DCT
2:19-cv-01860
Fairhaven Health LLC v
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Fairhaven Health, LLC (Washington)
- Defendant: BioOrigyn, LLC; Joanna Ellington aka Joanna Clifton; and Dennis Clifton (Washington)
- Plaintiff’s Counsel: Summit Law Group, PLLC; Paul Hastings LLP
- Case Identification: 2:19-cv-01860, W.D. Wash., 10/21/2020
- Venue Allegations: Plaintiff alleges venue is proper in the Western District of Washington because Defendant BioOrigyn is a Washington LLC with significant business contacts in the district, a substantial part of the events giving rise to the action occurred there, and relevant license agreements contain forum selection clauses for courts in Washington.
- Core Dispute: Plaintiff seeks a declaratory judgment that its perineal massage gel product does not infringe a patent related to nonspermicidal lubricants, and asserts related state law claims of breach of contract, fraudulent inducement, and unjust enrichment concerning prior license and consulting agreements.
- Technical Context: The technology relates to fertility-friendly personal lubricants formulated to avoid harming sperm, a key consideration for couples trying to conceive.
- Key Procedural History: The dispute arises from a long-term business relationship between the parties, which evolved from a wholesale customer arrangement into a consulting and product development partnership. The complaint details a series of agreements, including a 2014 Consulting Agreement and a 2014 License Agreement, which Plaintiff now alleges were procured through fraudulent misrepresentations by the Defendants regarding the scope, expiration, and applicability of their patents to the products being developed.
Case Timeline
| Date | Event |
|---|---|
| 1995-10-19 | ’509 Patent Priority Date |
| 2003-01-01 | Fairhaven's working relationship with Defendants begins (approx.) |
| 2010-11-23 | ’509 Patent Issue Date |
| 2014-10-15 | Parties execute the 2014 Consulting Agreement |
| 2014-11-25 | Parties execute the 2014 License Agreement |
| 2016-12-01 | First commercial manufacture of accused product BabyIt (approx.) |
| 2017-01-01 | First offer for sale and first sale of accused product BabyIt (approx.) |
| 2019-11-01 | Counsel for BioOrigyn sends Fairhaven a notice of default letter |
| 2020-10-21 | Amended Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,838,509 - "Methods and Compositions to Improve Germ Cell and Embryo Survival and Function"
- Patent Identification: U.S. Patent No. 7,838,509, "Methods and Compositions to Improve Germ Cell and Embryo Survival and Function," issued November 23, 2010.
The Invention Explained
- Problem Addressed: The patent's background section describes challenges in assisted reproduction, noting that many commercially available personal lubricants are "spermicidal" and that even saliva can harm sperm, creating a problem for infertile couples who may need lubrication during timed intercourse ('509 Patent, col. 3:41-54). Additionally, procedures like sperm washing and freezing can damage sperm cells, reducing their viability ('509 Patent, col. 1:21-30).
- The Patented Solution: The invention proposes compositions, including personal lubricants and cell culture media, that use specific polysaccharides containing arabinose, galactose, and/or hexuronic acid (termed "PCAGH"). These polysaccharides are described as non-toxic to sperm and are intended to improve sperm survival, motility, and overall function during handling or after intercourse ('509 Patent, Abstract; col. 4:17-24). The '509 Patent specifically claims a lubricant containing arabinogalactan, a type of PCAGH.
- Technical Importance: The technology aimed to provide a fertility-safe lubricant that would not impede but could potentially enhance the chances of conception for couples requiring lubrication, a significant gap in the market at the time ('509 Patent, col. 3:41-54).
Key Claims at a Glance
- The complaint seeks a declaratory judgment of non-infringement with respect to the "only independent claim," Claim 1 (Compl. ¶¶ 102, 111).
- The essential elements of independent Claim 1 are:
- A nonspermicidal lubricant
- comprising a balanced salt solution,
- a nonspermicidal lubricious compound which is able to lubricate vaginal mucosa, and
- arabinogalactan.
- The complaint does not mention any dependent claims.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Fairhaven's "BabyIt" product, a commercial perineal massage gel (Compl. ¶ 102).
Functionality and Market Context
- BabyIt is described as a gel designed for massaging the perineum of a mother-to-be to prepare for childbirth, with the goal of facilitating an "easier, less painful natural birth" (Compl. ¶ 113).
- The complaint alleges that the BabyIt product was purposefully designed by Defendants Joanna and Dennis Clifton to have a specific pH "physiologic to that of the skin in the perineal area," with specified pH ranges that allegedly make the product "not 'non-spermicidal,' and instead made the product just the opposite" (Compl. ¶¶ 112, 114). It is also alleged that BabyIt was not formulated to include a "balanced salt solution" (Compl. ¶ 116).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
This is a declaratory judgment action where the Plaintiff, Fairhaven, is alleging non-infringement. The following table summarizes Fairhaven's asserted bases for why its product does not meet the limitations of Claim 1.
’509 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A nonspermicidal lubricant... | The complaint alleges that the BabyIt product is not "nonspermicidal" because it was purposefully designed with a pH range that is spermicidal. | ¶¶ 112, 114 | col. 12:15-20 |
| ...comprising a balanced salt solution... | The complaint alleges that the BabyIt product "was not formulated by BioOrigyn to comprise a 'balanced salt solution' as the '509 patent's use of that term would be understood by one of ordinary skill in the art." | ¶¶ 112, 116 | col. 13:19-31 |
| ...a nonspermicidal lubricious compound which is able to lubricate vaginal mucosa... | The complaint's argument that the overall lubricant is not "nonspermicidal" (as noted above) applies to this element. | ¶¶ 112, 114 | col. 11:21-36 |
| ...and arabinogalactan. | The complaint alleges BabyIt does not practice the claims of the '509 Patent but focuses its detailed non-infringement arguments on the "nonspermicidal" and "balanced salt solution" limitations. | ¶ 112 | col. 12:41-44 |
- Identified Points of Contention:
- Scope Questions: A central dispute will be the proper construction of "nonspermicidal." The complaint suggests this term implies certain functional requirements (e.g., a specific pH range) that the BabyIt product was designed not to meet (Compl. ¶ 114). The court will have to determine if "nonspermicidal" has such a specific technical meaning or a more general one.
- Technical Questions: A key factual question is what constitutes a "balanced salt solution" in the context of the patent. The complaint argues that the BabyIt formulation does not contain one as understood by a person of ordinary skill in the art, raising the question of whether the product's actual composition falls within the scope of this claim term (Compl. ¶ 116).
V. Key Claim Terms for Construction
The Term: "nonspermicidal"
Context and Importance: This term is dispositive, as it is the first limitation of the independent claim and a primary basis for Fairhaven's non-infringement argument. Practitioners may focus on this term because Fairhaven alleges its product was intentionally designed with a pH that makes it spermicidal, directly contradicting this element (Compl. ¶¶ 112, 114).
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not provide an explicit numerical or pH-based definition. BioOrigyn might argue the term should be understood in its plain and ordinary sense, or relative to other known lubricants that are highly toxic to sperm, such as those mentioned in the background ('509 Patent, col. 3:46-54).
- Evidence for a Narrower Interpretation: The patent specification consistently frames the invention as improving sperm survival and function ('509 Patent, Abstract; col. 4:17-24). Fairhaven could argue that, in this context, "nonspermicidal" requires a formulation that actively preserves or is at least neutral to sperm viability, a standard it alleges its product does not meet.
The Term: "balanced salt solution"
Context and Importance: This is Fairhaven's second main non-infringement argument. The case may turn on whether the liquid base of the BabyIt product can be characterized as a "balanced salt solution."
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: BioOrigyn may argue that the term is not limited to the specific examples in the patent and can encompass any aqueous salt solution that is generally compatible with biological cells.
- Evidence for a Narrower Interpretation: The specification provides specific examples of what may constitute such a solution, including well-known scientific formulations like "Tyrode's albumin lactate phosphate (TALP), human tubal fluid (HTF), Ham's F10," and others ('509 Patent, col. 13:19-25). Fairhaven will likely argue that the term should be construed as being limited to these types of recognized biological buffers, which it alleges its product does not contain (Compl. ¶ 116).
VI. Other Allegations
This section is not applicable, as the complaint is a declaratory judgment action for non-infringement and does not contain counts for indirect or willful infringement against a defendant.
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this patent dispute, which is deeply intertwined with broader commercial claims of fraud and breach of contract, will likely depend on the answers to two central questions for the court.
- A core issue will be one of definitional scope: How is the term "nonspermicidal" to be construed? Does it require a formulation that actively supports sperm viability within a specific pH range, as Fairhaven alleges, or does it have a more general meaning of simply not being intentionally spermicidal, which might bring the accused product back within the claim's scope?
- A key evidentiary question will be one of compositional fact: What is the technical definition of a "balanced salt solution" in the context of the '509 Patent's claims and specification? The dispute will require a factual determination of whether the BabyIt product's formulation includes such a solution, a question that will be heavily influenced by expert testimony on how a person of ordinary skill in the art would understand that term.