Case 2:21-cv-09507 Document 1 Filed 12/08/21 Page 1 of 40 Page ID #:1
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`René P. Tatro (SBN 078383)
`Juliet A. Markowitz (SBN 164038)
`TATRO TEKOSKY SADWICK LLP
`333 S. Grand Avenue, Suite 4270
`Los Angeles, CA 90071
`Telephone: (213) 225-7171
`Facsimile:
`(213) 225-7151
`E-mail:
`rtatro@ttsmlaw.com
`jmarkowitz@ttsmlaw.com
`
`Raymond N. Nimrod (pro hac vice pending)
`Matthew D. Robson (pro hac vice pending)
`QUINN EMANUEL URQUHART & SULLIVAN LLP
`51 Madison Ave., 22nd Floor
`New York, NY 10010
`Telephone: (212) 849-7000
`Facsimile:
`(212) 849-7100
`E-mail:
`raynimrod@quinnemanuel.com
`matthewrobson@quinnemanuel.com
`
`Attorneys for Plaintiff Pharmavite LLC
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`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
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`PHARMAVITE LLC, a California limited
`liability company,
`
`Plaintiff,
`
`v.
`BAUSCH & LOMB INCORPORATED,
`a New York corporation, and PF
`CONSUMER HEALTHCARE 1 LLC, a
`Delaware corporation;
`Defendants.
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`Case No. 2:21-CV-09507
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`PHARMAVITE LLC’S COMPLAINT
`FOR:
`(1) MONOPOLIZATION
`(15 U.S.C. § 2);
`(2) ATTEMPTED
`MONOPOLIZATION
`(15 U.S.C. § 2);
`(3) CONSPIRACY TO
`MONOPOLIZE (15 U.S.C. § 2);
`and
`(4) DECLARATORY
`JUDGMENT—NON-
`INFRINGMENT, PATENT
`INVALIDITY, AND PATENT
`MISUSE (28 U.S.C. § 2201 et seq.)
`JURY TRIAL DEMANDED
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`Case 2:21-cv-09507 Document 1 Filed 12/08/21 Page 2 of 40 Page ID #:2
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`Plaintiff Pharmavite LLC (“Pharmavite”) hereby alleges as follows against
`defendants Bausch & Lomb Incorporated (“Bausch & Lomb”) and PF Consumer
`Healthcare 1 LLC (“PF Consumer Healthcare 1”) (collectively, “Defendants”):
`NATURE OF THE ACTION
`1.
`This case concerns Defendants’ attempts to monopolize the eye health
`supplement market and to keep competing products, including Pharmavite’s Nature
`Made® Vision supplement, off the market. Defendants have done so by filing a sham
`patent infringement lawsuit against Pharmavite; making false and misleading claims
`about Bausch & Lomb’s PreserVision® products, including making unlawful disease
`claims; and/or misusing and misrepresenting the scope of Defendants’ United States
`Patent No. 8,603,522 (“the ’522 Patent”).
`2.
`Pharmavite brings this action asserting claims for monopolization,
`attempted monopolization, and conspiracy to monopolize in violation of 15 U.S.C. § 2.
`3.
`Pharmavite also brings this action for a declaratory judgment that (a) it
`does not infringe, either directly or indirectly, any claim of the ’522 Patent; (b) the
`claims of the ’522 Patent are invalid for failure to comply with the requirements for
`patentability set forth in Title 35 of the United States Code and related judicial
`doctrines, including without limitation, 35 U.S.C. §§ 101, 102, 103, and/or 112 and/or
`obviousness-type double patenting; and (c) the claims of the ’522 Patent are
`unenforceable due to at least patent misuse. This action is necessary to resolve an
`actual, justiciable, and continuing controversy between Pharmavite and Defendants
`regarding the non-infringement, invalidity, and unenforceability of the ’522 Patent.
`THE PARTIES
`4.
`Plaintiff Pharmavite LLC is a California limited liability company with its
`principal place of business in West Hills, California.
`5.
`On information and belief, defendant Bausch & Lomb is a corporation
`organized and existing under the laws of New York, with a principal place of business at
`1400 North Goodman Street, Rochester, NY 14609. On information and belief,
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`Case 2:21-cv-09507 Document 1 Filed 12/08/21 Page 3 of 40 Page ID #:3
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`Bausch & Lomb conducts business within the State of California and has a registered
`agent in California.
`6.
`On information and belief, defendant PF Consumer Healthcare 1 is a
`limited liability company organized and existing under the laws of Delaware and having
`a place of business at 1209 Orange Street, Corporation Trust Center, Wilmington, DE,
`19801. On information and belief, PF Consumer Healthcare 1 conducts business
`within the State of California and has a registered agent in California.
`JURISDICTION AND VENUE
`7.
`This Court has subject matter jurisdiction over this action pursuant to 28
`U.S.C. §§ 2201-2202, 1331-1332, 1338(a), and 1367(a), and the doctrine of pendent
`jurisdiction.
`8.
`Pharmavite’s claims arose in this District, and Pharmavite or its agents may
`be found or transact affairs in this District. In addition, on information and belief,
`Bausch & Lomb has conducted business in this District by marketing, selling,
`advertising, and promoting its product called PreserVision®, and Defendants have
`conducted business in this District by misusing the ’522 Patent and expired United
`States Patent No. 6,660,297 (“the ’297 Patent”), thereby causing, or likely to cause, harm
`to Pharmavite in this District. Defendants have further filed a patent infringement
`lawsuit lacking any good faith basis in an unquestionably improper venue (the U.S.
`District Court for the District of Delaware) against Pharmavite, causing Pharmavite
`harm in this District. On information and belief, Bausch & Lomb has attempted to and
`has willfully and unlawfully maintained a monopoly in the eye health supplement market
`throughout the United States, including in this District, and PF Consumer Healthcare 1
`has conspired with Bausch & Lomb to do so, causing Pharmavite injury in this District
`and attempting to exclude Pharmavite’ Nature Made® Vision supplement from the U.S.
`market, including in this District. Accordingly, on information and belief, Defendants
`are subject to personal jurisdiction in California.
`9.
`Venue in this District is appropriate under 28 U.S.C. § 1391.
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`Case 2:21-cv-09507 Document 1 Filed 12/08/21 Page 4 of 40 Page ID #:4
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`FACTUAL BACKGROUND
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`A.
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`The Parties’ Dietary Supplements
`10.
`Pharmavite manufactures, largely in California, Nature Made® brand
`vitamins and dietary supplements. Nature Made® vitamins and dietary supplements are
`“The #1 Pharmacist Recommended Vitamin and Mineral Supplement Brand.” Among
`Pharmavite’s dietary supplements is a product called Nature Made® Vision AREDS 2
`(“Nature Made® Vision supplement”), which helps support an individual’s healthy
`vision and eye function.
`11. Defendant Bausch & Lomb has a line of “eye vitamin and mineral
`supplements” called PreserVision®. PreserVision® packaging states that the
`supplements contain the AREDS 2 Formula, as shown in Figures 1, 2, and 3 below
`(true and correct copies of the PreserVision® products taken from the
`PreserVision.com website, https://www.preservision.com/eyecare-professionals/the-
`areds-formula/, on December 8, 2021):
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` Figure 1
`Figure 3
`Figure 2
`12. The AREDS 2 Formula is a combination of vitamins and minerals—i.e.,
`vitamin C, vitamin E, copper, zinc, lutein, and zeaxanthin—in specific amounts that the
`National Eye Institute (“NEI”) of the United States Department of Health and Human
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`Case 2:21-cv-09507 Document 1 Filed 12/08/21 Page 5 of 40 Page ID #:5
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`Services’ National Institutes of Health (“NIH”) studied in a clinical trial known as
`AREDS 2.
`13. Bausch & Lomb’s PreserVision® AREDS 2 products directly compete
`with Pharmavite’s Nature Made® Vision supplement.
`B. Defendants’ Patents
`14. Defendants claim to be joint owners of the ’522 Patent, entitled
`“Nutritional Supplement to Treat Macular Degeneration.” Attached as Exhibit A is the
`form and content of the ’522 Patent. Pharmavite does not concede the truth or
`admissibility of any statement made within the ’522 Patent.
`15. The ’522 Patent is a continuation of an abandoned patent application,
`which in turn is a continuation of the now-expired ’297 Patent, which, on information
`and belief, also had been owned jointly by Defendants. Attached as Exhibit B is the
`form and content of the ’297 Patent. Pharmavite does not concede the truth or
`admissibility of any statement made within the ’297 Patent.
`16. The enforceable term of a United States patent begins on the date the
`patent issues and ends 20 years from the date on which the application for the patent
`was filed, absent certain exceptions. The application for the ’297 Patent was filed on
`March 23, 2001, and the patent issued on December 9, 2003. Thus, the enforceable
`term of the ’297 Patent ended March 23, 2021.
`17. The expired ’297 Patent included “composition” claims, which Defendants
`have previously alleged cover the AREDS 2 formulation itself. For patents claiming a
`composition, anyone using or selling the claimed composition in the United States
`during the patent’s enforceable term can be held liable as an infringer. The owner of a
`valid composition patent is therefore able to prevent the sale of the claimed
`composition in the United States, regardless of how the composition is to be used.
`18. Thus, during the enforceable term of the ’297 Patent, Bausch & Lomb
`could assert the patent to exclude any competing AREDS 2 formulation from the
`market, to the extent the ’297 Patent was valid and covered the AREDS 2 formula.
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`Case 2:21-cv-09507 Document 1 Filed 12/08/21 Page 6 of 40 Page ID #:6
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`Defendant Bausch & Lomb did so via numerous lawsuits, which lawsuits, upon
`information and belief, allowed Bausch & Lomb to increase and maintain its large
`market share.
`19. But that enforceable term ended on March 23, 2021, when the ’297 Patent
`expired. Thus, after March 23, 2021, Bausch & Lomb could no longer validly claim that
`the AREDS 2 formula is still patented—but Bausch & Lomb nonetheless continued
`(and continues) to make that claim. The post-March 23, 2021 PreserVision® claim of
`“Patented Formula” on the front or other panels of its packaging and on its website
`advertising is false.
`20. The patent application that issued as the ’522 Patent was filed by
`Defendants over a year after the ’297 Patent had issued, and claims priority to the same
`parent application as the ’297 Patent. The ’522 Patent, however, is not a composition
`patent. It does not claim any formula, much less the AREDS 2 formulation. Rather,
`the ’522 patent claims are narrow method claims reciting two key limitations relevant
`here. First, all claims require administering the AREDS 2 composition to a specific
`subset of the population, namely persons with the disease of early age-related macular
`degeneration (the disease is referred to herein as “AMD” and the limitation is referred
`to herein as the “early AMD limitation”). Second, all claims require that such
`administration achieve a specific result, namely treating or stabilizing visual acuity loss in
`persons with early AMD (the “stabilization limitation”). Claim 8 of the ’522 Patent is
`illustrative, and reproduced below with the stabilization and early AMD limitations,
`respectively, in bold underline:
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`8. A method of treating age-related macular degeneration consisting
`essentially of administering a daily dosage of not less than approximately
`420 mg and not more than approximately 600 mg vitamin C, not less
`than approximately 400 IU and not more than approximately 540 IU
`vitamin E, approximately 0.04 mg to 40 mg lutein-zeaxanthine
`combination, not less than approximately 60 mg and not more than
`approximately 100 mg zinc and at least 1.6 mg and not more than
`approximately 2.4 mg copper, wherein the daily dosage stabilizes
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`Case 2:21-cv-09507 Document 1 Filed 12/08/21 Page 7 of 40 Page ID #:7
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`visual acuity loss by reducing the risk of developing late stage or
`advanced age-related macular degeneration in persons with early age-
`related macular degeneration.
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`21. The ’522 Patent specification also makes numerous references to the
`method to treat the disease of early AMD. Pursuant to the ’522 Patent’s specification,
`the purported invention “relates to a ... nutritional or dietary supplement ... that decreases
`visual acuity loss … in persons with early age-related macular degeneration.” Exhibit A, ’522
`Patent at col. 1, lines 17-26 (emphasis added). See also id. at col. 2, lines 26-40 (“[t]he
`present invention ... strengthens and promotes retinal health ... in people with particular
`ocular diseases.... Visual acuity loss is decreased through the use of the present composition ...
`in persons with early age-related macular degeneration”) (emphasis added); id. at col. 9, lines 12-
`16 (invention is intended to provide a “safe and effective method of preventing, stabilizing,
`reversing and/or treating macular degeneration or visual acuity loss.... in persons with early age-
`related macular degeneration....”) (emphasis added).
`22. The preambles of the ’522 Patent claims are limiting because they breathe
`life into the claims. Confirming this, the applicants stated to the USPTO Examiner
`during prosecution of the application that issued as the ’522 Patent that they “ma[d]e
`certain” that each preamble “breathes life into the claim.”
`23. Accordingly, the ’522 Patent is limited to methods for administering the
`relevant composition to persons that already have the disease of early AMD, and for
`achieving the result of treating or stabilizing visual acuity loss. The claims of the ’522
`Patent do not cover administering the AREDS 2 formula to persons suffering from no
`eye conditions at all, such as persons with healthy vision and eye function who want to
`support the health and function of their eyes by taking dietary supplements. Nor do
`they cover administering the AREDS 2 formula to persons suffering from other ocular
`disorders or AMD that has advanced beyond the early stage. The applicants for the
`’522 Patent expressly relied on the narrow nature of the pending claims as covering only
`a method of preventing or stabilizing visual acuity loss in the “very specific ocular
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`Case 2:21-cv-09507 Document 1 Filed 12/08/21 Page 8 of 40 Page ID #:8
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`disease referred to in the art as early/intermediate stage age-related macular
`degeneration” in obtaining the ’522 patent. See ’522 Patent prosecution history, January
`14, 2010 Amendment and Response at 7 (“Applicants do not claim a method of
`preventing or stabilizing visual acuity loss from a plurality of ocular disease states, but
`rather, from a very specific ocular disease referred to in the art as early/intermediate-
`stage age-related macular degeneration.”).
`C. Defendants’ Improper Attempts to Monopolize the Eye Health Dietary
`Supplement Market
`24. Bausch & Lomb significantly dominates and maintains monopoly power in
`the eye health dietary supplement market. For the past several years, on information
`and belief, Bausch & Lomb’s share of the eye health dietary supplement market has
`increased steadily, from 68% in 2016 to 79% to 2019. Currently, year-to-date in 2021,
`on information and belief, Bausch & Lomb has an 80% share of the eye health dietary
`supplement market.
`25. Bausch & Lomb has monopolized, attempted to monopolize, and/or
`attempted to maintain a monopoly over the market using several unlawful, unfair, and
`fraudulent methods, including but not limited to, the following—each of which is
`described in more detail in the sections which follow below:
`i. Bausch & Lomb, together with co-defendant PF Consumer Healthcare
`1, has filed and is proceeding with a sham lawsuit against Pharmavite in
`which Defendants falsely claim that Pharmavite’s Nature Made®
`Vision supplement infringes Defendants’ ’522 Patent, which is limited
`to methods of treating or stabilizing visual acuity loss in a specific
`subset of the population, namely persons with early AMD. Pharmavite
`does not infringe the ’522 Patent because, among other reasons,
`Pharmavite does not advertise or sell its Nature Made® Vision
`supplement to treat any disease, much less early AMD. Nor have
`Defendants even alleged that Pharmavite directs persons with early
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`Case 2:21-cv-09507 Document 1 Filed 12/08/21 Page 9 of 40 Page ID #:9
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`AMD to take the Nature Made® Vision supplement, which would be
`necessary for any infringement claim. Defendants have filed similar
`sham lawsuits against other competitors also selling what they market
`as AREDS 2 supplements.
`ii. On information and belief, without approval of the U.S. Food and
`Drug Administration (“FDA”), Bausch & Lomb makes improper
`disease claims on its website and product packaging, misleading
`consumers into believing the PreserVision® product will treat a
`disease, including to the extent that Bausch & Lomb is referring to the
`’522 method-of-use patent in labeling and advertising its PreserVision®
`dietary supplement as “patented.”
`iii. Even after the ’297 Patent expired on March 23, 2021, Bausch & Lomb
`falsely labeled the PreserVision® product and falsely represented to
`consumers, including on its website, that its PreserVision® products
`are patent protected and contain a “patented” formula.
`iv. To the extent Bausch & Lomb was referring to the ’522 patent with its
`post-March 23, 2021 patent claims, such claims are false because the
`’522 patent cannot cover the AREDS 2 formula as a matter of law
`because it is a method-of-use patent, and Bausch & Lomb cannot
`lawfully practice or direct other persons to practice the claimed
`methods of use, all of which require the treatment of a disease, without
`the required approvals from the FDA (which on information and belief
`Bausch & Lomb does not have).
`v. On information and belief, with its false claim that its PreserVision®
`products contain a “patented formula,” Bausch & Lomb misleads
`consumers into believing the PreserVision® AREDS 2 formulation is
`unique and superior to competing products and that no other company
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`Case 2:21-cv-09507 Document 1 Filed 12/08/21 Page 10 of 40 Page ID #:10
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`may properly sell an AREDS 2 formula, thereby willfully maintaining,
`or attempting to establish monopoly power.
`i. Defendants’ Sham Patent Infringement Lawsuit
`26. On July 15, 2021, Defendants filed a lawsuit against Pharmavite and a
`related entity, Nature Made Nutritional Products (“Nature Made”), in the United States
`District Court for the District of Delaware, captioned Bausch and Lomb Incorporated and
`PF Consumer Healthcare 1 LLC v. Nature Made Nutritional Products and Pharmavite LLC,
`Case No. 21-cv-01030-LPS (the “Patent Infringement Lawsuit”), in which Defendants
`alleged that Pharmavite and Nature Made infringe the ’522 Patent by making and selling
`the Nature Made® Vision supplement. Venue for this lawsuit, however, was plainly
`improper in Delaware under 35 U.S.C. § 1400 because Pharmavite and Nature Made
`neither reside in nor have regular and established places of business in Delaware. They
`are instead both organized under the laws of the State of California, with their principal
`places of business in California, and with no place of business in Delaware.
`27. Rather than re-filing in a proper forum, Defendants doubled down on
`their improper choice of venue by filing an amended complaint (“the Delaware
`Amended Complaint”), naming as additional defendants entities related to Pharmavite
`and alleging that they had Delaware connections. But the additional defendants named
`for their alleged Delaware connections are separate legal entities from Pharmavite and
`have no connection to the accused product—these entities do not make, use, sell, offer
`for sale, or import the accused product, i.e., the Nature Made® Vision supplement, in
`the United States. The Delaware Amended Complaint is a transparent and improper
`attempt to manufacture venue.
`28. Even aside from the improper venue, the Patent Infringement Lawsuit is
`without merit and constitutes sham litigation. As discussed above, the ’522 Patent
`claims cover only specific uses of the recited formulations that must satisfy both the
`early AMD and the stabilization limitations. But Pharmavite, Nature Made, and the
`other named defendants in the Delaware Amended Complaint (collectively, the
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`Case 2:21-cv-09507 Document 1 Filed 12/08/21 Page 11 of 40 Page ID #:11
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`“Delaware Defendants”) have not engaged in any conduct that would satisfy either
`limitation—and no reasonable litigant could believe that they have.
`29. First, with respect to the early AMD limitation, that limitation requires
`administering the recited composition to persons already suffering from the disease of
`early AMD. But, the Delaware Defendants do not administer the accused product to
`anyone, much less specifically to persons with early AMD. Confirming the lack of merit
`of the Patent Infringement Lawsuit, despite Defendants’ inability to even allege that any
`of the Delaware Defendants administer the accused product to anyone, Defendants
`nevertheless allege direct infringement by the Delaware Defendants. Actual
`administration of the accused product, however, is a prerequisite to direct infringement
`of the ’522 method claims. Accordingly, the Delaware Defendants do not and cannot
`directly infringe any claim of the ’522 patent.
`30.
`Second, with respect to the stabilization limitation, that limitation requires
`that administration of the composition achieve a particular result—treating or stabilizing
`visual acuity loss. Again confirming the lack of merit of the Patent Infringement
`Lawsuit, Defendants do not allege that anyone ever had his or her visual acuity loss
`treated or stabilized by the Nature Made® Vision supplement, much less that the
`Delaware Defendants use the accused product to treat or stabilize visual acuity loss.
`The Delaware Amended Complaint thus does not plead any act of direct infringement
`for this additional reason.
`31. Defendants’ indirect infringement claims are equally meritless. Because
`Defendants did not plead any act of direct infringement, the indirect infringement
`claims necessarily fail as a matter of law for want of an underlying act of direct
`infringement.
`32. Moreover, the indirect infringement claims lack merit for the additional
`reason that none of the Delaware Defendants instruct persons with early AMD to take
`the accused product, nor do they instruct others to administer it to persons with early
`AMD. Instead, Pharmavite markets the accused product as “[a]n eye health supplement
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`Case 2:21-cv-09507 Document 1 Filed 12/08/21 Page 12 of 40 Page ID #:12
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`that helps support healthy vision and eye function,” as shown in Figure 4 below (a true
`and correct excerpt of the www.NatureMade.com website):
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`Figure 4
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`33.
`Further, as shown in Figure 4 above, Pharmavite’s Nature Made® Vision
`supplement states on its label that the supplement is to “help[] support health vision &
`eye function.” Tellingly, the Delaware Amended Complaint does not even allege that
`anyone with early AMD has ever even taken the Nature Made® Vision supplement.
`The Delaware Defendants therefore do not indirectly infringe in connection with the
`early AMD limitation.
`34. Nor do the Delaware Defendants indirectly infringe with respect to the
`stabilization limitation. None of the Delaware Defendants instruct that persons should
`take the accused product to treat or stabilize visual acuity loss. To the contrary,
`Pharmavite’s Nature Made® Vision supplement unmistakably states on the front of its
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`Case 2:21-cv-09507 Document 1 Filed 12/08/21 Page 13 of 40 Page ID #:13
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`label, in a vertical box on the right side, that “[t]his product is not intended to diagnose,
`treat, cure, or prevent any disease,” as shown below Figure 5, a true and correct picture
`of the front/right side of the Vision bottle. This statement is also made on the
`NatureMade.com website, as shown in Figure 4 above.
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`Figure 5
`35. Accordingly, at least for these reasons, Defendants’ Patent Infringement
`Lawsuit is objectively baseless, and no reasonable litigant could realistically expect
`success on the merits. Defendants’ meritless lawsuit is an improper attempt to continue
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`Case 2:21-cv-09507 Document 1 Filed 12/08/21 Page 14 of 40 Page ID #:14
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`to exclude competing AREDS 2 formulations from the market, when Defendants know
`they have no lawful basis to do so given their ’297 Patent is now expired.
`36. Defendants’ Patent Infringement Lawsuit is, on information and belief,
`brought with the intent to interfere directly with Pharmavite’s business relationships
`with its customers and exclude Pharmavite’s Nature Made® Vision supplement from
`the market. This is demonstrated not only by the fact that Defendants cannot
`realistically expect success on the merits, but also by the fact that Defendants’ Patent
`Infringement Lawsuit is one of at least a dozen lawsuits that Defendants have filed as
`part of their ongoing monopolization, and efforts to monopolize the eye health dietary
`supplement market and harm competitors’ business relationships with customers. That
`is, Defendants—which are large, multi-national entities with substantial resources—
`previously filed at least 11 other patent infringement actions against other, smaller
`competitors selling similar eye supplements.
`37. Defendants’ improper intent is further demonstrated by its intentionally
`filing the Patent Infringement Lawsuit in an improper venue (Delaware), three
`thousand miles from where Pharmavite and Nature Made (the only Delaware
`Defendants with any connection to the Nature Made® Vision supplement) reside and
`have their principal places of business—a venue where Pharmavite and Nature Made
`do not have any physical presence or employees who reside there. Rather than re-file in
`a proper venue or otherwise correct the venue issue, as discussed above, Defendants
`filed an amended complaint naming as defendants entities unconnected with the
`accused product in an improper attempt to manufacture venue.
`ii. Bausch & Lomb’s Improper Disease Claims
`38. Drugs and dietary supplements are subject to the federal Food, Drug, and
`Cosmetic Act (“FDCA”) and the FDA’s governing regulations. The FDA regulates
`several categories of statements that can be made on dietary supplement labels,
`including “disease claims” and “structure/function claims.”
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`Case 2:21-cv-09507 Document 1 Filed 12/08/21 Page 15 of 40 Page ID #:15
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`39.
` A disease claim is a statement that either “explicitly or implicitly” claims
`“to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.” 21
`U.S.C. § 343(r)(6); 21 C.F.R. § 101.93(g)(2). “Disease” means “damage to an organ,
`part, structure, or system of the body such that it does not function properly (e.g.,
`cardiovascular disease), or a state of health leading to such dysfunction (e.g.,
`hypertension)….” 21 C.F.R. § 101.93(g)(1). Supplement manufacturers may not
`include disease claims on product labels without FDA approval. 21 U.S.C. §
`343(r)(6)(C). On information and belief, Bausch & Lomb does not have FDA approval
`to make disease claims in connection with its PreserVision® products.
`40. The FDA has set out multiple criteria for determining if a statement
`qualifies as a disease claim. See, e.g., https://www.fda.gov/regulatory-
`information/search-fda-guidance-documents/small-entity-compliance-guide-
`structurefunction-claims. For example, “[a] statement is a disease claim if it mentions a
`specific disease or class of diseases.” Moreover, citation of a publication or study on a product
`label may qualify as a disease claim if the context of the labeling, as a whole, suggests as
`much. Specifically, “[i]f the citation implies treatment or prevention of a disease, it is a disease
`claim. Thus, if in the context of the labeling as a whole its presence implies treatment or
`prevention of disease (for example, by placement on the immediate product label or
`packaging, inappropriate prominence, or lack of relationship to the product’s express
`claims), the citation is a disease claim.”
`41.
`In contrast, a structure/function claim is a statement that, among other
`things, “describes the role of a nutrient or dietary ingredient intended to affect the
`structure or function in humans.” 21 U.S.C. § 343(r)(6)(A); 21 C.F.R. § 101.93(f). A
`manufacturer may include a structure/function statement on a supplement label without
`prior FDA approval if and only if: (1) the statement does not qualify as a disease claim,
`(2) the manufacturer “has substantiation that such statement is truthful and not
`misleading,” and (3) the manufacturer includes a disclaimer that “[t]his statement has
`not been evaluated by the Food and Drug Administration. This product is not intended
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`Case 2:21-cv-09507 Document 1 Filed 12/08/21 Page 16 of 40 Page ID #:16
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`to diagnose, treat, cure, or prevent any disease.” 21 U.S.C. § 343(r)(6)(C). Merely
`including such a disclaimer on the label does not itself render the statement a
`structure/function claim rather than a disease claim. If the statement qualifies as disease
`claim then “the product will be subject to regulation as a drug,” notwithstanding
`inclusion of the disclaimer.
`42. On information and belief, the FDA has not approved PreserVision® as a
`drug or approved any disease claims in connection with the PreserVision® products.
`Bausch & Lomb nonetheless is making unlawful disease claims in violation of the
`FDCA and its governing regulations. Bausch & Lomb makes explicit reference to the
`disease of age-related macular degeneration on its website, asserting as follows: “Only
`the patented PreserVision® formula contains the exact level of nutrients recommended
`by the NEI to help reduce the risk of moderate to advanced AMD progression,” (emphasis
`added), as shown in Figure 6 below (a true and correct image taken from Bausch &
`Lomb’s PreserVision® website at https://www.preservision.com/eyecare-
`professionals/the-areds-formula/ on or about December 8, 2021).
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`Figure 6
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`Case 2:21-cv-09507 Document 1 Filed 12/08/21 Page 17 of 40 Page ID #:17
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`43.
`Similarly, as shown in Figures 7 and 8 below (true and correct images
`taken from Bausch & Lomb’s PreserVision® website at
`https://www.preservision.com/Why-PreserVision/Ingredients-Matter/ on or about
`December 8, 2021), Bausch & Lomb informs consumers, under the “Ingredients
`Matter” section of the “Why PreserVision” tab on its website, that “PreserVision
`AREDS 2 contains high levels of a specific combination of vitamins and minerals
`recommended by the NEI to h