IPR2023-00723
`U.S. Patent 8,129,343
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`V.
`
`NOVO NORDISK A/S,
`Patent Owner
`
`Case IPR2023-00723
`Patent 8,129,343
`
`DECLARATION OF SA YEM OSMAN
`
`Novo Nordisk Exhibit 2009
`Mylan Pharms. Inc.v. Novo Nordisk A/S
`IPR2023-00723
`Page 00001
`
`
`U.S. Patent 8,129,343
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`V.
`
`NOVO NORDISK A/S,
`Patent Owner
`
`Case IPR2023-00723
`Patent 8,129,343
`
`DECLARATION OF SA YEM OSMAN
`
`Novo Nordisk Exhibit 2009
`Mylan Pharms. Inc.v. Novo Nordisk A/S
`IPR2023-00723
`Page 00001
`
`
`
`IPR2023-00723
`U.S. Patent 8,129,343
`I, Sayem Osman, make the following Declaration pursuant to 28 U.S.C. § 1746:
`
`1.
`
`I am a paralegal at the law firm of Groombridge, Wu, Baughman & Stone
`
`LLP.
`
`2.
`
`I provide this Declaration in connection with the above-identified Patent
`
`Owner's Preliminary Response to the Inter Partes Review proceeding that is being
`
`requested at the U.S. Patent and Trademark Office by Petitioners under 35 U.S.C.
`
`§§ 311-319, 37 C.F.R. § 42. Unless otherwise stated, the facts stated in this
`
`Declaration are based on my personal knowledge.
`
`3.
`
`EX2001 hereto is a true and correct copy of an excerpt of Defendants' Initial
`
`Invalidity Contentions, In re: Ozempic (Semaglutide) Patent Litigation, No. 1 :22-
`
`cv-01040-CFC, (D. Del. Oct. 20, 2022), which I retrieved on June 29, 2023, as an
`
`attachment to an email from Novo Nordisk A/S's counsel at Fenwick & West LLP.
`
`Other than excerpting the pages, striking through the confidentiality designation,
`
`and adding an exhibit label and page numbers to the bottom of all pages of
`
`EX2001, no other alterations have been made.
`
`4.
`
`EX2002 hereto is a true and correct copy of Jesper Lau, et al.'s article titled
`
`"Discovery of the Once-Weekly Glucaogn-Like Peptide-I (GLP-1) Analogue
`
`Semaglutide," Med. Chem., 58:7370-7380 (2015) which I purchased and retrieved
`
`on July 6, 2023, from https://pubs.acs.org/doi/full/10.1021/acs.jmedchem.5b00726.
`
`2
`
`Novo Nordisk Exhibit 2009
`Mylan Pharms. Inc.v. Novo Nordisk A/S
`IPR2023-00723
`Page 00002
`
`
`
`IPR2023-00723
`U.S. Patent 8,129,343
`An exhibit label and page numbers have been added to the bottom of all pages of
`
`EX2002 but no other alterations have been made.
`
`5.
`
`EX2003 hereto is a true and correct copy of United States Patent No.
`
`10,335,462 which I retrieved on June 21, 2023, from the United States Patent &
`
`Trademark Office's Patent Public Search Basic (PPUBS Basic) website
`
`(https://image-ppubs. uspto.gov/ dirsearch-public/print/ downloadPdf/ 103 3 5462). An
`
`exhibit label and page numbers have been added to the bottom of all pages of
`
`EX2003 but no other alterations have been made.
`
`6.
`
`EX2004 hereto is a true and correct copy of Brian Furman, et al.' s article
`
`titled "Targeting B-cell cyclic adenosine mono phosphate for the development of
`
`novel drugs for treating type 2 diabetes mellitus. A review," Pharmacy and
`
`Pharmacology, 56: 1477-1492 (2004) which I retrieved on July 6, 2023, from
`
`https://academic.oup.com/jpp/article/56/ 12/14 77 /614 7469?login=false and by
`
`clicking on the PDF link on that page. An exhibit label and page numbers have
`
`been added to the bottom of all pages of EX2004 but no other alterations have been
`
`made.
`
`7.
`
`EX2005 hereto is a true and correct copy ofWO1998032466 which I
`
`retrieved on June 21, 2023, from
`
`https://patentscope. wipo.int/search/docs2/pct/WO l 998032466/pdf/UivUql7 AzttnPI
`
`8dZ9ZDH8KNtOdF9wWBem-Q0nFNg5w. An exhibit label and page numbers
`
`3
`
`Novo Nordisk Exhibit 2009
`Mylan Pharms. Inc.v. Novo Nordisk A/S
`IPR2023-00723
`Page 00003
`
`
`
`IPR2023-00723
`U.S. Patent 8,129,343
`have been added to the bottom of all pages of EX2005 but no other alterations have
`
`been made.
`
`8.
`
`EX2006 hereto is a true and correct copy of United States Patent No.
`
`6,528,486 which I retrieved on June 27, 2023, from the United States Patent &
`
`Trademark Office's Patent Public Search Basic (PPUBS Basic) website
`
`(https://image-ppubs.uspto.gov/dirsearch-public/print/downloadPdf/6528486). An
`
`exhibit label and page numbers have been added to the bottom of all pages of
`
`EX2006 but no other alterations have been made.
`
`9.
`
`EX2007 hereto is a true and correct copy of WO 00/69911 which I retrieved
`
`onJune30,2023,from
`
`https ://patentscope. wipo .int/ search/ docs2/pct/WO2000069911 /pdf/M2qDw J v HF e7
`
`9OJ2 LpcACdMXx87AmgNiCF-gIVsQTTQ. An exhibit label and page numbers
`
`have been added to the bottom of all pages of EX2007 but no other alterations have
`
`been made.
`
`10. EX2008 hereto is a true and correct copy of an excerpt of Novo Nordisk's
`
`Initial Responses to Defendants' Initial Invalidity Contentions Regarding U.S.
`
`Patent Nos. 8,129,343; '8,536,122; 8,114,833; 8,920,383; 9,775,953; 9,457,154; and
`
`10,335,462, In re: Ozempic (Semaglutide) Patent Litigation, No. 1:22-cv-01040-
`
`CFC, (D. Del. Dec. 21, 2022) which I retrieved on June 29, 2023, as an attachment
`
`to an email from Novo Nordisk A/S's counsel at Fenwick & West LLP. Other than
`
`4
`
`Novo Nordisk Exhibit 2009
`Mylan Pharms. Inc.v. Novo Nordisk A/S
`IPR2023-00723
`Page 00004
`
`
`
`IPR2023-00723
`U.S. Patent 8,129,343
`excerpting the pages, striking through the confidentiality designation, and adding an
`
`exhibit label and page numbers to the bottom of all pages of EX2008, no other
`
`alterations have been made.
`
`11.
`
`I have been warned that willful false statements and the like are punishable
`
`by fine or imprisonment, or both. I make this declaration of my own personal
`
`knowledge, and all statements are true. If called to testify as to the truth of the
`
`matters stated herein, I could and would testify competently.
`
`12.
`
`I declare under penalty of perjury that the foregoing is true and correct.
`
`Executed on this 6th of July, 2023, at Washington, D.C.
`
`Sayem Osman
`
`5
`
`Novo Nordisk Exhibit 2009
`Mylan Pharms. Inc.v. Novo Nordisk A/S
`IPR2023-00723
`Page 00005
`
`
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