19406
`
`Federal Register I Vol. 75, No. 71 I Wednesday, April 14, 2010 I Notices
`
`TABLE 1.-ESTIMATED ANNUAL REPORTING 8URDEN1
`
`Food Code Survey
`
`No. of
`Respondents
`
`Annual Frequency per
`Response
`
`Total Annual
`Responses
`
`Hours per
`Response
`
`Total Hours
`
`300
`Respondents
`4
`75
`1 There are no capital costs or operating and maintenance costs associated with this collection of information.
`
`1
`
`300
`
`This estimate is based on FDA's
`experience and the number of updates
`received in the past 3 years. FDA
`estimates that 75 respondents will
`provide four quarterly updates each,
`resulting in an estimated 300 total
`annual responses. The agency estimates
`that each quarterly update will take
`about 1 hour. Of the 75 respondents,
`those who amend their regulations with
`changes unrelated to the risk factors and
`interventions, and those who are not
`adopting model FDA Food Code
`provisions, but are incorporating certain
`Conference for Food Protection
`recommendations only, will likely need
`only annual contact.
`Dated: April 9, 2010.
`Leslie Kux,
`Acting Assistant Commissioner for Policy.
`IFR Doc. 2010-8510 Filed 4-13-10; 8:45 amJ
`BILLING CODE 41611--0l-S
`
`DEPARTMENT OF HEAL TH AND
`HUMAN SERVICES
`
`Food and Drug Administration
`[Docket No. FDA-2009-E--0413]
`
`Determination of Regulatory Review
`Period for Purposes of Patent
`Extension; AFINITOR
`AGENCY: Food and Drug Administration,
`HHS.
`ACTION: Notice.
`
`SUMMARY: The Food and Drug
`Administration (FDA) has determined
`the regulatory review period for
`AFINITOR and is publishing this notice
`of that determination as required by
`law. FDA has made the determination
`because of the submission of an
`application to the Director of Patents
`and Trademarks, Department of
`Commerce, for the extension of a patent
`which claims that human drug product.
`ADDRESSES: Submit written comments
`and petitions to the Division of Dockets
`Management (HFA-305), Food and Drug
`Administration, 5630 Fishers Lane, rm.
`1061, Rockville, MD 20852. Submit
`electronic comments to http:!/
`www.regulations.gov.
`FOR FURTHER INFORMATION CONTACT:
`Beverly Friedman, Office of Regulatory
`Policy, Food and Drug Administration,
`
`10903 New Hampshire Ave., Bldg. 51,
`rm. 6222, Silver Spring, MD 20993-
`0002, 301-796-3602.
`SUPPLEMENTARY INFORMATION: The Drug
`Price Competition and Patent Term
`Restoration Act of 1984 (Public Law 98-
`417) and the Generic Animal Drug and
`Patent Term Restoration Act (Public
`Law 100-670) generally provide that a
`patent may be extended for a period of
`up to 5 years so long as the patented
`item (human drug product, animal drug
`product, medical device, food additive,
`or color additive) was subject to
`regulatory review by FDA before the
`item was marketed. Under these acts, a
`product's regulatory review period
`forms the basis for determining the
`amount of extension an applicant may
`receive.
`A regulatory review period consists of
`two periods of time: A testing phase and
`an approval phase. For human drug
`products, the testing phase begins w.hen
`the exemption to permit the clinical
`investigations of the drug becomes
`effective and runs until the approval
`phase begins. The approval phase starts
`with the initial submission of an
`application to market the human drug
`product and continues until FDA grants
`permission to market the drug product.
`Although only a portion of a regulatory
`review period may count toward the
`actual amount of extension that the
`Director of Patents and Trademarks may
`award (for example, half the testing
`phase must be subtracted as well as any
`time that may have occurred before the
`patent was issued), FDA's determination
`of the length of a regulatory review
`period for a human drug product will
`include all of the testing phase and
`approval phase as specified in 35 U.S.C.
`.
`156(g)(l )(B).
`FDA recently approved for marketing
`the human drug product AFINITOR
`(everolimus). AFINITOR is indicated for
`treatment of patients with advanced
`renal cell carcinoma after failure of
`treatment with sunitinib or sorafenib.
`Subsequent to this approval, the Patent
`and Trademark Office received a patent
`term restoration application for
`AFINITOR (U.S. Patent No. 5,665,772)
`from Novartis AG, and the Patent and
`Trademark Office requested FDA's
`assistance in determining this patent's
`eligibility for patent term restoration. In
`a letter dated September 2, 2009, FDA
`
`advised the Patent and Trademark
`Office that this human drug product had
`undergone a regulatory review period
`and that the approval of AFINITOR
`represented the first permitted
`commercial marketing or use of the
`product. Thereafter, the Patent and
`Trademark Office requested that FDA
`determine the product's regulatory
`review period.
`FDA has determined that the
`applicable regulatory review period for
`AFINITOR is 4,486 days. Of this time,
`4,212 days occurred during the testing
`phase of the regulatory review period,
`while 274 days occurred during the
`approval phase. These periods of time
`were derived from the following dates:
`1. The date an exemption under
`section 505(i) of the Federal Food, Drug,
`and Cosmetic Act (the act) (21 U.S.C.
`355(i)) became effective: December 19,
`1996. FDA has verified the applicant's
`claim that the date the investigational
`new drug application became effective
`was on December 19, 1996.
`2. The date the application was
`initially submitted with respect to the
`human drug product under section
`505(b) of the act: June 30, 2008. FDA
`has verified the applicant's claim that
`the new drug application (NDA) 22-334
`was submitted on June 30, 2008.
`3. The date the application was
`approved: March 30, 2009. FDA has
`verified the applicant's claim that NDA
`22-334 was approved on March 30,
`2009.
`This determination of the regulatory
`review period establishes the maximum
`potential length of a patent extension.
`However, the U.S. Patent and
`Trademark Office applies several
`statutory limitations in its calculations
`of the actual period for patent extension.
`In its application for patent extension,
`this applicant seeks 1,826 days of patent
`term extension.
`Anyone with knowledge that any of
`the dates as published are incorrect may
`submit to the Division of Dockets
`Management (see ADDRESSES) written or
`electronic comments and ask for a
`redetermination by June 14, 2010.
`Furthermore, any interested person may
`petition FDA for a determination
`regarding whether the applicant for
`extension acted with due diligence
`during the regulatory review period by
`October 12, 2010. To meet its burden,
`
`
`
`

`
`. .
`
`;
`
`Federal Register/Vol. 75, No. 71/Wednesday, April 14, 2010/Notices
`
`19407
`
`the petition must contain sufficient facts
`to merit an FDA investigation. (See H.
`Rept. 857, part 1, 98th Cong., 2d sess.,
`pp. 41-42, 1984.) Petitions should be in
`the format specified in 21 CFR 10.30.
`Comments and petitions should be
`submitted to the Division of Dockets
`Management. Three copies of any
`mailed information are to be submitted,
`except that individuals may submit one
`copy. Comments are to be identified
`with the docket number found in
`brackets in the heading of this
`document. Comments and petitions may
`be seen in the Division of Dockets
`Management between 9 a.m. and 4 p.m.,
`Monday through Friday.
`Dated: March 22, 2010.
`Jane A. Axelrad,
`Associate Director for Policy, Center far Drug
`Evaluation and Research.
`(FR Doc. 2010...8443 Filed 4-13-10; 8:45 nm]
`BILLING CODE 4160-01-S
`
`DEPARTMENT OF HEALTH AND
`HUMAN SERVICES
`
`Food and Drug Administration
`[Docket Nos. FDA-2009-E-0230 and FDA-
`2009-E-0231]
`
`Determination of Regulatory Review
`Period for Purposes of Patent
`Extension; SAVELLA
`AGENCY: Food and Drug Administration,
`HHS.
`.
`ACTION: Notice.
`
`SUMMARY: The Food and Drug
`Administration (FDA) has determined
`the regulatory review period for
`SA VELLA and is publishing this notice
`of that determination as required by
`law. FDA has made the determination
`because of the submission of
`applications to the Director of Patents
`and Trademarks, Department of
`Commerce, for the extension of patents
`which claim that human drug product.
`ADDRESSES: Submit written comments
`and petitions to the Division of Dockets
`Management (HF A-305), Food and Drug
`Administration, 5630 Fishers Lane, rm.
`1061, Rockville, MD 20852. Submit
`electronic comments to http://
`www.regulations.gov.
`FOR FURTHER INFORMATION CONTACT:
`Beverly Friedman, Office of Regulatory
`Policy, Food and Drug Administration,
`10903 New Hampshire Ave., Bldg. 51,
`rm. 6222, Silver Spring, MD 20993-
`0002, 301-796--3602.
`SUPPLEMENTARY INFORMATION: The Drug
`Price Competition and Patent Term
`Restoration Act of 1984 (Public Law 98-
`417) and the Generic Animal Drug and
`
`Patent Term Restoration Act (Public
`Law 100-670) generally provide that a
`patent may be extended for a period of
`up to 5 years so long as the patented
`item (human drug product, animal drug
`product, medical device, food additive,
`or color additive) was subject to
`regulatory review by FDA before the
`item was marketed. Under these acts, a
`product's regulatory review period
`forms the basis for determining the
`amount of extension an applicant may
`receive.
`A regulatory review period consists of
`two periods of time: A testing phase and
`an approval phase. For human drug
`products, the testing phase begins when
`the exemption to permit the clinical
`investigations of the drug becomes
`effective and runs until the approval
`phase begins. The approval phase starts
`with the initial submission of an
`application to market the human drug
`product and continues until FDA grants
`permission to market the drug product.
`Although only a portion of a regulatory
`review period may count toward the
`actual amount of extension that the
`Director of Patents and Trademarks may
`award (for example, half the testing
`phase must be subtracted as well as any
`time that may have occurred before the
`patent was issued). FDA's determination
`of the length of a regulatory review
`period for a human drug product will
`include all of the testing phase and
`approval phase as specified in 35 U.S.C.
`156(g)(l)(B).
`FDA recently approved for marketing
`the human drug product SA VELLA
`(milnacipran hydrochloride). SA VELLA
`is indicated for the management of
`fibromyalgia. Subsequent to this
`approval, the Patent and Trademark
`Office received patent term restoration
`applications for SA VELLA (U.S. Patent
`Nos. 6,602,911and6,992,110) from
`Cypress Bioscience, Inc., and the Patent
`and Trademark Office requested FDA's
`assistance in determining the patents'
`eligibility for patent term restoration. In
`a letter dated September 29, 2009, FDA
`advised the Patent and Trademark
`Office that this human drug product had
`undergone a regulatory review period
`and that the approval of SA VELLA
`represented the first permitted
`commercial marketing or use of the
`product. Thereafter, the Patent and
`Trademark Office requested that FDA
`determine the product's regulatory
`review period.
`FDA has determined that the
`applicable regulatory review period for
`SAVELLA is 2,571 days. Of this time,
`2,177 days occurred during the testing
`phase of the regulatory review period,
`while 394 days occurred during the
`
`approval phase. These periods of time
`were derived from the following dates:
`1. The date an exemption under
`section 505(i) of the Federal Food, Drug,
`and Cosmetic Act (the act) (21 U.S.C.
`355(i)) became effective: January 2,
`2002. FDA has verified the applicant's
`claim that the date the investigational
`new drug application became effective
`was on January 2, 2002.
`2. The date the application was
`initially submitted with respect to the
`human drug product under section
`505(b) of the act: December 18, 2007.
`FDA has verified the applicant's claim
`that the new drug application (NOA)
`22-256 was submitted on December 18,
`2007.
`3. The date the application was
`approved: January 14, 2009. FDA has
`verified the applicant's claim that NDA
`22-256 was approved on January 14,
`2009.
`This determination of the regulatory
`review period establishes the maximum
`potential length of a patent extension.
`However, the U.S. Patent and
`Trademark Office applies several
`statutory limitations in its calculations
`of the actual period for patent extension.
`In its applications for patent extension,
`this applicant seeks 435 days of patent
`term extension.
`Anyone with knowledge that any of
`the dates as published are incorrect may
`submit to the Division of Dockets
`Management (see ADDRESSES) written or
`electronic comments and ask for a
`redetermination by June 14, 2010.
`Furthermore, any interested person may
`petition FDA for a determination
`regarding whether the applicant for
`extension acted with due diligence
`during the regulatory review period by
`October 12, 2010. To meet its burden,
`the petition must contain sufficient facts
`to merit an FDA investigation. (See H.
`Rept. 85 7, part 1, 98th Cong., 2d sess.,
`pp. 41-42, 1984.) Petitions should be in
`the format specified in 21 CFR 10.30.
`Comments and petitions should be
`submitted to the Division of Dockets
`Management. Three copies of any
`mailed information are to be submitted,
`except that individuals may submit one
`copy. Comments are to be identified
`with the docket number found in
`brackets in the heading of this
`document. Comments and petitions may
`be seen in the Division of Dockets
`Management between 9 a.m. and 4 p.m.,
`Monday through Friday.
`Dated; March 22, 2010.
`Jane A. Axelrad,
`Associate Director for Policy, Center for Drug
`Evaluation and Research.
`IFR Doc. 201()...8518 Filed 4-13-10; 8:45 am]
`BILLING CODE 4160-01-S
`
`
`
`

`
`.,+"" uR•icrs."',. Department of Health and Human Services
`
`(:# FEB 1 7 2011
`
`.
`
`Public Health Service
`
`Food and Drug Administration
`Rockville, MD 20857
`
`Re: Afinitor
`Docket No. FDA-2009-E-0413
`
`The Honorable David J. Kappos
`Under Secretary of Commerce for Intellectual Property
`Director of the United States Patent and Trademark Office
`Mail Stop Hatch-Waxman PTE
`P.O. Box 1450.
`Alexandria, VA 22313-1450
`
`Dear Director Kappos:
`
`This is inregard to the patent term extension application for U.S. Patent No. 5,665,772 filed by
`Novartis AG under 35 U.S.C. § 156. The patent claims Afinitor (everolimus), new drug
`application (NDA) 22-334.
`
`In the April 14, 2010, issue of the Federal Register (75 Fed. Reg. 19406), the Food and Drug
`Administration published its determination of this product's regulatory review period, as required
`under 35 U.S.C. § l 56(d)(2)(A). The notice provided that on or before October 12, 2010, 180
`days after the publication of the determination, any interested person could file a petition with
`FDA under 35 U.S.C. § 156(d)(2)(B)(i) for a determination of whether the patent term extension
`applicant acted with due diligence during the regulatory review period.
`
`The 180-day period for filing a due diligence petition pursuant to this notice has expired and
`FDA has received no such petition. Therefore, FDA considers the regulatory review period
`determination to be final.
`
`Please let me know if we can provide further assistance.
`
`Sincerely yours,
`
`Associate Director for Policy
`Center for Drug Evaluation and.Research
`
`cc:
`
`Gregory C. Houghton
`Novartis Pharmaceuticals Corp
`Patents Pharma
`One Health Plaza, Bldg. 101
`East Hanover, NJ 07936-1080
`
`
`
`

`
`MAY 3 l 2011
`
`Gregory C. Houghton
`Novartis Pharmaceuticals Corp.
`Patents Pharma
`One Health Plaza, Bldg. 101
`East Hanover, NJ 07936-1080
`
`Commissioner for Patents
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`www.uspto.gov
`
`In Re: Patent Term Extension
`Application for
`U.S. Patent No. 5,665,772
`
`NOTICE OF FINAL DETERMINATION
`
`A determination has been made that U.S. Patent No. 5,665,772, claims of which cover the human
`drug product AFINITOR® (everolimus), is eligible for patent term extension under 35 U.S.C. §
`156. The period of extension .has been determined to be 5 years.
`
`A single request for reconsideration of this final determination as to the length of extension of the
`term of the patent may be made if filed within one month of the date of this notice.· Extensions
`of time under 37 CFR § 1.136(a) are not·applicable to this time period. In the absence of such
`request for reconsideration, the Director will issue a certificate of extension, under seal, for a
`period of 5 years.
`
`The period of extension, if calculated using the Food and Drug Administration determination of
`the length of the regulatory review period published in the Federal Register of April 14, 2010 (75
`Fed. Reg. 19406), would be 2,248 days. Under 35 U.S.C. § 156(c):
`
`Period of Extension
`
`RRP - PGRRP -DD - Y2 (TP - PGTP) 1
`4,486 -265 - 0 - Y2 (4,212 - 265)
`2,248 days (6.2 years)
`
`Since the regulatory review period began December 19, 1996, before the patent issued (September
`9, 1997), only that portion of the regulatory review period occurring after the date the patent issued
`has been considered in the above determination of the length of the extension period 35 U.S.C. §
`156(c). (From December 19, 1996, to and including September 9,' 1997, is 265 days; this period is
`subtracted for the number of days occurring in the testing phase according to the FDA
`determination of the length of the regulatory review period.) No determination of a lack of due
`diligence under 35 U.S.C. § 156(c)(l) was made.
`
`However, the five year limitation of 35 U.S.C. § 156(g)(6)(A) applies in the present situation,
`
`1 Consistent with 35 U.S.C. § 156(c), "RRP" is the total number of days in the regulatory
`review period, "PGRRP" is the number of days of the RRP which were on and before the date on
`which the patent issued, "DD" is the number of days of the RRP that the applicant did not act
`with due diligence, "TP" is the testing phase period described in paragraphs (1 )(B)(i), (2)(B)(i),
`(3)(B)(i), ( 4)(B)(i), and (5)(B)(i) of subsection (g) of 35 U.S.C. § 156, and "PGTP" is the number
`of days of the TP which were on and before the date on which the patent issued, wherein half
`days are ignored for purposes of the subtraction of Yz (TP - PGTP).
`
`
`
`

`
`U.S. Patent No. 5,665, 772
`
`Page 2
`
`because the patent was issued after the date of enactment of 35 ·U.S.C. § 156. Since the period of
`extension calculated under 35 U.S.C. § 156(c) for the patent cannot exceed five years under
`35 U.S.C. § 156(g)(6)(A), the period of extension will be for five years.
`
`The 14 year limitation of 35 U.S.C. § 156(c)(3) does not operate to further reduce the period of
`extension determined above.
`
`Upon issuance of the certificate of extension, the following information will be published in the
`Official Gazette:
`·
`
`U.S. Patent No.:
`
`5,665,772
`
`Granted:·
`
`Original Expir~tion Date2
`
`:
`
`September 9, 1997
`
`September 9, 2014
`
`Applicant:
`
`Sylvain Cottens et al. .
`
`Owner of Record:
`
`Novartis AG
`
`Title:
`
`0-Alkylated Rapamycin Derivatives and Their Use,
`Particularly as Immunosuppressants
`
`Product Trade Name:
`
`AFINITOR® ( everolimus)
`
`Term Extended:
`
`5 years
`
`Expiration Date of Extension:
`
`September 9, 2019.
`
`2Subject to the provisions of 35 U.S.C. § 4l(b).
`
`
`
`

`
`U.S. Patent No. 5,665, 772
`
`Page 3
`
`Any correspondence with respect to this. matter should be addressed as follows:
`
`By mail:
`
`Mail Stop Hatch-Waxman PTE
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450.
`
`By FAX:
`
`(571) 273-7755
`
`Telephone inquiries related to this determination should be directed to Mary Till at (571) 272-
`7755.
`
`Senior Legal Advisor
`Office of Patent Legal Administration
`Office of the Associate Commissioner
`for Patent Examination Policy
`
`cc:
`
`Office of Regulatory Policy
`Food and Drug Administration
`10903 New Hampshire Ave., Bldg. 51, Rm. 6222
`Silver Spring, MD 20993-0002
`
`RE: AFINITOR® (everolimus)
`Docket No.: FDA-2009-E-0413
`
`Attention: Beverly Friedman
`
`
`
`

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`MAR - 6 2012
`
`Commissioner for Patents
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`www.uspto.gov
`
`Gregory C. Houghton
`Novartis Pharmaceuticals Cprp.
`Patents Pharma
`One Health Plaza, Bldg. 101
`East Hanover, NJ 07936-1080
`
`Dear Mr. Houghton:
`
`In Re: Patent Term Extension
`Application for
`U.S. Patent No. 5,665,772
`
`A certificate under 35 U.S.C. § 156 is enclosed extending the term of U.S. Patent
`No. 5,665,772 for a period of 5 years. While a courtesy copy of this letter is being forwarded to
`the Food and Drug Administration (FDA), you should directly correspond with the FDA
`regarding any required changes to the patent expiration dates set forth in the Patent and
`Exclusivity Data Appendix of the Orange Book (Approved Drug Products with Therapeutic
`Equivalence Evaluations) or in the Patent Information set forth in the Green Book (FDA
`Approved Animal Drug Products). Effective August 18, 2003, patent submissions for
`publication in the Orange Book and Docket *95S-0117 need to be submitted on form FDA-3542
`which may be downloaded from FDA's Electronic Forms Download Website:
`http://www.fda.gov/opacom/morechoices/fdaforms/default.html.
`(http://www. f da. gov I opacom/morechoices/f daforms/FD A-3 54 2. pdf).
`
`Inquiries regarding this communication should be directed to the undersigned by telephone at
`(571) 272-7755, or by e-mail at mary.till@uspto.gov.
`
`~c~M
`
`Senior Legal Advisor
`Office of Patent Legal Administration
`Office of the Associate Commissioner
`for Patent Exami.nation Policy
`
`cc:
`
`Office of Regulatory Policy
`Food and Drug Administration
`10903 New Hampshire Ave., Bldg. 51, Rm. 6222
`Silver Spring, MD 20993-0002
`
`RE: AFINITOR® (everolimus)
`Docket No.: FDA-2009-E-0413
`
`Attention: Beverly Friedman
`
`
`
`

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`(12)
`
`CERTIFICATE EXTENDING PATENT TERM
`UNDER 35 U.S.C. § 156
`
`(68) PATENT NO.
`
`( 45)
`
`ISSUED
`
`(75)
`
`INVENTOR
`
`5,665,772
`
`September 9, 1997
`
`Sylvain Cottens et al.
`
`(73) PATENT OWNER
`
`Novartis AG
`
`(95) PRODUCT
`
`AFINITOR® (everolimus)
`
`This is to certify that an application under 35 U.S.C. § 156 has been filed in the United
`States Patent and Trademark Office, requesting extension of the term of U.S. Patent No.
`5,665,772 based upon the regulatory review of the product AFINITOR® (everolimus) by
`the Food and Drug Administration. Since it appears that the requirements of the law have
`been met, this certificate extends the term of the patent for the period of
`
`(94)
`
`5 years
`
`from September 9, 2014, the original expiration date of the patent, subject to the payment
`of maintenance fees as provided by law, with all rights pertaining thereto as provided by
`35 U.S.C. § 156.
`
`I have caused the seal of the United States Patent and
`Trademark Office to be affixed this lst day of March 2012.
`
`David J. Kappas
`Under Secretary of Commerce for Intellectual Property and
`Director of the United States Patent and Trademark Office
`
`
`
`

`
`~SStJED: ~3epternb€~r 091 1997
`FOR Q..,AJXYLATED RAP!\MYCIN DER:!V..:.\T!VES
`
`PO Box ·1450
`l~~~Jexandrias \/J\ 22313 ... 4450
`
`Sir:
`
`Forrn PTO 1050.
`
`fo~~ foHowlng tab!e:
`
`
`
`

`
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`Ach:frUon~~j~y~ the structures on page 2 of the
`! application, and in application dairn ·1 D of the
`
`I: G3 and C35 ln evero!imus.
`_J~~i!~!~:::~~~::~~:::~:~
`
`Attached !s c~ duplicate of Form PTO 1050, with ::~t te..sist one copy bc~ing suilable 'for prlr.tin::Jc
`
`of Novsrtis
`
`Novartis Phannaceutica~~> CorporaUon
`l)ne ~ .. ieafth Pi:az<~: Bkis1. 4~33
`East ~ .. ~aflO\.ter. r~kJ 07936
`
`Novartis Ph,~nm~c€1uticais Corpor~ttjon
`l)n£~ ~,4ea~.th Plaza~ B~dg, ;1 D1
`East t,~r~n(Y~ter~ NJ 07936
`+'l362T?ff783·i
`
`/Gregory Ferraro/
`
`Gregory Ferraro
`l\ttorney· for i.\ppHc~~nt
`Reg .. No. 36..~ '134
`
`
`
`

`
`MAIUNG ADDRESS O.F SENDER:
`(5regory Fernu~o
`No·vartis Fharn1aceuticaJs C~orporat1on
`One Health Pbza, Bldg. HH
`East }lanov{:r, NJ 07936
`+13627787831
`
`
`
`

`
`rvI1\ItJ_NG A.J)DRESS (}F SE-Nl)J~R-~
`Cirs:~gory Fern]ro
`Novartis Pharmaceuticals Corporation
`().ne l~eaJth Ph~_za~ Bldg. lOJ
`"t-:'.ast }·~anover., NJ 07936
`+18627787831
`
`PATENT NO. 5665T72
`
`
`
`

`
`Electronic Acknowledgement Receipt
`
`EFSID:
`
`Application Number:
`
`19967698
`
`08416673
`
`International Application Number:
`
`Confirmation Number:
`
`9777
`
`Title of Invention:
`
`0-ALKYLATED RAPAMYCIN DERIVATIVES AND THEIR USE, PARTICULARLY AS
`IMMUNOSUPPRESSANTS
`
`First Named Inventor/Applicant Name:
`
`SYLVAIN COTIENS
`
`Customer Number:
`
`1095
`
`Filer:
`
`Gregory David Ferraro./Cindy Klepacky
`
`Filer Authorized By:
`
`Gregory David Ferraro.
`
`Attorney Docket Number:
`
`100-7932
`
`Receipt Date:
`
`Filing Date:
`
`Time Stamp:
`
`26-AUG-2014
`
`07-APR-1995
`
`14:36:09
`
`Application Type:
`
`U.S. National Stage under 35 USC 371
`
`Payment information:
`
`Submitted with Payment
`
`I no
`
`File Listing:
`
`Document
`Number
`
`Warnings:
`
`Information:
`
`Document Description
`
`File Name
`
`Request for Certificate of Correction
`
`PATl 00_7932_US_PCT _Certific
`ate_Correction.pdf
`
`File Size( Bytes)/
`Message Digest
`
`Multi
`Part /.zip
`
`Pages
`(if appl.)
`
`637113
`
`9fbed054c4dc3a044c3e571 db8cc437 c26c
`21363
`
`no
`
`4
`
`
`
`

`
`Total Files Size (in bytes)
`
`637113
`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New Applications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
`
`National Stage of an International Application under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/E0/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International Application Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 181 O), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/R0/1 OS) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`
`
`

`
`Case 1:14-cv-01196-RGA Document 4 Filed 09/16/14 Page 1of1 PagelD #: 65
`
`AO 120 (Rev. 08/10)
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PA TENT OR
`TRADEMARK
`
`In CompliaQ.Ce with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`for the District of Delaware
`on the following
`filed in the U.S. District Court
`~Patents. ( D the patent action involves 35 U.S.C. § 292.):
`0 Trademarks or
`
`DOCKET NO.
`
`PLAINTIFF
`
`DATEFILED
`9/16/2014
`
`U.S. DISTRICT COURT
`for the District of Delaware
`DEFENDANT
`
`NOV AR TIS PHARMACEUTICALS CORPORATION
`and NOV ARTIS AG
`
`ROXANE LABO RA TORIES, INC. and
`BOEHRINGER INGELHEIM ROXANE, INC.
`
`PATENT OR
`TRADEMARK NO.
`
`DATE OF PATENT
`OR TRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
`1
`
`5,665,772
`
`September 9, 1997
`
`Novartis AG
`
`6,004,973
`
`6,239,124
`
`6,455,518
`
`2
`
`3
`
`4
`
`5
`
`December 21, 1999
`
`May 29, 2001
`
`Novartis AG
`
`Novartis AG
`
`September 24, 2002
`
`Novartis AG
`
`In the above-entitled case, the following patent(s)/ trademark(s) have been included:
`
`DA TE INCLUDED
`
`INCLUDED BY
`
`PATENT OR
`TRADEMARK NO.
`
`0 Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`D Answer
`
`D Cross Bill
`
`0 Other Pleading
`
`HOLDER OF PA TENT OR TRADEMARK
`
`1
`
`2
`
`3
`
`4
`
`5
`
`In the above-entitled case, the following decision has been rendered or judgement issued:
`
`IDECISION/JUDGEMENT
`
`,
`
`I (BY) DEPUTY CLERK
`
`Copy 1-Upon initiation of action, mail this copy to Director Copy 3-Upon termination of action, mail this copy to Director
`Copy 2-Upon filing document adding patent(s), mail this copy to Director Copy 4-Case file copy
`
`
`
`

`
`Case 1:14-cv-01289-UNA Document 4 Filed 10/10/14 Page 1of1 PagelD #: 51
`
`AO 120 (Rev. 08/10)
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`filed in the U.S. District Court
`for the District of Delaware
`on the following
`~Patents. ( D the patent action involves 35 U.S.C. § 292.):
`D Trademarks or
`
`DOCKET NO.
`
`PLAINTIFF
`
`DATE FILED
`10/10/2014
`
`U.S. DISTRICT COURT
`for the District of Delaware
`DEFENDANT
`
`NOV AR TIS PHARMACEUTICALS CORPORATION
`and NOVARTIS AG
`
`PAR PHARMACEUTICAL, INC.
`
`PATENTOR
`TRADEMARK NO.
`
`DATE OF PATENT
`OR TRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
`September 9, 1997
`
`Novartis AG
`
`December 21, 1999
`
`Novartis AG
`
`September 24, 2002
`
`Novartis AG
`
`5,665,772
`
`6,004,973
`
`6,455,518
`
`I
`
`2
`
`3
`
`4
`
`5
`
`In the above--entitled case, the following patent(s)/ trademark(s) have been included:
`
`DATE INCLUDED
`
`INCLUDED BY
`
`PATENTOR
`TRADEMARK NO.
`
`D Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`D Answer
`
`D Cross Bill
`
`D Other Pleading
`
`HOLDER OF PATENT OR TRADEMARK
`
`1
`
`2
`
`3
`
`4
`
`5
`
`In the above--entitled case, the following decision has been rendered or judgement issued:
`
`IDECISION/JUDGEMENT
`
`I (BY) DEPUTY CLERK
`
`Copy 1-Upon initiation of action, mail this copy to Director Copy 3-Upon termination of action, mail this copy to Director
`Copy 2-Upon filing document adding patent(s), mail this copy to Director Copy 4--Case file copy
`
`
`
`

`
`Case: 2:14-cv-01602-GLF-EPD Doc#: 4 Filed: 09/17/14 Page: 1of1 PAGEID #: 62
`
`AO 120 (Rev. 08/10)
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`FOR THE SOUTHERN DISTRICT OF OHIO
`filed in the U.S. District Court
`on the following
`Glf Patents.
`0 Trademarks or
`( 0 the patent action involves 35 U.S.C. § 292.):
`
`DOCKET NO.
`2:14-cv-1602
`PLAINTIFF
`
`DATE FILED
`9/17/2014
`
`U.S. DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF OHIO
`DEFENDANT
`
`NOVARTIS PHARMACEUTICALS CORPORATION and
`NOVARTIS AG
`
`ROXANE LABORATORIES, INC. and
`BOEHRINGER INGELHEIM ROXANE, INC.
`
`PATENTOR
`TRADEMARK NO.
`
`DATE OF PATENT
`OR TRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
`1 5,665,772
`
`2 6,004,973
`
`3 6,239,124
`
`4 6,455,518
`
`5
`
`9/9/1997
`
`NOVARTIS AG
`
`12/21/1999
`
`NOVARTIS AG
`
`5/29/2001
`
`9/24/2002
`
`NOVARTIS AG
`
`NOVARTIS AG
`
`In the above-entitled case, the following patent(s)/ trademark(s) have been included:
`
`DATE INCLUDED
`
`INCLUDED BY
`
`PATENTOR
`TRADEMARK NO.
`
`0 Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`0 Answer
`
`0 Cross Bill
`
`0 Other Pleading
`
`HOLDER OF PA TENT OR TRADEMARK
`
`1
`
`2
`
`3
`
`4
`
`5
`
`In the above-entitled case, the following decision has been rendered or judgement issued:
`
`I (BY) DEPU1Y CLERK
`
`Copy 1-Upon initiation of action, mail this copy to Director Copy 3-Upon termination of action, mail this copy to Director
`Copy 2-Upon filing document