DCT
6:20-cv-06441
Bausch & Lomb Inc v. Americon LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Bausch & Lomb Incorporated (New York) & PF Consumer Healthcare 1 LLC (Delaware)
- Defendant: Americon LLC (Minnesota)
- Plaintiff’s Counsel: The Wolford Law Firm LLP
- Case Identification: 6:20-cv-06441, W.D.N.Y., 06/30/2020
- Venue Allegations: Venue is alleged to be proper based on Defendant's business activities within the district, including developing, manufacturing, marketing, and selling products, and deriving substantial revenue from New York. Plaintiff Bausch & Lomb also maintains a place of business within the district.
- Core Dispute: Plaintiffs allege that Defendant’s "AREDS 2" nutritional supplement infringes patents related to specific formulations of vitamins and minerals for treating age-related macular degeneration.
- Technical Context: The technology concerns high-dose vitamin and mineral compositions, based on formulations from the Age-Related Eye Disease Study (AREDS), intended to slow the progression of age-related macular degeneration, a leading cause of vision loss in older adults.
- Key Procedural History: The complaint notes that U.S. Patent No. 6,660,297 survived an inter partes reexamination, with the U.S. Patent and Trademark Office issuing a Reexamination Certificate on April 30, 2013. This proceeding resulted in the amendment of some original claims and the addition of new claims, which may influence subsequent arguments regarding claim scope and validity.
Case Timeline
| Date | Event |
|---|---|
| 2001-03-23 | Priority Date for '297 and '522 Patents |
| 2003-12-09 | '297 Patent Issue Date |
| 2007-09-10 | '297 Patent Inter Partes Reexamination Requested |
| 2013-04-30 | '297 Patent Inter Partes Reexamination Certificate Issued |
| 2013-12-10 | '522 Patent Issue Date |
| 2020-06-30 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,660,297 - "Nutritional Supplement to Treat Macular Degeneration" (Issued Dec. 9, 2003)
The Invention Explained
- Problem Addressed: The patent identifies age-related macular degeneration (AMD) as a leading cause of severe vision loss for which no broadly effective treatment was known, particularly for the majority of individuals who are not candidates for laser photocoagulation ('297 Patent, col. 2:28-50). The background notes that while minerals like zinc and antioxidants were subjects of interest, their role and effective formulation for eye health were not well established ('297 Patent, col. 2:4-15).
- The Patented Solution: The patent describes a nutritional supplement composition comprising a specific combination of high-dose antioxidants (vitamin C and vitamin E), beta-carotene, zinc, and copper ('297 Patent, Abstract). The formulation, detailed in Table 1 of the specification, is designed to be taken daily to reduce the risk of developing advanced AMD in persons with early-stage AMD, thereby preventing, stabilizing, or treating associated vision loss ('297 Patent, col. 2:22-38; col. 3:28-39).
- Technical Importance: The invention is based on a large-scale clinical study and provided a specific, non-surgical formulation for slowing the progression of a major cause of blindness ('297 Patent, col. 3:40-47).
Key Claims at a Glance
- The complaint does not identify specific asserted claims. The following analysis focuses on re-examined independent claim 19, which appears relevant to the accused "AREDS 2" product.
- Re-examined Independent Claim 19 recites a composition with the following essential elements on a daily dosage basis:
- approximately 7 to 10 times the RDA of vitamin C;
- approximately 13 to 18 times the RDA of vitamin E;
- approximately 6 to 10 times the RDA of vitamin A in the form of beta-carotene, substituted or supplemented with lutein, zeaxanthine or a raw material combination thereof;
- approximately 4 to 7 times the RDA of zinc; and
- at least 1.6 mg and not more than approximately 2.4 mg copper.
- The complaint does not explicitly reserve the right to assert other claims, but its general allegations suggest this possibility.
U.S. Patent No. 8,603,522 - "Nutritional Supplement to Treat Macular Degeneration" (Issued Dec. 10, 2013)
The Invention Explained
- Problem Addressed: The '522 Patent, which is a continuation of the application leading to the '297 Patent, addresses the same technical problem of providing an effective, non-surgical method for treating AMD and stabilizing vision loss ('522 Patent, col. 2:30-44).
- The Patented Solution: The invention claims methods for stabilizing vision loss or treating AMD by administering a daily dosage of a specific nutritional composition ('522 Patent, Abstract). Critically, the claims of this patent recite formulations that include a "lutein-zeaxanthine combination" instead of beta-carotene, reflecting a clinical evolution of the original AREDS formulation ('522 Patent, col. 9:57-col. 10:1).
- Technical Importance: This patent covers the method of using a second-generation formulation (akin to AREDS 2), which substitutes lutein and zeaxanthin for beta-carotene, a change motivated in part by research indicating risks associated with beta-carotene supplementation in certain populations ('522 Patent, col. 5:15-23).
Key Claims at a Glance
- The complaint does not identify specific asserted claims. The following analysis focuses on independent claim 1, which appears central to the allegations.
- Independent Claim 1 recites a method with the following essential elements:
- A method for stabilizing visual acuity loss in persons with early age-related macular degeneration comprising:
- administering a daily dosage of a composition including: not less than approximately 420 mg and not more than 600 mg vitamin C; not less than 400 IU and not more than 540 IU vitamin E; approximately 0.04 mg to 40 mg lutein-zeaxanthine combination; not less than 60 mg and not more than 100 mg zinc; and at least 1.6 mg and not more than 2.4 mg copper.
- The complaint’s general allegations suggest the right to assert other claims is implicitly reserved.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is "Americon's AREDS 2 Antioxidants plus Optimal Zinc product," referred to in the complaint as the "AREDS 2 product" (Compl. ¶13).
Functionality and Market Context
- The complaint describes the accused product as a composition containing a "formulation of lutein, zeaxanthin, vitamins C and E, zinc, and copper" (Compl. ¶¶ 13, 26). It is alleged to be sold for the purpose of "treating or preventing age-related eye disease or for maintaining or preserving eye health or vision" (Compl. ¶¶ 13, 26). The complaint further alleges that the product is sold with instructions for use that cause and induce users to infringe the patents-in-suit (Compl. ¶¶ 14, 27). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
'297 Patent Infringement Allegations
| Claim Element (from Independent Claim 19) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A composition comprising on a daily dosage basis: approximately 7 to 10 times the RDA of vitamin C; | The accused "AREDS 2 product" is a composition that contains vitamin C. | ¶13 | col. 5:7-21 |
| approximately 13 to 18 times the RDA of vitamin E; | The accused "AREDS 2 product" is a composition that contains vitamin E. | ¶13 | col. 5:37-52 |
| approximately 6 to 10 times the RDA of vitamin A in the form of beta-carotene, substituted or supplemented with lutein, zeaxanthine or a raw material combination thereof; | The accused "AREDS 2 product" is a composition that contains lutein and zeaxanthin, which allegedly substitute for or supplement beta-carotene. | ¶13 | col. 8:12-26 |
| approximately 4 to 7 times the RDA of zinc; | The accused "AREDS 2 product" is a composition that contains zinc. | ¶13 | col. 6:47-61 |
| and at least 1.6 mg and not more than approximately 2.4 mg copper into a suitable dosage form. | The accused "AREDS 2 product" is a composition that contains copper. | ¶13 | col. 7:14-25 |
- Identified Points of Contention:
- Scope Question: A primary issue for claim construction may be the scope of the term "substituted or supplemented," which was added during re-examination. The question is whether the accused product's use of lutein and zeaxanthin falls within the meaning of this term as used in the patent.
- Factual Question: The complaint does not provide the specific formulation of the accused product. A key factual question will be whether the daily dosage of each component in the accused product meets the specific quantitative ranges recited in the claim, which are defined relative to the Recommended Dietary Allowance (RDA).
'522 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for stabilizing visual acuity loss in persons with early age-related macular degeneration comprising: administering a daily dosage of... | Defendant is alleged to sell its product with instructions for use in treating or preventing age-related eye disease, thereby inducing users to administer a daily dosage. | ¶¶26, 27 | col. 10:40-52 |
| ...not less than approximately 420 mg and not more than approximately 600 mg vitamin C, | The accused product contains vitamin C and is sold with instructions for daily use. | ¶26 | col. 5:15-23 |
| not less than approximately 400 IU and not more than approximately 540 IU vitamin E, | The accused product contains vitamin E and is sold with instructions for daily use. | ¶26 | col. 5:48-58 |
| approximately 0.04 mg to 40 mg lutein-zeaxanthine combination, | The accused product contains lutein and zeaxanthin and is sold with instructions for daily use. | ¶26 | col. 8:15-26 |
| not less than approximately 60 mg and not more than approximately 100 mg zinc | The accused product contains zinc and is sold with instructions for daily use. | ¶26 | col. 6:50-62 |
| and at least 1.6 mg and not more than approximately 2.4 mg copper. | The accused product contains copper and is sold with instructions for daily use. | ¶26 | col. 7:16-24 |
- Identified Points of Contention:
- Evidentiary Question: The infringement allegation depends entirely on the specific formulation of the accused product and the recommended daily dosage. The complaint lacks this specific data, raising the question of what evidence Plaintiffs will produce to show the accused product meets every quantitative limitation of the claim.
- Legal Question: The preamble of claim 1 recites a specific purpose ("stabilizing visual acuity loss") and patient population ("persons with early age-related macular degeneration"). A central legal dispute may be whether this preamble is limiting. If it is, Plaintiffs must show that Defendant specifically intended for users in this population to use the product for this purpose to prove induced infringement.
V. Key Claim Terms for Construction
Term: "substituted or supplemented with lutein, zeaxanthine" ('297 Patent, Claim 19)
- Context and Importance: This term is critical to the infringement allegation against an "AREDS 2" style product, which is defined by its use of lutein/zeaxanthin. As this language was added during re-examination, its interpretation will be a focal point. Practitioners may focus on this term because the entire infringement theory for the '297 Patent appears to rest on it.
- Intrinsic Evidence for a Broader Interpretation: The specification discusses lutein and zeaxanthin as alternative ingredients that can be added to the composition, stating they may be "used to supplement or substitute beta-carotene and/or zeaxanthine" ('297 Patent, col. 8:5-7). The disjunctive "or" in the claim ("substituted or supplemented") could support an interpretation where either a full replacement or a partial addition infringes.
- Intrinsic Evidence for a Narrower Interpretation: A defendant may argue that the context of the invention, which is heavily based on the original AREDS study results, limits the scope of what constitutes a "substitute." The prosecution history of the re-examination, where this language was added to overcome prior art, will be critical in determining the scope afforded to this term.
Term: "stabilizing visual acuity loss in persons with early age-related macular degeneration" ('522 Patent, Claim 1)
- Context and Importance: This phrase in the preamble defines the purpose and patient population for the claimed method. Its status as a claim limitation is a threshold issue for infringement. Practitioners may focus on this term because if it is deemed limiting, it significantly raises the evidentiary bar for proving induced infringement.
- Intrinsic Evidence for a Broader Interpretation (Non-limiting): Plaintiffs may argue that the body of the claim recites a complete method (administering a specific composition) and that the preamble merely states an intended use or benefit without imposing a separate limitation on the infringing act itself.
- Intrinsic Evidence for a Narrower Interpretation (Limiting): The patent title ("Nutritional Supplement to Treat Macular Degeneration") and the detailed description repeatedly emphasize the treatment of AMD as the core of the invention ('522 Patent, Title; col. 2:30-44). This context suggests the preamble is not mere surplusage but is essential to define the patented method, distinguishing it from general nutritional supplementation.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement. Inducement is based on the allegation that Defendant sells its "AREDS 2 product" with "instructions for use or promotions that cause and induce the user to infringe" (Compl. ¶¶ 14, 27). Contributory infringement is based on the allegation that the product constitutes a material part of the invention that is especially made or adapted for an infringing use and is not a staple article of commerce with substantial non-infringing uses (Compl. ¶¶ 15, 28).
- Willful Infringement: Willfulness is alleged based on Defendant’s purported knowledge of the patents. The complaint alleges that Defendant became aware of the '297 Patent on or after its issue date (December 9, 2003) and the '522 Patent on or after its issue date (December 10, 2013), and continued its allegedly infringing activities despite this knowledge (Compl. ¶¶ 16, 29).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of quantitative correspondence: will discovery reveal that the precise formulation of Americon’s "AREDS 2 product," when taken as directed, provides a daily dosage of each active ingredient that falls within the specific numerical ranges recited in the asserted claims? The viability of the direct infringement case rests on this factual evidence, which is absent from the complaint.
- For the '297 Patent, the case will involve a question of re-examination scope: can the claim term "substituted," which was added during inter partes re-examination, be construed to cover a formulation that fully replaces beta-carotene with lutein and zeaxanthin? The outcome will likely depend on a detailed analysis of the patent’s prosecution history.
- For the '522 method patent, a key question will be one of specific intent for inducement: assuming the preamble is limiting, can Plaintiffs prove that Defendant’s marketing and instructions specifically encouraged persons with "early age-related macular degeneration" to take the product for the express purpose of "stabilizing visual acuity loss," thereby establishing the requisite intent for induced infringement?