patent is contrary to its statutory jurisdiction and authority, and arbitrary, capricious, an
abuse of discretion, or otherwise not in accordance with law.
('959 Patent - Patent Term Adjustment Under 35 U.S.C. § 154) 63. Baxter incorporates the allegations of paragraphs 1-13 and 29-43 as if
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 face of the '959
Patent, is 415 days. (See Ex. C at p.l). This determination was based on an improper interpretation of 35 U.S.C. § 154(b)(1)(B) that improperly excluded time consumed by
1,807 days.
The PTO's incorrect calculation of the "B delay" adjustment for the '959
Patent led to an incorrect calculation of the total patent term adjustment for the '959
Patent. The PTO's calculation of the total term adjustment for the '959 Patent was based
on an improper interpretationof 35 U.S.C. § 154(b)(1)(B).
The PTO's patent term adjustment calculation of 1,807 days for the '959
('174 Patent - Patent Term Adjustment Under 35 U.S.C. § 154)
Baxter incorporates the allegations of paragraphs 1-13 and 44-58 as if
The currently challenged patent term adjustment for the '174 Patent, as
determined by the Defendant under 35 U.S.C. § 154(b), and listed on the face of the '174
Patent, is 1,043 days. (See Ex. E at p.l). This determination was based on an improper interpretation of 35 U.S.C. § 154(b)(1)(B) that improperly excluded time consumed by
1,202 days.
The PTO's incorrect calculation of the "B delay" adjustment for the '174
Patent led to an incorrect calculation of the total patent term adjustment for the '174
Patent. The PTO's calculation of the total term adjustment for the '174 Patent was based
on an improper interpretation of 35 U.S.C. § 154(b)(1)(B).
The PTO's patent term adjustment calculation of 1,043 days for the '174
WHEREFORE, Plaintiffrespectfully prays that this Court:
Issue an Order changing the period of patent term adjustment for the '579
Patent from 1,149 days to 1,557 days, and requiring Defendant to alter the term of the
'579 Patent to reflect the 1,557 day patent term adjustment;
Issue an Order changing the period of patent term adjustment for the '959
Patent from 415 days to 1,807 days, and requiring Defendant to alter the term of the '959
Patentto reflectthe 1,807 day patent term adjustment;
Issue an Order changing the period of patent term adjustment for the ' 174
Patent from 1,043 days to 1,202 days, and requiring Defendant to alter the term of the
' 174 Patent to reflect the 1,202 day patent term adjustment;
Grant such other and further relief as the nature of the case may admit or
require as may be just and equitable.
Dated: June 7, 2013
Sric C. Rusnak(VA Bar #65895)
Tel: 202-778-9000 Fax:202-778-9100
eric.rusnak@klgates.com
Attorneysfor Baxter International, Inc. and
robert.barrett@klgates.com
Robert Barz
robert.barz@klgates.com
Tel: 312.372.1121 Fax: 312.827.8000
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