supernus and united vs. u.s. patent and trademark office
TRANSCRIPT
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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
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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.
Compla in t 4
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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.
Complaint
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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.
Complaint 6
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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 ).
C o m p l a i n t
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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
Compla in t
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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.
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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.
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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
-14-
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JS44
CRev.
11/15)
CIVIL
C O V E R
S H E E T
TheJS44civil cover sheet
and
theinformation contained herein neither
rrolace
nor
supplement
provided localrulesof court Thisform,^}piovedby theJudicialConferenceoftheUnited I
purpose ofinitiatingthe civU docket
sheet
(SEEDiSTRUCnONSONNEXTPAGEOF THISFORM..
)lacenorsupplement die
ierence
o f th e
United
States
i
^INSTRUCTIONSONNEXTPAGEOFTHISFORM.)
filingandserviceofpleading orother
p{^>ers
as rrauiiedby law, exceptas
isin September1974,is requiredfor tiieuse ofthe Cleik of Courtfor the
I. (a)
PLAINTIFFS
Supernus Pharmaceuticals, Inc. and United Therapeutics
Corporation
(b)
County
of
Residence
ofFirstListed Plaintiff Montgomery County
DEFENDANTS
County ofResidence of
First
ListedDefendant Alexandria
(EXCEPTIN US. PLAINTIFFCASE^
(c)
Attorneys
(Firm
Name,
Address,
and
Telephone
Nw>^>er
eronica Susana Ascarrunz
ilson Sonsini Goodrich Rosati, P.C.,1700 K Street, NW
ashington, DC20007, Telephone: 202-973-8812
NOTE:
(2W
US. PLAINTIFFCASESONLY)
IN
LANDCONDEMNATION
CASES, USE
THE
LOCATION OF
THETRACT
OF
LAND INVOLVED.
Attorneys QfKnown)
IL
BASIS
OF
JURISDICTION
(Placean X in
One
BoxOnly
O I U.S.
Goveminent
PlainttfT
• 3 Fedoal Question
(US. GovernmentNot a Party)
in CITIZENSHIP OF PRINCIPAL
PARTIES
(Place an X inOne Box forPlaint^
(ForDiversityCases Onfy) and OneBoxforD^endant)
PT F DEF P T F D EF
CitizenofThisState • 1 • 1 locoipoiatedor FiincipalPlace 0 4 OA
o f
Business In This State
^^2
U.S.
Govenunent
Defendant
• 4 Divosity
(IndicateCitizensĥ ofParties inItemID)
1V» NATURE
OF
SUIT (Place an X'inOneBox
Onfy
CONTRACT
t ts
• llOInsuiancc
• 120 Marine
a ISOMiUerAct
• 140NegotiableInstnnnent
• ISORecoveiyof Overpayment
Enforcementof Judgment
• 151
Medicare Ac t
• 152Recoveryof Defaulted
Student
Loans
(ExcludesVeterans)
• 153RecovoyofOverpayment
ofVeteran s Benefits
• 16 0
Stockholders Suits
• 190Other
Contract
• 195ContractProductLiability
•
196Franchise
REALPROPERTY
•
210Land
Condemnation
a 220F(n«closure
• 230RentLease Ejectment
• 240 Torts to Land
• 245 TortProductLiability
• 290AllOtherRealProperty
PERSONAL INJURY
• 310Airplane
• 315AirplaneProduct
Liability
• 320 Assau lt ,L ib el
Slander
• 330FederalEoqiloyers'
Liability
• 34 0
Marine
• 345 Marine
Product
Liability
• 350
Motor
Vehicle
a 355M otorVehic le
Product
LiabiliQr
• 360 OtherPersonal
Injuiy
• 362Peisoial Injuiy-
Medical
\falpiactioc
a V l L
RIGHTS
• 440 OtherCivilRights
• 441 Voting
• 442 Enq>loyment
• 443 Housing/
Accommodations
•
445 Amer. w/EHsabilities
Employment
•
44 6
Amer. w/Disabilities
Other
a 448 Education
PERSONAL INJURY
• 365PersonalInjuiy -
ProductLiability
•
367
Health Care/
Pharmaceutical
PersonalInjuiy
Product Uabili^
• 368 Asbestos Personal
InjuryProduct
Liabili^
PERSONAL PROPERTY
• 370 OtherFraud
• 371Tiuth inLending
• 380 O t her
Peisonal
Property Damage
• 385 PropertyDamage
Product Liability
PRISONER PETmO N S
Habeas Corpus:
• 463 Al ienDeta inee
• 51 0
Motions
to Vacate
Sentence
• 530 General
• 535 Death Penalty
Other
• 540Mandamus Other
• 550 CivURights
• 555Pr ison
Condition
• 560Civ i lDe ta inee -
Ctmditions
of
Confinement
Citizen
of Another
State
• 2 a 2 Inc(npoiated ofm/PrincipalPlace
of Busmess In AnotherState
0 5 0 5
Citizen or Subject of a
Fordgg
Country
O 3 O 3 ForeignNation
FORFEITUREffENALTY
• 625DrugRelatedSeizure
ofPioperty21USC881
a 6900tfaer
MBQR
•
71 0
FairLabor Standards
Ac t
• 720Laboi/Managemettt
Relations
• 740RailwayLaborAct
• 751 FamilyandMedical
Leave Ac t
• 790OtherLaborLitigatio)
• 791Enqployee Retirement
IncomeSecurity Act
IMMIGRATION
• 462NaturalizationApplication
• 465OtherImmigration
Actions
BANKRUPTCY
a 422Appeal28 use 158
a 423 Withdrawal
28
u 15 7
>kOPkRT^Rl6tog-
• 820Copyrights
• 830 Patent
•
840Tiademaric
a 861HLV(1395fiO
• 862 BlackLung (923)
• 863DIWODIWW(405(g))
•
864
SSIDTitle
XV I
a 865 RSI (405(g))
FEDERALTAX SUITS
• 870 Taxes (U.S. Plaintiff
or Defendant)
• 871 IRS—TTiiid Party
26 u s e
7609
a 6 0 6
OTHER
STATUTES
•
375
False Claims
Act
• 376QuiTam(31USC
3729(a))
• 400S tateRo^itionment
•
410Antitnist
• 430 BanksandBanking
• 45 0
Commerce
• 460 Deportation
• 47 0 RacketeerInfluenced and
Comq>tOrganizations
•
480 ConsumerCredit
a 49 0 Cable/Sat
TV
•
850
Securities/Commodities/
Exchange
• 890OtherStatutoiyActions
• 891AgriculturalActs
• 893 EnvironmentalMatters
•
895 Freedom
of
Information
Ac t
• 896 Arbitration
•
899
Administrative
Procedure
Act/Reviewor Appealof
AgencyDecision
a 950Constitutionalityof
State
Statutes
V.
ORIGIN (Place
an
X
in
OneBox Onfy
^ 1
Original
• 2
Removed
fiom
• 3
Remanded from
• 4
Reinstated
or • S
Transferred
from
• 6
Multidistrict
Proceeding State Court AppellateCourt Reopened AnotherDistrict Litigation
Iare filing
(Zto
notcUeJurisdiction^statutesunless
diversify) .
V I. CAUSE O F ACTION
Brief
descriotioaof cauae;
Patent
Term Adjus tment
v n REQUESTED IN
•
CHECK
IF
THIS
ISA
CLASS ACTION
COMPLAINT;
UNDERRULE 23, F.R.CV.P.
Vm. RELATED CASE(S)
jpi
See
instructions ;
JUDGE
DEMANDS
SIGNATURE orATTORNEY OF MCORD
AT E
3/bif/A
eEUtebNLYOROFFIC
RECEIPT
AMOUNT
APPLYING IFP
JUDGE
CHECKYESonly if demandedincomplaint:
JURY DEMAND:
•
Yes
• No
DOCKET NUMBER
MAG. JUDGE
Case 1:16-cv-00342-GBL-IDD Document 1-1 Filed 03/28/16 Page 1 of 1 PageID# 16
-
8/18/2019 Supernus and United vs. U.S. Patent and Trademark Office
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
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8/18/2019 Supernus and United vs. U.S. Patent and Trademark Office
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