DCT
1:20-cv-01463
Bausch & Lomb Inc v. SBH Holdings LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Bausch & Lomb Incorporated (New York) & PF Consumer Healthcare 1 LLC (Delaware)
- Defendant: SBH Holdings LLC (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP; Venable LLP
- Case Identification: 1:20-cv-01463, D. Del., 10/28/2020
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant is a Delaware limited liability company and allegedly conducts substantial and systematic business in the state.
- Core Dispute: Plaintiff alleges that Defendant’s nutritional eye supplements infringe two patents related to formulations for reducing the risk of age-related macular degeneration.
- Technical Context: The technology concerns specific combinations and dosages of vitamins and minerals, based on the national Age-Related Eye Disease Study (AREDS), formulated to preserve eye health.
- Key Procedural History: The complaint notes that this action follows a prior lawsuit filed by the same plaintiffs against the same defendant in the Western District of New York on June 30, 2020. After the defendant moved to dismiss the New York case for improper venue, the plaintiffs filed the present action in Delaware. Additionally, U.S. Patent No. 6,660,297 survived an inter partes reexamination proceeding, with a certificate issuing on April 30, 2013, which amended and confirmed the patentability of several claims.
Case Timeline
| Date | Event |
|---|---|
| 2001-03-23 | Priority Date for ’297 Patent and ’522 Patent |
| 2003-12-09 | U.S. Patent No. 6,660,297 Issues |
| 2007-09-10 | Request for inter partes reexamination of ’297 Patent filed |
| 2013-04-30 | Inter Partes Reexamination Certificate for ’297 Patent issues |
| 2013-12-10 | U.S. Patent No. 8,603,522 Issues |
| 2020-06-30 | Plaintiffs file initial lawsuit in W.D.N.Y. |
| 2020-10-01 | Defendant moves to dismiss W.D.N.Y. lawsuit for improper venue |
| 2020-10-28 | Complaint filed in D. Del. |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,660,297 - “Nutritional Supplement to Treat Macular Degeneration”
The Invention Explained
- Problem Addressed: The patent addresses age-related macular degeneration (AMD), described as the leading cause of severe visual acuity loss in persons over 55. The background notes a need for non-surgical methods to slow the progression of the disease (’297 Patent, col. 1:29-32; col. 2:16-20).
- The Patented Solution: The invention is a nutritional supplement composition comprising a specific combination of high-dose antioxidants (vitamin C and vitamin E), beta-carotene, zinc, and copper. The patent states this specific formulation, based on a large-scale study by the National Institutes of Health, provides a greater protective effect than a placebo or the components taken individually (’297 Patent, Abstract; col. 3:39-49).
- Technical Importance: The invention provided a clinically-supported, non-invasive method to reduce the risk of progression to advanced AMD, a significant development for a widespread condition with few effective treatments at the time.
Key Claims at a Glance
- The complaint does not identify specific asserted claims. Based on the allegations, amended independent claim 19 appears relevant.
- Independent Claim 19 (as amended by the Inter Partes Reexamination Certificate) requires a composition with daily dosages of:
- approximately 7 to 10 times the Recommended Dietary Allowance (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, which is "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 of copper.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 8,603,522 - “Nutritional Supplement to Treat Macular Degeneration”
The Invention Explained
- Problem Addressed: The ’522 Patent, a continuation of the application leading to the ’297 Patent, addresses the same problem of treating AMD and associated visual acuity loss (’522 Patent, col. 2:20-24).
- The Patented Solution: The ’522 Patent claims methods of treating AMD or stabilizing vision loss by administering a daily dosage of a nutritional supplement. The claimed formulation explicitly includes a "lutein-zeaxanthine combination," reflecting a development in the field (the AREDS2 study) that established a benefit for these components, particularly as an alternative to beta-carotene (’522 Patent, col. 9:60-col. 10:1).
- Technical Importance: This patent family evolution reflects the scientific refinement of the AREDS formulation, adapting the treatment to include lutein and zeaxanthine, which became a new standard of care.
Key Claims at a Glance
- The complaint does not identify specific asserted claims. Independent claim 1 is a representative method claim.
- Independent Claim 1 requires a method for stabilizing visual acuity loss by administering a daily dosage of:
- not less than approximately 420 mg and not more than 600 mg vitamin C;
- not less than approximately 400 IU and not more than 540 IU vitamin E;
- approximately 0.04 mg to 40 mg lutein-zeaxanthine combination;
- not less than approximately 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 does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
The complaint identifies "SBH's MacularProtect® AREDS 2 and MacularProtect Complete® AREDS 2 products" (collectively, the "MacularProtect® AREDS 2 products") as the accused instrumentalities (Compl. ¶15).
Functionality and Market Context
The complaint alleges these are compositions sold for "treating or preventing age-related eye disease or for maintaining or preserving eye health or vision" (Compl. ¶15). The products are alleged to contain "a formulation of lutein, zeaxanthin, vitamins C and E, zinc, and copper" (Compl. ¶15, ¶28). The product name itself, "AREDS 2," suggests a formulation based on the second Age-Related Eye Disease Study, which is the subject of the ’522 Patent’s claims.
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
The complaint provides a high-level, narrative theory of infringement without a detailed claim chart or specific quantitative analysis of the accused products' formulations.
’297 Patent Infringement Allegations (Representative Claim 19, as amended)
| 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 complaint alleges the accused products contain vitamin C for treating age-related eye disease, but does not specify the dosage or allege it meets the claimed RDA multiple (Compl. ¶15). | ¶15 | col. 5:9-22 |
| approximately 13 to 18 times the RDA of vitamin E; | The complaint alleges the accused products contain vitamin E for treating age-related eye disease, but does not specify the dosage or allege it meets the claimed RDA multiple (Compl. ¶15). | ¶15 | col. 5:48-65 |
| approximately 6 to 10 times the RDA of vitamin A in the form of beta-carotene, substituted or supplemented with lutein, zeaxanthine... | The complaint alleges the accused products contain lutein and zeaxanthin (Compl. ¶15). The infringement theory appears to rely on this "substituted or supplemented" language to cover a formulation that may not contain beta-carotene. | ¶15 | col. 7:51-64; col. 8:1-11 |
| approximately 4 to 7 times the RDA of zinc; and | The complaint alleges the accused products contain zinc for treating age-related eye disease, but does not specify the dosage or allege it meets the claimed RDA multiple (Compl. ¶15). | ¶15 | col. 6:46-61 |
| at least 1.6 mg and not more than approximately 2.4 mg copper... | The complaint alleges the accused products contain copper for treating age-related eye disease, but does not specify the dosage or allege it meets the claimed range (Compl. ¶15). | ¶15 | col. 7:12-25 |
’522 Patent Infringement Allegations (Representative Claim 1)
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for stabilizing visual acuity loss...comprising: administering a daily dosage of... | The complaint alleges SBH sells its products "for the use in treating or preventing age-related eye disease" (Compl. ¶28), which implies administration for the claimed purpose. | ¶28 | col. 3:5-13 |
| not less than approx. 420 mg and not more than 600 mg vitamin C... | The complaint alleges the accused products contain vitamin C (Compl. ¶28), but does not provide the specific dosage. | ¶28 | col. 5:9-22 |
| not less than approx. 400 IU and not more than 540 IU vitamin E... | The complaint alleges the accused products contain vitamin E (Compl. ¶28), but does not provide the specific dosage. | ¶28 | col. 5:48-65 |
| approx. 0.04 mg to 40 mg lutein-zeaxanthine combination... | The complaint explicitly alleges the accused products contain a formulation of lutein and zeaxanthin (Compl. ¶28). The product name "AREDS 2" further suggests this combination is present. | ¶28 | col. 8:15-27 |
| not less than approx. 60 mg and not more than 100 mg zinc and... | The complaint alleges the accused products contain zinc (Compl. ¶28), but does not provide the specific dosage. | ¶28 | col. 6:46-61 |
| at least 1.6 mg and not more than 2.4 mg copper. | The complaint alleges the accused products contain copper (Compl. ¶28), but does not provide the specific dosage. | ¶28 | col. 7:12-25 |
- Identified Points of Contention:
- Evidentiary Questions: The complaint does not provide the specific dosages of the ingredients in the accused MacularProtect® products. A central question for discovery will be whether the actual formulations meet the specific numerical ranges and RDA multiples required by the asserted claims of both patents.
- Scope Questions: For the ’297 Patent, a key dispute may arise over the meaning of "beta-carotene, substituted or supplemented with lutein, zeaxanthine." The question is whether this language, added during reexamination, is broad enough to cover a modern AREDS2-style formulation that may omit beta-carotene entirely in favor of lutein and zeaxanthine.
V. Key Claim Terms for Construction
The Term: "substituted or supplemented with lutein, zeaxanthine" (’297 Patent, amended claim 19)
Context and Importance: This term is critical to the viability of the infringement claim for the ’297 Patent against a modern "AREDS 2" product. The original patent focused on beta-carotene. The defendant may argue that the accused product, which contains lutein and zeaxanthine, does not infringe because it omits beta-carotene, raising the question of whether "substituted" requires a one-for-one replacement and what "supplemented" permits. The construction will determine if the ’297 Patent’s scope can reach formulations developed after its original filing.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discusses lutein and zeaxanthine as "other ingredients believed to be of benefit in maintaining eye health" that "may likewise be added to the nutritional or dietary composition" (’297 Patent, col. 7:42-50). This could support an interpretation that the inventors contemplated their inclusion or substitution.
- Evidence for a Narrower Interpretation: A party could argue that the core of the invention described in the specification is the specific five-ingredient formulation from the original AREDS study, which requires beta-carotene (’297 Patent, Table 1, col. 3:28-36). The addition of the "substituted or supplemented" language during reexamination might be construed narrowly in light of arguments made to the PTO to overcome prior art.
The Term: "approximately" (appears in claims of both patents)
Context and Importance: This term affects the boundaries of every numerical limitation in the asserted claims. Practitioners may focus on this term because if the accused product's dosages are close to but not strictly within the recited ranges, the meaning of "approximately" will be dispositive of infringement.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term's plain meaning suggests some degree of flexibility. The specification’s discussion of manufacturing overages to compensate for degradation over time could support a broader construction, as it shows the inventors contemplated variations from a precise target amount (’297 Patent, col. 3:17-39).
- Evidence for a Narrower Interpretation: The specification provides highly specific target values (e.g., "450 milligrams" of vitamin C, "17.2 mg" of beta-carotene) derived from a clinical study (’297 Patent, Table 1, col. 3:28-36). A party could argue that "approximately" must be interpreted narrowly in light of this precision and the scientific basis for those specific amounts.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement on the basis that SBH sells its products with "instructions for use or promotions that cause and induce the user to infringe" (Compl. ¶16, ¶29). This suggests Plaintiff will rely on product labeling and marketing materials to show intent.
- Willful Infringement: Willfulness is alleged based on SBH’s continued infringement after gaining actual knowledge of the patents, at the latest, on June 30, 2020, the date the first lawsuit was filed in New York (Compl. ¶18, ¶31).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of factual proof: Can the Plaintiffs, through discovery, produce evidence that the precise dosages of the various components in Defendant's "MacularProtect AREDS 2" products fall within the specific numerical ranges recited in the asserted claims? The complaint's lack of such detail makes this the primary evidentiary hurdle.
- A second core issue will be one of claim scope: For the ’297 Patent, can the phrase "beta-carotene, substituted or supplemented with lutein, zeaxanthine," which was added during reexamination, be construed to cover a formulation that contains lutein and zeaxanthine but omits beta-carotene entirely? The outcome of this construction will likely determine the relevance of the older patent to modern AREDS2 products.
- Finally, a key strategic question will be the impact of the ’297 Patent's reexamination history. Plaintiffs may leverage the patent's survival of a PTO challenge to argue for its strength and validity, while Defendants will likely scrutinize the prosecution history for any disclaimers or arguments that could create prosecution history estoppel and limit the scope of the amended claims.