Professional Documents
Culture Documents
FILED
IN THE UNITED STATES DISTRICT COURT
50
ALEXANDRIA DIVISION
Rockville, MD 20850
l^6\/
COMPLAINT
Corporation ("UTC") (together, "Plaintiffs"), for their complaint against the Honorable
Michelle K. Lee, Under Secretary of Commerce for Intellectual Property and Director of the
United States Patent and Trademark Office, (hereinafter "Lee" or "Defendant"), state as
follows:
Complaint
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1. This is an action by Supemus, the owner and assignee of United States Patent No.
8,747,897 ("the '897 patent") (attached as Exhibit A), titled "OSMOTIC DRUG DELIVERY
SYSTEM", and by UTC, the exclusive licensee of the '897 patent, for review of the
determination by Defendant, pursuant to, inter alia, 35 U.S.C. 154(b)(4)(A), of the Patent
Term Adjustment of the '897 patent. Plaintiffs seek a judgment that the patent term adjustment
for the '897 patent be changed from 1,386 days to 2,032 days.
2. Plaintiffs seek a judgement that Defendant erred in applying 37 C.F.R. 1.704(c)(8)
and GileadScis., Inc. v. Lee, 778 F.3d 1341 (Fed. Cir. 2015) (''Gilead IF) to the instant case,
and that Defendant's application of Rule 37 C.F.R. 1.704(c)(8) to the facts of this case is
arbitrary and capricious in view of the straightforward and unambiguous language of 35 U.S.C.
154(b)(2)(C).
3. This action arises under 35 U.S.C. 154 and the Administrative Procedure Act, 5
U.S.C. 701-706.
THE PARTIES
5. UTC is a corporation organized and existing under the laws of the State of
Delaware, and having a place of business at 1040 Spring Street, Silver Spring, Maryland
20910. UTC is a biotechnology company focused on the development and cormnercialization
of products designed to address the needs of patients with chronic and life-threatening
conditions. UTC is the exclusive licensee to the '897 patent. UTC holds an approved New
Dmg Application (No. 203496) for Orenitram (treprostinil) Extended-Release Tablets. FDA
publishes the Approved Drug Products with Therapeutic Equivalents publication (also known
Complaint
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as the "Orange Book"). The Orange Book lists, inter alia, drugs approved by FDA and, for
each, certain patents that "could reasonably be asserted if a person not licensed by the owner
engaged in the manufacture, use, or sale of the drug." 21 U.S.C. 355(b)(1). The Orange
of Commerce for Intellectual Property and Director of the United States Patent and Trademark
Office ("PTO"). The Director is the head of the PTO and is responsible for superintendingor
performing all duties required by law with respect to the granting and issuing of patents. As
such. Director Lee is designated by statute as the official responsible for determining the period
of Patent Term Adjustments under 35 U.S.C. 154. 35 U.S.C. 154(b)(4)(A).
JURISDICTION AND VENUE
7. This Court has jurisdiction to hear this action and is authorized to issue the relief
sought under 28 U.S.C. 1331,1338(a), and 1361, 35 U.S.C. 154(b), and 5 U.S.C. 701706.
it is being filed within 180 days after the date of the Defendant's decision on Supemus' request
for reconsideration, September 30, 2015 (attached as Exhibit B).
BACKGROUND AND COMMON ALLEGATIONS
The *897 Patent
10. United States patent application number 11/412,100 ("the '100 application") was
filed on April 27, 2006, and issued as the '897 patent on June 10, 2014.
11. Plaintiff Supemus is the original applicant and assignee of the '897 patent, as
evidenced by records on deposit with the PTO and the face of the '897 patent.
12. Plaintiff UTC is the exclusive licensee of the '897 patent, holding an exclusive
license to develop, make, have made, use, offer for sale, sell, have sold and import products
Complaint
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covered by the '897 patent. For some of the period during prosecution, UTC took over the
right to prosecute the patent application and took actions as the applicant in that capacity.
Accordingly, for the sake of clarity and simplicity, "applicant" and "patentee" are used herein
to refer to Supemus and/or UTC as appropriate for the given timeframe.
13. On April 27, 2006, Supemus filed international application number
applicationentered the European regional phase and was accorded European application
number 07755989.6 ("the EP application").
14. On August 20, 2010, the PTO mailed a Final Rejection addressing the then-pending
claims of the '100 application.
15. On February 22, 2011, the applicant filed a Request for Continued Examination
("RCE") pursuant to 37 C.F.R. 1.114 along with an Information Disclosure Statement
("IDS"), amendment, and remarks responsive to the Final Rejection mailed on August 20,
2010.
16. On October 13,2011, the European Patent Office ("EPO") published its decision to
grant European patent number EP2010189 for the EP application.
17. On August 21, 2012, the EPO issued a Communication ("the EPO
18. The Sandoz Opposition cited the following documents, D1-D9, in support of its
Opposition:
Complaint
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D6: Verma et al., Critical Reviews in Therapeutic Drug Carrier Systems, 2004,
pages 477-520.
D7: Verma et al.. Drug Development and Industrial Pharmacy, 2000, pages 659708.
19. On September 11, 2012, the applicant received a letter from its Europeanpatent
attorney at Louis, Pohlau, and Lohrentz, informing Plaintiffs of the Sandoz Opposition filed
against the grant of EP2010189 ("the Foreign Attorney Letter").
20. On November 29, 2012, pursuant to 37 C.F.R. 1.97(b)(4), the applicant submitted
an IDS to the PTO before the mailing of a first Office action after an RCE, providing
documents D1 (and its English translation), D2, D4a, D4b, and D5-D8 cited in the Sandoz
Opposition,' the Sandoz Opposition, the EPO Communication dated August 21,2012, and the
Foreign Attorney Letter dated September 11,2012.
21. On September 10,2013, over nine months after submission of the references from
the Sandoz Opposition, the PTO issued the first Office action after the filing of the RCE.
22. On January 10, 2014, the applicant filed a response to the first Office action after
the filing of the RCE and, on February 4, 2014, the PTO issued a Notice of Allowance.
Complaint
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23. On April 30,2014, the applicant paid the issue fee for the '100 application and
26. On August 5, 2014, the patentee filed a Request for Reconsideration of Patent Term
Adjustment under 37 C.F.R. 1.705(d) to revise the PTAto 2,030 days. The patentee argued
that the PTA reduction of 646 days, that is, from the date the RCE was filed to the filing date of
the IDS triggered by the EPO Communication, as Applicant Delay under 37 C.F.R.
1.704(c)(8)was improper. The patentee also argued that the '897 patent was entitled to an
additional 126 days of PTA under 35 U.S.C. 154(b)(1)(B).
27. On July 2, 2015, the PTO mailed a Redetermination of Patent Term Adjustment, in
which the PTO found the patentee's arguments partially persuasive. The PTO awarded an
additional 126days of PTA as B Delay under 35 U.S.C. 154(b)(1)(B), yielding a total PTA of
1,386 days, but rejected the request to eliminate the 646 days of reduction as Applicant Delay
under 37 C.F.R. 1.704(c)(8) and in view of the Federal Circuit's decision in Gileadll.
28. On July 9, 2015, the patentee filed a second Request for Reconsideration of Patent
Term Adjustment under 37 C.F.R. 1.705(d) to request the PTO to revise the PTA of 1,386
days to 2,032 days. The patentee argued that the deduction of 646 days from the PTA as
Applicant Delay under 37 C.F.R. 1.704(c)(8) was improperand that the Applicant Delay was
zero days.
29. On September 30, 2015, the PTO issued a Decision on Patent Term Adjustment
(Attachment B), denying the patentee's requestwith respect to the PTA reduction of 646 days
as Applicant Delay and affirming the PTA of 1,386 days.
Complaint
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30. If Supemus had not filed the IDS submitted November 29,2012, the '897 patent
would have been entitled to the full 2,032 days of PTA now requested by Plaintiffs.
31. If Supemus had filed the IDS submitted November 29, 2012, after the Office action
issued on September 10, 2013, and either with or before Supemus' response to that Office
action, the '897 patent would have been entitled to the fiill 2,032 days of PTA now requested
by Plaintiffs.
Patent Term Guarantee
32. 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 concems that delays by the
PTO during the prosecution of patent applications could result in a shortening of the effective
life of the resulting patents to less than seventeen years. The amendments created patent term
33. Patent term adjustment applies to original utility patent applications (including
154(b)(1), any overlapping periods in the PTO delays under 35 U.S.C. 154(b)(2)(A), and
any applicant delays under 35 U.S.C. 154(b)(2)(C).
35. Under 35 U.S.C. 154(b)(1)(A), an applicant is entitled to PTA for the PTO's
failure to carry out certain acts during processingand examination within defined deadlines ("A
Delay").
attributable to the PTO'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 applicant under section 132(b)" ("B Delay").
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37. 35 U.S.C. 154(b)(2)(A) providies that "to the extent that 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."
the term of a patent under paragraph [154(b)(1)] shall be reduced by a period equal to the
period of time during which the applicant failed to engage in reasonable efforts to conclude
prosecution of the application" ("C Reduction").
39. 35 U.S.C. 154(b)(2)(C)(iii) states that "[t]he Director shall prescribe regulations
period for submission of an IDS triggered by a communication from a foreign patent office "if
it is accompanied by a statement that each item of information contained in the [IDS].:. was
not received .:. more than thirty days prior to the filing of the informationdisclosure
statement." This "thirty-day period ... is not extendable."
41. Under 35 U.S.C. 154(b)(4)(A), "[a]n applicant dissatisfied with the Director's
decision on the applicant's request for reconsideration under paragraph (3)(B)(ii) shall have
exclusive remedy by a civil action against the Director filed in the United States District Court
for the Eastern District of Virginia within 180 days after the date of the Director's decision on
the applicant's request for reconsideration. Chapter 7 of title 5 shall apply to such action."
The Proper Calculation of PTA for the *897 Patent
patent under [154(b)(1)] shall be reduced by a period equal to the period of time during which
the applicant failed to engage in reasonable efforts to conclude prosecutionof the application."
Complaint
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In the instant case, the applicant did not fail to engage in reasonable efforts to conclude
prosecution for any period of time. At most, the applicant could only be considered to have
failed to engaged in reasonable efforts to conclude prosecution for 49 days^the period of time
between the receipt of the EPO Communication on September 11, 2012, and the date that the
applicant filed the IDS triggered by the EPO Communication, November 29,2012, less the
thirty-day grace period to make such a filing without loss of PTA.
43. Under 35 U.S.C. 154(b)(2)(C)(i), at least the 546 days prior to the date of the EPO
Communication are attributable solely to the PTO's delay in prosecutingthe RCE, or A Delay
under 35 U.S.C. 154(b)(1)(A). Because no action or inaction by the applicant during this
period can be characterized as failure "to engage in reasonable efforts to conclude prosecution,"
the calculation of Applicant Delay cannot include at least these 546 days.
44. Applicant is further entitled to PTA to at least some portion beyond the 546 days
because the PTO's application to this case is arbitrary and capricious in view of and directly
contrary to 35 U.S.C. 154(b)(2)(C)(i).
45. In the instant case, the applicant only received a letter from its foreign patent
attorney on September 11,2012, regarding the August 21, 2012 EPO Communication. That
leaves only a mere 9 days left to meet the 30-day requirement for filing a statement under 37
C.F.R. 1.704(d) without a deduction of PTA assuming that the August 21,2012 EPO
Communications started the 30-day clock.
46. Under Rule 1.704(d), the thirty-day grace period is triggered by receipt of a
communication by any individual designated under Rule 1.56, i.e., any person who has a duty
of disclosure to the PTO. It is not always clear who has a duty of disclosure to the PTO or
when the start of the thirty-day grace period is triggered. See, e.g., AvidIdentification Sys., Inc.
V. Crystal Import Co., 603 F,3d 967, 973-77 (Fed. Cir. 2010). With respect to foreign
attorneys, whether they owe a duty of disclosure to the PTO depends upon the circumstances.
As the PTO explains, some foreign attorneys have a duty of disclosure to the PTO and trigger
the thirty-day period and some do not. MPEP 2732 As a result, sometimes the thirty-day
Complaint
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grace period starts when the foreign attorney receives the communication, and sometimes it
starts when the applicant is forwarded the communication by the foreign attorney. The prudent
approach, therefore, is to assume receipt by the foreign attorney triggers the thirty-day grace
period.
application of a mere 30-day grace period under 37 C.F.R. 1.704(d) that cannot be extended
is arbitrary and capricious in view of the potential consequences of missingthe grace period
(/.e., loss of PTA in excess of the time that an applicant may not have engaged in reasonable
efforts to conclude prosecution).
48. Under the PTO's current interpretation of the statutes and rules, submission of an
IDS just one day outside the 30-day grace period would lead to the forfeiture of any amount of
PTA accumulated for PTO delay up to that point, be it one day or several months (or years).
49. Here, the PTO's reduction of PTA by 646 days as Applicant Delay is arbitrary and
capricious in view of the clear and unambiguous language under 35 U.S.C. 154(b)(2)(C)(i),
which only permitsthe reduction "by a period equal to the period of time during whichthe
applicant failed to engage in reasonable efforts to conclude prosecutionof the application."
50. The correct PTA for the '897 patent is 2,032 days, consisting of the current PTA of
1,386 days plus the additional 646 days of A Delay, which was improperly deducted by
Defendant because applicant did not fail to engage in reasonable efforts to conclude
prosecution of the application, the only statutory basis for reducing PTA.
Defendant's Abrogation of the Patent Term Guarantee
51. Defendant has improperly calculated the PTA for the '897 patent in a manner that
deprives Plaintiffs of the full amount of A Delay, because Defendant reduced Plaintiffs'
Complaint
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accrued PTA by an amount that exceeded the general limitation on PTA reduction as set forth
at35U.S.C. 154(b)(2)(C)(i).
52. Defendant has inappropriately relied upon 37 C.F.R. 1.704(c)(8) to support its
flawed calculation of PTA. This subsection is silent with respect to an IDS filed after an RCE
and before the first Office action following an RCE, and Defendant's improper application of
this subsection led to a patent term reduction that is plainly contrary to the clear and
unambiguous language of 35 U.S.C. 154(b)(2)(C)(i).
53. Defendant has also improperly applied the Gilead//decision in a manner
inconsistent with 35 U.S.C. 154(b)(2)(C)(i). Gilead //concerned the submission of an IDS
U.S.C. 154(b)(2)(C)(i). As applied, 37 C.F.R. 1.704(d) does not reflect the reality of
modem day patent prosecution and potential delays caused by communication from foreign
patent offices, and does not comply with the plain language of 35 U.S.C. 154(b)(2)(C)(i).
55. To the extent that Defendant's application of 37 C.F.R. 1.704(c)(8), 37 C.F.R.
1.704(d), and Gilead //conflicts with the clear and unambiguous language of 35 U.S.C.
154(b)(2)(C)(i) and judicial interpretation of 37 C.F.R. 1.704(c)(8), 37 C.F.R. 1.704(d), and
Gilead II, Plaintiffs seek correction of PTA to reflect 2,032 days of PTA.
CLAIMS FOR RELIEF
COUNT ONE
56. The allegations of paragraphs 1-55 are incorporated in this claim for relief as if fully
and expressly set forth herein.
Complaint
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57. The PTO did not comply with 35 U.S.C. 154(b)(2)(C)(i) in determining the
reduction of Plaintiffs' patentterm adjustment, and thus unfairly deprived Plaintiffs of the full
amount of A Delay Plaintiffs are entitled to pursuant to 35 U.S.C. 154(b)(1)(A).
58. Plaintiffs made reasonable efforts to conclude prosecutionby filing an IDS with the
RCE, which was followed by a period of at least 546 days, during which the Plaintiffs were
diligent and exercised reasonable efforts to conclude prosecution.
59. Upon receiptof the EPO Communication on September 11, 2012, applicant acted
reasonably and diligently to file an IDS on November 29, 2012, which was timely filed more
than nine-months before the mailing of the first Office action following the RCE.
60. The PTO inappropriately applied 37 C.F.R. 1.704(c)(8), 37 C.F.R. 1.704(d), and
Gilead//when calculating the PTA for the '897 patent, resulting in an incorrect calculation of
PTA that deprived Plaintiffs of the full and appropriate term of the '897 patent, and in a manner
contrary to 35 U.S.C. 154(b)(2)(C)(i).
61. Reduction of the PTA by 646 days as Applicant Delay is inconsistent with 35
U.S.C. 154(b)(2)(C)(i).
62. The PTO's reduction of PTA by 646 days as Applicant Delay is also arbitrary and
capricious in view of the clear and unambiguous language under 35 U.S.C. 154(b)(2)(C)(i)
63. Plaintiffs are entitled to an additional 646 days of patent term for the '897 patent
such that the 1,386days of PTA granted by the PTO should be changed to 2,032 days.
COUNT TWO
(Declaratory Judgment Under The Administrative Procedures Act, 5 U.S.C. 702 etseq,)
64. The allegations of paragraphs 1-63 are incorporated in this claim for relief as if fully
and expressly set forth herein.
65. The PTO's application of 37 C.F.R. 1.704(c)(8), 37 C.F.R. 1.704(d), and Gilead
II to the facts of this case is arbitrary, capricious, an abuse of discretion, or otherwise not in
accordance with law within the meaning of 5 U.S.C. 706(2)(A) because it produces the unfair
Complaint
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and irrational result of depriving an applicant the entire A Delay accrued, including all the PTA
accrued prior to receiving a foreign patent office communication and during which the
applicant was diligent, regardless of whether an applicant acted reasonably or missed the 30-
day period for making a statement under 37 C.F.R. 1.704(d) by one day or significantly more
than one day. This undermines the intent of 35 U.S.C. 154(b)(2)(C)(i) to limit a reduction of
period of adjustment "to the period of time during which the applicant failed to engage in
reasonable efforts to conclude prosecution of the application."
66. Erroneous application of 37 C.F.R. 1.704(c)(8), 37 C.F.R. 1.704(d), and Gilead
//by the PTO resulted in an incorrect calculation of PTA that deprived Plaintiff of the full and
appropriate term of the '897 patent. The PTO's reduction of PTA by 646 days as Applicant
Delay is arbitrary and capricious, and unlawful pursuant to 5 U.S.C. 706(2)(A).
67. Plaintiffs have adequately exhausted all of the available administrative remedies
under 35 U.S.C. 154(b)(3)(A)-(B) or, in the alternative, pursuit of any further administrative
remedies is futile.
68. Defendant's determination of PTA for the '897 patent on September 20, 2015, under
35 U.S.C. 154(b)(3)(B)(ii), is the final agency action and is reviewable by a district court in
accordance with 35 U.S.C. 154(b)(4)(A) and 5 U.S.C. 704. Plaintiffs have been afforded
no adequate remedy at law for Defendant's determination of PTA for the '897 patent.
69. The PTO's action caused Plaintiffs to suffer legal wrong and adversely affected the
rights of Plaintiffs under the '897 patent. Plaintiffs will suffer irreparable injury if Defendant is
not directed to recalculate PTA for the '897 patent.
70. An order directing Defendant to recalculate PTA for the '897 would not
substantially injure any other interested parties, and the public interest will be furthered by
correcting a procedural action that is contrary to law.
71. Plaintiffs are entitled to additional patent term for the '897 patent such that the
1,386 days of PTA granted by the PTO should be changed to 2,032 days.
Complaint
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COUNT THREE
73. The Fifth Amendment of the Constitution of the United States provides in relevant
part, "nor shall private property be taken for public use, without just compensation."
74. Plaintiffs enjoy a substantial and cognizable private property right in the full and
complete term of the '897 patent.
75. Plaintiffs have not failed to pay any necessary maintenance fees to the PTO required
the '897 patent permanently deprived Plaintiffs of the patent term to which they are entitled
under 35 U.S.C. 154(b).
77. Defendant's purposeful and deliberate diminution of the patent term of the '897
patent constitutes a taking of Plaintiffs' property without just compensation, in violation of the
Fifth Amendment of the Constitution of the United States.
78. Plaintiffs are entitled to additional patent term for the '897 patent such that the
1,386 days of PTA granted by the PTO should be changed to 2,032 days.
A.
Issue an Order changing the period of PTA for the '897 patent from 1,386 days
to 2,032 days, or any period thereof, including at least 1,932 days, deemed in accordance with
35 U.S.C. 154(b)(2)(C) and requiring Defendant to alter the term of the '897 patent to reflect
such additional PTA;
B.
Complaint
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C.
Grant such other and further relief as the nature of the case may admit or require
By:
Washington, DC 20007
Telephone: 202-973-8812
Facsimile: 202-973-8899
vascarrunz@wsgr.com
Douglas Carsten
(application under Local Rule 83.1(D) to be filed)
Wilson Sonsini Goodrich & Rosati, P.C.
12235 El Camino Real
Suite 200
dcarsten@wsgr.com
Attorneysfor Plaintiffs United Therapeutics
Corporation and Supernus Pharmaceuticals, Inc.
Shaun R. Snader (VA Bar 68,670)
United Therapeutics Corporation
1735 Connecticut Avenue, N.W.
Second Floor
Washington, DC 20009
Telephone: 202-483-7000
Facsimile: 202-518-8477
ssnader@unither.com
Attorneyfor United Therapeutics Corporation
Complaint
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Please find enclosed, for filing, the following documents from Plaintiffs Supernus, Inc.
and United Therapeutics Corporation:
1. Complaint for Patent Term Adjustment
2. Civil Cover Sheet (original and one copy)
3. Summons (original plus two copies)
4.
General Counsel of the U.S. PTO registered agent through personal service. Please do not
hesitate to contact me at the number above if you have any questions regarding this matter.
Sincerely,
Veronica Ascarrunz
Enclosures
AUSTIN
NEW YORK
PALO ALTO
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SAN FRANCISCO
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SHANGHAI
WASHINGTON, D.C.
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