DCT

2:17-cv-03524

Janssen Biotech Inc v. Samsung Bioepis Co Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:17-cv-03524, D.N.J., 05/17/2017
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant intends to market and distribute its product in the United States, including New Jersey, through its commercialization partner Merck & Co., Inc., which is headquartered in New Jersey.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated Biologic License Application (aBLA) to the FDA for a biosimilar version of Plaintiff's Remicade® product constitutes an act of patent infringement under the Biologics Price Competition and Innovation Act (BPCIA).
  • Technical Context: The technology at issue relates to the commercial-scale manufacturing of biologic drugs, specifically chemically-defined cell culture media for growing antibody-producing cells and methods for purifying the resulting proteins.
  • Key Procedural History: The complaint is filed amidst a significant procedural dispute under the BPCIA. Plaintiff alleges Defendant refused to provide its aBLA and manufacturing information as part of the statutory information exchange process (the "patent dance"), making it impossible for Plaintiff to fully assess infringement. The complaint also notes that the validity of a pre-licensure "notice of commercial marketing," which Defendant provided, was a legal issue pending before the U.S. Supreme Court at the time of filing.

Case Timeline

Date Event
2001-02-15 U.S. Patent No. 6,900,056 Priority Date
2002-06-14 U.S. Patent No. 6,773,600 Priority Date
2004-08-10 U.S. Patent No. 6,773,600 Issue Date
2004-10-29 U.S. Patent No. 7,598,083 Priority Date
2005-05-31 U.S. Patent No. 6,900,056 Issue Date
2009-10-06 U.S. Patent No. 7,598,083 Issue Date
2016-05-20 FDA accepted Defendant's aBLA for review
2016-05-26 Defendant sent letter to Plaintiff refusing to provide aBLA information
2017-04-21 FDA approved Defendant's aBLA for its biosimilar product
2017-05-17 Complaint Filing Date

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

U.S. Patent No. 7,598,083 - "Chemically Defined Media Compositions"

  • Patent Identification: U.S. Patent No. 7,598,083, "Chemically Defined Media Compositions," issued October 6, 2009. (Compl. ¶39, Ex. A).
  • The Invention Explained:
    • Problem Addressed: The patent describes the risk of contaminating biopharmaceuticals with "adventitious particles" like viruses or prions (the cause of Bovine Spongiform Encephalopathy, or "Mad Cow Disease") that can be present in traditional cell culture media containing animal-derived components. (’971 Patent, col. 1:12-32).
    • The Patented Solution: The invention is a "chemically defined" cell culture media composition that is free of animal-derived components and proteins. This composition is designed to support high-density, highly viable eukaryotic cell cultures for producing biopharmaceuticals like antibodies, while also limiting the production of metabolic byproducts such as lactic acid. (’971 Patent, Abstract; col. 1:44-68).
    • Technical Importance: By eliminating animal-derived components, the invention provides a safer, more consistent, and more easily characterizable medium for the large-scale industrial production of biologic drugs. (’971 Patent, col. 1:33-48).
  • Key Claims at a Glance:
    • The complaint does not identify specific asserted claims. Independent claim 1 is directed to a soluble composition for producing a cell culture media.
    • The essential elements of independent claim 1 include a list of over 50 components, each within a specified concentration range, including:
      • Inorganic salts (e.g., CaCl₂, MgSO₄, FeSO₄·7H₂O)
      • Amino acids (e.g., L-arginine.HCl, L-leucine)
      • Vitamins and other organic compounds (e.g., d-biotin, folic acid, i-Inositol)
    • The complaint does not explicitly reserve the right to assert dependent claims but makes a general claim of infringement. (Compl. ¶108).

U.S. Patent No. 6,900,056 - "Chemically Defined Medium for Cultured Mammalian Cells"

  • Patent Identification: U.S. Patent No. 6,900,056, "Chemically Defined Medium for Cultured Mammalian Cells," issued May 31, 2005. (Compl. ¶40, Ex. B).
  • The Invention Explained:
    • Problem Addressed: The patent notes that commonly used serum and non-defined animal-derived protein supplements (e.g., primatone, albumin) are expensive, vary in quality from batch to batch, and may carry pathogens, creating manufacturing and regulatory challenges. (’056 Patent, col. 1:15-28).
    • The Patented Solution: The invention provides a "chemically defined media" (CDM) that replaces undefined animal-derived materials with a specific, known combination of components, including particular amino acids, lipids, carbohydrates, trace elements, and vitamins. This formulation is designed to support robust cell growth and high-level protein production in a more controlled and safer manner. (’056 Patent, col. 1:56–col. 2:13).
    • Technical Importance: This technology facilitates a move away from serum-dependent cell culture, enabling more reliable, scalable, and regulatorily favorable manufacturing of commercial biotherapeutics. (’056 Patent, col. 2:46-56).
  • Key Claims at a Glance:
    • The complaint does not identify specific asserted claims. Independent claim 1 is directed to a chemically defined medium for the adaptation and growth of immortalized mammalian cells.
    • The essential elements of independent claim 1 include a list of over 40 components, each within a specified concentration range, grouped into categories including:
      • Salts (e.g., sodium chloride, potassium chloride)
      • Buffering agents (HEPES)
      • Energy sources (glucose)
      • Vitamins, amino acids, and other additives (e.g., biotin, L-arginine, insulin, Pluronic F68)
    • The complaint makes a general claim of infringement without specifying dependent claims. (Compl. ¶113).

U.S. Patent No. 6,773,600 - "Use of a Clathrate Modifier, To Promote Passage of Proteins During Nanofiltration"

  • Patent Identification: U.S. Patent No. 6,773,600, "Use of a Clathrate Modifier, To Promote Passage of Proteins During Nanofiltration," issued August 10, 2004. (Compl. ¶44, Ex. C).
  • Technology Synopsis: This patent addresses challenges in separating large proteins (like antibodies) from small contaminants (like viruses) using nanofiltration. The patent states that proteins can aggregate or adhere to the filter, reducing yield and efficiency. (’600 Patent, col. 1:35-56). The invention purports to solve this by adding a "clathrate modifier" (e.g., sucrose) to a low pH, low ionic strength buffer, which is claimed to reduce the protein's size and self-association, thereby improving its passage through the nanofilter. (’600 Patent, col. 3:19-44).
  • Asserted Claims: The complaint does not specify which claims are asserted. (Compl. ¶118).
  • Accused Features: The complaint alleges on information and belief that the process used to manufacture the accused biosimilar, as described in Defendant's aBLA, infringes the ’600 patent. (Compl. ¶¶117-118).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is Defendant's proposed biosimilar infliximab product, also known as SB2 or Renflexis®. The act of infringement alleged is the submission of the aBLA for this product to the FDA for regulatory approval. (Compl. ¶¶1, 5, 66).
  • Functionality and Market Context: Renflexis® is a biosimilar version of Plaintiff's biologic drug Remicade®, which is a monoclonal antibody that binds to and neutralizes TNFα. (Compl. ¶¶30, 65). Remicade® is described as a "revolutionary" medicine used to treat several chronic inflammatory diseases, including Crohn's disease and rheumatoid arthritis. (Compl. ¶¶5, 33-35). The infringement allegations do not concern the function of the final drug product itself, but rather the alleged methods used for its manufacture and purification. (Compl. ¶¶38, 45). The complaint alleges that Defendant, by filing an aBLA, seeks to leverage Plaintiff's extensive research and development while avoiding royalty payments on patents covering the manufacturing process. (Compl. ¶¶3, 9).

IV. Analysis of Infringement Allegations

The complaint alleges that the submission of the aBLA for Renflexis® constitutes an act of infringement of the ’083, ’056, and ’600 patents under 35 U.S.C. § 271(e)(2)(C)(ii). (Compl. ¶¶108, 113, 118). However, the complaint provides no specific factual detail, element-by-element analysis, or claim chart to substantiate these allegations. Plaintiff states this is because Defendant refused to provide its aBLA and manufacturing information pursuant to the BPCIA's "patent dance" procedures, making it "impossible for Janssen to assess infringement of its patents." (Compl. ¶96). The infringement counts are therefore pleaded on information and belief, pending discovery of the accused manufacturing and purification processes.

The complaint does provide visual evidence in the form of figures from the asserted patents. For example, a graph in the ’083 patent shows high eukaryotic cell viability over a 28-day period when cultured in the patented media. (’083 Patent, Fig. 1; Compl. Ex. A, p. 27). Similarly, a graph in the ’056 patent shows significant IgG production in a spinner culture using the claimed chemically defined medium. (’056 Patent, Fig. 3; Compl. Ex. B, p. 40). These figures are presented in the patents as evidence of the inventions' performance and utility.

  • Identified Points of Contention:
    • Evidentiary Question: The central issue is factual and depends entirely on the contents of Defendant's confidential aBLA. Does the manufacturing process for Renflexis® in fact use a cell culture medium with the components and concentrations claimed in the ’083 and ’056 patents? Does its purification process utilize a "clathrate modifier" in a low pH, low conductivity buffer as claimed in the ’600 patent?
    • Scope Questions: If the accused processes are similar but not identical to the claims, a dispute may arise over the scope of the claims. For instance, if Defendant's medium includes a component not listed in the patents' extensive ingredient lists, does that place the medium outside the scope of a claim to a "chemically defined" composition?

V. Key Claim Terms for Construction

  • The Term: "chemically defined" (appears in the titles and claims of both the ’083 and ’056 patents)

    • Context and Importance: This term is central to the inventions, which are positioned as alternatives to "non-defined" media containing animal serum. The infringement analysis for the ’083 and ’056 patents will hinge on whether Defendant's cell culture medium falls within the scope of this term. Practitioners may focus on this term because its construction will determine whether minor variations in a synthetic formulation are sufficient to avoid infringement.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification of the ’083 patent states that "Ideally, such media are 'chemically defined' such that the media compositions contain only known chemical compounds, and are free of all proteins even those not of animal origin." (’083 Patent, col. 1:45-49). This language could support an interpretation where any medium free of undefined components is "chemically defined."
      • Evidence for a Narrower Interpretation: Both patents recite long and specific lists of components and concentration ranges in their independent claims. A party could argue that the term "chemically defined medium" as claimed is implicitly limited to media comprising those specific recited components, and that the addition of other, unlisted (even if known) chemicals would place it outside the claim's scope. (’083 Patent, Claim 1; ’056 Patent, Claim 1).

  • The Term: "clathrate modifier" (’600 patent)

    • Context and Importance: This is the key active agent in the claimed purification method. Infringement of the ’600 patent depends on whether Defendant uses a substance that qualifies as a "clathrate modifier."
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification defines the term broadly as "a substance that is capable of modifying the clathrate structure of a protein in an aqueous environment and reducing its overall specific volume," and includes "large globular proteins" as candidates. (’600 Patent, col. 5:60-65).
      • Evidence for a Narrower Interpretation: The patent repeatedly identifies the preferred embodiment as "a polyol sugar or sugar alcohol having from 4 to 8 hydroxyl groups," with sucrose being a specific example. (’600 Patent, col. 3:45-54). A party could argue the term should be construed more narrowly in line with these preferred embodiments, particularly sucrose.

VI. Other Allegations

  • Indirect Infringement: The complaint pleads direct infringement under 35 U.S.C. § 271(e)(2) and does not contain specific allegations of induced or contributory infringement.
  • Willful Infringement: The complaint alleges willful infringement for all three patents. (Compl. ¶¶109, 114, 119). The basis for this allegation is Defendant's alleged pre-suit knowledge of the patents, stating on "information and belief, Bioepis has been aware of the ['083/'056/'600] patent since a time before Bioepis filed its aBLA." (Compl. ¶¶107, 112, 117).

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

  • A primary issue in this case is evidentiary and procedural: what are the contents of Defendant's confidential aBLA, and what are the consequences of Defendant’s alleged failure to participate in the BPCIA’s statutory "patent dance"? The infringement analysis cannot proceed until the accused manufacturing process is revealed through discovery.
  • A second core issue will be one of compositional identity and claim scope: assuming discovery reveals the accused process, does Defendant's cell culture medium literally fall within the specific ingredient lists and concentration ranges claimed in the ’083 and ’056 patents? The interpretation of "chemically defined" will be critical in determining whether any variation in the formulation is sufficient to avoid infringement.
  • A third key question will be one of functional mechanism: does Defendant’s protein purification process, if it uses additives like sucrose, do so in a manner that constitutes the use of a "clathrate modifier" for the purpose of reducing a protein's hydrodynamic radius, as claimed in the ’600 patent, or does it operate via a different, non-infringing mechanism?