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FILED
IN THE UNITED STATES DISTRICT COURT

FORTHE EASTERN DISTRICT OF VIRGjJfJ4j/^f| 28 P

50

ALEXANDRIA DIVISION

CLERK US DISTRICT COURT
ALEXANDRIA, VIRGINIA

SUPERNUS PHARMACEUTICALS, INC.
1550 East Gude Drive

Rockville, MD 20850

Civil Action No.

l^6\/

UNITED THERAPEUTICS CORPORATION

1040 Spring Street
Silver Spring, Maryland 20910
Plaintiffs,
V.

HON. MICHELLE K. LEE

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

401 Dulany Street
Alexandria, VA 22314
Office of the General Counsel
United States Patent and Trademark Office

Madison Building East, Room 10B20
600 Dulany Street, Alexandria, VA 22314
Defendant.

COMPLAINT

Plaintiffs Supemus Pharmaceuticals, Inc. ("Supemus") and United Therapeutics

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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NATURE OF THE ACTION

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

4. Supemus is a Delaware corporation with a place of business at 1550 East Gude

Drive, Rockville, MD 20850. Supemus is a specialty pharmaceutical company focused on
developing and commercializing products for the treatment of central nervous system (CNS)
disorders.

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

Book lists the '897 patent for Orenitram®.
6. Defendant Michelle K. Lee is named in her official capacity as the Under Secretary

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.

8. Venue is proper in this district under at least 35 U.S.C. § 154(b)(4)(A).

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

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

PCT/US2007/009969, which claims priority to the '100 application. This international

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

Communication") of a Notice of Opposition ("the Sandoz Opposition") regarding an opposition
filed by SandozAG on August 8, 2012, against the grant of European patent number
EP2010189.

18. The Sandoz Opposition cited the following documents, D1-D9, in support of its
Opposition:

Dl: Rudolf Voigt, Lehrbuch der Pharmazeutischen Technologic, 6th edition,
VCH, 1987, pages 613-615.

D2: US 2005/0165111 A1, publication date July 28, 2005.

Complaint

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D3: M. Gomberg-Maitland and H. Olschewski, Prostacyclin therapies for the
treatment of pulmonary arterial hypertension, European Respiratory Journal,
2008, pages 891-901.

D4a: Product Information Treprostinil.
D4b: Product Information Treprostinil (diethanolamine salt).

D5: WO 2005/007081 A2, publication date January 27, 2005.

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.

D8: Verma et al.. Journal of Controlled Release, 2002, pages 7-27.
D9: US 2005/0053653 A1, publication date March 10, 2005.

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.

Applicant previously disclosed References D3 and D9 to the USPTO.

Complaint

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23. On April 30,2014, the applicant paid the issue fee for the '100 application and

satisfied all outstanding requirements for issuance of a patent.
24. On June 10, 2014, the PTO published the '897 patent, reflecting a patent term
adjustment ("PTA") of 1,260 days on the face of the patent.
25. Section 154(b)(2)(C) permits the PTO to reduce PTA only "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."

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

adjustment, commonly referred to as PTA, a means of adjusting patent term to accoimtfor
delays at the PTO.

33. Patent term adjustment applies to original utility patent applications (including

continuations, divisional, and continuations-in-part) filed on or after May 29,2000.
34. In calculating PTA, Defendant must take into account PTO delays under 35 U.S.C.

§ 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").

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

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").

Complaint

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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."

38. Reduction of period of adjustment is subject to limitations under 35 U.S.C. §
154(b)(2), including 35 U.S.C. § 154(b)(2)(C)(i), which states "[t]he period of adjustment of

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

establishing the circumstances that constitute a failure of an applicant to engage in reasonable
efforts to conclude processing or examination of an application."
40. For instance, the PTO promulgated 37 C.F.R § 1.704(d) to provide a 30-day grace

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

42. Under 35 U.S.C. § 154(b)(2)(C)(i), "[t]he period of adjustment of the term of a

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

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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.

47. Given practical realities, includingmailing delays and delays associatedwith
receiving notifications from a foreign attorney or agent, who often must translate the foreign
patent office communication to English in informing an applicant in the United States,

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

after filing a response to an election or restriction requirement, which is distinguishable from an
IDS triggered by a "communication that was issued by a patent office in a counterpart foreign
or international application" and filed after an RCE but before the first Office action following
the RCE.

54. Defendant improperly applied 37 C.F.R. § 1.704(d) in a manner contrary to 35

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

(Patent Term Adjustment Under 35 U.S.C. § 154)

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

(Violation of the Fifth Amendment of the Constitution of the United States)
72. The allegations of paragraphs 1-71 are incorporated in this claim for relief as if fully
set forth herein.

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

to maintain their rights in the '897 patent.
76. Defendant's promulgation of 37 C.F.R. § 1.704(d) and MPEP § 2732 (9th ed. Rev.
7, Nov. 2015), and reliance upon 37 C.F.R. § 1.704(c)(8) in improperly calculating the PTA for

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.

WHEREFORE, Plaintiffs respectfully pray that this Court:

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.

Declare pursuant to 35 U.S.C. § 154(b)(2)(C) that 37 C.F.R. § 1.704(d), as

applied, is invalid and contrary to law; and

Complaint

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C.

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

and as may be just and equitable.
Dated: March 28,2016

By:

Veronica Susana Ascarrunz (VA Bar 67,913)
Wilson Sonsini Goodrich & Rosati, P.C.
1TOOK Street, NW

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

San Diego, CA 92130
Telephone: 858-350-2305
Facsimile: 858-350-2399

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

-15-

Case 1:16-cv-00342-GBL-IDD Document 1-1 Filed 03/28/16 Page 1 of 1 PageID# 16
JS44 CRev. 11/15)

CIVIL COVER SHEET

TheJS44civil cover sheet and theinformation contained herein neither rrolace
)lace norsupplement die filingandserviceof pleading or otherp{^>ers as rrauiied by law, exceptas

provided

local rules of court This form, ^}piovedby the JudicialConferenceof
the United
I is in
ierence ofthe
United States
i September 1974, is required for tiie use of the Cleik of Court for the

purpose ofinitiating the civU docket sheet (SEEDiSTRUCnONS
ONNEXTPAGE OF THISFORM..
^INSTRUCTIONS ONNEXTPAGEOF
THIS FORM.)

I. (a) PLAINTIFFS

DEFENDANTS

Supernus Pharmaceuticals, Inc. and United Therapeutics
Corporation
(b) County of Residence of FirstListed Plaintiff

Montgomery County

County ofResidence ofFirst Listed Defendant

(EXCEPT IN US. PLAINTIFF CASE^

Alexandria

(2W US. PLAINTIFF CASESONLY)
NOTE:

IN LAND CONDEMNATION CASES, USE THE LOCATION OF
THE TRACT OF LAND INVOLVED.

(c) Attorneys (Firm Name, Address, andTelephone Nw>^>er)

Attorneys QfKnown)

Veronica Susana Ascarrunz

Wilson Sonsini Goodrich & Rosati, P.C.,1700 K Street, NW
Washington, DC 20007, Telephone: 202-973-8812

IL BASIS OF JURISDICTION (Placean "X"inOneBoxOnly)

in. CITIZENSHIP OF PRINCIPAL PARTIES (Place an"X" inOne BoxforPlaint^
(For Diversity Cases Onfy)

O I

U.S. Goveminent

3

Fedoal Question
(US. Government Not a Party)

PlainttfT

Citizenof This State

and OneBoxforD^endant)

PTF

DEF

1

PTF

1 locoipoiatedor FiincipalPlace

DEF

0

4

OA

0

5

0

5

a

6

0

6

ofBusiness In This State

^^2

• 4

U.S. Govenunent
Defendant

Divosity

Citizen ofAnother State

2

a

2

(Indicate Citizensh^ ofParties in ItemID)

Inc(npoiated ofm/PrincipalPlace
of Busmess In Another State

Citizen or Subject of a

O 3

O

3

Foreign Nation

Fordgg Country

1V» NATURE OF SUIT (Place an "X'in One Box Onfy)
CONTRACT



a

torts

llOInsuiancc
120 Marine
ISOMiUerAct

• 310 Airplane
• 315 AirplaneProduct
Liability

• 140 NegotiableInstnnnent
• ISORecoveiy of Overpayment • 320 Assault, Libel &
& Enforcementof Judgment
Slander
• 151 Medicare Act
• 330 FederalEoqiloyers'
• 152Recoveryof Defaulted
Liability
Student Loans

(ExcludesVeterans)
• 153Recovoy of Overpayment

ofVeteran's Benefits
160 Stockholders'Suits
190 Other Contract


• 365 PersonalInjuiy Product Liability

368 Asbestos Personal

Injuiy
• 362 Peisoial Injuiy-

360 Other Personal

370 Other Fraud

Act

380 Other Peisonal

• 230 RentLease& Ejectment

240 Torts to Land

• 245 Tort Product Liability
• 290 All OtherReal Property

440 Other Civil Rights
441 Voting
442 Enq>loyment
443 Housing/

Accommodations
445 Amer. w/EHsabilities'

PRISONER PETmONS

Habeas Corpus:

463 Alien Detainee

510 Motions to Vacate
Sentence

446 Amer. w/Disabilities'
Other
a 448 Education

540 Mandamus & Other

• 550 CivURights

>kOPkRT^Rl6tog• 820 Copyrights

410Antitnist

430 Banks and Banking


450 Commerce

460 Deportation

470 Racketeer Influenced and


a

480 Consumer Credit
490 Cable/Sat TV
850 Securities/Commodities/


Exchange
890 Other StatutoiyActions
891 AgriculturalActs


893 Environmental Matters
895 Freedom of Information

896 Arbitration

899 Administrative Procedure

830 Patent
840Tiademaric

a 861HLV(1395fiO
• 862 Black Lung (923)

• 740 RailwayLabor Act
• 751 Family and Medical

• 863 DIWODIWW (405(g))
864 SSID Title XVI

a 865 RSI (405(g))

Leave Act

• 790 Other Labor Litigatio)
• 791 Enqployee Retirement
Income Security Act

Act

FEDERAL TAX SUITS

• 870 Taxes (U.S. Plaintiff
or Defendant)

• 871 IRS—TTiiid Party
26 use 7609

Act/Review or Appeal of
AgencyDecision
a 950 Constitutionalityof
State Statutes

IMMIGRATION

Other:

376QuiTam(31USC
3729(a))
400 State Ro^itionment

423 Withdrawal
28 use 157

530 General

• 535 Death Penalty

Employment

Relations

Property Damage
• 385 Property Damage
Product Liability

aVlL RIGHTS




a

Comq>tOrganizations

710 Fair Labor Standards

• 720Laboi/Managemettt

Medical \falpiactioc
REALPROPERTY

375 False Claims Act

MBQR

• 371 Tiuth in Lending

6900tfaer

Injury Product
Liabili^

OTHER STATUTES

BANKRUPTCY

a 422 Appeal28 use 158

PERSONAL PROPERTY •

Product LiabiliQr

210 Land Condemnation
220F(n«closure

a

Personal Injuiy
Product Uabili^

Liability

• 195ContractProductLiability


a

• 625 Drug Related Seizure
ofPioperty21USC 881

367 Health Care/
Pharmaceutical

340 Marine
345 Marine Product

• 350 Motor Vehicle
a 355 Motor Vehicle

196 Franchise

FORFEITUREffENALTY

PERSONAL INJURY

PERSONAL INJURY

• 462 NaturalizationApplication
• 465 Other Immigration
Actions

555 Prison Condition
560Civil DetaineeCtmditions of
Confinement

V. ORIGIN (Place an "X" inOne Box Onfy)

^ 1 Original

Proceeding

• 2 Removed fiom
State Court

• 3 Remanded from

• 4 Reinstated or • S Transferred from

Appellate Court

Reopened

Another District

• 6 Multidistrict
Litigation

Iare filing (Zto notcUeJurisdiction^statutesunlessdiversify)'.
VI. CAUSE OF ACTION

Brief descriotioa of cauae;
Patent Term Adjustment

vn. REQUESTED IN

COMPLAINT;

CHECK IF THIS ISA CLASS ACTION

CHECKYES only if demandedin complaint:

DEMANDS

UNDER RULE 23, F.R.CV.P.

Vm. RELATED CASE(S)

jpi

JURY DEMAND:

(See instructions);
JUDGE

DOCKET NUMBER

SIGNATURE orATTORNEY OF MCORD

DATE

3/bif/A

FOROFFIC
eEUtebNLY
RECEIPT#

AMOUNT

APPLYING IFP

JUDGE

MAG. JUDGE

Yes

• No

Case 1:16-cv-00342-GBL-IDD Document 1-2 Filed 03/28/16 Page 1 of 1 PageID# 17
1700 K Street, NW, Fifth Floor

Washington, D.C 20006-3817

Wilson Sonsini Goodrich & Rosati

PHONE 202.973.8800
FAX 202.973.8899

PROFESSIONAL CORPORATION

t, www.wsgr.com

March 28, 2016

"2;

1%
BY HAND

CP

-0

Fernando Galindo, Clerk
United States District Court for the

cP

Eastern District of Virginia
Albert V. Bryan U.S. Courthouse
401 Courthouse Square
Alexandria, VA 22314
Re:

Supernus Pharmaceuticals^ Inc et al. v. Hon« Michelle K. Lee et al.

Dear Sir or Madam:

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.

Check for $400.00

5. Financial Interest Disclosure Statement, Local Rule 7.1
The documents will be served on Defendant Hon. Michelle K. Lee and Office of the

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

SAN DIEGO

SAN FRANCISCO

SEATTLE

SHANGHAI

WASHINGTON, D.C.

GBL-IDD Document 1-3 Filed 03/28/16 P

Court Nafles Mted States Bistrict Court
Divisions 1

Receipt Huaber^ 14683858083
Cashier IDs rbi^aden
Transactibil Dates 03/28/2016

Payer HaiseVBlLSON

CIVIL FIUHG FEE
For; MILSOH SOHSINI

fiidunts

$460.00 '

CHECK

Reaitters MILSON SOHSlMl
Check/Boney Order Hubs 50188
fist Tendereds

$400.00

. Total Dues
$480.S
Total Tendered 5 $400.6

Change Aats
FILING FEE
116Cy34e

...

K"::

$0.00

, : .