`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
`
`MYLAN PHARMACEUTICALS INC.
`
`Petitioner
`
`v.
`
`POZEN INC. and HORIZON PHARMA USA, INC.
`
`Patent Owners
`____________________________
`
`Case No. IPR2017-01995
`U.S. Patent No. 9,220,698
`____________________________
`
`CORRECTED DECLARATION OF BRYAN D. BEEL IN SUPPORT OF
`PETITIONER’S EVIDENCE
`
`
`
`Page 1 of 8
`
`Patent Owner Ex. 2068
`Mylan v. Pozen
`IPR2017-01995
`
`MYLAN PHARMS. INC. EXHIBIT 1090 PAGE 1
`
`
`
`1.
`
`I, Bryan D. Beel, am over the age of eighteen (18) and otherwise
`
`competent to make this Declaration. I am an attorney at Perkins Coie LLP, and
`
`counsel for Mylan Pharmaceuticals Inc. (“Petitioner”) in the present action. I make
`
`this Declaration based on my personal knowledge of the facts set forth in this
`
`Declaration and am competent to testify to the same.
`
`2.
`
`All of the exhibits to which Patent Owners objected are either publicly
`
`available or derived from documents that are publicly available.
`
`3.
`
`Exhibit 1006 is a true and correct copy of an article authored by C. W.
`
`Howden titled Review Article: Immediate-Release Proton-Pump Inhibitor Therapy
`
`- Potential Advantages published in the journal ALIMENTARY PHARMACOLOGY &
`
`THERAPEUTICS in 2005 in volume 22, supplement 3, beginning on page 25.
`
`4.
`
`Exhibit 1008 is a true and correct copy of pages accessed and printed
`
`on August 23, 2017, by me or under my direction from the FDA website
`
`(www.accessdata.fda.gov). To print this document, I or someone under my direction
`
`first accessed the Drugs@FDA website (www.accessdata.fda.gov) at the URL or
`
`webpage address: https://www.accessdata.fda.gov/scripts/cder/daf/. NDA No.
`
`20067 was entered into the search box, and the Search button was clicked, yielding
`
`a website with the address https://www.accessdata.fda.gov/scripts/cder/daf/index.
`
`cfm?event=BasicSearch.process, showing basic information for NDA No. 20067,
`
`held by Atnahs Pharma US for EC-Naprosyn. Clicking the Print button on the NDA-
`
`- 1 -
`
`Page 2 of 8
`
`Patent Owner Ex. 2068
`Mylan v. Pozen
`IPR2017-01995
`
`MYLAN PHARMS. INC. EXHIBIT 1090 PAGE 2
`
`
`
`information browser page, and selecting PDF as the desired output, yielded the
`
`information shown in Exhibit 1008.
`
`5.
`
`Exhibit 1009 is a true and correct copy of the EC-Naprosyn prescribing
`
`information. It bears the notation “Revised: September 2007” on page 27, and
`
`“Revised: January 2007” on page 30. It is publicly available from the FDA website
`
`(www.accessdata.fda.gov) at https://www.accessdata.fda.gov/drugsatfda_docs/label
`
`/2007/017581s108,18164s58,18965s16,20067s14lbl.pdf. Exhibit 1009 was printed
`
`by me or under my direction.
`
`6.
`
`Exhibit 1010 is a true and correct copy of the FDA approval letter for
`
`Zegerid dated June 15, 2004, and the prescribing information. The approval letter
`
`and prescribing information are publicly available from the FDA website
`
`(www.accessdata.fda.gov)
`
`at
`
`https://www.accessdata.fda.gov/scripts/cder/daf/
`
`index.cfm?event=overview.process&ApplNo=021636. Once on this page, under
`
`“Approval Date(s) and History, Letters, Labels, Reviews for NDA 021636” there is
`
`an option to view a .pdf file of the label and the letter. The label is available at
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21636_zegerid_lbl.pdf
`
`and the letter is available at https://www.accessdata.fda.gov/drugsatfda_docs/
`
`appletter/2004/21636ltr.pdf. Exhibit 1010 was printed by me or under my direction.
`
`7.
`
`Exhibit 1011 is a true and correct copy of an abstract authored by Jay
`
`L. Goldstein et al. titled A Single Tablet Multilayer Formulation of Enteric-Coated
`
`- 2 -
`
`Page 3 of 8
`
`Patent Owner Ex. 2068
`Mylan v. Pozen
`IPR2017-01995
`
`MYLAN PHARMS. INC. EXHIBIT 1090 PAGE 3
`
`
`
`Naproxen Coupled with Non-Enteric Coated OMEPRAZOLE is Associated with a
`
`Significantly Reduced Incidence of Gastric Ulcers vs. Enteric-Coated Naproxen: A
`
`Prospective, Randomized, Double-Blind Study published
`
`in
`
`the
`
`journal
`
`GASTROENTEROLOGY supplement in 2008 in volume 134, number 4, supplement 1,
`
`beginning on page A-19.
`
`8.
`
`Exhibit 1012 is a true and correct copy of a poster authored by Marc
`
`Hochberg et al. titled A Novel, Single-Tablet Formulation that Delivers Immediate-
`
`Release Omeprazole Followed by Enteric-Coated (EC) Naproxen Significantly
`
`Reduces the Incidence of Gastric Ulcers Compared with EC Naproxen Alone:
`
`Results of a Prospective, Randomised, Double-Blind, 6-Month Study including
`
`Patients with OA and RA, which bears the notation “EULAR 2008, Paris, France,
`
`11-14 June 2008.” On its webpage titled “POZEN Pharmaceutical Development
`
`Company: Poster Presentations,” Pozen represented that this poster was presented at
`
`EULAR
`
`2008.
`
` The webpage
`
`address
`
`listing
`
`the
`
`poster was
`
`http://www.pozen.com:80/product/poster.asp, and the web address of the poster
`
`itself was
`
`http://www.pozen.com:80/product/posters/EULAR%20AZ44531_
`
`hochberg.pdf. Pozen has been merged into Aralez Pharmaceuticals, and a version
`
`of each of these pages is now available at the Internet Archive. The abstract for the
`
`Hochberg poster was also published in Annals of the Rheumatic Diseases, vol. 67
`
`(supp. II), 168 (2008), an issue that compiled information about presentations made
`
`- 3 -
`
`Page 4 of 8
`
`Patent Owner Ex. 2068
`Mylan v. Pozen
`IPR2017-01995
`
`MYLAN PHARMS. INC. EXHIBIT 1090 PAGE 4
`
`
`
`at EULAR 2008, which was held June 11-14, 2008.
`
`9.
`
`Exhibit 1014 is a true and correct copy of an article authored by M.
`
`Michael Wolfe and George Sachs titled Acid Suppression: Optimizing Therapy for
`
`Gastroduodenal Ulcer Healing, Gastroesophageal Reflux Disease, and Stress-
`
`Related Erosive Syndrome published in the journal GASTROENTEROLOGY in 2000 in
`
`volume 118, beginning on page S9.
`
`10. Exhibit 1016 is a true and correct copy of an article authored by M.
`
`Hassan-Alin et al. titled Lack of Pharmacokinetic Interaction between Esomeprazole
`
`and the Nonsteroidal Anti-Inflammatory Drugs Naproxen and Rofecoxib in Healthy
`
`Subjects published in the journal CLINICAL DRUG INVESTIGATION in 2005 in volume
`
`25, number 11, beginning on page 731.
`
`11. Exhibit 1017 is a true and correct copy of an article authored by Reza
`
`Khosravan, Ph.D. et al. titled Pharmacokinetic Interactions of Concomitant
`
`Administration of Febuxostat and NSAIDs published in the JOURNAL OF CLINICAL
`
`PHARMACOLOGY in 2006 in volume 46, beginning on page 855.
`
`12. Exhibit 1020 is a true and correct copy of the Naprosyn/EC-
`
`Naprosyn/Anaprox DS prescribing information dated March 2017. It is publicly
`
`available
`
`from
`
`the
`
`FDA
`
`website
`
`(www.accessdata.fda.gov)
`
`at
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017581s113,018164s0
`
`63,020067s020lbl.pdf. Exhibit 1020 was printed by me or under my direction.
`
`- 4 -
`
`Page 5 of 8
`
`Patent Owner Ex. 2068
`Mylan v. Pozen
`IPR2017-01995
`
`MYLAN PHARMS. INC. EXHIBIT 1090 PAGE 5
`
`
`
`13. Exhibit 1021 is a true and correct copy of chapter 3 from HARRISON’S
`
`PRINCIPLES OF INTERNAL MEDICINE (Dennis L. Kasper et al. eds., 16th ed. 2005).
`
`Exhibit 1021 comprises the book cover, date of publication, authorship, and chapter
`
`3, entitled Principles of Clinical Pharmacology. Exhibit 1021 comprises excerpts
`
`from a publicly available document. If requested, Defendants can provide the entire
`
`book for public inspection.
`
`14. Exhibit 1028 is a true and correct copy of an article authored by T. Lind
`
`et al. titled Esomeprazole Provides Improved Acid Control vs. Omeprazole in
`
`Patients with Symptoms of Gastro-Oesophageal Reflux Disease published in the
`
`journal ALIMENTARY PHARMACOLOGY & THERAPEUTICS in 2000 in volume 14,
`
`beginning on page 861.
`
`15. Exhibit 1030 is a true and correct copy of the Vimovo prescribing
`
`information dated December 2014. It is publicly available from the FDA website
`
`(www.accessdata.fda.gov)
`
`at
`
`https://www.accessdata.fda.gov/drugsatfda_docs
`
`/label/2014/022511s017lbl.pdf. Exhibit 1030 was printed by me or under my
`
`direction.
`
`16. Exhibit 1042 is a true and correct copy of an abstract authored by Barry
`
`Goldlust, Ph.D. et al. titled Nighttime Dosing of Omeprazole Immediate-Release
`
`Oral Suspension Rapidly Decreases Nocturnal Gastric Acidity published in THE
`
`AMERICAN JOURNAL OF GASTROENTEROLOGY in October 2004, in volume 99,
`
`- 5 -
`
`Page 6 of 8
`
`Patent Owner Ex. 2068
`Mylan v. Pozen
`IPR2017-01995
`
`MYLAN PHARMS. INC. EXHIBIT 1090 PAGE 6
`
`
`
`number 10, supplement, beginning on page S39.
`
`17.
`
`I hereby declare that all statements made herein of my own knowledge
`
`are true and that all statements made on information and belief are believed to be
`
`true; and further that these statements are made with the knowledge that willful false
`
`statements and the like are punishable by fine, imprisonment, or both, under Section
`
`1001 of Title 18 of the United States Code.
`
`
`
`Dated: June 1, 2018
`
`
`/Bryan D. Beel/
`
`
`- 6 -
`
`Page 7 of 8
`
`Patent Owner Ex. 2068
`Mylan v. Pozen
`IPR2017-01995
`
`MYLAN PHARMS. INC. EXHIBIT 1090 PAGE 7
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served a true and
`
`correct copy of the foregoing: CORRECTED DECLARATION OF BRYAN D.
`
`BEEL IN SUPPORT OF PETITIONER’S EVIDENCE by email to the electronic
`
`service addresses for Patent Owner:
`
`Thomas A. Blinka
`Jonathan G. Graves
`Susan Krumplitsch
`Cooley LLP
`zIPR2017-01995@cooley.com
`
`Margaret J. Sampson
`Stephen M. Hash
`Jeffrey S. Gritton
`Baker Botts LLP
`pozen-vimovoBB@bakerbotts.com
`
`Dated: June 1, 2018
`
`
`
`
`
`
`
`
`
`/Bryan D. Beel/
`
`Counsel for Petitioner Mylan Pharmaceuticals Inc.
`
`Page 8 of 8
`
`Patent Owner Ex. 2068
`Mylan v. Pozen
`IPR2017-01995
`
`MYLAN PHARMS. INC. EXHIBIT 1090 PAGE 8
`
`
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