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`Case 3:12—cv-02154-JAP—TJB Document 1-8
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`Filed 04l10l12 Page 1 of 3 PagelD: 148
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`EXHIBIT
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`Depomed Exhibit 2108
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`Case 3:12-cv-02154-JAP-TJB Document 1-8
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`Filed 04/10/12 Page 2 of 3 PageID: 149
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`www. pamha r: may :3
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`US. Patent No. 6,488,962 (“the ‘962 patent”), which is listed as expiring on June 20,
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`PHARMACE’IUIlCRL
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`CONFIDENTIAL
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`March 27, 2012
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`Matthew M. Gosling
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`Senior Vice President and General Counsel
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`Depomed, Inc.
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`1360 O’Brien Drive
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`Menlo Park, CA 94025
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`VIA REGISTERED EXPRESS MAIL
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`RETURN RECEIPT REQUESTED
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`Re:
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`Gabapentin 300 mg and 600 mg Tablets
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`United States Patent Nos. 6,340,475, 6,488,962, 6,635,280, 6,723,340, 7,438,927,
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`and 7,731,989
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`Notice of Paragraph IV Certification
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`Dear Sirs:
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`This is a notice of certification letter on behalf of Par Pharmaceutical, Inc., (“Par”) pursuant to §
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`5050)(2)(B)(ii) of the Federal Food, Drug and Cosmetic Act (“the Act”) and 21 U.S.C. §
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`3550)(2)(B)(ii) and § 314.95 of Title 21 of the Code of Federal Regulations:
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`1.
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`An Abbreviated New Drug Application (“ANDA”) containing any required
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`bioavailability or bioequivalence data or information has been submitted under § 5050)
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`of the Act for the drug with respect to which the certification is made to obtain approval
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`to engage in the commercial manufacture, use, or sale of the drug before the expiration
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`date of United States Patent Nos. 6,340,475, 6,488,962, 6,635,280, 6,723,340, 7,438,927,
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`and 7,731,989, listed in the Approved Drug Products with Therapeutic Equivalence
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`Evaluations (the “Orange Book”). The Food and Drug Administration (“FDA”) has
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`received this application.
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`The ANDA number is 203757.
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`The established name of Par’s proposed drug product is: Gabapentin Tablets.
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`The active ingredient, strength, and dosage form of the proposed drug product is 300 mg
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`and 600 mg of gabapentin. The dosage form is a tablet for oral administration.
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`The Orange Book lists the following US. Patents for GRALISEM tablets: (1) US. Patent
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`No. 6,340,475 (“the ‘475 patent”), which is listed as expiring on September 19, 2016; (2)
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`Case 3:12-cv-02154-JAP-TJB Document 1-8
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`Filed 04/10/12 Page 3 of 3 PagelD: 150
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`'7) PPRPHARMACEUTICAL
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`2020; (3) U.S. Patent No. 6,635,280 (“the ‘280 patent”), which is listed as expiring on
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`September 19, 2016; (4) U.S. Patent No. 6,723,340 (“the ‘340 patent”), which is listed as
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`expiring on October 25, 2021; (5) U.S. Patent No. 7,438,927 (“the ‘927 patent), which is
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`listed as expiring on February 26, 2024; and (6) U.S. Patent No. 7,731,989 (“the ‘989
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`patent”), which is listed as expiring on October 25, 2022. New product exclusivity until
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`January 28, 2014 has been granted. The ANDA indicates that Par intends to market the
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`product before the expiration of the ‘475, ‘962, ‘280, ‘340, ‘927, and ‘989 patents, and
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`contains a certification pursuant to 21 U.S.C. § 3550)(2)(A)(vii)(IV), that in Par’s
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`opinion, these patents are invalid, unenforceable and/or will not be infringed by the
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`manufacture, use, or sale of the product for which the application is submitted.
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`An Offer of Confidential Access to the ANDA, pursuant to § 505(j)(5)(C)(i)(III) of the
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`Act accompanies this notice as a separate enclosure.
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`Attached is a detailed statement of the factual and legal bases of Par’s patent certification. This
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`information is supplied for the sole purpose of complying with the above-referenced statutes and
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`regulations. Neither Par nor its attorneys waive any attorney—client privilege or work-product
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`immunity concerning the subject matter of this communication.
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`Sincerely,
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`Duplicate with enclosure Via UPS
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`VWfld/II/XV flaw/WM: 7%4/flg/M
`Michelle Bonomi-Huvala
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`Vice President, Regulatory Affairs
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`Par Pharmaceutical, Inc.
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`300 Tice Boulevard, 3rd Floor
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`Woodcliff Lake, NJ 07677
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`Encl.: Detailed Statement of the Factual and Legal Bases for Par’s Paragraph IV Patent
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`Certification and Offer of Confidential Access
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