IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re
`
`Inventor
`
`Issue Date
`
`For
`
`Assignee
`
`Date
`
`U.S Patent No 5654301
`
`KOHN Harold et al
`
`1997
`
`August
`AMINO ACID DERIVATIVE ANTICONVULSANT
`
`Research Corporation Technologies
`
`Inc
`
`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
`
`non-profit corporation
`
`organized and existing under the laws of Delaware and having
`
`principal place of business at
`
`5210 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 5654301 granted to Harold Kohn and Darrell
`
`Watson for Amino Acid Derivative Anticonvulsant as reflected in the assignment document
`
`recorded by the U.S Patent and Trademark Office on January 12 1993 at Reel 006433 Frame
`
`0347 Attached at Exhibit
`
`is
`
`Power of Attorney document appointing the undersigned
`
`patent attorney as legal representative of Applicant
`
`Schwarz Biosciences
`
`corporation of the state of Delaware
`
`and having
`
`Inc Schwarz
`place of business at 1209 Orange St Wilmington DE 19801 is the owner of
`New Drug Application NDA for VIMPAT injection NDA number NDA 22-254 Schwarz
`
`MYLAN - EXHIBIT 1020
`
`

`
`c.IR I.J JU.tJJt
`Application for Extension of Patent Term
`Attorney Docket 325 55-0002-2
`
`Pharma AG SPAG having its registered office at Alfred-Nobel Strasse 10 40789 Monheim
`Germany has exclusive license rights under U.S Patent No 5654301 to lacosamide R-2-
`
`and SPAG are related companies
`Acetamido-N-benzyl-3-methoxypropionamide
`being wholly owned by UCB S.A which has its registered office at Allée de Ia Recherche 60
`
`Schwarz
`
`Letter of Reliance document granting to the
`1070 Brussels Belgium Attached at Exhibit
`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
`
`is
`
`obtaining any and all patent
`VIMPAT injection
`
`term extensions available
`
`in conjunction with the approval of
`
`Applicant
`
`acting through its duly authorized
`
`aftorney 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 VIMPAT injection is lacosamide and lacosamide falls within the ambit
`
`of the claims of U.S Patent No 5654301 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 1.7l0-l.785 and presented in the manner set forth at 37 CFR 1.740
`
`Product As By Appropriate
`Identification Of The Approved
`Complete
`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 C13H18N2O3 and has molecular
`in VIMPAT injection in the form of
`
`single
`
`weight of 250.30
`
`Lacosamide is present
`
`enantiomer and has the structural
`
`formula
`
`

`
`U.S Patent No 5654301
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`H3C
`
`CH3
`
`Lacosamide is prepared as white to light yellow powder that is sparingly soluble in acetonitrile
`
`and ethanol The approved product
`is formulated for intravenous injection as
`sterile solution containing 10 mg lacosamide per mL for intravenous infusion One 20 mL vial
`
`clear colorless
`
`contains 200 mg of
`sodium chloride
`and water
`lacosamide plus inactive
`injection Hydrochloric acid is used for pH adjustment giving VIMPAT injection
`
`ingredients
`
`for
`
`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 maintenance dose of
`
`200 to 400 mg/day based upon individual patient response and tolerability is reached
`
`Identification Of The Federal Statute
`The Applicable
`Complete
`Including
`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
`
`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
`letter from the Food and Drug Administration FDA
`355 on October 28 2008
`
`copy of
`
`indicating the date of approval
`
`is attached hereto at Exhibit
`
`

`
`U.S Patent No 5654301
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`Drug Product An Identification Of Each Active Ingredient
`In The Case Of
`In
`The Product And As To Each Active Ingredient
`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-
`Statement Of When The Active
`Ingredient Was
`Serum-Toxin Act Or
`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
`in VIMPAT injection is lacosamide which has not been
`
`The active ingredient
`
`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
`
`Statement That The Application Is Being Submitted Within The Sixty Day
`37 CFR 1.720f And An
`Period Permitted For Submission Pursuant
`to
`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
`
`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
`
`Patent Number
`
`Issue Date
`
`Expiration Date
`
`Harold Kohn and Darrell Watson
`
`5654301
`
`August
`
`1997
`
`August
`
`2014 without extension under 35 U.S.C 156
`
`Copy Of The Patent For Which An Extension Is Being Sought
`Entire Specification Including Claims And Drawings
`complete copy of U.S Patent No 5654301 is annexed as Exhibit
`
`Including The
`
`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
`
`certificate of correction duly issued by the
`
`

`
`U.S Patent No 5654301
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`U.S Patent and Trademark Office
`copy of the certificate of correction dated November 27
`2001 is included at the end of the copy of U.S Patent No 6654301 annexed as Exhibit
`
`The
`
`first
`
`two scheduled maintenance fees for U.S Patent 5654301 were duly paid on February
`
`2001 and December
`
`2004 by Applicant
`
`and the next maintenance fee is due to be paid by
`
`February
`
`2009 Copies of the maintenance fee statements evidencing past payments are
`
`annexed as Exhibit
`
`Method Of
`Statement That The Patent Claims The Approved Product Or
`The Approved Product And
`Showing Which Lists
`Using Or Manufacturing
`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 5654301 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
`
`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
`
`compound is compared to the approved product
`
`in the table below
`
`Patent Claim
`
`39
`
`compound of the formula
`
`Approved Product
`The active ingredient of the approved
`is lacosamide which is
`
`product
`
`2-acetamido-N-benzyl-3-
`
`methoxypropionamide
`formula identified
`has the structural
`of
`above
`
`Lacosamide
`
`this
`
`in
`
`Section
`
`p.1
`
`II
`
`or
`
`the
`
`pharmaceutically
`
`acceptable
`
`salts thereof wherein
`
`is aryl aryl
`
`of
`
`Comparison
`application
`formula above with that in
`structural
`claim 39 shows that the benzyl group
`right of
`the
`the
`at
`far
`structural
`formula identified above in Section
`
`the
`
`lower alkyl heterocyclic
`
`heterocychc
`
`alkyl
`
`cycloalkyl or
`
`lower cycloalkyl
`
`lower
`
`lower alkyl
`is an unsubstituted aryl
`and
`claims
`thus
`the
`satisfies
`lower definition of
`The -CH3 group at
`the far left of the structure in Section
`
`alkyl
`
`wherein
`
`is
`
`unsubstituted
`
`or
`
`is
`
`substituted
`
`with
`
`at
`
`least
`
`one
`
`electron
`
`________________________________________
`
`is
`
`that satisfies the
`lower alkyl
`claims definition of R1
`The two
`double-bonded oxygen atoms satisfy
`
`

`
`U.S Patent No 5654301
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`withdrawing group or
`
`an electron
`
`donating
`
`group
`
`R1 is hydrogen or lower alkyl arid
`
`R1
`
`is unsubstituted or substituted with at
`
`least
`
`one electron withdrawing group or at
`
`least one
`
`electron donating group
`
`and
`
`are both
`
`one of R2 and R3 is hydrogen and
`
`the other is lower alkyl which is substituted with
`
`an
`
`electron
`
`donating
`
`group
`
`or
`
`electron
`
`withdrawing group and
`
`is 1-4
`
`thus
`
`the claims definition of both
`and
`The central chiral carbon
`atom is bonded to
`hydrogen and
`CH2OCH3
`lower alkyl
`group
`methoxy group
`substituted with
`claims
`the
`satisfying
`that one of R2 and R3 be
`requirement
`hydrogen while the other of R2 and
`lower alkyl substituted with
`R3 is
`an electron donating group
`lower
`-OCH3 group is
`alkoxy such as
`defined by dependent claim 43 and
`the
`as
`specification
`suitable
`
`electron
`donating
`Lacosamide qualifies as
`defined by claim 39 when
`to
`
`group
`chemical
`
`is equal
`
`Claim 46 covering
`
`therapeutic composition is compared to the approved product
`
`in the table
`
`below
`
`Patent Claim
`
`46
`
`An
`
`anti-convulsant
`
`composition
`
`comprising
`
`an
`
`anti-convulsant
`
`effective amount of
`
`compound from any one
`
`of claim 37-42 and
`
`pharmaceutical
`
`carrier
`
`therefor
`
`Approved Product
`The active ingredient of the approved
`and
`lacosamide
`product
`lacosamide falls within the scope of
`The
`claim 39 as indicated above
`
`is
`
`approved product
`intravenous
`
`for
`
`is
`
`composition
`
`injection
`
`that
`
`contains
`pharmaceutical
`water and sodium chloride
`
`carrier
`
`Claim 47 covering
`
`method of treating central nervous system disorders is compared to the
`
`approved product and its indicated use in the table below
`
`Patent Claim
`
`47
`
`method of
`
`treating CNS
`
`disorders in an animal comprising administering
`
`to
`
`said animal
`
`an anti-convulsant
`
`effective
`
`amount of
`
`compound of any one of claims 39
`
`Approved Product
`The active ingredient of the approved
`and
`lacosamide
`product
`lacosamide falls within the scope of
`claim 39
`above
`indicated
`as
`
`is
`
`Lacosamide
`an
`anticonvulsant
`approved for the treatment of partial
`
`is
`
`

`
`U.S Patent No 5654301
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`44
`
`onset
`seizures
`epilepsy which is
`
`in
`
`patients with
`
`central nervous
`
`system CNS disorder
`
`

`
`U.S Patent No 5654301
`Application for Extension of Patent Term
`Attorney Docket 3255 5-0002-2
`
`10
`
`New Page Of The Relevant Dates And
`Beginning On
`Statement
`156g In Order To Enable The Secretary Of
`Information Pursuant To 35 U.S.C
`Agriculture As Appropriate To Determine The Applicable Regulatory Review
`Human Drug Product Antibiotic
`Period As Follows Ci For
`Patent Claiming
`Or Human Biological Product The Effective Date Of The Investigational New
`Drug IND Application And The ND Number The Date On Which
`New
`Drug Application NDA Or
`Product License Application PLA Was Initially
`Submitted And The NDA Or PLA Number And The Date On Which The NDA
`Was Approved Or The Product License Issued
`Inc was notified via telephone that the IND for VIMPAT
`
`Schwarz Biosciences
`
`injection IND 68407 became effective on November 14 2003 and received
`December 24 2003 from the FDA confirming that ND 68407 became effective on that earlier
`
`letter dated
`
`date For purposes of this application
`ND date of at
`
`least as early as November 14 2003.1
`
`for patent
`
`is entitled to an
`term extension the Applicant
`The NDA NDA 22-254 for VIMPAT
`submitted to the Food and Drug Administration on September 28 2007
`
`injection was initially
`
`and was approved on October 28 2008
`
`tablet
`
`to Schwarz Harris FRC Corp previously filed IND 57939 for V1MPAT lacosamide
`in interest
`predecessor
`on May 19 1999 and was followed by NDA 22-253 on September 28 2007
`IND 57939 became effective
`NDA 22-253 was approved on October 28 2008 for VIMPAT lacosamide tablet Both NDA approvals for NDA
`tolerance studies for lacosamide See Exhibit
`22-253 and NDA22-254 rely upon the same Phase
`safety
`page
`lND 68407 Submissions chart
`was made to all
`15 2003
`indicating on October
`cross-referencing
`for
`preclinicat and clinical reports from oral IND Applicant understands that where multiple INDs are in effect and
`is the policy of the FDA
`data from such multiple INDs was material to the determination to approve the product
`IND became
`it would be appropriate to define the testing phase
`as having begun when the first
`to consider whether
`effective Applicant therefore submits that an earlier IND effective date namely May 19 1999 may be appropriate
`term extension application
`term of the regulatory review period for this patent
`for use in
`calculating
`information concerning ThTD 57939 and/or NDA 22-253
`this application with additional
`Applicant will supplement
`upon request by the Patent Office and/or the FDA
`
`the full
`
`it
`
`

`
`U.S Patent No 5654301
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`II
`
`New Page Of The Significant Activities
`Brief Description Beginning On
`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
`
`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
`
`This exhibit provides
`
`chronology of the major communications
`
`between
`
`the marketing
`
`applicant and the Food and Drug Administration including
`
`brief summary of the subject matter
`
`and date of these communications
`
`Applicant
`
`reserves the right
`
`to supplement
`
`the chronology of Exhibit
`
`with
`
`materials from which it was derived or other evidence related to Applicants conduct
`the approval of VIMPAT injection See e.g 21 CFR 60.32
`
`in obtaining
`
`

`
`U.S Patent No 5654301
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`12
`
`New Page That
`Statement Beginning On
`In The Opinion Of The Applicant
`Statement As To The Length Of
`Is Eligible For The Extension And
`The Patent
`The Extension Claimed Including How The
`Length Of Extension Was
`Determined
`
`Applicant is of the opinion that U.S Patent No 5654301 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 l56a 37 CFR 1.720a
`U.S Patent No 5654301 claims
`
`product
`
`product and
`
`method of using
`
`35 U.S.C 156a1 37 CFR 1.720g
`The term of U.S Patent No 5654301 has not expired before submission
`
`of this application
`
`35 U.S.C 156aX2 37 CFR 1.720b
`The term of U.S Patent No 5654301 has never previously been extended
`
`under 35 U.S.C 156
`
`35 U.S.C 156a3 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 156d
`
`and the rules of the U.S Patent and Trademark Office
`
`35 U.S.C l56aX4 37 CFR l.720d
`The product VIMPAT injection has been subject
`
`to
`
`regulatory review
`
`period as defined in 35 U.S.C 156g before its commercial marketing or
`
`use
`
`10
`
`

`
`U.S Patent No 5654301
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`35 U.S.C 156a5A 37 CFR 1.72Ofefi
`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 156c4 37 CFR 1.720h
`No other patent has been extended for the same regulatory review period
`for the product VIMPAT injection
`
`35 U.S.C 156dI 37 CFR 1.720f
`
`This application is submitted within the permitted 60 day period beginning
`
`on the date the product
`
`first
`
`received permission for commercial marketing
`
`or use
`
`Applicant is of the opinion that U.S Patent No 5654301 is eligible for extension
`
`under 35 U.S.C
`
`156 for 1104 days as determined pursuant to 37 CFR 1.775 as follows
`
`Patent
`
`Information
`
`Patent 5654301 Issue Date
`
`Earliest non-provisional priority date
`
`Days Extension under 35 U.S.C 154b
`
`FDA Information
`
`Date IND Became Effective
`
`Date NDA Submitted to the FDA
`Date NDA Approved by the FDA
`
`11
`
`August
`
`1997
`
`February 15 1985
`
`November 14 2003
`
`September 28 2007
`
`October 28 2008
`
`

`
`U.S Patent No 5654301
`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
`
`Egu1atory Review Period Allowed
`NDA Review Period days
`
`Regulatory Review Period days
`
`Reg Rev Period less 72 ThTD period days
`
`1414
`
`707
`
`397
`
`1811
`
`1104
`
`Statutory Limitations
`
`Patent Expiration Date 17 year term
`
`year extension limitation Date
`Expiration under
`Expiration under 14 from NDA approval
`
`limitation Date
`
`Expiration based upon full
`
`review period Date
`
`Final Expiration Date Earliest of Date
`
`Date
`
`or Date
`
`Maximum Extension in Days
`
`August
`
`August
`
`2014
`
`2019
`
`October 28 2022
`
`August 13 2017
`
`August 13 2017
`
`11042
`
`relevant
`
`date for when the
`above are performed assuming that November 14 2003 is the appropriate
`All calculations
`is possible that the FDA could
`regulatory review period started As noted above
`in footnote
`on page
`date as early as May 19 1999 is the appropriate date for the start of the regulatory review period
`determine that
`Should that earlier date or another earlier date in fact be the appropriate start date for the regulatory review period
`later Date
`then Applicant would be entitled to
`above For example
`longer calculated review period and thus
`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
`lasted 3451 days Thus the regulatory
`regulatory review period will have
`IND period as calculated would be 1924 days This would make the expiration of patent no
`review period less V2
`be November 11 2019 In this scenario Applicant
`5654301 based upon the full regulatory review period Date
`five-year extension of patent no 5654301 making it expire August
`would be entitled to
`2019 i.e Date
`full
`above
`
`it
`
`12
`
`

`
`US Patent No 5654301
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`13
`
`Duty To Disclose To The
`Statement That Applicant Acknowledges
`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
`
`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 1.20j
`
`for receiving and acting upon this
`
`application
`
`is to be charged to the Deposit Account of Applicants
`
`undersigned attorney as
`
`authorized in the attached letter
`
`15
`
`The Name Address And Telephone Number Of The Person To Whom Inquiries
`And Correspondence Relating To The Application For Patent Term Extension
`Are To Be Directed
`
`Please address all correspondence to
`
`Kevin
`
`Shaw
`
`Hartson LLP
`Hogan
`555 Thirteenth St NW
`Washington DC 20004
`
`16
`
`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
`
`

`
`U.S Patent No 5654301
`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
`
`The undersigned is registered to practice before the Patent and Trademark
`
`Office and is making this declaration as
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`patent attorney who has general
`
`authority to act on behalf of the applicant
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`in patent matters
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`The undersigned
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`has
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`reviewed
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`and understands
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`the contents
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`of
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`the
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`application being submitted pursuant to this section
`
`The undersigned believes the patent
`to an extension pursuant
`is subject
`1.7 10 in the event of NDA approval and in the interim is
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`37 C.F.R
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`to
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`subject to an extension pursuant
`
`to 37 C.F.R
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`1.790
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`The undersigned believes an extension of the length claimed is justified
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`under 35 U.S.C 156 and the applicable regulations and
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`The undersigned believes the patent
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`for which extension is being sought
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`meets the conditions for extension of the term of
`patent as set forth in 37
`1.720 in the event of NDA approval and meets the requirements
`
`C.F.R
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`for an interim extension of
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`patent set forth in 37 C.F.R
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`1.790
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`If
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`this application for extension of patent
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`term is held to be informal applicant
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`may seek to have that holding reviewed by filing
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`petition with the required fee as necessary
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`pursuant
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`to 37 C.F.R
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`1.181 1.182 or 1.183 as appropriate within such time as may be set in
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`any notice that the application has been held to be informal or if no time is set within one month
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`of the date on which the application was held informal
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`14
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`

`
`U.S Patent No 5654301
`Application for Extension of Patent Term
`Attorney Docket 32555-0002-2
`
`Dated December 23 2008
`
`HOGAN
`HARTSON LLP
`I3j Street N.W
`Washington D.C 20004
`202-637-5600
`Telephone
`Facsimile 202-637-5910
`Email kgshawhhlaw.com
`CustomerNo 24633
`
`Respectfully submitted
`
`By________________________
`Kevj4 Shaw
`egistration No.43110
`
`15