UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
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`SLAYBACK PHARMA LLC,
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`Petitioner,
`
`v.
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`EYE THERAPIES, LLC,
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`Patent Owner.
`
`__________________
`
`Case IPR2022-00146
`U.S. Patent No. 9,259,425
`__________________
`
`DECLARATION OF DAVID FISHER IN RESPONSE TO SLAYBACK’S
`OBJECTIONS TO PATENT OWNER’S EXHIBIT NO. 2011
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`Eye Therapies Exhibit 2211, 1 of 9
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`I, David Fisher, declare as follows:
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`I.
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`INTRODUCTION
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`1.
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`I have been asked to submit this declaration on behalf of Eye Therapies,
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`LLC (“Eye Therapies” or “Patent Owner”), which I understand is being submitted
`
`in response to Slayback Pharma LLC’s (“Slayback” or “Petitioner”) objections to
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`Patent Owner’s Exhibit 2011.
`
`2.
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`3.
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`I have personal knowledge of the facts set forth herein.
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`I am currently Vice President, Marketing within the Bausch + Lomb
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`family of companies (“Bausch”). My employment at Bausch began in 1996 in a role
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`related to financial planning and analysis.
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`II.
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`DISCUSSION
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`4.
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`The press release in EX-2011 is an authentic record of Bausch’s
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`regularly conducted business activities and is based on the same. EX-2011 was made
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`at or near the time of the acts, events, or conditions recorded therein and was made
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`by—or from information transmitted by—an employee or representative of Bausch
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`with knowledge of the acts, events, or conditions recorded. It is in the regular course
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`of Bausch’s business to make these records, and it is in the regular course of
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`1
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`Eye Therapies Exhibit 2211, 2 of 9
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`Bausch’s business to keep these records. EX-2011 is a true and correct copy of the
`
`original.1
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`5.
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`Bausch + Lomb and Bausch Health, in collaboration with Glaucoma
`
`Research Foundation, conducted a survey of glaucoma patients regarding the impact
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`of hyperemia in glaucoma patients. Prior studies indicated that hyperemia is the most
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`common side effect of certain glaucoma treatments, and the primary reason for
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`nonadherence and discontinuation of the glaucoma treatments.
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`6.
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`The survey included 101 adults (18 years and older) in the United
`
`States, who have glaucoma and have experienced hyperemia caused by glaucoma
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`treatments.
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`7.
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`The survey results demonstrated that the emotional cost of hyperemia
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`is high, with 71% of the participants feeling self-conscious and 55% of the
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`participants feeling embarrassed about their red eyes. The participants indicated that
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`there was some social stigma associated with having red eyes. Forty-one participants
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`1 Since the submission of EX-2011, the link for the press release has changed to
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`https://pi.bausch.com/globalassets/pdf/news-archive/bauschhealthpdf/01-04-2022-
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`115911342.pdf. A copy of the press release downloaded from this website address
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`is enclosed as Appendix A.
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`2
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`Eye Therapies Exhibit 2211, 3 of 9
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`noted concerns about experiencing negative social interactions due to hyperemia.
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`Sixty-six participants reported feeling more confident when their eyes were not red.
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`8.
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`The survey also showed that nearly half (43 out of 101) of the
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`participants consulted their doctors about changing their glaucoma treatments due to
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`hyperemia. Twelve participants reported skipping doses or discontinuing their
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`prescription eye drops for glaucoma. And 1 in 10 patients stopped their treatment in
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`certain social or professional circumstances. The survey found that only a few
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`glaucoma patients knew about hyperemia when they started glaucoma treatments,
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`with 61% of the participants reporting that they only became aware of hyperemia
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`after experiencing it.
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`9.
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`The press release provided in EX-2011 accurately reflects the results of
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`the survey conducted. There is not a formal report reflecting these results—the
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`purpose of the press release was to publish the results of the survey, in place of
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`another type of deliverable, such as a report. In the ordinary course of Bausch’s
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`business, the company chooses different types of deliverables based on costs,
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`resources, and purpose of a project—that the deliverable for this survey was a press
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`release, rather than a formal report. The press release is an accurate summary of the
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`results and went through Bausch’s standard review process to ensure accuracy, prior
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`to publication.
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`3
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`10.
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`I declare that all statements made herein of my knowledge are true, that
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`all statements made herein on information and belief are believed to be true, and that
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`these statements were made with the knowledge that willful false statements and the
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`like so made are punishable by fine or imprisonment, or both, under Section 1001 of
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`Title 18 of the United States Code.
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`Executed on June 15, 2022.
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`/
`
`/
`
`David Fisher
`Vice President, Marketing
`Bausch + Lomb
`
`4
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`Eye Therapies Exhibit 2211, 5 of 9
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`Appendix A
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`Eye Therapies Exhibit 2211, 6 of 9
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`New Survey from Bausch + Lomb and Glaucoma Research
`Foundation Reveals Emotional and Social Impact of Hyperemia on
`Glaucoma Patients
`
`January 04, 2022
`
`Survey Results Are Released During Glaucoma Awareness Month
`
`LAVAL, Quebec, and SAN FRANCISCO, Jan. 4, 2022 /PRNewswire/ -- Bausch + Lomb, a leading global eye health business of Bausch
`Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health"), and Glaucoma Research Foundation (GRF), a national non-profit
`organization with the vision of curing glaucoma, today released, during Glaucoma Awareness Month, new key findings from a survey of
`glaucoma patients that was designed to gain a greater understanding of the impact that hyperemia can have in the treatment and lives
`of people living with glaucoma. In the United States, glaucoma is one of the leading causes of preventable blindness in individuals over
`1,2
`60, affecting approximately three million people
`.
`
`For people with glaucoma, adherence to a treatment regimen is critical for managing their condition and controlling intraocular pressure,
`3
`which helps to slow disease progression . Certain treatments for glaucoma can result in hyperemia of the eye due to an increase in
`4,5
`blood flow in vessels at the surface of the eye, resulting in red eyes
`. Patient's concern about and dissatisfaction with side effects are
`6
`among the primary reason for non-adherence and discontinuation . With hyperemia as the most common documented side effect,
`6
`some glaucoma patients stop or skip medication as a result , which may have implications for long-term treatment and patient eye
`health.
`
`"Bausch + Lomb is proud to collaborate with Glaucoma Research Foundation to raise awareness of hyperemia and how it may have an
`impact on the lives of patients with glaucoma," said Joe Gordon, U.S. president, Bausch + Lomb. "The survey results demonstrated
`that the emotional cost of hyperemia is high, with 71 percent of participants feeling self-conscious and 55 percent feeling embarrassed
`about their red eyes. It is our hope that by raising awareness of this issue, we can help facilitate discussions among patients and their
`eye care professionals about their options and the importance of adhering to their treatment regimen."
`
`The survey included 101 adults, 18 years and older in the United States, who have glaucoma and have experienced hyperemia as a
`result of their treatment. The survey found that few glaucoma patients know about hyperemia when starting treatment for glaucoma,
`with 61 percent reporting that they only became aware of the condition after experiencing it themselves.
`
`Additionally, nearly half (43 out of 101) of the respondents reported talking to their doctors about changing their glaucoma treatment
`as a result of hyperemia, and 12 out of 101 either skipped doses or stopped using their prescription eye drops. Approximately 66 out
`of 101 participants reported feeling more confident when their eyes were not red, and respondents also indicated that there was some
`social stigma associated with having red eyes. In fact, one in 10 patients stopped their treatment in certain social or professional
`circumstances and 41 out of 101 noted concerns about experiencing negative social interactions as a result.
`
`"These findings build upon earlier evidence that hyperemia presents a challenge to people with glaucoma and sheds light on how the
`condition may not only impact how they treat their glaucoma, but how they live their lives," said Andrew Iwach, M.D., board chair,
`Glaucoma Research Foundation, and executive director, Glaucoma Center of San Francisco. "The results reinforce the importance for eye
`care professionals to have an open dialogue with their patients about the available treatment options and any concerns that they may
`have. This can help patients to feel confident about managing their glaucoma and demonstrate the importance of taking control of their
`eye health by maintaining the appropriate treatment regimen."
`
`For more information on glaucoma, visit the GRF website at https://www.glaucoma.org/ or the Bausch + Lomb website at
`https://www.bausch.com/your-eye-concerns/diseases-and-disorders/glaucoma.
`
`About Glaucoma 
`Glaucoma is a complex disease that occurs when build-up of fluid creates pressure in the eye, leading to damage of the optic nerve. The
`optic nerve is responsible for the communication of information between the eye and brain. Damage to the optic nerve can lead to
`severe vision loss, and in the worst case, blindness. As one of the leading causes of preventable blindness, glaucoma affects about
`1,2
`three million people in the United States
`.
`
`About Hyperemia
`Hyperemia may occur due to multiple causes such as in response to allergic inflammation, irritants, infections, and multiple ocular
`7
`diseases, and is also the most common documented side effect of certain glaucoma treatments . Hyperemia occurs when there is an
`increase in blood flow to certain organs or parts of the body. When this happens in the eye, the increased diameter of veins/blood
`4
`vessels causes an increase in blood flow which makes the eye appear red .
`
`About Glaucoma Research Foundation 
`Founded in 1978, GRF has been upholding its mission to cure glaucoma through innovative research, leading the industry as a non-
`profit organization. Building a team of collaborators through researchers and scientists over the years, all sharing the common goal of
`finding a cure - GRF is committed to raising awareness, spreading the word and encouraging others to have a shared goal. For more
`information visit, https://www.glaucoma.org/, and follow them on Facebook, Instagram, LinkedIn, and Twitter.
`
`About Bausch + Lomb Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., is solely focused on
`helping people see. Its core businesses include over-the-counter products, dietary supplements, eye care products, ophthalmic
`pharmaceuticals, contact lenses, lens care products, ophthalmic surgical devices and instruments. Bausch + Lomb develops,
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`manufactures and markets one of the most comprehensive product portfolios in the industry, which is available in approximately 100
`countries. For more information, visit www.bausch.com.   
`
`About Bausch Health
`Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people's lives with our health care
`products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in
`the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative
`company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and
`LinkedIn.
`
`Forward-looking Statements 
`This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates,"
`"hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and
`variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are
`subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking
`statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch Health's most
`recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange
`Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are
`not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its
`potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a
`material adverse impact on Bausch Health, including but not limited to its project development timelines, launches and costs (which may
`increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking
`statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking
`statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
`
`References
`
`Mayo Clinic. Retrieved from https://www.mayoclinic.org/diseases-conditions/glaucoma/symptoms-causes/syc-20372839. Reviewed on
`Nov. 30, 2021.
`U.S. Centers for Disease Control and Prevention. Retrieved from https://www.cdc.gov/visionhealth/resources/features/glaucoma-
`awareness.html. Reviewed on Nov. 3, 2021.
`National Eye Institute: Glaucoma and Eye Pressure. Retrieved from https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-
`and-diseases/glaucoma/glaucoma-and-eye-pressure. Reviewed on Nov. 12, 2021.
`Medical News Today. Retrieved from https://www.medicalnewstoday.com/articles/319416. Reviewed on Nov. 5, 2021.
`Stalmans I, Lemij H, Clarke J, Baudouin C; GOAL study group. Signs and Symptoms of Ocular Surface Disease: The Reasons for
`Patient Dissatisfaction with Glaucoma Treatments. Clin Ophthalmol. 2020;14:3675-3680. Published 2020 Oct 30.
`doi:10.2147/OPTH.S269586
`Ophthalmology Times: Glaucoma: Hyperemia a common cause for medication changes.
`https://www.ophthalmologytimes.com/view/glaucoma-hyperemia-common-cause-medication-changes . Reviewed on November 10,
`2021.
`Review of Ophthalmology: Code Red: The Key Features of Hyperemia.  https://www.reviewofophthalmology.com/article/code-red-the-
`key-features-of-hyperemia. Reviewed on December 1, 2021.
`
`All product/brand names and/or logos are trademarks of the respective owners.
`© 2022 Bausch & Lomb Incorporated or its affiliates.
`VYZ.1538.USA.21
`
`Glaucoma Research Foundation Media Contact: 
`Andrew J. Jackson
`(415) 986-3162
`ajackson@glaucoma.org
`
`Bausch Health Investor Contact:
`Arthur Shannon
`arthur.shannon@bauschhealth.com
`(514) 865-3855
`(877) 281-6642 (toll free)
`
`Bausch Health Media Contact:
`Lainie Keller
`lainie.keller@bauschhealth.com
`(908) 927-1198
`
`Eye Therapies Exhibit 2211, 8 of 9
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`View original content to download multimedia:https://www.prnewswire.com/news-releases/new-survey-from-bausch--lomb-and-
`glaucoma-research-foundation-reveals-emotional-and-social-impact-of-hyperemia-on-glaucoma-patients-301452996.html
`
`SOURCE Bausch Health Companies Inc.
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`Eye Therapies Exhibit 2211, 9 of 9
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