DCT
2:17-cv-01935
Physicians Recommended Nutriceuticals LLC v. Lunovus LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Physicians Recommended Nutriceuticals, LLC (Delaware)
- Defendant: Lunovus, LLC (Alabama)
- Plaintiff’s Counsel: White and Williams LLP
- Case Identification: 2:17-cv-01935, E.D. Pa., 04/27/2017
- Venue Allegations: Plaintiff alleges venue is proper because Defendants have sold the accused products in the district, placed them into the stream of commerce with the expectation of purchase by residents, and committed acts of infringement within the district.
- Core Dispute: Plaintiff alleges that Defendant’s nutraceutical supplement for eye health infringes patents covering specific compositions and methods for improving meibomian gland function and treating dry eye conditions.
- Technical Context: The technology involves oral nutritional supplements, specifically omega-3 fatty acid formulations in a particular chemical form and dosage, designed to alter the biochemical composition of tear film to treat eye conditions like dry eye and blepharitis.
- Key Procedural History: The complaint does not reference prior litigation or administrative proceedings involving these patents. U.S. Patent No. 9,381,183 is a continuation-in-part of the application that matured into U.S. Patent No. 9,115,078, indicating a shared specification and prosecution lineage that may be relevant for claim construction and estoppel analyses.
Case Timeline
| Date | Event |
|---|---|
| 2011-07-18 | Priority Date for U.S. Patent Nos. 9,115,078 & 9,381,183 |
| 2015-08-25 | U.S. Patent No. 9,115,078 Issued |
| 2016-07-05 | U.S. Patent No. 9,381,183 Issued |
| 2017-04-27 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,115,078 - "Compositions for Improving the Quality of the Meibum Composition of Inflamed or Dysfunctional Meibomian Glands," Issued August 25, 2015
The Invention Explained
- Problem Addressed: The patent describes how dysfunction of the eye's meibomian glands leads to the production of poor-quality, pro-inflammatory meibum (the oily component of tears). This causes the tear film to evaporate too quickly, resulting in chronic dry eye symptoms. The background notes that prior attempts to treat this with dietary supplements had not shown a significant effect on meibum lipid composition (’078 Patent, col. 2:35-48).
- The Patented Solution: The invention is a nutritional composition designed to change the quality of the meibum from the inside out. It provides a specific formulation of omega-3 fatty acids, delivered in the triglyceride form at a daily dosage greater than 600 mg, which is claimed to normalize the oil produced by the meibomian glands (’078 Patent, Abstract; col. 2:50-59). The triglyceride form is presented as being important for the body's ability to absorb the omega-3s (’183 Patent, col. 5:40-49, incorporated by reference).
- Technical Importance: The invention claims to provide a nutritional therapy that addresses the underlying biochemical cause of certain dry eye conditions by altering the fatty acid profile of the tear film, rather than merely providing topical, symptomatic relief (’078 Patent, col. 2:50-59).
Key Claims at a Glance
- The complaint asserts infringement of "at least one or more claims" (Compl. ¶31). Independent claim 1 is the broadest composition claim.
- Independent Claim 1:
- A composition consisting of a single fatty acid for improving the quality of the meibum composition of inflamed or dysfunctional meibomian glands,
- wherein said fatty acid consists of omega-3 fatty acids in the triglyceride form
- in an amount greater than 600 mg.
- The complaint does not explicitly reserve the right to assert dependent claims but makes a general assertion against "one or more claims" (Compl. ¶31).
U.S. Patent No. 9,381,183 - "Methods for Improving the Quality of the Meibum Composition of Meibomian Glands," Issued July 5, 2016
The Invention Explained
- Problem Addressed: The ’183 Patent addresses the same technical problem as the ’078 Patent: dysfunctional meibomian glands producing pro-inflammatory meibum that leads to dry eye symptoms (’183 Patent, col. 2:5-14).
- The Patented Solution: This patent claims a method for treating the condition. The method involves administering the specific omega-3 composition to achieve specific, measurable physiological results: an increase in anti-inflammatory omega-3 levels and a decrease in inflammatory omega-6 levels within the patient's meibum (’183 Patent, col. 21:24-22:4).
- Technical Importance: This patent moves beyond claiming the composition itself to claiming the therapeutic method and its direct, in-vivo biochemical effects, providing a different scope of protection tied to the physiological outcome of the treatment (’183 Patent, Abstract).
Key Claims at a Glance
- The complaint asserts infringement of "at least one or more claims" (Compl. ¶41). Independent claim 1 is the broadest method claim.
- Independent Claim 1:
- A method for improving the quality of the meibum composition of inflamed or dysfunctional meibomian glands, comprising the steps of:
- administering a composition consisting of an effective amount of omega-3 fatty acids on a daily dosage basis to a mammal...
- wherein said omega-3 fatty acids includes eicosapentaenoic acid (EPA) in an amount greater than 600 mg and comprising the triglyceride form;
- increasing levels of anti-inflammatory omega-3’s in a composition of meibum of said treated meibomian glands; and
- decreasing levels of inflammatory omega-6’s in said composition of meibum.
- The complaint does not explicitly reserve the right to assert dependent claims but makes a general assertion against "one or more claims" (Compl. ¶41).
III. The Accused Instrumentality
Product Identification
- Defendant's "TEAR SUPPORT PLUS +" nutraceutical product (Compl. ¶16).
Functionality and Market Context
- The accused product is an oral supplement marketed for dry eye relief. The complaint alleges the product was formulated by copying the Plaintiff's patented product and contains "identical ingredients and dosage amounts" (Compl. ¶20, ¶47). The complaint provides a screenshot from an online retailer showing the accused "TEAR SUPPORT PLUS +" product bottle, which lists "Mineral Supplement and Eye Vitamin" on its label (Compl., Ex. C, p. 54). It is advertised with claims that it contains "essential ingredients proven to benefit dry eye" and that "We developed this formula to treat the core of the problem from the inside out" (Compl. ¶38, ¶48). The complaint alleges Lunovus is a direct competitor to PRN in the nutriceutical industry (Compl. ¶16).
IV. Analysis of Infringement Allegations
'078 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A composition consisting of a single fatty acid for improving the quality of the meibum composition... | The TEAR SUPPORT PLUS+ product is a nutritional composition sold for improving eye health. | ¶16, ¶29 | col. 14:27-30 |
| wherein said fatty acid consists of omega-3 fatty acids | The complaint alleges that the "Supplement Facts" label of the accused product shows that its formulation is "identical" to PRN's patented product, which is based on omega-3 fatty acids. | ¶20, ¶29 | col. 14:30-31 |
| in the triglyceride form | The complaint alleges the infringing product is identical to the formulation of PRN's product, which the patent specifies is in the triglyceride form to enhance bioavailability. | ¶20 | col. 14:32 |
| in an amount greater than 600 mg. | The complaint alleges the "substantially identical 'Supplement Facts' label" of the accused product shows an amount of omega-3s that meets this limitation. | ¶20, ¶29 | col. 14:33 |
'183 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for improving the quality of the meibum composition...comprising the steps of: administering a composition... | Defendant sells the TEAR SUPPORT PLUS+ product with instructions and advertising that allegedly induce consumers to administer it for dry eye relief, thereby performing the claimed method steps. | ¶38, ¶41 | col. 21:24-29 |
| wherein said omega-3 fatty acids includes eicosapentaenoic acid (EPA) in an amount greater than 600 mg and comprising the triglyceride form; | The complaint alleges the product's formulation, as evidenced by its "Supplement Facts" label, is identical to that disclosed in the patent and meets these specific compositional requirements. | ¶40, Ex. C | col. 21:30-34 |
| increasing levels of anti-inflammatory omega-3’s in a composition of meibum...; and decreasing levels of inflammatory omega-6’s in said composition of meibum. | The complaint alleges that because the accused product's formulation is identical to the one claimed and studied in the patent, its administration to users necessarily achieves these claimed physiological and biochemical results. | ¶37, ¶40 | col. 21:35-40 |
- Identified Points of Contention:
- Scope Questions: A central issue for the ’078 Patent will be the interpretation of the phrase "consisting of a single fatty acid." A defendant may argue this language is highly restrictive and that the presence of any other fatty acids or even other active ingredients like vitamins in the accused product places it outside the scope of the claim.
- Technical Questions: For the ’183 Patent, a key dispute will surround the evidence required to prove the result-based limitations (e.g., "increasing levels of...omega-3's...in meibum"). The complaint infers these results from the alleged "identical" formulation of the accused product. The court will need to determine whether this inference is sufficient or if Plaintiff must provide direct clinical evidence showing that use of the accused product actually causes the claimed physiological changes in users.
V. Key Claim Terms for Construction
The Term: "consisting of a single fatty acid" (’078 Patent, Claim 1)
- Context and Importance: This transitional phrase is legally distinct from "comprising" and is generally interpreted to be closed, meaning it excludes any elements not specified. The entire infringement analysis for the ’078 patent may depend on whether the accused product, a commercial supplement, can meet this restrictive language.
- Evidence for a Broader Interpretation: Plaintiff may argue that in the context of the specification, the term is meant to define the active fatty acid component of the composition, distinguishing it from prior art with mixed fatty acid profiles. They may point to dependent claims and other embodiments that add Vitamin D, suggesting the "consisting of" language does not exclude all other possible ingredients in a final product formulation (’078 Patent, Claim 17).
- Evidence for a Narrower Interpretation: Defendant may argue for a strict "plain meaning" interpretation, where the presence of any other fatty acid type, or perhaps any other active ingredient not explicitly recited, would mean the accused product does not infringe. They could argue the patentee chose this restrictive term and must be held to it.
The Term: "increasing levels of anti-inflammatory omega-3’s in a composition of meibum" (’183 Patent, Claim 1)
- Context and Importance: This is a method-of-treatment limitation defined by a physiological result. Proving infringement requires showing that the accused method achieves this specific outcome. Practitioners may focus on this term because it shifts the dispute from the product's composition to its effect on the human body.
- Intrinsic Evidence for Interpretation: The patent specification provides detailed clinical study results purporting to demonstrate this effect when using the claimed composition (’183 Patent, Tables 1-8; col. 15:1-12). Plaintiff will argue these studies show that a composition with this formulation inherently produces the claimed result. A defendant would counter that the claim requires proof of the result from the accused method itself, and evidence related to the patentee's own product is not dispositive of what the defendant's product does.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement to infringe the ’183 method patent. The allegations are based on Defendant's marketing and advertising materials, including statements on Amazon.com, which allegedly instruct and encourage consumers to use the TEAR SUPPORT PLUS+ product to treat dry eye, thereby performing the steps of the claimed method (Compl. ¶38, ¶41).
- Willful Infringement: The complaint alleges willful infringement, asserting that Defendants "willfully and knowingly" infringed (Compl. ¶20, ¶43). The factual basis for this claim appears to be the allegation that Defendant copied the exact formulation of PRN's patented product and then falsely advertised that "We developed this formula," suggesting knowledge of the patents and an attempt to conceal the copying (Compl. ¶20, ¶47-48).
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this dispute may turn on the court's determination of the following central questions:
- A core issue will be one of claim scope: Can the restrictive claim language "consisting of a single fatty acid" in the ’078 composition patent be interpreted to read on a commercial supplement that may contain other standard excipients or even other active ingredients, or is the claim limited to a composition where omega-3s are the sole fatty acid component to the exclusion of all others?
- A key evidentiary question will be one of functional proof: For the ’183 method patent, is the allegation that the accused product has an "identical" formulation sufficient to prove it achieves the claimed physiological results (e.g., increased omega-3s in meibum), or must the Plaintiff provide direct clinical evidence of this effect from the use of the accused product itself?
- A central factual question will be one of origin and intent: Did the Defendant, as alleged, copy the Plaintiff's patented formula, which would strongly support the claim of willful infringement, or did it independently arrive at a similar formulation, which would not excuse infringement but could defeat a finding of willfulness?