Supernus and United vs. U.S. Patent and Trademark Office

8/18/2019 Supernus and United vs. U.S. Patent and Trademark Office

1/18

FILED

IN T H E UNITED

STATES D I ST R IC T C O U R T

FORTHEEASTERN DISTRICT OFVIRGjJfJ j ^f| 28 P 50

L E X N D R I D I V I S I O N

SUPERNUS PHARMACEUTICALS INC.

1550 E as t Gude Drive

Rockville MD

20850

UNITED THERAPEUTICS CORPORATION

1040 Spring Street

Silver Spring, Maryland 20910

Plaintiffs,

V

HON.

MICHELLE

K.

LEE

Under Secretary ofCommerce for Intellectual

Property and Director of the United States

Pa ten t and Trademark Office

401 Dulany Street

Alexandria,

VA 22314

Office

o f

the

General

Counsel

Un it ed S ta te s Paten t and Trademark Off ice

Madison Building East, Room 10B20

600 Dulany Street, Alexandria, VA 22314

Defendant.

CLERK

US

DISTRICT COURT

LEX NDRI VIRGINI

Civil

Action No.

l^6\/

C O M P L I N T

Plaintiffs Supemus Pharmaceuticals, Inc. Supemus ) and United Therapeutics

Corporation UTC ) together, Plaintiffs ), for their complaintagainst theHonorable

MichelleK. Lee, Under Secretaryof Commercefor IntellectualProperty and Director

of

the

United States Patent and Trademark Office, hereinafter Lee or Defendant ), state as

follows:

C o m p l a i n t

1

Case 1:16-cv-00342-GBL-IDD Document 1 Filed 03/28/16 Page 1 of 15 PageID# 1


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N TURE O F T HE TION

1. This is an action by Supemus, the owner and assignee ofUnited 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 P RTIES

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

ofCommerce 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

performingall duties requiredby lawwith respect to the grantingand issuing

of

patents. As

such.DirectorLee is designatedby statute as the officialresponsible for determining theperiod

of PatentTermAdjustments under35

U S C

§ 154. 35U.S.C. § 154(b)(4)(A).

JURIS I TION AND VENUE

7. This Court has jurisdiction to hear this action and is authorized to issue the relief

soughtunder 28U.S.C.§§ 1331,1338(a), and 1361,35U.S.C. § 154(b), and 5 U.S.C. §§701-

706.

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 accordancewith 35U.S.C. § 154(b)(4)(A)because

it is being filed within 180daysafter the dateof the Defendant s decisionon Supemus request

for reconsideration, September30, 2015 (attachedas Exhibit B).

BACKGROUND AND COMMON ALLEGATIONS

The 897 Paten t

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. PlaintiffSupemus 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. PlaintiffUTC is the exclusive licensee

of

the 897 patent, holding an exclusive

license to develop, make, havemade, 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 EuropeanregionalphaseandwasaccordedEuropeanapplication

number 07755989.6 ( the EP application ).

14.OnAugust20, 2010, the PTOmailed a Final Rejection addressingthe 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 remarksresponsive to the FinalRejectionmailedonAugust20,

2010

16.On October 13,2011, the EuropeanPatent 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 NoticeofOpposition ( the ndoz Opposition ) reg rding an opposition

filed by SandozAGonAugust8, 2012, against the grantof European patentnumber

EP2010189

18.The Sandoz Oppositioncited the followingdocuments,D1-D9, in supportof 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.

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D3: M. Gomberg-Maitland and H. Olschewski, Prostacyclin therapies for the

treatment ofpulmonary 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 659-

708

D8: Verma et al.. Journal

of

Controlled Release, 2002, pages 7-27.

D9: US 2005/0053653 A1, publication date March 10, 2005.

19. On September11, 2012, the applicantreceiveda letter from its Europeanpatent

attorney at Louis, Pohlau, and Lohrentz, informingPlaintiffs of the SandozOpposition filed

against the grant

of

EP2010189 the Foreign Attorney Letter ).

20. OnNovember29, 2012, pursuantto 37C.F.R. § 1.97 b) 4), the applicant submitted

an IDS to the PTO beforethemailing

of

a first Officeactionafter 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 SandozOpposition, 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 ofAllowance.

Applicant previously disclosed References D3 and D9 to the USPTO.

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

satisfiedall outstandingrequirementsfor issuanceofa patent.

24. OnJune 10, 2014, the PTO published the 897 patent, reflectinga patent term

adjustment ( PTA )

of

1,260dayson the face

of

the patent.

25. Section 154(b)(2)(C) permits the PTO to reducePTA only by a period equal to the

period of time duringwhich the applicant failed to engage in reasonableefforts to conclude

prosecution of the application.

26. OnAugust 5, 2014, the patentee filed a Request for Reconsideration ofPatent Term

Adjustment under37 C.F.R. § 1.705 d to revise the PTAto 2,030 days. The patentee argued

that the PTAreduction of 646 days, that is, from the datetheRCEwas filed to the filing dateof

the

IDS

triggered by theEPOCommunication, as Applicant Delay under37C.F.R. §

1.704(c)(8)was improper. The patentee also argued that the 897 patentwas entitled to an

additional 126days

of

PTAunder35U.S.C. § 154(b)(1)(B).

27. OnJuly 2, 2015, the PTOmaileda Redetermination of PatentTermAdjustment, in

which the PTO found the patentee s arguments partiallypersuasive. The PTOawardedan

additional 126daysof PTAas B Delayunder35U.S.C. § 154(b)(1)(B), yielding a totalPTAof

1,386days, but rejectedthe request to eliminate the 646 days

of

reductionas ApplicantDelay

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 secondRequest 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 2,032days. The patenteearguedthat the deduction of 646 days fromthe PTAas

ApplicantDelayunder37 C.F.R.§ 1.704(c)(8) was improperand that theApplicantDelaywas

zero days.

29. On September30, 2015, the PTO issueda Decisionon PatentTermAdjustment

(Attachment B),denying thepatentee s requestwith respect to thePTAreduction of 646days

as Applicant Delay and affirming the PTA of 1,386 days.

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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 patentwould have beenentitled to the fiill 2,032 days

of

PTA nowrequested

by Plaintiffs.

P a te n t T e rm u a ra nt ee

32. The Patent Term Guarantee Act

of

1999, a part

of

the American Inventors

ProtectionAct ( AIPA ), amended 35 U.S.C. § 154(b)to address concems that delays by the

PTO during the prosecution ofpatent 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 afterMay 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 35U.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 carryout certain acts duringprocessingandexamination withindefineddeadlines ( 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 theUnitedStates, butnot including any time consumedbyContinued

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 ofdelay

attributable to grounds specified in paragraph [154(b)(1)] overlap, the periodof anyadjustment

granted under this subsection shall not exceed the actual number ofdays the issuance

of

the

patent was delayed.

38. Reductionof period of adjustment is subject to limitations under 35U.S.C. §

154(b)(2), including35U.S.C. § 154(b)(2)(C)(i), which states [t]he period ofadjustmentof

the termof a patentunderparagraph [154(b)(1)] shall be reduced by a periodequalto 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 prescriberegulations

establishing the circumstances that constitutea failureof an applicantto engagein reasonable

efforts to concludeprocessingor examination of an application.

40. For instance, the PTO promulgated37 C.F.R § 1.704(d)to provide a 30-daygrace

period for submission of an IDS triggeredby a communication froma foreignpatent office

if

it is accompanied by a statement that each itemof information contained in the [IDS].:. was

not received

more than thirtydays prior to the filingof 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 reconsiderationunder 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 ofVirginia within 180days after the date

of

the Director s decision on

the applicant s request for reconsideration. Chapter 7 of title 5 shall apply to suchaction.

The

Proper Calculat ion o f PTA

f or t he

897

Paten t

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 duringwhich

the applicantfailed to engage in reasonable efforts to concludeprosecutionof the application.

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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

failedto engaged in reasonable efforts to concludeprosecution for49 days—^the periodof 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 attributablesolely to the PTO s delay in prosecutingthe RCE,orA Delay

under 35U.S.C. § 154(b)(1)(A). Becausenoactionor inactionby the applicantduringthis

periodcanbe characterized as failure to engagein reasonable efforts to concludeprosecution,

the calculationofApplicantDelay 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 ofPTA 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

ofdisclosure 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 graceperiod is triggered. See e g AvidIdentification Sys Inc.

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 communicationby the foreign attorney. The prudent

approach, therefore, is to assumereceipt by the foreign attorney triggers the thirty-daygrace

period.

47. Givenpracticalrealities, includingmailingdelaysanddelaysassociatedwith

receivingnotifications from a foreign attorneyor agent,whooftenmust translatethe foreign

patent office communication to English in informing an applicant in the United States,

application

of

a mere 30-daygrace period under 37 C.F.R. § 1.704(d) that cannotbe extended

is arbitrary andcapricious in viewof thepotential consequences of missingthegraceperiod

(/.e., loss of PTA in excessof the time that an applicantmay not have engaged in reasonable

efforts to conclude prosecution).

48. Under the

PTO s

current interpretation of the statutes and rules, submission of an

IDSjust one day outside the 30-daygrace periodwould lead to the forfeitureofany 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 ApplicantDelay is arbitrary and

capricious in view of the clear and unambiguous language under35U.S.C.§ 154(b)(2)(C)(i),

whichonlypermitsthe reduction by a periodequalto the periodof timeduringwhichthe

applicantfailed to engagein reasonable efforts to conclude prosecutionof the application.

50. The correct PTA for the 897 patent is 2,032 days, consisting

of

the currentPTA

of

1,386daysplus the additional 646 daysof A Delay,whichwas improperly deductedby

Defendant because applicant did not fail to engage in reasonable efforts to conclude

prosecution

of

the application, the only statutory basis for reducing PTA.

D e f e n d a n t s A b r o g a ti o n of t h e atent

Term

uarantee

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

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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

th e R CE .

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.

L IMS

FOR RELI EF

OUNT ONE

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

56. The allegations ofparagraphs 1-55 are incorporated in this claim for reliefas if fully

and expressly set forth herein.

Complaint 11



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13/18

and irrational result of depriving an applicant the entire A Delay accrued, includingall the PTA

accrued prior to receiving a foreign patent office communication and duringwhich the

applicantwas diligent, regardlessofwhether an applicant acted reasonablyor missed the 30-

day period for makinga statementunder 37C.F.R. § 1.704(d) by one day or significantly more

than one day. This undermines the intent of35 U.S.C. § 154(b)(2)(C)(i) to limit a reduction of

period of adjustment to the periodof time duringwhich 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 Plaintiffof 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 ofPTA 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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OUNT

THR

(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 reliefas 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 Consti tution

of

the Uni ted

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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16/18

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I. (a)

PLAINTIFFS

Supernus Pharmaceuticals, Inc. and United Therapeutics

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v n REQUESTED IN

•

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IF

THIS

ISA

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COMPLAINT;

UNDERRULE 23, F.R.CV.P.

Vm. RELATED CASE(S)

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DOCKET NUMBER

MAG. JUDGE

Case 1:16-cv-00342-GBL-IDD Document 1-1 Filed 03/28/16 Page 1 of 1 PageID# 16


17/18

Wilson Sonsini Goodrich Rosati

P RO F E S S I O NA L COR PORAT ION

1700 K Street, NW, Fifth Floor

Washington

D.C 20006-3817

PHONE

202.973.8800

FAX

202.973.8899

t, www.wsgr.com

BY

HAND

Fernando Galindo Clerk

United

States

District

Cour t

f or t he

Eastern District ofVirginia

Albert V. Bryan U.S. Courthouse

401 Courthouse Square

Alexandria VA

22314

March 28 2016

1

CP

cP

Re:

Supe rnu s

Pharmaceut icals^

In c e t

a l. v .

Hon«

Michel le K .

L ee e t

al.

Dear S ir 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 fo r

400.00

5.

Financial

Interest

Disclosure Statement Local Rule

7.1

The

documents

wil l be

served

on De fendan t Hon.

Michelle K.

Lee

and Of fi ce

o f th e

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 S HANGHA I WASHI NG TON D .C .

2;

Case 1:16-cv-00342-GBL-IDD Document 1-2 Filed 03/28/16 Page 1 of 1 PageID# 17


18/18

Court

Nafles

Mted

States

Bistrict

Court

ivisions

1

Receipt

Huaber^

14683858083

Cashier

IDs

rbi^aden

Transactibil Dates 03/28/2016

Payer aiseV lLSON

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

Tendered5 400.6

Change

Aats

0 00

FILING FEE •

116Cy34e

L-IDD Document 1-3 Filed 03/28/16

Supernus and United vs. U.S. Patent and Trademark Office

Documents

Transcript of Supernus and United vs. U.S. Patent and Trademark Office