DCT
1:22-cv-05712
Seppic Inc v. Pharmactive Biotech Products Slu
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Seppic, Inc. (New Jersey)
- Defendant: Pharmactive Biotech Products, S.L.U. (Spain)
- Plaintiff’s Counsel: McDermott Will & Emery LLP
- Case Identification: 1:22-cv-05712, D.N.J., 09/26/2022
- Venue Allegations: Plaintiff alleges that venue is proper and that the Court has personal jurisdiction over the foreign Defendant pursuant to Federal Rule of Civil Procedure 4(k)(2), based on Defendant's purposeful contacts with the United States, including obtaining the patent-in-suit, entering into U.S. distribution agreements for its own product, and sending a cease-and-desist letter into the forum state.
- Core Dispute: Plaintiff Seppic, Inc. seeks a declaratory judgment that its saffron-based ingredient does not infringe Defendant Pharmactive's patent covering methods of using a specific saffron extract composition for treating low mood, and further contends that the patent is invalid.
- Technical Context: The lawsuit concerns the nutraceuticals market, specifically standardized saffron extracts marketed for mood support and the management of stress-related symptoms.
- Key Procedural History: The complaint was filed following a cease-and-desist letter from Pharmactive. Notably, the patent-in-suit, U.S. Patent No. 10,933,110, survived an ex parte reexamination proceeding, with an August 30, 2021 certificate confirming the patentability of all original claims. This successful reexamination, which concluded prior to the filing of the complaint, strengthens the patent’s presumption of validity against the prior art considered during that proceeding.
Case Timeline
| Date | Event |
|---|---|
| 2011-05-27 | Alleged on-sale date of Plaintiff's Safr'Inside™ product |
| 2014-10-02 | Alleged online publication date of Defendant's clinical trial |
| 2016-04-18 | Priority Date of U.S. Patent No. 10,933,110 |
| 2021-03-02 | Issue Date of U.S. Patent No. 10,933,110 |
| 2021-08-30 | Ex Parte Reexamination Certificate issued, confirming claims 1-4 of the '110 Patent |
| 2022-05-12 | Defendant sends cease-and-desist letter to Plaintiff |
| 2022-09-26 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,933,110 - "Saffron Extract and Its Use for the Prevention of Mood Disorders Related to Depression"
The Invention Explained
- Problem Addressed: The patent's background section asserts that many commercially available saffron extracts are analyzed using a non-specific spectrophotometric standard (ISO3632) that can fail to accurately quantify the active compounds, safranal and crocins, leading to an "overestimated value of the safranal content" and potentially ineffective products (ʼ110 Patent, col. 3:11-24).
- The Patented Solution: The invention claims a method of treating low mood using a saffron extract composition that is standardized by a more precise method, High Performance Liquid Chromatography (HPLC). This HPLC analysis is used to guarantee that the composition contains specific minimum concentrations of safranal and a defined profile of crocin isomers, which are identified as the key bioactive components for mood-related effects (ʼ110 Patent, Abstract; col. 4:1-17).
- Technical Importance: By requiring HPLC-based quantification, the patented method purports to offer a more reliable and consistently effective natural composition for mood support, distinguishing it from products that may lack a verified therapeutic dose of the active ingredients (ʼ110 Patent, col. 2:25-35).
Key Claims at a Glance
- The complaint puts independent claim 1 and dependent claims 2-4 at issue (Compl. ¶21).
- Independent Claim 1 requires:
- A method for treatment of low mood,
- comprising administering to a subject in need thereof a therapeutically effective amount of a composition comprising an extract of saffron stigmas analyzed by HPLC,
- the composition comprising:
- between 0.03% and 1% dry weight of safranal, and
- at least 3.48% dry weight of crocins, wherein said crocins comprise trans-crocin-4, trans-crocin-3, trans-crocin-2', cis-crocin-4, trans-crocin-2, and/or trans-cro-cin-1.
III. The Accused Instrumentality
Product Identification
The accused instrumentality is Plaintiff Seppic's saffron-based ingredient, tradenamed "Safr'Inside™" (Compl. ¶3).
Functionality and Market Context
Safr'Inside™ is an ingredient that Seppic exclusively distributes in the United States for use in various consumer products (Compl. ¶3). The complaint states that Pharmactive has accused Seppic's distribution of this product of infringing the ʼ110 Patent (Compl. ¶10). Seppic alleges its advertising connects Safr'Inside™ with managing "emotional stress," a characterization that Pharmactive reportedly contends is an "unlawful attempt to side-step the Pharmactive Patent" directed to "low mood" (Compl. ¶33).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
The complaint seeks a declaratory judgment of non-infringement. The following table summarizes Seppic's stated bases for its non-infringement position.
’110 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Non-Infringing Functionality (per Plaintiff's Complaint) | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for treatment of low mood... | Plaintiff Seppic alleges that it "does not make, use, offer for sale or sell Safr’Inside™ for the treatment of low mood" and therefore does not infringe. | ¶23 | col. 7:17-21 |
| ...a composition comprising... a) between 0.03% and 1% dry weight of safranal, and b) at least 3.48% dry weight of crocins... | Plaintiff Seppic alleges that its "Safr’Inside™ does not meet the specific limitations in the claimed formulation." | ¶24 | col. 4:40-45 |
- Identified Points of Contention:
- Scope Questions: A primary dispute will be whether Seppic’s marketing of Safr’Inside™ for "emotional stress" induces its customers or end-users to infringe a method claim for the "treatment of low mood." This raises a legal and factual question regarding the overlap between these terms in the context of the patent and the relevant consumer market.
- Technical Questions: The complaint asserts that the Safr'Inside™ composition does not meet the patent's specific concentration requirements for safranal and crocins (Compl. ¶24). A key factual question will be what the evidence shows regarding the actual chemical composition of Seppic's product.
- Validity Questions: The complaint challenges the patent's validity on grounds of anticipation, citing a French patent, an alleged on-sale bar from its own product, and Defendant's own prior clinical trial publication (Compl. ¶28-30). A central legal question is whether these invalidity arguments can overcome the strengthened presumption of validity established by the successful ex parte reexamination of the ’110 Patent.
V. Key Claim Terms for Construction
"low mood"
- Context and Importance: This term is critical to the infringement analysis. Seppic's primary non-infringement argument is that it markets its product for "emotional stress," not "low mood" (Compl. ¶23, ¶33). The construction of "low mood" will determine whether Seppic's activities fall within the scope of the claimed method.
- Intrinsic Evidence for a Broader Interpretation: The patent states that the claimed composition is for preparing a medicament for the prevention of "mood disorders... associated with depression, such as fatigue, stress and anxiety, among others" (ʼ110 Patent, col. 4:52-55). This language may support an interpretation where "low mood" encompasses conditions like "stress."
- Intrinsic Evidence for a Narrower Interpretation: The patent's clinical trial evaluated subjects with "low mood but not depression" (ʼ110 Patent, col. 14:23-26), suggesting "low mood" is a specific, defined condition distinct from general feelings of stress. Seppic may argue the term requires a sub-clinical depressive state that is not equivalent to the "emotional stress" it markets its product for.
"analyzed by HPLC"
- Context and Importance: The patent repeatedly distinguishes its invention from prior art based on the use of the more accurate HPLC analysis method versus the less reliable ISO3632 standard (ʼ110 Patent, col. 3:1-33). Practitioners may focus on this term because the patentability and scope of the claims appear to rest heavily on this analytical step.
- Intrinsic Evidence for a Broader Interpretation: The claim language itself does not specify a particular HPLC protocol, which could support an interpretation that any valid HPLC analysis demonstrating the claimed concentrations suffices.
- Intrinsic Evidence for a Narrower Interpretation: Pharmactive might argue that the term should be construed in light of the detailed HPLC protocol described in Example 1 (ʼ110 Patent, col. 10:5-29), asserting that this specific method is necessary to achieve the "objective" certification that is a core feature of the invention.
VI. Other Allegations
Indirect Infringement
The complaint directly counters an anticipated allegation of induced infringement. By alleging that it does not market Safr'Inside™ for the "treatment of low mood," Seppic preemptively argues that it lacks the specific intent required to encourage or aid others in practicing the patented method (Compl. ¶23).
Willful Infringement
While this is a declaratory judgment action, the complaint establishes that Seppic had pre-suit knowledge of the ’110 Patent via the May 12, 2022 cease-and-desist letter (Compl. ¶9). This fact would be central to any future counterclaim for willful infringement brought by Pharmactive.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the claim term "low mood," which the patent describes in the context of preventing mood disorders related to depression, be construed to cover the management of "emotional stress" for which Seppic markets its product? The answer will likely dictate the outcome of the induced infringement analysis.
- A second central issue will be the impact of the prior reexamination: Seppic's invalidity case relies on prior art references, but the patent’s claims were confirmed by the USPTO in an ex parte reexamination. A key question is whether Seppic's invalidity arguments can overcome the heightened evidentiary burden required to invalidate claims that have already survived a second PTO review.
- A third key question will be compositional evidence: does Seppic's Safr'Inside™ product, which it claims was on sale before the patent's priority date, actually meet the specific chemical composition limitations of claim 1? This factual determination is essential for resolving both Seppic's direct non-infringement defense and its invalidity defense based on an on-sale bar.