1
`
`••
`
`•
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent of
`
`Bengt AGERUP
`
`Patent No. 5,827,937
`
`Issued:. October 27, 1998
`
`FOR:
`
`POL YSACCHARIDE GEL
`COMPOSITION
`
`MAIL STOP: PATENT EXTENSION
`RECEIVED
`r;~3 1 o 2004
`REEXAMUNIT
`
`VIA HAND-CARRY TO USPTO
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`TRANSMITTAL LETTER FOR APPLICATION FOR EXTENSION
`OF PATENT TERM UNDER 35 U.S.C. § 156
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`-~•.·
`~·(cid:173)
`~;
`
`\
`
`(
`
`Enclosed is an Application for Extension of Patent Term Under 35 U.S.C. § 156 (an
`original and three copies) for the above-identified patent.
`
`Also enclosed with the original and each of the three copies ar~ the following documents:
`
`-1.
`
`2.'
`
`3.
`4.
`
`5.
`
`6.
`
`7.
`
`Attachment A(Copy,of Product Information About RESTYLANE®
`Injectable Gel)
`Attachment B ~Copy of Approval Letter from the FDA for
`RESTYLANE Injectable Gel)
`Attachment C (Copy of U.S. Patent No. 5,827,9.37)
`Attachment D (Copy of Statutory Disclaimer of Claim 4 for U.S. Patent
`No. 5,827,937)
`Attachment E (Copies of Maintenance Fee Statement for U.S. Patent No.
`5,827,937)
`A:ttachment F (Copy of Recorded Assignment Document for U.S. Patent
`No. 5,827,937)
`Attachment G (Copy of Authorization from Q-MED Scandinavia to Q(cid:173)
`MED AB to Rely Upon Activities ofQ-MED Scandinavia Before the
`FDA in Making Its Applications for Extension and Extension of Patent
`Term)
`·
`·
`
`ALL 2057
`PROLLENIUM V. ALLERGAN
`IPR2019-01505 et al.
`
`Page 1
`
`
`
`••
`
`•
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent of
`
`Bengt AGERUP
`
`Patent No. 5,827,937
`
`Issued:. October 27, 1998
`
`FOR:
`
`POL YSACCHARIDE GEL
`COMPOSITION
`
`MAIL STOP: PATENT EXTENSION
`RECEIVED
`r;~3 1 o 2004
`REEXAMUNIT
`
`VIA HAND-CARRY TO USPTO
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`TRANSMITTAL LETTER FOR APPLICATION FOR EXTENSION
`OF PATENT TERM UNDER 35 U.S.C. § 156
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`-~•.·
`~·(cid:173)
`~;
`
`\
`
`(
`
`Enclosed is an Application for Extension of Patent Term Under 35 U.S.C. § 156 (an
`original and three copies) for the above-identified patent.
`
`Also enclosed with the original and each of the three copies ar~ the following documents:
`
`-1.
`
`2.'
`
`3.
`4.
`
`5.
`
`6.
`
`7.
`
`Attachment A(Copy,of Product Information About RESTYLANE®
`Injectable Gel)
`Attachment B ~Copy of Approval Letter from the FDA for
`RESTYLANE Injectable Gel)
`Attachment C (Copy of U.S. Patent No. 5,827,9.37)
`Attachment D (Copy of Statutory Disclaimer of Claim 4 for U.S. Patent
`No. 5,827,937)
`Attachment E (Copies of Maintenance Fee Statement for U.S. Patent No.
`5,827,937)
`A:ttachment F (Copy of Recorded Assignment Document for U.S. Patent
`No. 5,827,937)
`Attachment G (Copy of Authorization from Q-MED Scandinavia to Q(cid:173)
`MED AB to Rely Upon Activities ofQ-MED Scandinavia Before the
`FDA in Making Its Applications for Extension and Extension of Patent
`Term)
`·
`·
`
`ALL 2057
`PROLLENIUM V. ALLERGAN
`IPR2019-01505 et al.
`
`Page 1
`
`
`
`Application for Extension of
`•
`Patent Term Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`8.
`
`Attachment H (Copy of Power of Attorney).
`
`Please charge the requisite fee in the amount of $1,120.00 to Deposit Account No. 02-
`
`4800.
`
`The Director is hereby authorized to charge any appropriate fees that may be required by
`this paper, and to credit any overpayment, to Deposit account No. 02-4800. This paper is
`submitted in duplicate.
`
`Respectfully submitted,
`
`BURNS, DOANE, SWECKER & MA THIS, LLP
`
`~l<i}d{#J.
`
`Benton S. Duffett, Jr.
`Registration No. 22,030
`
`P.O. Box 1404
`Alexandria, Virginia 22313-1404
`(&03) 838-6620
`
`Date: February 10, 2004
`
`2
`
`Page 2
`
`
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`•
`
`•
`
`Patent
`Attorney's Docket No. 003300-356
`
`,
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent of
`
`Bengt AGERUP
`
`Patent No.: 5,827,937
`
`Issued: October 27, 1998
`
`For:
`
`POL YSACCHARIDE GEL
`COMPOSITION
`
`) MAIL STOP: PATENT EXTENSION
`)
`.RECEIVED
`)
`fttJ '\ O 2004
`)
`)
`REEXAM UNIT
`)
`)
`)
`)
`)
`
`APPLICATION FOR EXTENSION OF
`PATENT TERM UNDER 35 U.S.C. § 156
`
`MAIL STOP: PATENT EXTENSION
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`In accordance with the provisions of 35 U.S.C. § 156 and 37 C.F.R. § 1.710 et seq., the
`
`owner ofrecord of U.S. Pi:ttent No. 5,827,937 requests that the term of this patent be extended by
`
`879 days to expire on December 12, 2017.
`
`U.S. Patent No. 5,827,937 was filed on July 17, 1995 and issued on October 27, 1998 for •
`
`"POL YSACCHARIDE GEL COMPOSITION," listing Bengt Agerup as the sole inventor. The
`
`term of U.S. Patent No. 5,827,937 will expire, unless extended, on July 17, 2015 (i.e., twenty
`
`years from the date on which the application for the patent was filed in the United States).
`
`Page 3
`
`
`
`•'
`
`•
`
`•
`
`Application For Extension Of
`Patent Term Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`Q-MED AB, a Swedish corporation, is the assignee of the entire right, title and interest in
`
`US. Patent No. 5,827,937, granted to BengtAgerup, on October 27, 1998 for
`
`POL YSACCHARIDE GEL COMPOSITION, by virtue of an assignment from the inventors to
`
`Q-MED AB, Upsala, Sweden, recorded on September 8, 1997 at Reel 8741, Frame 0942.
`
`Q-MED AB submits this application for extension of the patent term of U.S. Patent No.
`
`5,827,937 by providing the following information in accordance with 35 U.S.C. § 156 and 37
`
`C.F.R. § 1.710 et seq., and follows the numerical format set forth in 37 C.F.R. §l.740(a)(l)-(15)
`
`2
`
`Page 4
`
`
`
`,,
`
`•
`
`•
`
`Application For Extension Of
`Patent Term Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`(1)
`
`COMPLETE IDENTIFICATION OF PRODUCT
`
`The product presently subject to regulatory review is RESTYLANE® Injectable Gel
`
`(trade name). Product information from the U.S. Food and Drug Administration website
`
`regarding RESTYLANE® Injectable Gel is attached atATTACHMENT A.
`
`RESTYLANE® Injectable Gel contains 20 mg/ml of non-animal stabilized hyaluronic
`
`acid (hereinafter "NASHA") in buffered physiological sodium chloride solution pH 7.
`
`RESTYLANE® Injectable Gel is a sterile, transparent, viscous gel supplied in a 1 ml disposable
`
`glass syringe filled with 0.4 or 0.7 ml gel. The syringe is equipped with a tip cap, finger grip,
`
`plunger stopper and plunger rod. The product is for single use only. A sterile 30G needle is
`
`supplied in the package.
`
`Hyaluronic acid is a polymer containing alternating units of glucuronic acid (GlcUA) and
`
`N-acetylglucosamine (GlcNAc). NASHA is a generic name for the stabilized forms of
`
`Hyaluronic Acid (hereinafter "HA") from Q-MED. The HA in RESTYLANE® Injectable Gel is
`
`stabilized by adding a minimum amount of 1,4-butanediol diglycidyl ether to allow formation of
`
`a 3-dimensional HA molecular network (gel). The patented chemical stabilizing process used by
`
`Q-MED does not change the polyanionic character of the polysaccharide chain. As only about
`
`1 % of the polysaccharide has been stabilized the substance remains biocompatible.
`
`Hyaluronic acid belongs to a group of very few substances, which are identical in all
`
`living organisms.· It is a natural polysaccharide that is present throughout the tissues of the body.
`
`3
`
`Page 5
`
`
`
`•l
`
`•
`
`•
`
`Application For Extension Of
`Patent Term Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`It occurs as an important structural element in the skin and in subcutaneous and connective
`
`tissues as well as in the synovial tissue and fluid. RESTYLANE® Injectable Gel is biologically
`
`almost identical to hyaluronic acid and is degraded in the body by the same metabolic pathway
`
`as endogenous hyaluronic acid. RESTYLANE® Injectable Gel acts by adding volume to the
`
`tissue, thereby restoring the skin contours to the desired level of correction. RESTYLANE®
`
`Injectable Gel is naturally integrated into the tissue and will in .time undergo isovolemic
`
`degradation.
`
`4
`
`Page 6
`
`
`
`"
`
`•
`
`•
`
`Application For Extension Of
`Patent Term Under 35 U .S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`(2)
`
`.
`IDENTIFICATION OF FEDERAL STATUTE/PROVISION OF LAW
`
`.
`
`RESTYLANE® Injectable Gel is subject to regulatory review under Section 515 of the
`
`Federal Food, Dnig, and Cosmetic Act (21 U.S.C. § 355), as a Class III medical device.
`
`5
`
`Page 7
`
`
`
`"
`
`•
`
`•
`
`Application For Extension Of
`Patent Term Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`(3)
`
`DATE ON WHICH PRODUCT RECEIVED PERMISSION FOR COMMERCIAL
`
`MARKETING OR USE
`
`RES_TYLANE® Injectable Gel received permission for commercial marketing under
`
`Section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355) on December 12,
`
`2003. A copy of the approval letteris attached as ATTACHMENT B.
`
`6
`
`Page 8
`
`
`
`•
`
`•
`
`Application For Extension Of
`Patent Term Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`(4)
`
`IDENTIFICATION OF EACH ACTIVE. INGREDIENT
`
`3 7 C.F .R. § 1. 7 40( a)( 4) requires that 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."
`
`. RESTYLANE® Injectable Gel is a Class III medical device, not a drug product.
`
`Moreover, _RESTYLANE® Injectable Gel does not contain any active ingredient. Accordingly,
`
`this section is not applicable.
`
`7
`
`Page 9
`
`
`
`•
`
`•
`
`Application For Extension Of
`Patent Term Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`(5)
`
`TIME PERIOD FOR SUBMITTING APPLICATION
`
`This application is being submitted within the sixty day period permitted for submission
`
`pursuant to§ l.720(f). Specifically, this application is being submitted within the sixty-day
`
`period "beginning on t~e date the product first received permission for commercial marketing or
`
`use under the provisions of law under which the applicable regulatory review period occurred."
`
`RESTYLANE® Injectable Gel received permission for commercial marketing under
`
`Section 515-ofthe Federal Food, Drug, and Cosm~tic Act (21 U.S.C. § 355) on December 12,
`
`2003. A copy of the approval letter is attached at ATTACHEMENT B. Sixty days from
`
`December 12, 2003 would be February 10, 2004.
`
`Thus, the last day on which this application could be submitted is February 10, 2004.
`
`8
`
`Page 10
`
`
`
`•
`
`•
`
`Application For Extension Of
`Patent Tenn Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`(6)
`
`IDENTIFICATION OF PATENT
`
`The patent for which patent term extension is being sought is U.S. Patent No. 5,827,937,
`
`which was filed on July 17, 1995 and issued on October 27, 1998 for "POLYSACCHARIDE
`
`GEL COMPOSITION," listing Berigt Agerup as the sole inventor.
`
`The term of U.S. Patent No. 5,827,937 will expire, unless extended, on July 17, 2015
`
`_ (twenty years from the date on which the application for the patent was filed in the United
`
`States).
`
`9
`
`Page 11
`
`
`
`:
`
`•
`
`•
`
`Application For Extension Of
`Patent Term Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`(7)
`
`COPYOFPATENT
`
`A copy of U.S. Patent No. 5,827,937 is attached as ATTACHMENT C.
`
`10
`
`Page 12
`
`
`
`•
`
`•
`
`Application For Extension Of
`Patent Tenn Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`(8)
`
`OTHER PATENT DOCUMENTS
`
`A copy of the statutory disclaimer of Claim 4 is attached as ATTACHMENT D.
`
`The records of the undersigned do not indicate that any other disclaimer, certificate of
`
`correction or reexamination certificate were issued in U.S. Patent No. 5,827,937.
`
`The fourth-year maintenance fee has been paid, and a copy of the maintenance fee
`
`statement (from the U.S. Patent & Trademark Office Web site) verifying the payment is attached
`
`as ATTACHMENT E.
`
`A copy of the recorded Assignment documents (from the records of the U.S. Patent and
`
`Trademark Office) are attached as ATTACHMENT F.
`
`11
`
`Page 13
`
`
`
`•
`
`•
`
`Application For Extension Of
`Patent Term Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`· Attorney Docket No.: 003300-356
`
`(9)
`
`CLAIM(S) COVERING THE PRODUCT
`
`The claims of U.S. Patent No. 5,827,937 cover the approved product, RESTYLANE®
`
`Injectable Gel, as well as a method of manufacturing the approved product.
`
`As required, Applicants provide a showing below, which lists each applicable patent
`
`claim and demonstrates the manner in which each of the following claims reads upon the
`
`approved product and the method of manufacturing the approved product.
`
`Claim as-issued
`
`RESTYLANE® Injectable Gel
`
`1. A process for preparing a cross-linked
`biocompatible polysaccharide gel
`composition, which process comprises the
`following steps:
`
`RESTYLANE® Injectable Gel is a cross-
`linked biocompatible polysaccharide gel
`composition.
`
`(i) forming an aqueous solution of a water RESTYLANE® Injectable Gel is
`soluble, cross-linkable polysaccharide;
`manufactured by a process whereby
`hyaluronic acid prepared by fermentation
`of Streptococcus is first dissolved in an
`alkaline aqueous solution. Hyaluronic
`acid is a "a water soluble, cross-linkable
`polysaccharide."
`
`(ii) initiating a first cross-linking reaction
`whereby cross-linking of said
`polysaccharide is effected using a
`polyfunctional cross:-linking agent
`therefor;·
`
`A cross-linking agent, 1,4-butanediol
`diglycidyl ether, is used to initiate a first
`cross-linking reaction. Thus, cross
`linking of the polysaccharide is effected
`using "a polyfunctional cross-linking
`agent." (See, e.g., column 4, lines 10-21
`of U.S. Patent. No. 5,827,937 for the
`
`12
`
`Page 14
`
`
`
`•
`
`•
`
`Application For Extensjon Of
`Patent Tenn Under 35 U .S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`Claim as-issued
`
`RESTYLANE® Injectable Gel
`
`(iii) sterically hindering the first cross-
`linking reaction such that it is terminated
`before gelation occurs, resulting in the
`production of an activated polysaccharide;
`
`and
`
`(iv) performing a second cross-linking
`reaction after sterically unhindered
`conditions are reintroduced for said
`activated polysaccharide to produce a
`viscoelastic gel.
`.
`
`definition of polyfunctional cross-linking
`agent.)
`
`The above solution was first incubated
`and then diluted in a physiological buffer
`and neutralized. The dilution step
`accomplishes the step of "sterically
`hindering the first cross-linking reaction
`such that it is terminated before gelation
`occurs, resulting in the production of an
`activated polysaccharide," as recited in
`the claims. (See, e.g., column 3, lines 25-
`31 of U.S. Patent No. 5,827,937.)
`
`The activated polysaccharide was then
`rotary evaporated to form a viscoelastic
`gel with a neutral pH and a HA
`concentration of about 2% (w/w). The
`rotary evaporation step accomplishes the
`step of "performing a second cross-linking
`. reaction after sterically unhindered
`conditions are reintroduced for said ·
`activated polysaccharide to produce a
`viscoelastic gel." (See, e.g., column 3,
`lines 32-56 of U.S. Patent No. 5,827,937.)
`
`Thus, Claim 1 reads on the method or
`manufacture for RESTYLANE®
`Injectable Gel.
`
`2. A process according to claim 1,
`wherein the polysaccharide is selected
`
`RESTYLANE® Injectable Gel comprises
`a cross-linked gel of hyaluronic acid.
`
`13
`
`Page 15
`
`
`
`•
`
`•
`
`Application For Extension Of
`Patent Term Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`Claim as-issued
`
`RESTYLANE® Injectable Gel
`
`from the group consisting of glucose
`amino glucans.
`
`Hyaluronic acid is a polysaccharide that is
`a "glucose amino glucan.". Thus, Claim 2
`reads on the method of manufacture for
`RESTYLANE® Injectable Gel.
`
`3. A process according to claim 2,
`wherein said glucose amine glucan
`comprises hyaluronic acid.
`
`5. A process according to claim 4,
`wherein said glycidyl ether comprises 1,4-
`butanediol diglycidylether.
`_
`
`6. A process according to claim 1,
`wherein said sterically hindering of the
`cross-linking reaction comprises diluting
`the aqueous medium in which the cross(cid:173)
`linking reaction is performed, to
`accomplish a lower concentration of the
`polysaccharide in said medium.
`
`RESTYLANE® Injectable Gel comprises
`a cross-linked gel of hyaluronic acid,
`which is a glucose amine glucan. Thus,
`Claim 3 reads on the method of
`manufacture for RESTYLANE®
`Injectable Gel.
`
`RESTYLANE® Injectable Gel uses a
`glycidyl ether, which cpmprises 1 ;4-
`butanediol diglycidylether. Thus, Claim 5
`reads on the method of manufacture for
`RESTYLANE® Injectable Gel.
`
`As discussed above, the manufacture of
`RESTYLANE® Injectable Gel comprises
`a "cross-linking reaction" that includes
`"diluting the aqueous medium in which
`the cross-linking reaction is performed, to
`accomplish a lower concentration of the
`polysaccharide in said medium." Thus,
`Claim 6 reads on the method of
`manufacture for RESTYLANE®
`Injectable Gel.
`
`7. A process according to claim 1,
`wherein said reintroduction of sterically
`. unhindered conditions comprises
`evaporating the aqueous medium in which
`
`The manufacture of RESTYLANE®
`Injectable Gel comprises a "reintroduction
`of sterically unhindered conditions" that
`includes "evaporating the aqueous
`
`14
`
`Page 16
`
`
`
`•
`
`•
`
`Application For Extension Of
`Patent Term Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`Claim as-issued
`
`RESTYLANE® Injectable Gel
`
`the cross-linking reaction is performed, to
`accomplish a higher concentration of the
`polysaccharide in said medium.
`
`9. A process according to claim 1,
`wherein the initial cross-linking reaction
`in the presence of a polyfunctional cross-
`linking agent is performed at an alkaline
`pH, ether cross-linking reactions thereby
`being promoted.
`
`10. The process of claim 9, wherein the
`cross-linking is effected at a pH above pH
`9.
`
`12. A process according to claim .1,
`wherein said sterical hindrance of the
`cross-linking reaction is accomplished
`before said cross-linking agent has been
`consumed.
`
`medium in which the cross-linking
`reaction is performed, to accomplish a
`higher concentration of the polysaccharide
`in said medium." Thus, Claim 7 reads on
`the method of manufacture for
`RESTYLANE® Injectable Gel.
`
`The manufacture ofRESTYLANE®
`Injectable Gel comprises an "initial cross-
`linking reaction in the presence of a
`polyfunctional cross-linking agent" that is
`"performed at an alkaline pH," with "ether
`cross-linking reactions thereby being
`promoted." Thus, Claim 9 reads on the
`method of manufacture for
`RESTYLANE® Injectable Gel.
`
`The manufacture of RESTYLANE®
`Injectable Gel comprises a "cross-linking"
`reaction that is "effected at a pH above pH
`9." Thus, Claim 10 reads on the method
`of manufacture for RESTYLANE®
`Injectable Gel.
`
`. The manufacture of RESTYLANE®
`Injectable Gel comprises a dilution step,
`which accomplishes "sterical hindrance of
`the cross-linking reaction." The dilution
`step is "accomplished before said cross-
`linking agent has been consumed." Thus,
`Claim 12 reads on the method of
`manufacture for RESTYLANE®
`Injectable Gel.
`
`24. A cross-linked biocomoatible
`
`RESTYLANE® Injectable Gel is a cross-
`
`15
`
`Page 17
`
`
`
`..
`
`•
`
`•
`
`Application For Extension Of
`Patent Term Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`Claim as-issued
`
`RESTYLANE® Jnjectable Gel
`
`polysaccharide gel composition, which is
`obtainable by cross-linking of a cross-
`linkable polysaccharide with a
`polyfunctional cross-linking agent
`therefor in two steps,
`
`linked biocompatible polysaccharide gel
`composition, which is obtainable by
`cross-linking of a cross-linkable
`polysaccharide with a polyfunctional
`cross-linking agent in two steps.
`
`the first cross-linking step being
`terminated before gelation occurs by a
`sterical hindrance of the cross-linking
`reaction, and
`
`the second cross-linking step being
`initiated by reintroducing sterically
`unhindered conditions for said cross-
`linking reaction to continue the same up
`to a viscoelastic gel,
`
`In a first step, a cross-linking agent, 1,4-
`butanediol diglycidyl ether, is used to
`initiate a first cross-linking reaction. The
`above solution is incubated and then
`. diluted in a physiological buffer and
`neutralized. The dilution step
`accomplishes the step of "sterically
`hindering the first cross-linking reaction
`such that it is terminated before gelation
`occurs, resulting in the production of an
`activated polysaccharide," as recited in
`the claims. (See, e.g., column 3, lines 25-
`31 of U.S. Patent No. 5,827,937.)
`
`In a second step, the activated
`polysaccharide is then rotary evaporated
`to form a viscoelastic gel with a neutral
`pH and a HA concentration of about 2%
`(w/w). The rotary evaporation step
`accomplishes the step of "performing a
`second cross-linking reaction after
`sterically unhindered conditions are
`reintroduced for said activated
`polysaccharide to produce a viscoelastic
`gel." (See, e.g., column 3, lines 32-56 of
`U.S. Patent No. 5,827,937.)
`
`16
`
`Page 18
`
`
`
`•
`
`•
`
`Application For Extension Of
`Patent Term Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`Claim as-issued
`
`RESTYLANE@ Injectable Gel
`
`wherein said gel composition exhibits
`retained biocompatibility, viscoelasticity
`and does not swell substantially when
`placed in contact with water.
`
`33. A medical or prophylactic
`composition comprising a polysaccharide
`gel composition according to claim 24.
`
`RESTYLANE® Injectable Gel exhibits
`retained biocompatibility, viscoelasticity
`and does not swell substantially when
`placed in contact with water.
`
`Thus, Claim 24 reads on.the method of
`manufacture for RESTYLANE®
`Injectable Gel.
`
`RESTYLANE® is a medical or
`prophylactic composition that comprises
`"a polysaccharide gel composition
`according to claim 24." Thus, Claim 33
`reads on the method of manufacture for
`RESTYLANE® Injectable Gel.
`
`17
`
`Page 19
`
`
`
`..
`
`•
`
`•
`
`Application For Extension Of
`Patent Tenn Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`(10) RELEVANT DATES AND INFORlVIATION
`PURSUANT TO 35 U.S.C. § 156(g)
`
`The relevant dates and information pursuant to 35 U.S.C. § 156(g), and 37 C.F.R. §
`
`l.740(a)(10)(v), to enable the Secretary of Health and Human Services to determine the
`
`applicable regulatory review period for a.patent claiming a medical device are as follows:
`
`(a)
`
`The effective date of the investigational device exemption (IDE) and the IDE
`
`number: IDE G990258 was submitted by Q-MED Scandinavia, Inc. on
`
`October 14, 1999, and became effective on August 4, 2000.
`
`(b)
`
`The date on which the application for product approval or notice of
`
`completion of a product development protocol under section 515 of the
`
`Federal Food, Drug, and Cosmetic Act was initially submitted and the
`
`number of the application or protocol: The application for product approval
`
`under section 515 of the Federal Food, Drug, and Cosmetic Act was.initially
`
`submitted on June 19, 2002. The application number was P020023.
`
`(c)
`
`The date on which the application was approved: December 12, 2003.
`
`18
`
`Page 20
`
`
`
`,,
`
`:
`
`•
`
`•
`
`Application For Extension Of
`Patent Term Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`(11) BRIEF DESCRIPTION OF SIGNIFICANT ACTIVITIES
`
`The following is a brief description of the significant activities undertaken by the
`
`marketing applicant during the applicable regulatory review period with respect to
`
`RESTYLANE® Injectable Gel and the significant dates applicable to such activities.
`
`Date
`March 17, 1999
`
`To
`FDA
`
`From
`Akin,
`Gump
`
`Type
`Summary
`Submission Meeting request Letter
`Pre-IDE Meeting
`
`October 14, 1999 FDA
`
`AJG
`
`Submission
`
`November 12,
`1999
`
`AJG
`
`FDA
`
`Facsimi.le
`
`December 3,
`1999
`December 15,
`1999
`
`December 28,
`1999
`January 6, 2000
`
`FDA
`
`AJG
`
`Letter
`
`Minutes
`
`FDA
`
`AJG
`
`Submission
`
`January 11, 2000
`
`Minutes
`
`Filed original IDE for treatment of
`cutaneous contour deformities such as
`nasolabial folds.
`FDA granted conditional approval for
`two sites with 10 subjects each. FDA
`stated that issues of clinical design
`remain that must be addressed. Letter
`lists deficiencies and the protocol and
`RPI must be revised. ·
`Requested a meeting with FDAto
`discuss clinical issues
`Safety, study design, hypersensitivity and
`other issues were addressed. From the
`minutes it appears that a formal meeting
`was set for January 11, 2000.
`First screening visit; patient examined
`and received collagen test in the arm
`Submission of safety data in responst: to
`questions raised in FDA's November 12,
`1999 letter.
`This letter also refers to the December
`15, 1999 conference call.
`Safety and clinical 1ssues were discussed.
`FDA expects a revised orotocol and
`
`19
`
`Page 21
`
`
`
`•
`
`Date
`
`To
`
`From
`
`Type
`
`February 4, 2000 A/G
`
`FDA
`
`Letter
`
`March. 16, 2000
`
`March 16, 2000
`
`FDA
`
`A/G
`
`Submission
`
`April 13, 2000
`
`A/G
`
`FDA
`
`Letter
`
`April 26, 2000
`
`Minutes
`
`Mav 11, 2000
`May 26, 2000
`
`FDA
`
`A/G
`
`Minutes
`Submission
`
`June 9, 2000
`
`FDA
`
`A/G
`
`Submission
`
`June 29, 2000
`
`A/G
`
`FDA
`
`Letter
`
`' '
`
`•
`
`Application For Extension Of
`Patent Term Under 35 U.S.C. §.156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`Summary
`invited further teleconferences.
`FDA acknowledged the January 6, 2000
`submission and conditionally approved
`the IDE for 45 days but still for only 2
`. sites and 10 patients each. The
`deficiencies from the November 12, 1999
`letter must be corrected.
`First Patient included and treated within
`the study
`Filed responses to FDA's November 12,
`1999 letter and submitted a revised
`protocol (31 GE 0003) and CRF.
`FDA acknowledged the March 16, 2000
`submission but still only granted
`conditional approval. The protocol was
`still considered unacceptable.
`Teleconference minutes cover various
`protocol issues including duration, touch-
`up, validation of clinical endpoints,
`statistics, informed consent, etc.
`Teleconference
`Provided FDA with revised protocol, the
`minutes of the May 11, 2000
`teleconference, and specific responses to
`deficiencies.
`Provided FDA with copies of various
`CRFs.
`FDA acknowledged receipt of
`submissions dated May 26 and June 9
`2000. Letter states the application
`remains conditionally approved and
`limited to 5 sites and 30 subjects. At
`issue is the validity of the clinical
`endpoints. FDA expects a revised
`protocol.
`
`20
`
`Page 22
`
`
`
`•
`
`Date
`July 6, 2000
`
`July 7, 2000
`
`To
`
`From
`
`Type
`Minutes
`
`Minutes
`
`July 11, 2000
`
`FDA
`
`August 4, 2000
`
`BI
`
`Buchanan Submission
`Ingersoll
`(Bl)
`FDA
`
`Letter
`
`October 12, 2000 FDA
`
`BI
`
`Letter
`
`November 3,
`2000
`November 14,
`2000
`
`December 11,
`2000
`
`December 12,
`2000
`
`BI
`
`FDA
`
`Letter
`
`FDA
`
`BI
`
`Submission
`
`BI
`
`FDA
`
`Letter
`
`FDA
`
`BI
`
`Submission
`
`January 12, 2001 BI
`
`FDA
`
`Letter
`
`January 31, 2001 FDA
`
`BI
`
`Fax
`
`21
`
`•
`
`Application For Extension Of
`Patent Term Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`Summary
`Minutes of a teleconference with FDA
`covering the June 29, 2000 letter. Call
`covered statistical issues.
`Minutes of a teleconference with FDA
`covering the June 29, 2000 letter. Call
`covered not statistical issues.
`Submitted revised protocol, patient
`diaries, CRFs, example photographs in
`response to FDA's June 29, 2000 letter.
`FDA approved the IDE. FDA provided
`two points of advice regarding the
`analysis of data for safety and
`effectiveness.
`Requested that FDA allow the addition of
`another clinical site.
`FDA allowed the addition of one more
`clinical site.
`Covers manufacturing changes: scale up
`from 4000 to 15,000 syringes; removed
`methanol from process; changed test
`methods and added bioburden.
`FDA acknowledged the November 14,
`2000 letter.
`FDA accepted the manufacturing
`changes submitted.
`Submitted ''Validation of the Wrinkle
`Severity Rating Scale A Sub-study
`within 31 GE 0003.
`Submission of December 12, 2000
`unacceptable. Submission only covers a
`2-point scale while the protocol requires
`a 5-point scale. FDA requested data
`within 45 days of date of the letter.
`Sent FDA a copy of the July 6, 2000
`teleconference minutes. -
`
`Page 23
`
`
`
`•
`
`Date
`February 26,
`2001
`
`To
`FDA
`
`From
`BI
`
`Type
`Submission
`
`March 22, 2001
`
`BI
`
`FDA
`
`Letter
`
`· June 19, 2002
`
`FDA
`
`Q-MED
`
`Submission
`
`July 30, 2002
`
`Q-MED
`
`FDA
`
`Letter
`
`September 6,
`2002
`
`September 12,
`2002
`
`FDA
`
`Q-MED
`
`Submission
`
`FDA
`
`Q-MED
`
`Submission
`
`October 4, 2002 Q-MED
`
`FDA
`
`Letter
`
`· November 18,
`2002
`
`December 27,
`2002
`
`Q-MED
`
`FDA
`
`Letter
`
`FDA
`
`Q-MED
`
`Submission
`
`22
`
`•
`
`Application For Extension Of
`Patent Term Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`'
`
`Summary
`Submitted revised clinical validation
`report- see December 12, 2000 and
`January 12, 2001.
`FDA acknowledged submission of
`February 26, 2001. FDA accepted the
`revised validation report.
`Submitted original PMA for the
`treatment of cutaneous contour
`deformities such as nasolabial folds.
`Also informed FDA facility ready for
`inspection in August 2002.
`FDA made a threshold determination that
`the PMA is sufficiently complete to
`permit substantive review and suitable
`for filing.
`Deficiencies were noted in the letter.
`Provided a partial response to FDA is
`issues listed in the July 30, 2002 FDA
`letter. Responds to 3 of 7 deficiencies
`including clinical, manufacturing,
`statistical areas.
`Provided financial disclosure in and also
`informed FDA that some labeling would
`be modified per FDA's request (July 30,
`2002 letter).
`FDA scheduled a meeting for October
`10, 2002; this was a 100-day meeting to
`·discuss deficiencies in the PMA. FDA
`listed the current deficiencies in the
`aoolication.
`FDA stated PMA lacks information to
`complete review. This 10-page letter
`lists the deficiencies found by FDA.
`Provided a complete response to FDA's
`November 18, 2002 letter. Some
`
`Page 24
`
`
`
`•
`
`Date
`
`To
`
`From
`
`Type
`
`May 5, 2003
`June 16, 2003
`
`Q-MED
`FDA
`
`FDA
`Q-MED
`
`Letter
`Submission
`
`Aug 8, 2003
`
`FDA
`
`Q-MED
`
`Letter
`
`November 21,
`2003
`December 12,
`2003
`
`Q-MED
`
`FDA
`
`Approval
`Letter
`
`•
`
`Application For Extension Of
`Patent Term Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`Summary
`additional information was included as
`well to update the PMA. Also, provided
`comments regarding the need for a Panel
`meeting.
`Received a deficiency letter from FDA.
`Provided a complete response to the FDA
`deficiency letter of May 5, 2003.
`Provided data for risk assessment for
`residual BDDE, adverse events for other
`countries, safety data on specific ethnic
`groups.•
`Notified FDA that the letter represents
`the final report for the IDE and stated
`_that the final report was submitted in the
`PMA. No further clinical trials are
`anticipated.
`Advisory Panel meeting
`
`FDA approved the PMA for mid-to-deep
`dermal implantation for the correction of
`moderate to severe facial wrinkles and
`folds, such as nasolabial folds. There was
`agreement to perform a Phase IV study.
`
`23
`
`Page 25
`
`
`
`,,
`
`•
`
`•
`
`Application For Extension Of
`Patent Term Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`PLEASE NOTE: IDE 0990258 was submitted by Q-MED Scandanavia on October 14,
`
`1999 and became effective on August 4, 2000. P020023 was submitted by Q-MED Scandinavia,
`
`Inc. on June 19, 2002, and approved by the FDA on December 12, 2003. Q-MED Scandinavia,
`
`Inc. is a wholly owned subsidiary of Q-MED AB. An authorization from Q-MED Scandinavia,
`
`Inc. to Q-MED AB, to rely upon the activities of Q-MED Scandinavia, Inc. before the FDA
`
`during the regulatory review period in making its applications for extension and extension of
`
`patent term, and granting the Commissioner for Patents and the Secretary for Health and Human
`
`Services and/or Commissioner of Food and Drugs the right to refer to IDE 0990258 and
`
`P020023 in determining the eligibility of Q-MED AB for such extensions, is attached as
`
`ATTACHMENT G .
`
`. ,
`
`24
`
`Page 26
`
`
`
`...
`
`•
`
`•
`
`Application For Extension Of
`Patent Term Under 35 U.S.C. § 156
`for U.S. Patent No. 5,827,937
`Attorney Docket No.: 003300-356
`
`(12) ELIGIBILITY FOR EXTENSION OF PATENT TERM
`
`In the opinion of Q-MED AB, U.S. Patent No. 5,827,937 is eligible for the requested
`
`extension of patent term, and the length of extension claimed is 879 days.
`
`The length of extension of the-term of U.S. Patent No. 5,827,937 of 879 days is based
`
`upon 3 7 C.F .R. § 1. 777, which states that the term of the patent for a medical device will be
`
`extended by the length of the regulatory review period for the product as determined by the
`
`Secretary of Health and Human ,Services, reduced .as appropriate pursuant to paragraphs ( d)( 1)
`
`through ( d)( 6) of this section.
`
`37 C.F.R. §1.777{c)
`
`First of all, the length of the regulatory review period for a medical device will be
`
`determined by the Secretary of Health and Human Services. Under 35 U.S.C. 156(g)(3)(B), it is
`
`the sum of:
`
`(1) The number of days in the period beginning on the date a
`clinical investigation on humans involving the device was
`begun and ending on the date an application was initially
`su
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