UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`SLAYBACK PHARMA LLC,
`
`Petitioner,
`
`v.
`
`EYE THERAPIES, LLC,
`
`Patent Owner.
`
`__________________
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`__________________
`
`DECLARATION OF JOHN FERRIS
`
`Eye Therapies Exhibit 2023, 1 of 24
`Slayback v. Eye Therapies - IPR2022-00142
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`
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`SLAYBACK PHARMA LLC,
`
`Petitioner,
`
`v.
`
`EYE THERAPIES, LLC,
`
`Patent Owner.
`
`__________________
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`__________________
`
`DECLARATION OF JOHN FERRIS
`
`Eye Therapies Exhibit 2023, 1 of 24
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`Declaration of John Ferris
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`Table of Contents
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`DISCUSSION.................................................................................................. 2
`
`Lumify Is a #1 Doctor Recommended and Award-Winning
`Brand ..................................................................................................... 2
`
`Lumify’s Commercial Strategy Centers on Redness Reduction
`Using Low-Dose Brimonidine .............................................................. 3
`
`Bausch’s Market Research Related to Lumify ..................................... 9
`
`Lumify Is a Key Product to Bausch’s Business ..................................13
`
`Lumify Has Had Extraordinary Market Penetration...........................15
`
`III. DOCUMENTATION AT BAUSCH: MARKET DATA RECORDS.........17
`
`i
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`I, John Ferris, declare as follows:
`
`I.
`
`INTRODUCTION
`
`1.
`
`I have been asked to submit this declaration on behalf of Bausch’s
`
`partner, Eye Therapies, LLC (“Eye Therapies” or “Patent Owner”), which I
`
`understand is being submitted in support of the Patent Owner’s Response in
`
`connection with IPR2022-00142.
`
`2.
`
`3.
`
`I have personal knowledge of the facts set forth herein.
`
`I am currently Senior Vice President, Global Consumer within the
`
`Bausch + Lomb family of companies (“Bausch”). My employment at Bausch began
`
`in 2011 in a role related to marketing of over-the-counter (OTC) eye vitamins. Over
`
`the years, I have held various roles and titles, with my current responsibilities
`
`starting in January 2022. Prior to joining Bausch, I held marketing, sales, and
`
`commercial leadership positions of increasing responsibility over 15 years with
`
`Wyeth Consumer Health and Pharmaceuticals and Becton Dickinson.
`
`4.
`
`In my capacity of SVP, I have 6 direct reports, with a total of 1,100 total
`
`reports. I oversee all marketing and commercial efforts related to Lumify and have
`
`responsibility for the same. In this capacity, I have personal knowledge related to
`
`Lumify-related finances, marketing, sales, and promotional material, among other
`
`things. For example, I have actively participated in meetings of the Bausch
`
`1
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`promotional review committee (“PRC”)1 for products within my responsibility, such
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`Case IPR2022-00142
`Declaration of John Ferris
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`as Lumify eye drops.
`
`II.
`
`DISCUSSION
`
`Lumify Is a #1 Doctor Recommended and Award-Winning
`Brand
`
`5.
`
`Lumify (brimonidine tartrate ophthalmic solution, 0.025%) is the first
`
`and only OTC eye drop developed with low-dose brimonidine tartrate for the
`
`treatment of ocular redness due to minor eye irritation. It is backed by multiple
`
`clinical trials with hundreds of patients, and works differently than other redness
`
`relievers.
`
`6.
`
`Lumify’s success speaks for itself: It is the #1 doctor recommended
`
`redness relieving drop, and has received multiple awards and recognitions since
`
`launch, including:
`
`(cid:120) 2018:
`o The Zoe Report: Best Affordable Beauty Winner
`o New You: The Eyes Have It
`o NACDS Product of the Year
`(cid:120) 2019:
`o Brides: The Best of Beauty (Eyes)
`o New Beauty: Best Innovations
`
`
`
`
`
`
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`2
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`(cid:120) 2020: “Superstar” category of Nielsen BASES’ Top 25 Breakthrough
`Innovations List.
`(cid:120) 2021: Into the Gloss: Top 25: Cheap Thrills
`(cid:120) 2022:
`o New Beauty Magazine Beauty Awards: “Never Knew We Needed”
`o Glamour: “Best Beauty Innovators of 2022”
`
`(See EX-2100, EX-2101, EX-2114, EX-2125, EX-2144, EX-2152, EX-2153, EX-
`
`2154, EX-2155.)
`
`7.
`
`Lumify has been and continues to be a groundbreaking redness
`
`relieving option for a variety of patients, effectively setting a new standard of care
`
`in the field. Among Eye Care Professionals (ECPs), including Optometrists and
`
`Ophthalmologists, as stated above, Lumify very quickly became their #1
`
`recommended brand of redness reliever. Prior to Lumify, existing redness relievers
`
`were known to have common side effects, which made ECPs hesitant to recommend
`
`them—in fact, less than 10% of ECPs recommended any redness relievers to their
`
`patients. Since the launch of Lumify, that number has grown to 50% of ECPs
`
`recommending redness relievers with 85% of those recommendations being for
`
`Lumify.
`
`Lumify’s Commercial Strategy Centers on Redness
`Reduction Using Low-Dose Brimonidine
`
`8.
`
`Since its launch, the commercial strategy for Lumify has consistently
`
`centered on the product’s unique ability to reduce eye redness, helping eyes look
`
`3
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`whiter and brighter to reveal their natural beauty. All marketing, promotional, and
`
`sales materials tie back to the FDA-approved indication for reducing eye redness.
`
`9.
`
`Promoting Lumify drops for reduction of eye redness is—quite
`
`simply—required. As background,
`
`the pharmaceutical
`
`industry
`
`is highly
`
`regulated. One of the core components of this regulation relates to on- versus off-
`
`label promotion. Although I am not a lawyer, as a person with a career in marketing,
`
`I am aware of and highly sensitive to the fact that pharmaceutical products, like
`
`Lumify eye drops, must be promoted on-label, meaning they can only be promoted
`
`with claims consistent with the approved product labeling. Penalties for anything
`
`else (i.e., off-label promotion) are severe. For that reason, we at Bausch hold
`
`ourselves to a very high standard in ensuring that our promotional efforts are
`
`consistent with the approved product label.
`
`10. The FDA-approved indication for Lumify eye drops is reducing eye
`
`redness caused by minor eye irritation. Every piece of promotional content has been
`
`(and will continue to be) reviewed by Bausch PRC to ensure consistency with this
`
`approved indication. Promotion consistent with the label (i.e., on-label promotion)
`
`is a strict standard that Bausch lives by—to the extent the commercial team would
`
`attempt to do something different (i.e., to use “off-label” material), such material
`
`would not be approved for circulation by the Bausch PRC.
`
`
`
`
`
`4
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` our promotional material and commercial efforts for
`
`Lumify eye drops have been consistent with its FDA-approved indication of
`
`reducing eye redness.
`
`11. The fact that the promotional material for Lumify eye drops are
`
`centered on redness reduction is easy to verify. For example, below are screenshots
`
`from the Lumify consumer website (www.lumifydrops.com), a PDF of which is also
`
`provided as EX-2109:
`
`
`
`5
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`Eye Therapies Exhibit 2023, 7 of 24
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`12. But it does not end there. The consumer website also offers a section
`
`called The Science of Lumify that centers on this same educational material. For
`
`example, below are screenshots from The Science of Lumify portion of the Lumify
`
`website (https://www.lumifydrops.com/lumify-science), a PDF of which is also
`
`provided as EX-2112:
`
`6
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`Eye Therapies Exhibit 2023, 8 of 24
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`7
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`13. The messaging for ECPs further describes the science behind Lumify
`
`and highlights Lumify’s uniqueness. For example, below are screenshots from the
`
`professional
`
`portion
`
`of
`
`the
`
`Lumify
`
`website
`
`(https://www.lumifydrops.com/professional), a PDF of which is also provided as
`
`EX-2111:
`
`
`
`
`
`8
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`Eye Therapies Exhibit 2023, 10 of 24
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`Bausch’s Market Research Related to Lumify
`
`14.
`
`In order to better understand ECPs’ perceptions of Lumify and its
`
`competitors on the market, Bausch conducted awareness and usage research, which
`
`is typical in the pharmaceutical industry. This type of research—and the resulting
`
`data generated—is something that Bausch and others in the pharmaceutical industry
`
`routinely conduct and rely upon in making strategy decisions and would be generally
`
`accepted and relied upon in the industry. Below, I summarize relevant data from
`
`
`
`. Specifically,
`
`this was a survey commissioned by Bausch for market research purposes by Ipsos
`
`Healthcare (“Ipsos”). Ipsos is a known, reputable service that describes itself as
`
`“dedicated to understanding the motivations, behavior and influences of the multiple
`
`stakeholders driving commercial success in the healthcare industry.” (See EX-
`
`2157.) Based on my experience in the industry, surveys like those conducted by
`
`Ipsos would be generally accepted and relied upon in the industry. The survey
`
`described herein included
`
`9
`
`
`
`
`
`
`
`
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`Eye Therapies Exhibit 2023, 11 of 24
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` The complete report for the Attitudes and Usage Study as provided to
`
`Bausch is included as EX-2156.
`
`15.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`10
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`Eye Therapies Exhibit 2023, 12 of 24
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`Eye Therapies Exhibit 2023, 13 of 24
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`Eye Therapies Exhibit 2023, 14 of 24
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`Eye Therapies Exhibit 2023, 15 of 24
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`20.
`
`In terms of revenue,
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`Declaration of John Ferris
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`,3 and is a core component of Bausch’s revenue. For example, as
`
`publicly reported in Bausch’s Q1 2022 earnings presentation, Lumify’s revenues
`
`amounted to $108M in FY2021, which accounts for about 7.5% of the entire Vision
`
`Care Consumer Product segment. (Compare EX-2068 at 27 to EX-2068 at 29.) This
`
`proportion is expected to continue to grow, as the Lumify product continues to drive
`
`its growth and success anchored by its outstanding clinical results.
`
`21. To have the opportunity to commercialize this successful product,
`
`Bausch has partnered with Patent Owner, Eye Therapies, and has paid substantial
`
`milestones and royalties (
`
` at the time of writing) to Patent
`
`Owner. Bausch has also incurred
`
` to date in R&D expenditures
`
`related to Lumify and spent
`
` per year on sales and marketing for
`
`Lumify between 2018 and 2022.
`
`
`3 This is particularly interesting because Lumify has a higher price point than its
`
`competitors—meaning, generally, that a customer is likely to be willing to pay more
`
`to obtain the superior redness relieving effects of Lumify.
`
`14
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`Lumify Has Had Extraordinary Market Penetration
`
`22.
`
`Lumify’s success is demonstrated by Lumify’s fast-growing market
`
`share in the redness reliever category. For example, Bausch reported publicly in
`
`September 2018, that “[w]ithin three months of launching, LUMIFY is already the
`
`number one doctor recommended brand of redness reliever eye drops and has
`
`already reached a market share of over 20% share of the redness reliever category,”
`
`based on IRI data (retail dollar share for the week ending Aug. 26, 2018). (EX-
`
`2158.) Achieving 20% market penetration within mere months of launch was—and
`
`continues to be—hugely impressive. This success has continued, with Lumify
`
`remaining the number one doctor recommended redness relieving drop, and
`
`obtaining approximately
`
` of weekly market share in this category in Q2 2022,
`
`despite launching in just 2018. (See EX-2159 at 14.)
`
`23. Much of this growth has been driven by new households entering the
`
`redness relief category and strong repeat rates which are both indicators of very
`
`strong product performance. In the latest
`
`, according to IRI data,
`
` of
`
`Lumify users are new to the redness relief category, and
`
` are new to eye care
`
`overall. Additionally,
`
`of Lumify purchases are repeated within
`
`,
`
`which is significantly higher than traditional redness reliever repeat rates.
`
`24.
`
`Lumify’s disruption of the redness reliever category is clear, as
`
`represented in the graph below, which depicts the redness reliever market (with and
`
`15
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`Eye Therapies Exhibit 2023, 17 of 24
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`without Lumify), based on IRI reported retail dollar sales. As shown below,4 while
`
`the redness reliever market (without Lumify) has stayed relatively flat from 2016 to
`
`present, the launch of Lumify in 2018 has changed the trajectory and driven growth
`
`of the entire category.
`
`25.
`
`Further demonstrating the tangible and unique performance of Lumify,
`
`the brand has garnered over
`
`media impressions consisting of unpaid
`
`endorsements from media, make-up artists, celebrities and beauty influencers. On
`
`4 The graph below was taken from the live IRI database (US all outlets) from the
`
`week ending July 10, 2022.
`
`16
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`Eye Therapies Exhibit 2023, 18 of 24
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`TikTok alone, Lumify users have generated organic content with over
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`Declaration of John Ferris
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`views.
`
`26. Overall, Lumify is an extremely impressive product, with a unique
`
`formulation and outstanding clinical results in redness reduction that have been
`
`recognized and rewarded by the eye care industry (both ECPs and consumers), not
`
`only in terms of sales, but also in terms of awards, praise, and impressive, continuous
`
`growth.
`
`III. DOCUMENTATION AT BAUSCH: MARKET DATA RECORDS
`
`27. As is typical in the pharmaceutical industry, Bausch collects data in
`
`several different ways, both internally and externally. In this regard, Bausch collects
`
`and relies upon certain established market reports and commercial publications that
`
`are generally accepted and relied upon in the industry. For example, Bausch
`
`subscribes to a data-collection service provided by a company called IRI, a well-
`
`known, established company that aggregates otherwise disconnected retail data.
`
`(See EX-2160 (“As one of the original innovators in big data, IRI integrates the
`
`world’s largest set of otherwise disconnected purchase, media, social, causal and
`
`loyalty data to help CPG, retail, over-the-counter health care and media companies
`
`grow their businesses.”).) IRI is one of two major data-aggregation sources in the
`
`United States—the other being its competitor, Nielsen. Both IRI and Nielsen source
`
`17
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`data from the same national consumer panel and are considered leaders in the
`
`industry due to their reliability.
`
`28. Bausch—like most, if not all, pharmaceutical companies with a retail,
`
`over-the-counter business arm—subscribes to IRI. With this subscription, Bausch
`
`has access to a variety of data sets, which live in the IRI workspace, available online.
`
`Bausch, like all IRI subscribers, can then generate exports of such data, fitting the
`
`needs of a particular data request. As one example relevant to this matter, Bausch
`
`has access to aggregate data related to the “redness reliever” category of the eyecare
`
`market.
`
`
`
`
`
`
`
`
`
` In IRI, while data
`
`is saved for years, it is important to keep in mind that there can be things like
`
`“restatements” that account for data corrections.
`
`29.
`
`Importantly, because the IRI database requires knowledge about both
`
`how data is stored, how data is processed, and its user interface, it is important that
`
`whoever exports the data is knowledgeable about the workspace;
`
`
`
`
`
`
`
`18
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`30. Bausch, and in particular the Bausch commercial team, relies upon IRI
`
`data in the ordinary course of its business.
`
`
`
`
`
` In particular, Bausch relies on two high-level categories of data: Panel data and
`
`POS data. The IRI Panel data are based on projections from a national consumer
`
`panel, while the IRI POS data are based on point-of-sale data from retail
`
`stores. Panel data is more inclusive of channels—meaning the entire world of
`
`consumption (aiming at capturing 100% of total consumption). This data provides
`
`a picture of long-term consumption, holistically, but lacks certain details. On the
`
`other hand, POS data does not include the entire view of total US data (because it
`
`captures a more limited channels of data), but there is a lot more granularity of data.
`
`Together, the commercial team and data analysists at Bausch review and rely upon
`
`one or both types of data, depending on the purpose of the review. In my role as
`
`SVP of Marketing, my team regularly relies on IRI data and considers the IRI data
`
`to be a reliable compilation of market data—in fact, I have a particular expertise with
`
`this data, as I previously worked at IRI.
`
`31. The spreadsheet at LUMIFY LEGAL DATA JULY 2022 (hereinafter,
`
`“IRI Panel Data”) (EX-2057) is an authentic export of IRI panel data. It includes
`
`the US geography, including all outlets (which includes total brick-and-mortar and
`
`online sales). It includes the overarching redness reduction category
`
`
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`, as well as the individual major branded products
`
`within the redness reduction category. This is an example of IRI data on which
`
`Bausch regularly relies. It comes from “living” data updated at IRI, and was
`
`provided by an employee or representative of Bausch with knowledge of the
`
`database. In the regular course of Bausch’s business, Bausch exports and relies on
`
`these types of data, and in the regular course of Bausch’s business, Bausch keeps
`
`and updates these records. The IRI Panel Data is a true and correct copy of the
`
`exported Panel Data, as of June 12, 2022, and accurately reflects the data provided
`
`by IRI, to the best of the company’s knowledge.
`
`32. The spreadsheet at LUMIFY LEGAL DATA POS JULY 2022
`
`(hereinafter, “IRI POS Data”) (EX-2058) is an authentic export of IRI data. It
`
`includes the US geography, including multiple outlets (which includes the food
`
`channel, drug channel, mass channel, and selected club retailers, excluding online-
`
`exclusive sales (meaning bought online and delivered to home)). It includes the
`
`overarching redness reduction category, as well as the individual products within the
`
`redness reduction category. The revenues and prices in the IRI POS data generally
`
`reflect what consumers pay at the register. Units captured in the IRI POS data refer
`
`to packages (such that, for example, one package with two bottles would be captured
`
`as one unit) while volume in the IRI POS data is in fluid ounces. Additionally, the
`
`“Price per Unit” measure is closer to net price (i.e., price paid by customer at the
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`register after any promotions/discounts/coupons have been applied) while the “Price
`
`per Unit No Merch” measure is closer to gross price (i.e., without any
`
`promotions/discounts/coupons applied); therefore, the “Price per Unit No Merch”
`
`price may be higher than the price per unit, in light of promotions that may have
`
`lowered the sales price. This is an example of IRI data on which Bausch regularly
`
`relies. It comes from “living” data updated at IRI, and was provided by an employee
`
`or representative of Bausch with knowledge of the database. In the regular course of
`
`Bausch’s business, Bausch exports and relies on these types of data, and in the
`
`regular course of Bausch’s business, Bausch keeps and updates these records. The
`
`IRI POS Data is a true and correct copy of the exported POS data, as of July 3, 2022,
`
`and accurately reflects the data provided by IRI, to the best of the company’s
`
`knowledge.
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`Eye Therapies Exhibit 2023, 24 of 24
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