1
`\
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`U.S. Patent No. 5,654,301
`
`Inventor:
`
`KOHN, Harold et al.
`
`Issue Date:
`
`August 5, 1997
`
`For:
`
`AMINO ACID DERIVATIVE ANTICONVULSANT
`
`Assignee:
`
`Research Corporation Technologies, Inc.
`
`Date:
`
`December 23, 2008
`
`Attorney Docket:
`
`32555-0002-2
`
`NDA:
`
`NDA 22-254 (VIMPAT® injection)
`
`Mail Stop Hatch-Waxman PTE
`Commissioner for Patents
`
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`APPLICATION FOR EXTENSION OF PATENT
`
`TERM UNDER 35 U.S.C.
`
`156
`
`Commissioner for Patents:
`
`Applicant, Research Corporation Technologies,
`
`Inc., a non-profit corporation
`
`organized and existing under the laws of Delaware, and having a principal place of business at
`
`5210 E. Williams Circle, Suite 240, Tucson, Arizona 85711-4410, represents that it is the owner
`
`of the entire interest in and to U.S. Patent No. 5,654,301, granted to Harold Kohn and Darrell
`
`Watson for “Amino Acid Derivative Anticonvulsant,” as reflected in the assigmnent document
`
`recorded by the U.S. Patent and Trademark Office on January 12, 1993 at Reel 006433, Frame
`
`0347. Attached at Exhibit A is a Power of Attorney document appointing the undersigned
`
`patent attorney as legal representative of Applicant.
`
`Schwarz Biosciences, Inc. (“Schwarz”), a corporation of the state of Delaware
`
`and having a place of business at 1209 Orange St., Wilmington, DE 19801, is the owner of a
`New Drug Application (“NDA”) for VIMPAT® injection, NDA number NDA 22-254. Schwarz
`
`EXHIBIT
`ACTAVIS, AMNEAL,
`AUROBINDO,
`BRECKENRIDGE,
`VENNOOT, SANDOZ,
`SUN
`
`|PR2014-01126-1007, p. 1
`
`IPR2014-01126- Exhibit 1007, p. 1
`
`

`
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`Pharma AG (“SPAG”), having its registered office at Alfred-Nobel Strasse 10, 40789 Monheim,
`
`Germany, has exclusive license rights under U.S. Patent No. 5,654,301 to lacosamide, R-2-
`
`Acetamido-N-benzyl-3-methoxypropionamide.
`
`Schwarz and SPAG are related companies,
`
`being wholly owned by UCB S.A., which has its registered office at Allée de la Recherche 60,
`
`1070 Brussels, Belgium. Attached at Exhibit B is a Letter of Reliance document granting to the
`
`Applicant from Schwarz the right to rely upon NDA 22-254 and the activities of SPAG and its
`
`predecessors in interest supporting FDA approval of VIMPAT® injection for purposes of
`
`obtaining any and all patent term extensions available in conjunction with the approval of
`
`VIMPAT® injection.
`
`Applicant, acting through its duly authorized attorney, hereby submits this
`
`application for extension of patent term under 35 U.S.C. §156, based upon the approval by the
`
`Food and Drug Administration for commercial marketing or use of VIMPAT® injection, since
`
`the active ingredient of VlMPAT® injection is lacosamide and lacosamide falls within the ambit
`
`of the claims of U.S. Patent No. 5,654,301. The information contained in this Application and its
`
`Exhibits is provided in accordance with the rules promulgated by the U.S. Patent and Trademark
`
`Office at 37 CFR §§l.710-1.785 and presented in the manner set forth at 37 CFR §1.740.
`
`1.
`
`A Complete Identification Of The Approved Product As By Appropriate
`Chemical And Generic Name, Physical Structure Or Characteristics
`
`The approved product, VIMPAT® injection, contains lacosamide as its active
`
`ingredient and is indicated for adjunctive therapy in the treatment of partial—onset seizures in
`
`patients with epilepsy aged 17 years and older when oral administration is temporarily not
`
`feasible.
`
`The
`
`IUPAC chemical name of
`
`lacosamide
`
`is
`
`(R)-2-acetamido-N—benzyl-3-
`
`methoxypropionamide. Lacosamide has the empirical formula C13H13N203, and has a molecular
`
`weight of 250.30. Lacosamide is present in VIMPAT® injection in the form of a single (R)-
`
`enantiomer, and has the structural formula:
`
`
`
`IPR2014-01126- Exhibit 1007, p. 2
`
`

`
`U.S. Patent No. 5,654,301
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`H30 if
`if
`
`N
`
`O
`
`0 A
`
`H
`
`Lacosamide is prepared as a white to light yellow powder that is sparingly soluble in acetonitrile
`
`and ethanol. The approved product is formulated for intravenous injection as a clear, colorless,
`
`sterile solution containing 10 mg lacosamide per mL for intravenous infusion. One 20 mL vial
`
`contains 200 mg of lacosamide, plus inactive ingredients sodium chloride and water for
`
`injection. Hydrochloric acid is used for pH adjustment, giving VIMPAT® injection a pH of 3.5
`
`to 5.0. The initial recommended dosage regimen is 100 mg of lacosamide infusion per day, and
`
`dosage can be increased, such as at weekly intervals of 100 mg/day, until a maintenance dose of
`
`200 to 400 mg/day (based upon individual patient response and tolerability) is reached.
`
`2.
`
`A Complete Identification Of The Federal Statute Including The Applicable
`Provisions Of Law Under Which The Regulatory Review Occurred
`
`The approved product, VIMPAT® injection, was subject to regulatory review
`
`under Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §355).
`
`3.
`
`An Identification Of The Date On Which The Product Received Permission For
`
`Commercial Marketing Or Use Under The Provision Of Law Under Which The
`Applicable Regulatory Review Period Occurred
`
`The approved product, VIMPAT® injection, received permission for commercial
`
`marketing or use under Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
`
`§355) on October 28, 2008. A copy of a letter from the Food and Drug Administration (“FDA”)
`
`indicating the date of approval is attached hereto at Exhibit C.
`
`|PR2014—01126— Exhibit 1007, p. 3
`
`IPR2014-01126- Exhibit 1007, p. 3
`
`

`
`U.S. Patent No. 5,654,301
`Application for Extension of Patent Tenn
`Attorney Docket 32555-0002-2
`
`4.
`
`In The Case Of A Drug Product, An Identification Of Each Active Ingredient In
`The Product And As To Each Active Ingredient, A Statement That It Has Not
`Been Previously Approved For Commercial Marketing Or Use Under The Federal
`Food, Drug, and Cosmetic Act, The Public‘Health Service Act, Or The Virus-
`Serum-Toxin Act, Or A Statement Of When The Active Ingredient Was
`Approved For Commercial Marketing Or Use (Either Alone Or In Combination
`With Other Active Ingredients), The Use For Which It Was Approved, And The
`Provision Of Law Under Which It Was Approved
`
`The active ingredient in VIMPAT® injection is lacosamide, which has not been
`
`previously approved for commercial marketing or use under the Federal Food, Drug, and
`
`Cosmetic Act, the Public Health Service Act, or the Virus-Serum-Toxin Act.
`
`A Statement That The Application Is Being Submitted Within The Sixty Day
`Period Permitted For Submission Pursuant
`to 37 CFR
`1.720
`And An
`
`Identification Of The Date Of The Last Day On Which The Application Could Be
`Submitted
`
`This application is being submitted within the permitted sixty (60) day period, the
`
`last day of which is December 26, 2008.
`
`6.
`
`A Complete Identification Of The Patent For Which An Extension Is Being
`Sought By The Name Of The Inventor, The Patent Number, The Date Of Issue,
`And The Date Of Expiration
`
`The complete identification of the patent for which extension is sought is:
`
`Inventors:
`
`Harold Kohn, and Darrell Watson
`
`Patent Number:
`
`5,654,301
`
`Issue Date:
`
`August 5, 1997
`
`Expiration Date:
`
`August 5, 2014 (without extension under 35 U.S.C. §l56)
`
`7.
`
`8.
`
`A Copy Of The Patent For Which An Extension Is Being Sought, Including The
`Entire Specification (Including Claims) And Drawings
`
`A complete copy of U.S. Patent No. 5,654,301 is annexed as Exhibit D.
`
`A Copy Of Any Disclaimer, Certificate of Correction, Receipt Of Maintenance
`Fee Payment, Or Reexamination Certificate Issued In The Patent
`
`The patent for which extension is being sought has not been the subject of any
`
`disclaimer or reexamination certificate, but has had a certificate of correction duly issued by the
`
`|PR2014—01126— Exhibit 1007, p. 4
`
`IPR2014-01126- Exhibit 1007, p. 4
`
`

`
`U.S. Patent No. 5,654,301
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`U.S. Patent and Trademark Office. A copy of the certificate of correction, dated November 27,
`
`2001, is included at the end of the copy of U.S. Patent No. 6,654,30l annexed as Exhibit D. The
`
`first two scheduled maintenance fees for U.S. Patent 5,654,301 were duly paid on February 2,
`
`2001 and December 3, 2004 by Applicant, and the next maintenance fee is due to be paid by
`
`February 6, 2009. Copies of the maintenance fee statements evidencing past payments are
`
`annexed as Exhibit E.
`
`9.
`
`A Statement That The Patent Claims The Approved Product Or A Method Of
`Using Or Manufacturing The Approved Product, And A Showing Which Lists
`Each Applicable Patent Claim And Demonstrates The Manner In Which At Least
`One Such Patent Claim Reads On The Approved Product Or Method Of Using Or
`Manufacturing The Approved Product
`
`U.S. Patent No. 5,654,301 claims the approved product, VIMPAT® injection.
`
`More specifically, claims 39-45 read on the approved product and claim the active ingredient of
`
`the final approved product lacosamide, claim 46 reads on the approved product and claims a
`
`composition comprising lacosamide, and claim 47 reads on methods that comprise using
`
`lacosamide for treatment of CNS (i.e., central nervous system) disorders. Claim 39, covering a
`
`compound, is compared to the approved product in the table below.
`
`
`
`
`
`
`A roved Product
`
`
`
`Patent Claim
`
`39' A compound ofthe formula
`
`-
`
`
`
`
`
`
`
`
`
`
`The active ingredient of the approved
`product is lacosamide, which is- (R)-
`2-acetamido-N-benzyl-3-
`methoxypropionamide. Lacosamide
`
`
`has the structural formula identified
`-
`, Q
`
`
`[
`ll
`above
`in
`Section
`1
`of
`this
`1
`'
`
`
`
`A application. Comparison ofQ R3, the
`
`
`structural formula above with that in
`
`
`
`
`acceptable salts thereof wherein R is aryl, aryl
`
`claim 39 shows that the benzyl group
`at
`the far
`right of the structural
`formula identified above in Section 1
`
`
`
`or
`
`the
`
`pharrnaceutically
`
`
`
`lower alkyl
`is an unsubstituted aryl
`and
`thus
`satisfies
`the
`claim’s
`
`definition of “R.” The -CH3 group at
`the far left of the structure in Section
`
`
`
`
`
`lower alkyl, heterocyclic, heterocyclic lower
`
`alkyl, cycloalkyl or
`
`lower cycloalkyl
`
`lower
`
`alkyl, wherein R ' is
`
`unsubstituted
`
`or
`
`is
`
`substituted with
`
`is a lower alkyl that satisfies the
`1
`claim’s definition of “R1.” The two
`at
`least
`one
`electron
`
`
`double-bonded ox gen atoms satisf
`
`
`
`
`|PR2014—01126— Exhibit 1007, p. 5
`
`IPR2014-01126- Exhibit 1007, p. 5
`
`

`
`U.S. Patent No. 5,654,301
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`withdrawing group or an electron donating
`
`group;
`
`R1 is hydrogen or lower alkyl and
`
`R.
`
`is unsubstituted or substituted with at least
`
`one electron withdrawing group or at least one
`
`electron donating group;
`
`A and Q are both 0;
`
`one of R2 and R3 is hydrogen and
`
`the other is lower alkyl which is substituted with
`
`an electron donating group or
`
`a electron
`
`withdrawing group and n is 1-4.
`
`the claim’s definition of both “A”
`
`and “Q.” The central chiral carbon
`atom is bonded to a hydrogen and a -
`CH2OCH3 group (a
`lower
`alkyl
`substituted with a methoxy group),
`thus
`satisfying
`the
`claim’s
`requirement that one of R2 and R3 be
`a hydrogen while the other of R2 and
`R3 is a lower alkyl substituted with
`an electron donating group. A lower
`alkoxy, such as a -OCH3 group,
`is
`defined by dependent claim 43 and
`the
`specification
`as
`a
`suitable
`electron
`donating
`group.
`Lacosamide qualifies as a chemical
`defined by claim 39 when n is equal
`to 1.
`
`Claim 46, covering a therapeutic composition, is compared to the approved product in the table
`
`below.
`
`46.
`
`An
`
`anti-convulsant
`
`composition
`
`comprising
`
`an
`
`anti-convulsant
`
`effective amount of a compound from any one
`
`of claim 37-42 and a pharmaceutical carrier
`
`therefor. The active ingredient of the approved
`
`A roved Product
`
`and
`lacosamide,
`is
`product
`lacosamide falls within the scope of
`claim 39 as indicated above. The
`
`is a composition
`approved product
`injection
`that
`for
`intravenous
`contains
`a pharmaceutical carrier,
`water and sodium chloride.
`
`Claim 47, covering a method of treating central nervous system disorders, is compared to the
`
`approved product and its indicated use in the table below.
`
`Patent Claim
`
`A roved Product
`
`an anti-convulsant effective amount of a compound of any one of claims 39-
`
`47. A method of treating CNS
`
`disorders in an animal comprising administering
`
`to said animal
`
`The active ingredient of the approved
`product
`is
`lacosamide,
`and
`lacosamide falls within the scope of
`claim 39
`as
`indicated
`above.
`
`Lacosamide
`
`is
`
`an
`
`anticonvulsant
`
`approved for the treatment of partial-
`
`|PR2014—01126— Exhibit 1007, p. 6
`
`IPR2014-01126- Exhibit 1007, p. 6
`
`

`
`U.S. Patent No. 5,654,301
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`system (“CNS”) disorder.
`
`patients with
`in
`seizures
`onset
`epilepsy, which is a central nervous
`
`|PR2014—01126— Exhibit 1007, p. 7
`
`IPR2014-01126- Exhibit 1007, p. 7
`
`

`
`US. Patent No. 5,654,301
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`10.
`
`A Statement, Beginning On A New Page, Of The Relevant Dates And
`Information Pursuant To 35 U.S.C. § 1561g) In Order To Enable The Secretgg; Of
`Agriculture, As Appropriate, To Determine The Applicable Regulatory Review
`Period As Follows ti): For A Patent Claiming A Human Drug Product, Antibiotic,
`Or Human Biological Product, The Effective Date Of The Investigational New
`Drug (IND) Application And The IND Number‘, The Date On Which A New
`Drug Application (NDA) Or A Product License Application gPLA) Was Initially
`Submitted And The NDA Or PLA Number And The Date On Which The NDA
`
`Was Approved Or The Product License Issued
`
`Schwarz Biosciences, Inc. was notified via telephone that the IND for VIMPAT®
`
`injection (IND 68,407) became effective on November 14, 2003, and received a letter dated
`
`December 24, 2003 from the FDA confirming that IND 68,407 became effective on that earlier
`
`date. For purposes of this application for patent term extension, the Applicant is entitled to an
`
`IND date of at least as early as November 14, 2003.l The NDA (NDA 22-254) for VIMPAT®
`
`injection was initially submitted to the Food and Drug Administration on September 28, 2007
`
`and was approved on October 28, 2008.
`
`l A predecessor in interest to Schwarz, Harris FRC Corp., previously filed IND 57,939 for VIMPAT®(1acosamide)
`tablet.
`IND 57,939 became effective on May 19, 1999, and was followed" by NDA 22-253 on September 28, 2007.
`NDA 22-253 was approved on October 28, 2008 for VIMPAT®(1acosamide) tablet. Both NDA approvals (for NDA
`22-253 and NDA22-254) rely upon the same Phase 1 safety & tolerance studies for lacosamide. (See Exhibit F, page
`1
`for “1ND 68,407 Submissions” chart
`indicating on October 15, 2003 a cross-referencing was made to "all
`preclinical and clinical reports from oral IND"). Applicant understands that, where multiple INDs are in effect, and
`data from such multiple INDs was material to the determination to approve the product, it is the policy ofthe FDA
`to consider whether it would be appropriate to define the testing phase as having begun when the first IND became
`effective. Applicant therefore submits that an earlier IND effective date, namely May 19, 1999, may be appropriate
`for use in
`calculating the full term of the regulatory review period for this patent term extension application.
`Applicant will supplement this application with additional infonnation concerning IND 57,939 and/or NDA 22-253
`upon request by the Patent Office and/or the FDA.
`
`|PR2014—01126— Exhibit 1007, p. 8
`
`IPR2014-01126- Exhibit 1007, p. 8
`
`

`
`U.S. Patent No. 5,654,301
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`11.
`
`A Brief Description Beginning On A New Page Of The Significant Activities
`Undertaken By The Marketing Applicant During The Applicable Regulatory
`Review Period With Respect To The Approved Product And The Significant
`Dates Applicable To Such Activities
`
`A brief description of significant activities undertaken by the marketing applicant
`
`during the regulatory review period with respect to the approved product is annexed as Exhibit
`
`F. This exhibit provides a chronology of the major communications between the marketing
`
`applicant and the Food and Drug Administration, including a brief summaiy of the subject matter
`
`and date of these communications.
`
`Applicant reserves the right to supplement the chronology of Exhibit F with
`
`materials from which it was derived or other evidence related to Applicant’s conduct in obtaining
`
`the approval of VIMPAT® injection. See, e.g., 21 CFR § 60.32.
`
`|PR2014—01126— Exhibit 1007, p. 9
`
`IPR2014-01126- Exhibit 1007, p. 9
`
`

`
`U.S. Patent No. 5,654,301
`Application for Extension of Patent Tenn
`Attorney Docket 32555-0002-2
`
`12.
`
`A Statement Beginning On A New Page That In The Opinion Of The Applicant
`The Patent Is Eligible For The Extension And A Statement As To The Length Of
`The Extension Claimed,
`Including How The Length Of Extension Was
`Determined
`
`Applicant is of the opinion that U.S. Patent No. 5,654,301 is eligible for extension
`
`under 35 U.S.C. § 156, because it satisfies all of the requirements for such extension as follows:
`
`35 U.S.C.
`
`156 a ' 37 CFR 1.720 a
`
`U.S. Patent No. 5,654,301 claims a product, and a method of using a
`
`product.
`
`35 U.S.C.
`
`156 a 1
`
`' 37 CFR 1.720
`
`The term of U.S. Patent No. 5,654,301 has not expired before submission
`
`of this application.
`
`35 U.S.C.
`
`156 a 2 ‘ 37 CFR 1.720 b
`
`The term of U.S. Patent No. 5,654,301 has never previously been extended
`
`under 35 U.S.C. §156.
`
`35 U.S.C.
`
`156 a 3 ' 37 CFR 1.730
`
`This application for extension is submitted by the authorized agent or the
`
`owner of record in accordance with the requirement of 35 U.S.C. §156(d)
`
`and the rules of the U.S. Patent and Trademark Office.
`
`35 U.S.C.
`
`156 a 4 ' 37 CFR 1.720 d
`
`The product VIMPAT® injection has been subject to a regulatory review
`
`period as defined in 35 U.S.C. §156(g) before its commercial marketing or
`
`USC.
`
`10
`
`|PR2014—01126— Exhibit 1007, p. 10
`
`IPR2014-01126- Exhibit 1007, p. 10
`
`

`
`U.S. Patent No. 5,654,301
`
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`35 U.S.C. §156ga1g51gA1,- 37 CFR §1.7201e)(il
`
`The commercial marketing or use of the product VIMPAT® injection after
`
`the regulatory review period is the first permitted commercial marketing
`
`or use of the product under the provision of the Federal Food, Drug, and
`
`Cosmetics Act
`
`(21 U.S.C. §360) under which such regulatory review
`
`period occurred.
`
`35 U.S.C. §156§c)§4),' 37 CFR§l.7201h)
`
`No other patent has been extended for the same regulatory review period
`
`for the product VIMPAT® injection.
`
`35 U.S.C.
`
`156 d 1
`
`'37 CFR 1.720
`
`This application is submitted within the permitted 60 day period beginning
`
`on the date the product first received permission for commercial marketing
`
`01' USC.
`
`Applicant is of the opinion that U.S. Patent No. 5,654,301 is eligible for extension
`
`under 35 U.S.C. § 156 for 1 104 days, as determined pursuant to 37 CFR §1.775 as follows:
`
`Patent Information:
`
`Patent 5,654,301 Issue Date
`
`Earliest non-provisional priority date
`
`Days Extension under 35 U.S.C. 154(b)
`
`FDA Information:
`
`Date IND Became Effective
`
`Date NDA Submitted to the FDA
`
`Date NDA Approved by the FDA
`
`August 5, 1997
`
`February 15, 1985
`
`0
`
`November 14, 2003
`
`September 28, 2007
`
`October 28, 2008
`
`11
`
`|PR2014—01126— Exhibit 1007, p. 11
`
`IPR2014-01126- Exhibit 1007, p. 11
`
`

`
`U.S. Patent No. 5,654,301
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`IND Period:
`
`Start Date of Regulatory Review Period
`
`November 14, 2003
`
`IND Period (days)
`
`‘/2 IND Period (days)
`
`Regulatory Review Period Allowed:
`
`NDA Review Period (days)
`
`Regulatory Review Period (days)
`
`Reg. Rev. Period less ‘/2 IND period (days)
`
`1414
`
`707
`
`397
`
`1811
`
`1 104
`
`Statutory Limitations:
`
`Patent Expiration Date (17 year term)
`
`August 5, 2014
`
`Expiration under 5 year extension limitation (Date 1)
`
`August 5, 2019
`
`Expiration under 14 from NDA approval limitation (Date 2)
`
`October 28, 2022
`
`Expiration based upon full review period (Date 3)
`
`August 13, 2017
`
`Final Expiration Date (Earliest of Date 1, Date 2, or Date 3)
`
`August 13, 2017
`
`Maximum Extension in Days:
`
`11042
`
`2 All calculations above are performed assuming that November 14, 2003 is the appropriate date for when the
`relevant regulatory review period started. As noted above in footnote 1 on page 8, it is possible that the FDA could
`determine that a date as early as May 19, 1999 is the appropriate date for the start of the regulatory review period.
`Should that earlier date, or another earlier date, in fact be the appropriate start date for the regulatory review period,
`then Applicant would be entitled to a longer calculated review period, and thus a later “Date 3" above. For example,
`should the applicable regulatory review period be determined to have started on May 19, 1999, then the IND period
`will have lasted 3054 days, and the full regulatory review period will have lasted 3451 days. Thus, the regulatory
`review period less ‘/2 IND period as calculated would be 1924 days. This would make the expiration of patent no.
`5,654,301 based upon the full regulatory review period (Date 3) be November 1 1, 2019.
`In this scenario, Applicant
`would be entitled to a full five-year extension of patent no. 5,654,301, making it expire August 5, 2019 (i.e, Date 1
`above).
`
`12
`
`|PR2014—01126— Exhibit 1007, p. 12
`
`IPR2014-01126- Exhibit 1007, p. 12
`
`

`
`U.S. Patent No. 5,654,301
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`13.
`
`A Statement That Applicant Acknowledges A Duty To Disclose To The
`Commissioner Of Patents And Trademarks And The Secretary Of Health And
`Human Services Any Information Which Is Material To The Determination Of
`Entitlement To The Extension Sought
`
`Applicant acknowledges a duty to disclose to the Commissioner of Patents and
`
`Trademarks and the Secretary of Health and Human Services any information which is material
`
`to any determinations of entitlement to the extension sought in the Application.
`
`14.
`
`The Prescribed Fee For Receiving And Acting Upon The Application For
`Extension
`
`The prescribed fee pursuant to 37 CFR §l.20(i) for receiving and acting upon this
`
`application is to be charged to the Deposit Account of Applicant’s undersigned attorney as
`
`authorized in the attached letter.
`
`15.
`
`The Name, Address, And Telephone Number Of The Person To Whom Inguiries
`And Correspondence Relating To The Application For Patent Term Extension
`Are To Be Directed
`
`Please address all correspondence to:
`
`Kevin G. Shaw
`
`Hogan & Hartson, LLP
`
`555 Thirteenth St., NW
`
`Washington, DC 20004
`
`16.
`
`A Duplicate Of The Application Papers, Certified As Such
`
`Applicant hereby certifies that this application for extension is being filed in
`
`triplicate.
`
`17.
`
`An Oath Or Declaration
`
`Applicant, through its undersigned patent attorney authorized to practice before
`
`the Patent and Trademark Office and who has general authority from the agent or owner to act
`
`on behalf of the agent or owner in patent matters, being duly warned that willful false statements
`
`are punishable by fine or imprisonment or both under section 1001 of Title 18, United States
`
`13
`
`|PR2014—01126— Exhibit 1007, p. 13
`
`IPR2014-01126- Exhibit 1007, p. 13
`
`

`
`U.S. Patent No. 5,654,301
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`Code and that willful false statements and the like may jeopardize the validity of this application
`
`and the patent to which it relates, states and declares that the following statements made based on
`
`his own knowledge are true and that all statements made on information and belief are believed
`
`to be true:
`
`(1)
`
`The undersigned is registered to practice before the Patent and Trademark
`
`Office and is making this declaration as a patent attorney who has general
`
`authority to act on behalf of the applicant in patent matters.
`
`(2)
`
`The undersigned has reviewed and understands the contents of the
`
`application being submitted pursuant to this section;
`
`(3)
`
`The undersigned believes the patent is subject to an extension pursuant to
`
`37 C.F.R. § 1.710 in the event of NDA approval and, in the interim, is
`
`subject to an extension pursuant to 37 C.F.R. § 1.790;
`
`(4)
`
`The undersigned believes an extension of the length claimed is justified
`
`under 35 U.S.C. 156 and the applicable regulations; and
`
`(5)
`
`The undersigned believes the patent for which extension is being sought
`
`meets the conditions for extension of the term of a patent as set forth in 37
`
`C.F.R. § 1.720 in the event of NDA approval, and meets the requirements
`
`for an interim extension of a patent set forth in 37 C.F.R. § 1.790.
`
`If this application for extension of patent term is held to be informal, applicant
`
`may seek to have that holding reviewed by filing a petition with the required fee, as necessary,
`
`pursuant to 37 C.F.R. §§ 1.181, 1.182 or 1.183, as appropriate, within such time as may be set in
`
`any notice that the application has been held to be informal, or if no time is set, within one month
`
`of the date on which the application was held informal.
`
`14
`
`|PR2014—01126— Exhibit 1007, p. 14
`
`IPR2014-01126- Exhibit 1007, p. 14
`
`

`
`U.S. Patent No. 5,654,301
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`Dated: December 23, 2008
`
`HOGAN & HARTSON LLP
`555 13"‘ Street, N.W.
`Washington, D.C. 20004
`Telephone: 202-637-5600
`Facsimile: 202-637-5910
`
`Email: kgshaw@hhlaw.com
`Customer No.: 24633
`
`Respectfully submitted,
`
`
`
`egistration No. 43,1 10
`
`15
`
`|PR2014—01126— Exhibit 1007, p. 15
`
`IPR2014-01126- Exhibit 1007, p. 15