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35 U.S.C. § 156 For: Inhibitors of Bruton's Tyrosine Kinase

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35 U.S.C. § 156 For: Inhibitors of Bruton's Tyrosine Kinase UNITED STATES PATENT AND TRADEMARK OFFICE Commissioner for Patents United States Patent and Trademark Office P.O. Box 1450 Alexandria, VA 22313-1450 www uspto goy Michael Hostetler Wilson Sonsini Goodrich & Rosati '!JEC T2 '2bW 12235 El Camino Real, Suite 200 San Diego, CA 92130 In re Patent Term Extension Application of U.S. Patent No. 8,008,309 Decision on Petition to Waive the Issue Date: August 30, 2011 EFS Legal Framework Prohibition Application No. : .12/499,005 on Filing Initial Application under PTE Filing Date: December 23, 2013 35 u.s.c. § 156 For: Inhibitors of Bruton's Tyrosine Kinase: The above-identified application has been forwarded to the Office of Patent Legal Administration in the United States Patent and Trademark Office (the "Office") for consideration of a petition under 3 7 C.F .R. § 1.182 to waive the prohibition in the legal framework of the Office's Electronic Filing System (EFS), which prohibits filing of an initial application for patent term extension under 35 U.S.C. § 156 via EFS. The petition is granted because the requirements of37 C.F.R. § 1.740 have now been met and the statutory requirements of35 U.S.C. § 156(d)(1)(A)-(E) were met upon filing. Background and Analysis On December 23, 2013, Petitioner filed an initial application for patent term extension ("PTE application") pursuant to the provisions of35 U.S.C. § 156(d)(1) via the Office EFS. Petitioner's EFS acknowledgement receipt indicates that a "PTE Interim Patent Extension Filed." On January 20, 2014, Petitioner contacted USPTO seeking a status update on their application for patent term extension filed by the EFS. USPTO then informed Petitioner that the PTE application had been improperly filed usi.J::!g the EFS. The USPTO directed Petitioner to the Federal Register notice, 74 Fed. Reg. 55202, October 27, 2009, which provides information on the prohibition against filing initial applications for patent term extension via EFS. The Office directed Petitioner to file a petition to seek waiver of the prohibition and to comply with the additional filings requirements in 37 C.F.R. § 1.740(b). On February 21, 2014, Petitioner filed the present petition seeking waiver of the EFS legal framework prohibition and an opportunity to comply with the filing requirements of 37 C.F.R. § 1.740(b). The Office is treating the present petition under 3 7 C.F .R. § 1.182, which addresses all situations not specifically provided for in other regulations. Because Petitioner has now complied with 37 U.S. Patent No. 8,008,309 Page2 C.P.R. 1.740(b) and had timely filed an application for patent term extension which complies with the requirements in 35 U.S.C. § 156(d)(l)(A)-(E), the petition is granted. Conclusion The petition under 3 7 C.F .R. § 1.182 is granted. The rules and statutory provisions governing the operations of the U.S. Patent and Trademark Office require payment of a fee on filing each petition. See 37 C.P.R. § 1.17(f). The required petition fee was correctly set forth in the petition. Telephone inquiries with regard to this communication should be directed to Mary C. Till at (571) 272-7755. ~lftrldt)j Senior Legal Advisor Office of Patent Legal Administration Office of the Deputy Commissioner for Patent Examination Policy cc: Office of Regulatory Policy RE: IMBRUVICA® (ibrutinib) Food and Drug Administration Docket No.: FDA-2014-E- 10903 New Hampshire Ave., Bldg. 51, Rm. 6222 Silver Spring, MD 20993-0002 Attention: Beverly Friedman DEC 1 6 2014 Center for Drug Evaluation and Research PATENT IN THE UNITED STATES PATENT AND TRADEMARK OFFICE Patent No.: 8,008,309 Issued: August 30, 2011 Expiration Date: December 28, 2026 Inventors: Lee Honigberg, Erik Verner, and Zhengying Pan. Title: INHIBITORS OF BRUTON'S TYROSINE KINASE RECEIVED DEC 2 3 2013 Mail Stop Patent Extension Commissioner for Patents PATENT EXTENSION P.O. Box 1450 OPLA Alexandria, VA 22303-1450 APPLICATION FOR EXTENSION OF PATENT TERM (37 C.F.R. §1.740) Pursuant to 35 U.S.C. §156(d) and 37 C.P.R. §1.740, Pharrnacyclics, Inc., ("Applicant") as Assiguee and patent owner of the above-captioned patent, hereby petitions for extension of U.S. Patent No. 8,008,309 (the '309 Patent). In support of such Petition, Applicant provides the following information: I. SIGNATURE REQUIREMENTS (37 C.F.R. §1.730) A. IDENTIFICATION OF PERSON(S) SUBMITTING THE APPLICATION I, Michael J. Hostetler, represent that I am a registered practitioner appointed by the patent owner of record. B. RECORDAL OF ASSIGNMENT IN PTO This application issued from U.S.S.N. 12/499,005, which is a divisional application of U.S.S.N. 12/356,498, now U.S. Patent No. 8,088,781; which is a divisional application of U.S.S.N. 11/617,645, now U.S. Patent No. 7,514,444; which claims priority to U.S. Provisional Application No. 60/828,590 filed October 06, 2006; and U.S. Provisional Application No. 60/826,720, filed September 22, 2006. An assigument of U.S.S.N. 12/356,498 was recorded as follows: Reel/Frame: 023408/0028 Recorded: Assignors: Lee Honigberg Execution: 10/21/2009 Erik Verner Execution: 10/2112009 Zhengying Pan Execution: 10/21/2009 C. PROOF OF AUTHORIZATION OF SIGNATORY TO ACT ON BEHALF OF THE PATENT OWNER Attached as Exhibit 1 is a Power of Attorney establishing authorization of Michael J. Hostetler to act on behalf of the patent owner. II. APPLICATION REQIDREMENTS (37 C.F.R. §1.740) A. IDENTIFICATION OF APPROVED PRODUCT (§1.740{a)(1)) The United States Food and Drug Administration ("FDA") has approved New Drug Application ("NDA'') No. 205552 for IMBRUVICA'"' (ibrutinib). The active ingredient of IMBRUVICATM is ibrutinib. A copy of the approved labeling is attached hereto as Exhibit 2. The chemical name for ibrutinib is 1-((R)-3-(4-amino-3-( 4-phenoxyphenyl)-1H-pyrazolo[3,4- d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one and the molecular formula is C 25H24N60 2• Ibrutinib has the following structural formula: Each capsule of IMBRUVICATM contains 140 mg of ibrutinib. B. IDENTIFICATION OF THE FEDERAL STATUTE UNDER WHICH REGULATORY REVIEW OCCURRED (§1.740{a)(2)) 2 Regulatory review for this product occurred under the Federal Food Drug & Cosmetic Act ("FDC Act") §505(b), 21 U.S.C. §355 (new drugs). C. DATE OF APPROVAL (§1.740(a)(3)) The FDA approved No. 205552 for IMBRUVICA 1M for commercial marketing or use under §505 of the FDC Act on November 13, 2013. D. IDENTIFICATION OF ACTIVE INGREDIENTS AND PREVIOUS APPROVAL INFORMATION (§1.740(a)(4)) IMBRUVICA1M (ibrutinib) is a human drug product, the sole active ingredient of which is ibrutinib. Ibrutinib has not been previously approved, alone or in combination, for commercial marketing or use under the Food, Drug & Cosmetic Act, the Public Health Service Act, or the Virus-Serum-Toxin Act. E. TIMELY SUBMlSSION OF APPLICATION (60 DAYS) (§1.740(a)(5)) This application is being submitted within the sixty-day time period permitted for submission pursuant to 37 C.F.R. §1.720(f). The last date this application may be submitted is January 12,2014. F. IDENTIFICATION OF PATENT (§1.740(a)(6), (7), (8)) Name of the Inventors: Lee Honigberg Erik Verner Zhengying Pan Patent No. 8,008,309 Date of Issue: August 30, 2011 Date of Original Expiration: December 28, 2026 A copy of the patent, including the entire specification (with claims), and drawings, is attached as Exhibit 3. A copy of the Terminal Disclaimer filed February 28, 2011, is attached hereto as Exhibit 4. No Maintenance Fee Statement has issued in the '309 patent. 3 No reexamination certificate has issued in the '309 patent. G. IDENTIFICATION OF CLAIMS READING ON THE APPROVED PRODUCT (§1.740(a)(9)) The '309 patent claims the active ingredient of the approved Product which is ibrutinib. The '309 patent includes 15 claims, of which claims 1-7, 10, and 14 claim the active ingredient ibrutinib. A claim chart that lists each applicable claim of the '309 Patent and demonstrates the manner in which each claim reads on the approved Product is attached as Exhibit 5. 4 H. RELEVANT DATES AND INFORMATION (§1.740(a)(10)) The patent claims a human drug product. Effective date of the investigational new drug (IND) application was September 8, 2008 and the IND No. is 102,688. The new drug application (NDA) was initially submitted on June 28, 2013. The NDA No. is 205552. The new drug application (NDA) was approved on November 13, 2013. 5 I. DESCRIPTION OF SIGNIFICANT ACTIVITIES OF APPLICANT DURING REGULATORY REVIEW (§1.740(a)(ll)) Attached as Exhibit 6 is a "Description of Significant Activities Of Applicant During Regulatory Review" that provides a description of the significant activities undertaken by the marketing applicant during the applicable regulatory review period with respect to the approved Product and the significant dates applicable to such activities. 6 J. STATEMENT THAT APPLICANT IS ELIGIBLE FOR EXTENSION (§1.740(a)(12)) Attached as Exhibit 7 is a "Statement That Applicant is Eligible For Extension And Length of Extension Claimed(§ 1.740(a)(12))" K. ACKNOWLEDGEMENT OF DUTY OF DISCLOSURE (§1.740(a)(13)) I, Michael J. Hostetler, the person signing below, acknowledge the duty to disclose to the Director of the U.S. Patent and Trademark Office and to the Secretary of Health and Human Services any information which is material to the determination of entitlement to the extension which is being sought herein.
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