DOCUMENTS CONSIDERED
`
`I.
`
`Documents Considered that are Cited in the Cameron Declaration
`
`• Ex. 1001 - U.S. Patent No. 9,220,631.
`
`• Ex. 1005 - Commission Investigative Staff’s Pre-Hearing Brief (Public
`
`Version). In the Matter of Certain Pre-filled Syringes for Intravitreal Injections
`
`and Components Thereof. U.S. International Trade Commission. Investigation
`
`No. 337-TA-1207. March 26, 2021.
`
`• Ex. 1027 - “Highlights of Prescribing Information.” Lucentis. FDA. Revised
`
`June 2010.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125156s053lbl.pdf.
`
`• Ex. 1040 - “Highlights of Prescribing Information.” Eylea. FDA. November
`
`2011.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125387lbl.pdf.
`
`• Ex. 1105 – Reply Declaration of Horst Koller. April 12, 2022.
`
`• Ex. 1106 – Reply Declaration of Dr. Szilárd Kiss. April 12, 2022.
`
`
`
`
`
`
`
`
`
`
`Regeneron Exhibit 1171.001
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`I.
`
`Documents Considered that are Cited in the Cameron Declaration
`
`• Ex. 1001 - U.S. Patent No. 9,220,631.
`
`• Ex. 1005 - Commission Investigative Staff’s Pre-Hearing Brief (Public
`
`Version). In the Matter of Certain Pre-filled Syringes for Intravitreal Injections
`
`and Components Thereof. U.S. International Trade Commission. Investigation
`
`No. 337-TA-1207. March 26, 2021.
`
`• Ex. 1027 - “Highlights of Prescribing Information.” Lucentis. FDA. Revised
`
`June 2010.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125156s053lbl.pdf.
`
`• Ex. 1040 - “Highlights of Prescribing Information.” Eylea. FDA. November
`
`2011.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125387lbl.pdf.
`
`• Ex. 1105 – Reply Declaration of Horst Koller. April 12, 2022.
`
`• Ex. 1106 – Reply Declaration of Dr. Szilárd Kiss. April 12, 2022.
`
`
`
`
`
`
`
`
`
`
`Regeneron Exhibit 1171.001
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`• Ex. 1115 - “Highlights of Prescribing Information.” Lucentis. FDA. June 2006.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125156lbl.pdf.
`
`• Ex. 1172 - Deposition of James E. Malackowski. March 29, 2022.
`
`• Ex. 1173 - David, Jesse and Stewart, Marion B. "Commercial Success:
`
`Economic Principles Applied to Patent Litigation." In Economic Damages in
`
`Intellectual Property. Edited by Daniel Slottje (Hoboken, NJ: John Wiley &
`
`Sons, Inc., 2006). 159-170.
`
`• Ex. 1174 - McNelis, John T. “New Designs: Licenses May Be Evidence of the
`
`Nonobviousness of an Invention.” Fenwick & West LLP. 1998.
`
`https://assets.fenwick.com/legacy/FenwickDocuments/New_Designs.pdf.
`
`• Ex. 1175 - Turbert, David. “Anti-VEGF Treatments.” American Academy of
`
`Ophthalmology. March 2, 2019. https://www.aao.org/eye-health/drugs/anti-
`
`vegf-treatments.
`
`• Ex. 1176 - “Highlights of Prescribing Information.” Lucentis. FDA. Revised
`
`March 2018.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125156s117lbl.pdf.
`
`
`
`
`
`
`
`
`
`
`Regeneron Exhibit 1171.002
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`• Ex. 1177 - “Highlights of Prescribing Information.” Eylea. FDA. Revised
`
`March 2021,
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125387s069lbl.pdf.
`
`• Ex. 1178 - “Novartis Ophthalmics and Genentech announce development and
`
`commercialization agreement for age-related macular degeneration treatment,
`
`Lucentis(TM).” Novartis Pharma AG press release. June 25, 2003.
`
`https://www.globenewswire.com/news-
`
`release/2003/06/25/1839492/0/en/Novartis-Ophthalmics-and-Genentech-
`
`announce-development-and-commercialization-agreement-for-age-related-
`
`macular-degeneration-treatment-Lucentis-TM.html.
`
`• Ex. 1179 - “Bayer HealthCare AG And Regeneron Pharmaceuticals, Inc. To
`
`Collaborate On VEGF Trap For The Treatment Of Eye Diseases; Regeneron
`
`Retains U.S. Commercialization Rights, Receives $75 Million Upfront, And
`
`Eligible For Up To $245 Million Of Milestone Payments.” Bayer HealthCare
`
`press release. October 19, 2006.
`
`https://www.biospace.com/article/releases/bayer-healthcare-ag-and-regeneron-
`
`pharmaceuticals-inc-to-collaborate-on-vegf-trap-for-the-treatment-of-eye-
`
`diseases-b-regeneron-b-retains-u-s-c/.
`
`
`
`
`
`
`
`
`
`
`Regeneron Exhibit 1171.003
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`• Ex. 1180 - “Eylea prefilled syringe now available.” Healio. December 12, 2019.
`
`https://www.healio.com/news/ophthalmology/20191212/eylea-prefilled-
`
`syringe-now-available.
`
`• Ex. 1182 - Okada, Mali et al. “Nonadherence or Nonpersistence to Intravitreal
`
`Injection Therapy for Neovascular Age-Related Macular Degeneration: A
`
`Mixed Methods Systematic Review.” Ophthalmology 128(2):234-247. August
`
`5, 2020.
`
`• Ex. 1184 - Turbert, David. “What is Avastin?” American Academy of
`
`Ophthalmology. April 23, 2021. https://www.aao.org/eye-health/drugs/avastin.
`
`• Ex. 1185 - REGITC01117015.
`
`• Ex. 1186 - “Highlights of Prescribing Information.” Avastin. FDA. Revised
`
`December 2020.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125085s337lbl.pdf.
`
`• Ex. 1187 - Navitsky, Callan. “The Regulation of Compounding Pharmacies.”
`
`Retina Today. November/December 2012.
`
`
`
`
`
`
`
`
`
`
`Regeneron Exhibit 1171.004
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`https://retinatoday.com/articles/2012-nov-dec/the-regulation-of-compounding-
`
`pharmacies.
`
`• Ex. 1188 - “Highlights of Prescribing Information.” Beovu. FDA. Revised
`
`February 2022.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761125s010s012s0
`
`13lbl.pdf.
`
`• Ex. 1189 - “US FDA approves updated Novartis Beovu® label, to include
`
`additional safety information.” Novartis press release. June 11, 2020.
`
`https://www.novartis.com/node/63226/printable/print.
`
`• Ex. 1190 - Liu, Angus. “Novartis calls off 3 Beovu trials testing more frequent
`
`dosing on concerns of vision-threatening side effect.” FiercePharma. June 1,
`
`2021. https://www.fiercepharma.com/marketing/novartis-takes-its-eyes-off-3-
`
`beovu-trials-more-frequent-dosing-safety-concerns.
`
`• Ex. 1191 - “Highlights of Prescribing Information.” Macugen. Revised July
`
`2011.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021756s018lbl.pdf.
`
`
`
`
`
`
`
`
`
`
`Regeneron Exhibit 1171.005
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`• Ex. 1192 - “Highlights of Prescribing Information.” Susvimo. Revised October
`
`2021.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf.
`
`• Ex. 1193 - “Susvimo 10 Mg/0.1Ml Implant Solution Macular Degeneration
`
`Treatment Agents-VEGF Antagonist Type- Uses, Side Effects, and More.”
`
`WebMD. https://www.webmd.com/drugs/2/drug-182612/susvimo-
`
`intravitreal/details.
`
`• Ex. 1194 - “FDA Approves Genentech’s Susvimo, a First-of-Its-Kind
`
`Therapeutic Approach for Wet Age-Related Macular Degeneration (AMD).”
`
`Genentech press release. October 22, 2021. https://www.gene.com/media/press-
`
`releases/14935/2021-10-22/fda-approves-genentechs-susvimo-a-first-.
`
`• Ex. 1195 - Gardner, Jonathan. “Roche wins FDA approval for rival to
`
`Regeneron’s lucrative eye drug.” BioPharma Dive. January 31, 2022.
`
`https://www.biopharmadive.com/news/roche-vabysmo-fda-approval-eye-drug-
`
`regeneron/618032/.
`
`
`
`
`
`
`
`
`
`
`Regeneron Exhibit 1171.006
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`• Ex. 1196 - “Highlights of Prescribing Information.” Vabysmo. FDA. Revised
`
`January 2022.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf.
`
`• Ex. 1197 - Jarosz, John and Vigil, Robert L. “Assessing Commercial Success at
`
`the U.S. Patent Trial and Appeal Board.” International In-house Counsel
`
`Journal. Vol. 8, No. 32. Summer 2015.
`
`• Ex. 1198 - “Research Design: Model Specification.” Reference Manual on
`
`Scientific Evidence, 3rd edition.
`
`• Ex. 1199 - Wooldridge, Jeffrey M. Econometric Analysis of Cross Section and
`
`Panel Data. Cambridge, MA: MIT Press, 2010.
`
`• Ex. 1200 - “Highlights of Prescribing Information.” Lucentis. FDA. Revised
`
`October 2016.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125156s110lbl.pdf.
`
`• Ex. 1201 - “Highlights of Prescribing Information.” Lucentis. FDA. Revised
`
`January 2017.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125156s111lbl.pdf.
`
`
`
`
`
`
`
`
`
`
`Regeneron Exhibit 1171.007
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`• Ex. 1202 - “Highlights of Prescribing Information.” Lucentis. FDA. Revised
`
`August 2012.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076
`
`lbl.pdf.
`
`• Ex. 1203 - NOVITCCH00190794.
`
`• Ex. 1204 - “Our Services.” Vetter. https://www.vetter-pharma.com/en/services/.
`
`• Ex. 1205 - REGITC00375880.
`
`• Ex. 1234 - “Highlights of Prescribing Information.” Lucentis. FDA. Revised
`
`February 2015.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125156s106lbl.pdf.
`
`• Ex. 1235 - “Highlights of Prescribing Information.” Eylea. FDA. Revised
`
`August 2019.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125387s060lbl.pdf.
`
`• Ex. 1236 - “Highlights of Prescribing Information.” Eylea. FDA. Revised
`
`September 2012.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125387s004lbl.pdf.
`
`
`
`
`
`
`
`
`
`
`Regeneron Exhibit 1171.008
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`• Ex. 1237 - “Highlights of Prescribing Information.” Eylea. FDA. Revised
`
`October 2014.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125387s043lbl.pdf.
`
`• Ex. 1238 - “Highlights of Prescribing Information.” Eylea. FDA. Revised
`
`March 2015.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125387s048lbl.pdf.
`
`• Ex. 1239 - “Highlights of Prescribing Information.” Lucentis. FDA. Revised
`
`February 2013.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125156s081lbl.pdf.
`
`• Ex. 1240 - “Highlights of Prescribing Information.” Lucentis. FDA. Revised
`
`April 2017.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125156s114lbl.pdf.
`
`• Ex. 1241 - “Highlights of Prescribing Information.” Eylea. FDA. Revised May
`
`2019.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125387s061lbl.pdf.
`
`
`
`
`
`
`
`
`
`
`Regeneron Exhibit 1171.009
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`• Ex. 1242 - McDuff, R. DeForest, Ryan C. Andrews, and Matt D. Brundage.
`
`“Thinking Economically about Commercial Success.” Landslide. Vol. 9, Iss. 4.
`
`March-April 2017.
`
`• Ex. 1243 –Varghese, Kevin L. “No Need to Neglect Nexus: Prosecution
`
`Lessons from FOX Factory v. SRAM.” Intellectual Property & Technology
`
`Law Journal. Vol. 32, No. 6. June 2020.
`
`• Ex. 1244 - Berndt, Ernst R. et al. “Information, Marketing, and Pricing in the
`
`U.S. Antiulcer Drug Market.” The American Economic Review 85(2). 1995.
`
`• Ex. 1245 - Opening Report of Szilárd Kiss, M.D. United States International
`
`Trade Commission. In the Matter of Certain Pre-filled Syringes for Intravitreal
`
`Injection and Components Thereof. January 22, 2021.
`
`• Ex. 1246 - GlobalData Healthcare. “The dominance of Eylea isExpected to
`
`persist in the foreseeable future.” Pharmaceutical Technology. July 1, 2020
`
`(updated December 1, 2021). https://www.pharmaceutical-
`
`technology.com/comment/eylea-bayer-regeneron/.
`
`
`
`
`
`
`
`
`
`
`Regeneron Exhibit 1171.010
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`• Ex. 1247 - Marshall, Helen. “Eylea (aflibercept).” Medical News Today.
`
`February 16, 2020. https://www.medicalnewstoday.com/articles/eylea#eylea-
`
`vs-lucentis.
`
`• Ex. 2016 - “Finance Report 2018.” Roche.
`
`https://assets.cwp.roche.com/f/126832/x/76260d5548/fb18e.pdf.
`
`• Ex. 2099 - GENEITC_1207-0000030.
`
`• Ex. 2121 - NOVITC(CH)00005765.
`
`• Ex. 2123 - NOVITC(CH)00007283.
`
`• Ex. 2124 - NOVITC(CH)00008409.
`
`• Ex. 2132 - NOVITC(CH)00170859.
`
`• Ex. 2133 - NOVITC(CH)00170896.
`
`• Ex. 2143 - NOVITC(CH)01495912.
`
`• Ex. 2146 - NOVITC(CH)01863785.
`
`
`
`
`
`
`
`
`
`
`Regeneron Exhibit 1171.011
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`• Ex. 2163 - “Finance Report 2019.” Roche.
`
`https://assets.cwp.roche.com/f/126832/dc13dd5d97/fb19e.pdf.
`
`• Ex. 2166 - NOVITC(US)00389194.
`
`• Ex. 2168 - NOVITC(US)00395564.
`
`• Ex. 2169 - NOVITC(US)00395565.
`
`• Ex. 2170 - NOVITC(US)00507243.
`
`• Ex. 2201 - Supplemental Declaration of Karl R. Leinsing, PE. In Support of
`
`Novartis’s Patent Owner Response. January 18, 2022.
`
`• Ex. 2205 - Declaration of James E. Malackowski. In Support of Patent Owner
`
`Response. January 18, 2022.
`
`• Ex. 2206 - Declaration of Juergen Sigg, Ph.D. In Support of Novartis’s Patent
`
`Owner Response. January 18, 2022.
`
`• Ex. 2276 - “Finance Report 2017.” Roche.
`
`https://assets.cwp.roche.com/f/126832/x/4a446c5c71/fb17e.pdf.
`
`
`
`
`
`
`
`
`
`
`Regeneron Exhibit 1171.012
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`• Paper No. 1. Petition for Inter Partes Review of U.S. Patent No. 9,220,631.
`
`Regeneron Pharmaceuticals, Inc. v. Novartis Pharma AG, Novartis Technology
`
`LLC, and Novartis Pharmaceuticals Corporation. April 16, 2021.
`
`II. Documents Considered that are not Cited in the Cameron Declaration
`
`• Ex. 1003 – Declaration of Horst Koller. April 16, 2021.
`
`• Ex. 1031 - Declaration of Dr. Szilárd Kiss. April 15, 2021.
`
`• Ex. 1157 - REGITC01116755.
`
`• Ex. 1248 - REG_SDNY_03832114.
`
`• Ex. 1249 - REGITC01116432.
`
`• Ex. 2001 - Declaration of Karl R. Leinsing. In Support of Novartis’ Patent
`
`Owner Preliminary Response. July 28, 2021.
`
`• Ex. 2134 - NOVITC(CH)00170915.
`
`• Ex. 2204 - Declaration of Andrew F. Calman, M.D., Ph.D. In Support of Patent
`
`Owner Response. January 18, 2022.
`
`
`
`
`
`
`
`
`
`
`Regeneron Exhibit 1171.013
`Regeneron v. Novartis
`IPR2021-00816
`
`
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
