DCT

1:18-cv-03296

BioZone Laboratories Inc v. Next Step Laboratories Corp

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-03296, E.D.N.Y., 06/05/2018
  • Venue Allegations: Plaintiff alleges venue is proper because Defendants have committed acts of patent infringement in the district and maintain a regular and established place of business there.
  • Core Dispute: Plaintiff alleges that Defendant’s cosmetic ingredient platforms, "QuSomes" and "Inflacin," infringe six patents related to self-forming liposome delivery systems and specific anti-inflammatory lipid compounds.
  • Technical Context: The technology involves chemical compositions that enable the creation of stable liposomes for delivering active ingredients, and specific lipid compounds designed to inhibit enzymes involved in inflammation, which is significant for both the pharmaceutical and cosmetics industries.
  • Key Procedural History: The complaint alleges that Defendants have been aware of the patents-in-suit since their issuance dates, or at least since June 2005. It further alleges that Defendants have previously admitted that Plaintiff’s "QuSome" and "Inflacin" technologies are patented by BioZone, which may be relevant to the question of willful infringement.

Case Timeline

Date Event
2000-12-20 Earliest Priority Date ('322, '160, '883, '190 Patents)
2001-03-23 Earliest Priority Date ('596, '421 Patents)
2002-12-17 U.S. Patent No. 6,495,596 Issues
2003-08-26 U.S. Patent No. 6,610,322 Issues
2005-06-01 Alleged Date of Defendant's Awareness of Patents-in-Suit
2005-10-25 U.S. Patent No. 6,958,160 Issues
2006-02-14 U.S. Patent No. 6,998,421 Issues
2006-12-19 U.S. Patent No. 7,150,883 Issues
2010-05-18 U.S. Patent No. 7,718,190 Issues
2018-06-05 Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 6,610,322

  • Patent Identification: U.S. Patent No. 6,610,322, "Self forming, thermodynamically stable liposomes and their applications," issued August 26, 2003.

The Invention Explained

  • Problem Addressed: The patent describes conventional methods for manufacturing liposomes as being complex, labor-intensive, and difficult to scale up. These methods often involve harsh conditions like high pressure, high temperatures, and high shear, which can degrade the lipids and any encapsulated compounds (e.g., drugs or cosmetic agents) ('322 Patent, col. 1:39-44).
  • The Patented Solution: The invention is a method for spontaneously creating thermodynamically stable liposomes by simply mixing specific lipids with an aqueous solution. This is achieved by using diacylglycerol-polyethyleneglycol (PEG) lipids that possess specific "packing parameters" and a melting temperature that allows them to be in liquid form during mixing, thereby avoiding the need for high-energy processes like sonication or extrusion ('322 Patent, Abstract; col. 3:6-14).
  • Technical Importance: This approach simplifies the manufacturing of liposomes, making the process more reproducible, scalable, and gentler, which is critical for preserving the integrity of sensitive encapsulated agents ('322 Patent, col. 7:6-12).

Key Claims at a Glance

  • The complaint asserts independent claim 1 ('Compl. ¶35).
  • The essential elements of claim 1 are:
    • A method of spontaneously preparing liposomes, the method consisting essentially of:
    • providing an aqueous solution;
    • providing one or more diacylglycerol-PEG lipids where the lipid or lipids have a packing parameter with respect to surface (Pa) between about 0.84 and 0.88 and a packing parameter with respect to volume (Pv) between about 0.88 and 0.93; and
    • combining the lipid or lipids and the aqueous solution at a temperature above the melting point of the lipid or lipids.
  • The complaint reserves the right to assert other claims ('Compl. ¶34).

U.S. Patent No. 6,958,160

  • Patent Identification: U.S. Patent No. 6,958,160, "Self forming, thermodynamically stable liposomes and their applications," issued October 25, 2005.

The Invention Explained

  • Problem Addressed: Like its parent '322 patent, this patent addresses the difficulties and harshness of conventional liposome manufacturing processes ('160 Patent, col. 1:29-65).
  • The Patented Solution: Instead of claiming the method, this patent claims the resulting product: a liposome composition itself. The invention is a liposome comprised of specific diacylglycerol-PEG lipids defined by a combination of properties: specific packing parameter ranges, a melting point below 40°C, and acyl chains of a certain minimum length ('160 Patent, Abstract; col. 2:1-9).
  • Technical Importance: By claiming the composition, the patent provides protection for the stable liposome product, which complements the method protection of the ’322 Patent and creates a broader defensive scope ('160 Patent, col. 7:11-17).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶43).
  • The essential elements of claim 1 are:
    • A liposome comprising:
    • one or more lipids where the total lipids have a Pa between about 0.84 and 0.88 and a Pv between about 0.88 and 0.93;
    • where one or more of the lipids is a diacylglycerol-PEG;
    • where the melting point of the diacylglycerol-PEG is below about 40 degrees C; and
    • where the acyl chains of the diacylglycerol-PEG are greater than or equal to 14 carbons in length.
  • The complaint reserves the right to assert other claims (Compl. ¶42).

U.S. Patent No. 7,718,190

  • Patent Identification: U.S. Patent No. 7,718,190, "Self forming, thermodynamically stable liposomes and their applications," issued May 18, 2010.
  • Technology Synopsis: This patent claims a composition for preparing a liposome, where the composition comprises both an active compound (from a list including proteins, peptides, and nutrients) and one or more specified lipids (from a Markush group including PEG-12 GDM). The invention connects the liposome technology directly to the delivery of specific categories of active ingredients (Compl. ¶49).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶51).
  • Accused Features: The "QuSomes Products" are accused of infringement, as they allegedly combine active compounds with lipids specified in the claim, such as PEG-12 GDM (Compl. ¶10, ¶13, ¶52).

U.S. Patent No. 7,150,883

  • Patent Identification: U.S. Patent No. 7,150,883, "Patent for inventions covering Self forming, thermodynamically stable liposomes and their applications," issued December 19, 2006.
  • Technology Synopsis: This patent claims a composition for use in preparing a liposomal formulation of a "therapeutic agent." It specifies the physical characteristics of the lipids (packing parameters, melting point, acyl chain length) in combination with a therapeutic agent, creating protection for a medically-oriented application of the core liposome technology (Compl. ¶58).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶60).
  • Accused Features: The "Inflacin Products" are accused of infringement, as they are alleged to be liposomal formulations containing a therapeutic agent (Compl. ¶26, ¶60).

U.S. Patent No. 6,495,596

  • Patent Identification: U.S. Patent No. 6,495,596, "Covering compounds and methods for inhibition of phospholipase A2 and cyclooxygenase-2," issued December 17, 2002.
  • Technology Synopsis: This patent claims a specific lipid compound defined by a chemical formula (a diacylglycerol-PEG structure) and further characterized by a functional property: the ability to inhibit the biological activity of the phospholipase A2 enzyme, which is involved in inflammation. The invention focuses on the biochemical function of the compound itself, not its role in a liposome structure ('596 Patent, Abstract; Compl. ¶66).
  • Asserted Claims: Independent claim 16 is asserted (Compl. ¶68).
  • Accused Features: The "Inflacin Products" are accused of infringement because they allegedly contain PEG-23 GDS, a compound that Plaintiff contends meets the claimed chemical formula and functional limitation (Compl. ¶23, ¶25, ¶68).

U.S. Patent No. 6,998,421

  • Patent Identification: U.S. Patent No. 6,998,421, "Compounds and methods for inhibition of phospholipase A2 and cyclooxygenase - 2," issued February 14, 2006.
  • Technology Synopsis: As a continuation of the application leading to the ’596 Patent, this patent claims a lipid compound represented by the same general chemical formula and also characterized by its ability to inhibit phospholipase A2. It provides further protection for the anti-inflammatory compound technology (’421 Patent, col. 1:12-18; Compl. ¶74).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶76).
  • Accused Features: The "Inflacin Products," which allegedly use PEG-23 GDS, are accused of infringement (Compl. ¶23, ¶25, ¶76).

III. The Accused Instrumentality

  • Product Identification: The complaint accuses two product lines: the "QuSomes Products" and the "Inflacin Products" (Compl. ¶16, ¶26).
  • Functionality and Market Context:
    • The QuSomes Products are described as a platform of cosmetic ingredients based on liposomes that allegedly form spontaneously when mixed with water (Compl. ¶11). The complaint states these products are made using PEG-12 Glyceryl Dimyristate (PEG-12 GDM) to encapsulate and deliver active ingredients such as salicylic acid, peptides, and vitamins (Compl. ¶10, ¶13). A chemical diagram in the complaint depicts the general structure of the PEG-12 GDM molecule (Compl. p. 4). Defendants allegedly market these products as offering improved efficacy, lower irritation, and enhanced delivery compared to conventional vehicles (Compl. ¶10, ¶12).
    • The Inflacin Products are described as anti-inflammatory products, including cleansers and lotions, that use PEG-23 Glyceryl Distearate (PEG-23 GDS) (Compl. ¶23, ¶26). The complaint alleges this compound is a lipid that functions by inhibiting the phospholipase A2 (PLA2) enzyme, thereby reducing inflammation, redness, and irritation (Compl. ¶19, ¶25). A chemical diagram is provided to represent the structure of the PEG-23 GDS molecule (Compl. p. 6). These products are allegedly recommended for use in sensitive skin and anti-aging applications (Compl. ¶21).

IV. Analysis of Infringement Allegations

U.S. Patent No. 6,610,322 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a method of spontaneously preparing liposomes, the method consisting essentially of: providing an aqueous solution; The method of making QuSomes Products allegedly involves combining an aqueous solution with the lipid component. ¶17 col. 10:33-35
providing one or more diacylglycerol-PEG lipids where the lipid or lipids have a Pₐ between about 0.84 and 0.88 and a Pᵥ between about 0.88 and 0.93... Defendants' process allegedly uses PEG-12 GDM, which the complaint states has a Pₐ of .853 and a Pᵥ of .889, falling within the claimed ranges. ¶13, ¶15 col. 4:24-28
and combining the lipid or lipids and the aqueous solution at a temperature above the melting point of the lipid or lipids. The manufacturing process allegedly entails combining PEG-12 GDM, described as a fluid at 25°C, with an aqueous solution at a temperature above 25°C, which is above the lipid's melting point. ¶15, ¶17 col. 10:41-44

U.S. Patent No. 6,958,160 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A liposome comprising: one or more lipids where the total lipids have a Pₐ between about 0.84 and 0.88 and a Pᵥ between about 0.88 and 0.93... The accused QuSomes Products are liposomes allegedly made with PEG-12 GDM, a lipid which the complaint states has a Pₐ of .853 and a Pᵥ of .889. ¶15, ¶17 col. 4:24-28
where one or more of the lipids is a diacylglycerol-PEG, The QuSomes Products allegedly use PEG-12 Glyceryl Dimyristate (PEG-12 GDM), which is a diacylglycerol-PEG lipid. ¶13, ¶14 col. 12:4-5
where the melting point of the diacylglycerol-PEG is below about 40 degrees C, The PEG-12 GDM used in the QuSomes Products is alleged to be a fluid at 25°C, which implies a melting point below 40°C. ¶15 col. 12:6-7
and where the acyl chains of the diacylglycerol-PEG are greater than or equal to 14 carbons in length. The PEG-12 GDM is alleged to be represented by a formula where the fatty acid chains (R₁ and R₂) have fourteen carbons. ¶14, ¶15 col. 12:8-10
  • Identified Points of Contention:
    • Evidentiary Questions: The infringement allegations for both the ’322 and ’160 patents depend on the specific numerical values for the packing parameters (Pₐ and Pᵥ) and physical properties of the lipids allegedly used by Defendants (Compl. ¶15, ¶25). A primary point of contention will be the factual accuracy of these alleged values and whether they apply to the specific materials used in the accused products.
    • Scope Questions: For the ’322 Patent, the claim term "consisting essentially of" raises the question of whether other ingredients in Defendants' formulations materially affect the "spontaneous" formation of liposomes. Defendants may argue that additional components alter the basic and novel properties of the invention, thereby placing their process outside the claim's scope.
    • Functional Questions: For the ’596 and ’421 patents, infringement hinges on whether Defendants' PEG-23 GDS compound is "characterized by the ability to inhibit biological activity of phospholipase A2" (Compl. ¶66, ¶74). A technical question will be what level of inhibition is required by the claim and whether the accused compound demonstrates that specific functionality.

V. Key Claim Terms for Construction

  • The Term: "spontaneously preparing" (’322 Patent, Claim 1)

    • Context and Importance: This term is central to the method claim, as it defines the core novelty over prior art methods that required significant energy input. Practitioners may focus on this term because its construction will determine what level of mixing or agitation is permissible within the claim scope.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent specification contrasts the invention with prior art that required "sonication, extrusion..., French press extrusion and homogenization" ('322 Patent, col. 1:35-37). The specification also notes that "little or no energy need be added" ('322 Patent, col. 3:19-21) and explicitly states that "Kinetic energy, such as shaking or vortexing, may be provided" ('322 Patent, col. 8:2-4), suggesting that simple mixing is contemplated.
      • Evidence for a Narrower Interpretation: The abstract describes a liposome suspension that "forms spontaneously upon adding a diacylglycerol-PEG lipid to an aqueous solution," which could be argued to imply a more passive process. Defendants may argue that their commercial-scale mixing processes constitute more than the "spontaneous" combination envisioned by the patent.

  • The Term: "liposome" (’160 Patent, Claim 1)

    • Context and Importance: The definition of this term is critical to determining if the accused compositions are infringing structures. Practitioners may focus on this term because if the accused products form structures that are technically not "liposomes" (e.g., micelles or other aggregates), infringement may be avoided.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The term is used generally throughout the patent to refer to lipid-based vesicles for delivery. A party could argue for its plain and ordinary meaning as understood in the art at the time.
      • Evidence for a Narrower Interpretation: The specification defines liposomes as "self-closed colloidal particles in which membranes composed of one or more lipid bilayer(s) encapsulate a fraction of the aqueous solution" ('160 Patent, col. 1:24-27). This definition, particularly the requirement of an encapsulated aqueous phase, could be used to argue that structures without it (like micelles, as depicted in Figure 3) are not "liposomes" under the patent's own lexicography.

VI. Other Allegations

  • Indirect Infringement: The complaint includes boilerplate allegations of indirect infringement for all asserted patents (e.g., Compl. ¶34, ¶36). The factual basis is not specifically detailed, beyond alleging that Defendants "directly and indirectly" infringe.
  • Willful Infringement: The complaint alleges that Defendants have been aware of the Patents-in-Suit "since their dates of issuance or since June 2005" (Compl. ¶8). It also alleges that Defendants have admitted Plaintiff's technologies are patented (Compl. ¶7). These allegations of pre-suit knowledge form the basis for a claim of willful infringement, for which Plaintiff seeks treble damages (Compl. p. 15, ¶C).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A central issue will be one of technical verification: can the Plaintiff prove that Defendants' accused "QuSomes" and "Inflacin" products are manufactured using lipids that actually possess the specific numerical packing parameters (Pₐ and Pᵥ), melting points, and acyl chain lengths required by the asserted claims? The complaint's assertions regarding these physical properties will be a primary focus of expert discovery and testing.
  • A key legal question will be one of claim scope: for the '322 patent's method claim, does the transitional phrase "consisting essentially of" permit the inclusion of the various other active and inactive ingredients found in Defendants' final cosmetic formulations, or will Defendants be able to show that these additions materially alter the "basic and novel" characteristic of spontaneous liposome formation?
  • A fundamental evidentiary question will be one of functional proof: for the '596 and '421 patents, does the accused PEG-23 GDS compound in the "Inflacin" products actually perform the function of inhibiting phospholipase A2 to the extent required by the claims, and how will that "ability to inhibit" be measured and proven in court?