`
`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
`
`
`
`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
`
`
`
`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
`
`
`
`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
`
`
`
`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
`
`
`
`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
`
`
`
`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
`
`
`
`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
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
