DCT

1:18-cv-00218

Copan Italia Spa v. Puritan Medical Products Co LLC

Log In
Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-00218, D. Me., 06/01/2018
  • Venue Allegations: Venue is alleged to be proper in the District of Maine because Defendants are incorporated in Maine and maintain a regular and established place of business in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s flocked swab products for biological specimen collection infringe five of its U.S. patents and that Defendant has engaged in false advertising and unfair competition.
  • Technical Context: The technology concerns flocked swabs, which use electrostatically applied short fibers to improve the collection and subsequent release of biological samples for diagnostic testing, a key component in the preanalytics market.
  • Key Procedural History: The complaint details a history of competition between the parties, including pre-suit correspondence regarding Copan’s patent portfolio starting in 2011. It also describes prior infringement litigation in Germany between the parties over related German utility models and alleges that Puritan publicly misrepresented the outcome of those proceedings.

Case Timeline

Date Event
2003-04-01 Earliest Priority Date for all Asserted Patents
2003-01-01 Copan releases its first flocked swabs (FLOQSwabs™)
2010-01-01 Puritan begins manufacturing and selling flocked swabs
2011-04-22 Copan’s counsel sends letter to Puritan re: patent rights
2011-12-22 Puritan press release acknowledges Copan patent application
2012-02-14 U.S. Patent No. 8,114,027 Issues
2012-11-27 U.S. Patent No. 8,317,728 Issues
2015-03-17 U.S. Patent No. 8,979,784 Issues
2015-04-21 U.S. Patent No. 9,011,358 Issues
2015-11-03 U.S. Patent No. 9,173,779 Issues
2016-03-08 Puritan’s counsel letter acknowledges Copan’s U.S. patents
2018-06-01 Complaint Filed

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

U.S. Patent No. 8,114,027 - METHOD FOR COLLECTING BIOLOGICAL SPECIMENS

  • Patent Identification: U.S. Patent No. 8,114,027, "METHOD FOR COLLECTING BIOLOGICAL SPECIMENS", issued February 14, 2012.

The Invention Explained

  • Problem Addressed: The patent describes conventional swabs, made with a wad of wrapped fiber like cotton or rayon, as inefficient for specimen collection because the liquid sample penetrates deep into the fiber mass, making it difficult to recover for analysis and leading to a sample loss of up to 60% (’027 Patent, col. 4:1-17). This can reduce the sensitivity of diagnostic tests and increase false negatives (’027 Patent, col. 4:11-14).
  • The Patented Solution: The invention is a method of using a swab where the tip is covered not by a wrapped wad, but by a layer of short fibers applied via "flocking" (’027 Patent, col. 4:35-37). This process, particularly electrostatic flocking, orients the fibers perpendicularly to the tip's surface, creating a brush-like structure (’027 Patent, col. 5:11-20). This ordered arrangement holds the specimen near the surface through capillary action, allowing for both rapid absorption and a significantly higher release rate (around 90%) during analysis (’027 Patent, col. 5:21-28; Fig. 2). A 2007 Copan brochure image in the complaint visually contrasts a traditional swab's absorbent "internal mattress core" with the flocked swab's surface-based sample retention (Compl. ¶25).
  • Technical Importance: This method provided a solution to the long-standing problem of poor sample recovery, directly improving the reliability and sensitivity of microbiological and diagnostic tests that depend on swab-based collection (Compl. ¶28, ¶¶36-42).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶148).
  • Essential elements of independent claim 1 include:
    • A method for collecting a biological specimen with a swab comprising a rod with a tip covered by a layer of fibers.
    • The layer of fibers has a uniform thickness between 0.6 and 3 mm and a fiber count between 1.7 and 3.3 Dtex.
    • The fibers are disposed in an ordered arrangement, perpendicular to the tip's surface, by flocking.
    • The method comprises collecting a liquid specimen by absorbing 40 µl to 100 µl, storing and transporting the specimen, and releasing it for analysis.

U.S. Patent No. 8,317,728 - METHOD OF USING FLOCKED SWAB FOR COLLECTING BIOLOGICAL SPECIMENS

  • Patent Identification: U.S. Patent No. 8,317,728, "METHOD OF USING FLOCKED SWAB FOR COLLECTING BIOLOGICAL SPECIMENS", issued November 27, 2012.

The Invention Explained

  • Problem Addressed: As a continuation of the '027 Patent, the ’728 Patent addresses the same technical problem: the inefficiency of traditional fiber-wad swabs, which entrap biological samples and yield low recovery rates for analysis (’728 Patent, col. 2:9-25).
  • The Patented Solution: The patent claims a method of using a flocked swab to collect a specimen. The swab structure, created by depositing fibers via flocking, forms an ordered, brush-like layer on the tip (’728 Patent, col. 3:18-20). This structure facilitates superior absorption and release of the specimen by holding it in capillaries between the perpendicularly-oriented fibers, a concept illustrated in the complaint via a diagram of "COPAN's Flocking Process" (Compl. ¶34; ’728 Patent, col. 5:41-47).
  • Technical Importance: This technology was foundational to creating high-recovery swabs that became a new standard in clinical diagnostics, recommended by organizations like the CDC for improved testing performance (Compl. ¶42).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶161).
  • Essential elements of independent claim 1 include:
    • A method for collecting a biological specimen using a swab with a rod and tip.
    • A layer of fibers is disposed by flocking to cover the tip.
    • The fiber layer has a thickness of 0.6 to 3 mm and a fiber count of 1.7 to 3.3 Dtex.
    • The method comprises collecting a specimen by absorbing a quantity of 40 µl to 100 µl of the specimen into the fiber layer.

U.S. Patent No. 8,979,784 - SWAB FOR COLLECTING BIOLOGICAL SPECIMENS

  • Patent Identification: U.S. Patent No. 8,979,784, "SWAB FOR COLLECTING BIOLOGICAL SPECIMENS", issued March 17, 2015.
  • Technology Synopsis: This patent claims the swab apparatus itself, rather than a method of use. It addresses the sample recovery problem by defining a swab with a plastic rod and a tip covered by a layer of flocked fibers arranged perpendicularly to the surface. This structure is configured to absorb between 40 µl and 100 µl of a specimen (’784 Patent, Claim 1).
  • Asserted Claims: At least independent claim 1 (Compl. ¶174).
  • Accused Features: The physical construction of Puritan's flocked swabs, which comprise a rod and a tip covered with electrostatically deposited fibers, is alleged to infringe (Compl. ¶¶57-58).

U.S. Patent No. 9,011,358 - SWAB FOR COLLECTING BIOLOGICAL SPECIMENS

  • Patent Identification: U.S. Patent No. 9,011,358, "SWAB FOR COLLECTING BIOLOGICAL SPECIMENS", issued April 21, 2015.
  • Technology Synopsis: This patent includes claims to both the swab apparatus and methods of collecting specimens. It describes a swab with a tip covered by a perpendicularly-oriented layer of flocked fibers, having a specific thickness (0.6 to 3 mm) and fiber count (1.7 to 3.3 Dtex). This flocked layer is configured to absorb a specified quantity of liquid specimen (e.g., 40 µl or 100 µl) via capillarity (’358 Patent, Claims 1, 14, 23, 24).
  • Asserted Claims: At least independent claims 1, 14, 23, and 24 (Compl. ¶180).
  • Accused Features: Puritan’s flocked swabs are alleged to embody the claimed apparatus, and their sale with user instructions is alleged to constitute infringement of the method claims (Compl. ¶¶57-59).

U.S. Patent No. 9,173,779 - SWAB FOR COLLECTING BIOLOGICAL SPECIMENS

  • Patent Identification: U.S. Patent No. 9,173,779, "SWAB FOR COLLECTING BIOLOGICAL SPECIMENS", issued November 3, 2015.
  • Technology Synopsis: This patent claims both the swab apparatus and a method of collection. The invention is a swab with a tip covered by a layer of fibers applied by flocking, where the fibers are ordered perpendicularly to the tip's surface. The claims specify a fiber layer thickness of 0.6 to 3 mm, configured to absorb 40 µl of liquid specimen (’779 Patent, Claims 1, 13).
  • Asserted Claims: At least independent claims 1 and 13 (Compl. ¶193).
  • Accused Features: The physical structure and instructed use of Puritan’s flocked swabs are alleged to infringe (Compl. ¶¶57-59).

III. The Accused Instrumentality

  • Product Identification: The accused products are Puritan’s HydraFlock® and PurFlock Ultra® swabs (Compl. ¶57).
  • Functionality and Market Context: The complaint alleges that the accused swabs are designed for the collection of biological specimens and feature rod tips covered in small fiber particles deposited using an electrostatic flocking process (Compl. ¶58). A Puritan infographic included in the complaint, titled "PROCESS," illustrates this functionality, showing a "FLOCKED NYLON HEAD" and a "MULTI-LENGTH FLOCK APPLICATION" designed for "ROBUST SAMPLE COLLECTION" (Compl. ¶35). Puritan is positioned as a "direct competitor" of Copan that entered the flocked swab market "around 2010-2011" after initially expressing skepticism about the technology (Compl. ¶¶50, 52, 54-56). The complaint alleges Puritan advertises that its swabs provide "superior collection and release for analysis" compared to traditional swabs (Compl. ¶58).

IV. Analysis of Infringement Allegations

The complaint references claim chart exhibits that are not provided; therefore, the infringement allegations are summarized below in prose.

The core of Copan's infringement theory is that Puritan makes, uses, sells, and offers for sale flocked swabs that embody the inventions claimed in the asserted patents (Compl. ¶¶148, 161, 174, 180, 193). For the asserted method claims (e.g., in the ’027 and ’728 Patents), the complaint alleges that Puritan's customers and end-users directly infringe by using the accused swabs according to Puritan's instructions to perform the claimed steps of collecting, transporting, and releasing a biological specimen (Compl. ¶¶59, 156). For the asserted apparatus claims (e.g., in the ’784 Patent), the complaint alleges that the physical structure of Puritan's swabs—a rod with a tip coated in a layer of electrostatically deposited fibers—directly reads on the claim limitations (Compl. ¶¶58, 174). An advertisement in the complaint shows a side-by-side comparison of a Puritan "HydraFlock" swab and a "COMPETITOR Nylon Flock Swab," which may be used to demonstrate that the products are intended for the same purpose and function in a similar manner (Compl. ¶100).

  • Identified Points of Contention:
    • Scope Questions: A central question for the court will be whether the structure of Puritan's swabs falls within the scope of claim terms such as "ordered arrangement" and "perpendicular to the surface." Puritan's marketing materials refer to "proprietary multi-length flock fibers" and a "'fiber-within-fiber' design" with "split ends" (Compl. ¶¶35, 107). The dispute may focus on whether these features are structurally and functionally equivalent to the claimed invention or represent a distinct, non-infringing technology.
    • Technical Questions: A factual question will be whether the accused swabs meet the quantitative limitations of the claims, such as the fiber layer thickness (0.6 to 3 mm), fiber count (1.7 to 3.3 Dtex), and specimen absorption volume (40 µl to 100 µl). The complaint alleges infringement of these limitations, but the determination will likely require expert testimony and empirical testing of the accused products.

V. Key Claim Terms for Construction

  • The Term: "a layer of fibers ... disposed in an ordered arrangement and perpendicular to the surface of the tip by flocking" (from ’027 Patent, Claim 1).

  • Context and Importance: This phrase defines the central structural characteristic of the invention that distinguishes it from prior art wrapped-fiber swabs. The construction of "ordered arrangement" and "perpendicular" will be critical, as Puritan may argue that its "multi-length" or "split end" fibers do not meet this definition. Practitioners may focus on this term because it lies at the heart of the infringement and validity disputes.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes the flocking process generally as one that "deposits the fibres in an ordered manner, perpendicular to the surface of the tip" (’027 Patent, col. 5:14-16). A party could argue this describes the general outcome of the process, allowing for minor variations and imperfections, rather than a requirement of perfect geometric alignment for every fiber.
    • Evidence for a Narrower Interpretation: The specification also states that an "expedient to be respected" is maintaining an arrangement that is "substantially parallel to each other and normal to the surface of the rod, avoiding any overlapping of fibres" to ensure capillary function (’027 Patent, col. 5:38-44). A party could argue this language supports a stricter interpretation requiring a high degree of uniformity and alignment.

  • The Term: "absorbing a quantity between 40 µl and 100 µl of liquid specimen" (from ’027 Patent, Claim 1).

  • Context and Importance: This functional limitation quantifies the performance of the claimed swab. The infringement analysis will depend on whether the accused products are capable of absorbing a specimen volume that falls within this specified range.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claim recites a range, suggesting that any swab capable of absorbing a volume within that range infringes. The specification notes that "in general 100 microliters" is a desired quantity, positioning the claimed range as a typical performance characteristic (’027 Patent, col. 4:51-52).
    • Evidence for a Narrower Interpretation: The patent's Example 1 describes a specific embodiment that results in an absorbing capacity of 40 µl (’027 Patent, col. 5:4-10). A party might argue that the claimed range is tied to the specific embodiments disclosed and should not be read to cover devices optimized for different absorption volumes.

VI. Other Allegations

  • Indirect Infringement: The complaint pleads indirect infringement for all asserted patents, including both induced and contributory infringement. It alleges inducement based on Puritan providing its flocked swabs with instructions and marketing materials that direct end-users (e.g., medical professionals, scientists) to use the swabs in a manner that performs the steps of the patented methods (Compl. ¶¶59, 156, 169). The complaint alleges the swabs are especially made for this infringing use and are not staple articles of commerce with substantial non-infringing uses (Compl. ¶¶154-155).
  • Willful Infringement: Willfulness is alleged for all asserted patents. The complaint alleges that Puritan had pre-suit knowledge of Copan's patent rights based on specific communications, including a 2011 letter from Copan's counsel identifying its patent applications and a 2016 letter from Puritan's own counsel acknowledging Copan's U.S. patents in the field of flocked swabs (Compl. ¶¶61, 65). Puritan's 2011 press release acknowledging Copan's patent application is also cited as evidence of knowledge (Compl. ¶62).

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

  • A core issue will be one of technical scope and claim construction: can the claim language requiring an "ordered arrangement" of fibers "perpendicular to the surface" be construed to cover Puritan’s accused swabs, which are described as using "multi-length" and "split end" bicomponent fibers? The case will likely involve a detailed factual and expert-driven inquiry into whether Puritan's technology is merely a different-looking version of the same inventive concept or a distinct, non-infringing alternative.
  • A second central question will revolve around willfulness and damages: given the extensive pre-suit history of correspondence and litigation detailed in the complaint, will the court find that Puritan's alleged infringement was willful? The resolution of this question, which depends on Puritan's state of mind and the objective baselessness of any non-infringement defenses, could expose the defendant to the risk of enhanced damages.
  • An additional key question relates to the unfair competition claims: beyond patent infringement, the court must determine whether Puritan's alleged public statements regarding the prior German litigation and the comparative performance of its products constitute false advertising under the Lanham Act. This will depend on proving the statements were literally false or misleading to consumers.