DCT
2:20-cv-09299
Merck Sharp & Dohme Corp v. Microspherix LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Merck Sharp & Dohme Corp., Merck Sharp & Dohme B.V., and Organon USA, Inc. (New Jersey & Netherlands)
- Defendant: Microspherix LLC (Florida)
- Plaintiff’s Counsel: McCarter & English, LLP; Gibson, Dunn & Crutcher LLP
- Case Identification: 2:20-cv-09299, D.N.J., 07/22/2020
- Venue Allegations: Plaintiff alleges venue is proper because Defendant previously filed an infringement action involving the same patents in the District of New Jersey, thereby consenting to venue.
- Core Dispute: Plaintiff seeks a declaratory judgment that its Nexplanon® contraceptive implant does not infringe Defendant's patents related to brachytherapy seeds and strands, and that those patents are invalid.
- Technical Context: The dispute centers on implantable drug-delivery devices, pitting patents originally developed for localized cancer treatment (brachytherapy) against a product that provides long-term, systemic hormonal contraception.
- Key Procedural History: This declaratory judgment action follows a prior lawsuit filed by Microspherix against Merck on June 5, 2017, in the same court, which asserted three of the four patents-in-suit. The fourth patent issued in 2019 as a continuation of a previously asserted patent, and the complaint notes that Microspherix had previously informed Merck of its intent to expand its patent estate.
Case Timeline
| Date | Event |
|---|---|
| 1999-03-09 | Merck allegedly begins feasibility experiments for an X-ray visible implant |
| 2000-11-16 | Earliest Priority Date for '401, '402, '835, and '181 Patents |
| 2014-09-02 | U.S. Patent No. 8,821,835 Issues |
| 2017-05-02 | U.S. Patent No. 9,636,401 Issues |
| 2017-05-02 | U.S. Patent No. 9,636,402 Issues |
| 2017-06-05 | Microspherix files initial infringement lawsuit against Merck |
| 2017-07-25 | Microspherix counsel informs Merck of pending patent application |
| 2019-12-03 | U.S. Patent No. 10,493,181 Issues |
| 2020-07-22 | Merck files Complaint for Declaratory Judgment |
II. Technology and Patent(s)-in-Suit Analysis
No probative visual evidence provided in complaint.
U.S. Patent No. 9,636,402 - "Flexible and/or Elastic Brachytherapy Seed or Strand," Issued May 2, 2017
The Invention Explained
- Problem Addressed: The patent specification describes conventional brachytherapy—the use of small, radioactive "seeds" to treat cancer—as being limited primarily to prostate cancer due to the rigidity of the seeds (Compl. p. 4; ’402 Patent, col. 1:36-39). This rigidity makes it difficult to implant them accurately in mobile or irregularly shaped tissues, and temporary implants that address this issue often require hospitalization and subsequent removal procedures (’402 Patent, col. 3:36-41).
- The Patented Solution: The invention is a flexible or elastic strand that can be permanently implanted into tissue (Compl. p. 4). This strand contains a therapeutic agent and an imaging marker within a biocompatible carrier, allowing it to conform to the shape of the target tissue and deliver treatment locally over an extended period (’402 Patent, Abstract; col. 4:1-11).
- Technical Importance: This approach was intended to expand the application of localized, implant-based therapy beyond the prostate to other areas, such as breast cancer or cancers of the tongue, where rigid implants were not feasible (’402 Patent, col. 3:12-24).
Key Claims at a Glance
The complaint seeks a declaratory judgment of non-infringement of all valid claims and does not identify specific asserted claims. Independent claim 1 is representative of the patented technology.
- An implantable strand for administering a therapeutic agent, comprising:
- a therapeutically effective amount of the therapeutic agent;
- a biocompatible component comprising a polymer;
- a radio-opaque material, wherein the radio-opaque material is encapsulated in the biocompatible component; and
- a polymeric coating;
- wherein the polymeric coating covers the strand and wherein radiopaque material allows for the position of the strand to be determined following administration wherein the strand is non-radioactive and does not contain a radioisotope.
U.S. Patent No. 9,636,401 - "Flexible and/or Elastic Brachytherapy Seed or Strand," Issued May 2, 2017
The Invention Explained
- Problem Addressed: As with its related '402 patent, this patent addresses the limitations of rigid, conventional brachytherapy seeds, which are difficult to use effectively in soft or mobile tissues (’401 Patent, col. 1:36-39; col. 3:36-41).
- The Patented Solution: The patent describes a flexible, non-radioactive implantable strand that functions as a marker component with a "hollow interior." This hollow interior contains a biocompatible component and a therapeutic agent, which can pass out through at least one opening in the strand's wall to treat the surrounding tissue (’401 Patent, Abstract; FIG. 2).
- Technical Importance: The invention aims to provide a flexible and conformable implant structure for localized drug delivery, overcoming the placement and dosimetry challenges associated with rigid seeds in non-prostate cancers (’401 Patent, col. 3:12-24).
Key Claims at a Glance
The complaint seeks a declaratory judgment of non-infringement of all valid claims and does not identify specific asserted claims. Independent claim 1 is representative of the patented technology.
- A flexible non-radioactive strand for implantation into a subject, comprising:
- a marker component configured to allow for the determination of the position of the strand within a target tissue, the marker component having a length and a substantially continuous wall bounding a hollow interior;
- a biocompatible component; and a therapeutic, prophylactic, and/or diagnostic agent;
- wherein the marker, biocompatible component and agent are disposed within the hollow interior;
- wherein the length of the marker component is greater than the diameter of the hollow interior; and
- wherein the substantially continuous wall includes at least one opening adapted to allow the agent to pass out of the hollow interior wherein the strand do not contain a radioisotope.
Multi-Patent Capsule: U.S. Patent No. 8,821,835
- Patent Identification: U.S. Patent No. 8,821,835, "Flexible and/or Elastic Brachytherapy Seed or Strand," Issued September 2, 2014.
- Technology Synopsis: Part of the same patent family, the ’835 Patent discloses an implantable "seed" rather than a "strand." It describes a marker component with a hollow interior that contains a therapeutic agent, designed for localized delivery to a target tissue. The technology remains focused on solving the problems of conventional, rigid brachytherapy seeds by providing a more adaptable implant structure (’835 Patent, Abstract; col. 1:30-45).
- Asserted Claims: Claim 1 is the sole independent claim.
- Accused Features: The complaint alleges non-infringement by the Nexplanon® system, which is described as a systemic contraceptive implant, contrasting with the patent’s focus on localized delivery for brachytherapy (Compl. ¶ 48).
Multi-Patent Capsule: U.S. Patent No. 10,493,181
- Patent Identification: U.S. Patent No. 10,493,181, "Flexible and/or Elastic Brachytherapy Seed or Strand," Issued December 3, 2019.
- Technology Synopsis: As a continuation of the '402 Patent, the ’181 Patent shares the same specification but claims an implantable rod for delivering a hormone. The claimed rod is non-radioactive and comprises a biocompatible polymer, an encapsulated radio-opaque material, and a polymeric coating (’181 Patent, Abstract; Claim 1). The claims appear drafted to more closely target the features of a systemic contraceptive implant.
- Asserted Claims: Claim 1 and Claim 15 are the independent claims.
- Accused Features: The Nexplanon® system is accused, with the complaint arguing that the patent’s claims and disclosure are fundamentally limited to localized brachytherapy, not systemic hormone release (Compl. ¶ 57).
III. The Accused Instrumentality
Product Identification
- The Merck Nexplanon® System (Compl. ¶ A, p. 2).
Functionality and Market Context
- The Nexplanon® system is a long-acting contraceptive comprising a matchstick-sized, flexible polymer implant and an applicator device for insertion (Compl. ¶ A, p. 2). The implant contains the synthetic hormone etonogestrel.
- Once inserted subcutaneously in the upper arm, the implant provides a systemic release of etonogestrel into the bloodstream to prevent ovulation for up to three years (Compl. ¶ A, p. 2). The complaint emphasizes this systemic delivery mechanism as being fundamentally different from the localized treatment described in the patents-in-suit (Compl. ¶ D, p. 6).
- The implant contains barium sulfate mixed into its polymer core, which makes the device visible by X-ray to allow for confirmation of its location post-insertion (Compl. ¶ E.1, p. 7).
IV. Analysis of Infringement Allegations
As this is a complaint for declaratory judgment of non-infringement, the following tables summarize the product features that Microspherix would likely allege meet the claim limitations.
9,636,402 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a therapeutically effective amount of the therapeutic agent | The etonogestrel hormone contained within the Nexplanon® implant to prevent pregnancy. | ¶ A, p. 2 | col. 4:2-4 |
| a biocompatible component comprising a polymer | The polymer matrix forming the core of the Nexplanon® implant rod. | ¶ E.1, p. 7 | col. 5:6-9 |
| a radio-opaque material, wherein the radio-opaque material is encapsulated in the biocompatible component | The barium sulfate mixed into the polymer core of the Nexplanon® implant to make it visible on X-ray. | ¶ E.1, p. 7 | col. 4:5-7 |
| a polymeric coating... wherein the polymeric coating covers the strand | The complaint does not provide sufficient detail for analysis of a distinct polymeric coating. | N/A | col. 24:15 |
| wherein the strand is non-radioactive and does not contain a radioisotope | The Nexplanon® implant is a hormonal contraceptive and does not contain any radioactive material. | ¶ D, p. 6 | col. 24:18-19 |
9,636,401 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A flexible non-radioactive strand... comprising: a marker component... having a substantially continuous wall bounding a hollow interior | The flexible, solid polymer rod of the Nexplanon® implant. | ¶ A, p. 2 | col. 16:21-23 |
| a biocompatible component; and a therapeutic... agent, wherein the marker, biocompatible component and agent are disposed within the hollow interior | The etonogestrel hormone, barium sulfate, and polymer matrix that are mixed together to form the solid rod. | ¶ A, p. 2; ¶ E.1, p. 7 | col. 15:1-3 |
| wherein the substantially continuous wall includes at least one opening adapted to allow the agent to pass out of the hollow interior | The elution of the etonogestrel hormone from the solid polymer matrix into the bloodstream. | ¶ A, p. 2 | col. 24:12-14 |
- Identified Points of Contention:
- Scope Questions: The central contention raised in the complaint is whether claims from patents whose specifications are exclusively directed to localized cancer treatment via brachytherapy can be construed to cover a product for systemic, hormonal contraception. The complaint alleges the patents distinguish their localized approach from the systemic method used by the accused product (Compl. ¶ C, p. 4; ¶ D, p. 6).
- Technical Questions: A primary technical question for the ’401 Patent is whether a solid polymer rod with dispersed agents, like Nexplanon®, can meet the claim requirement of a "hollow interior" with an agent "disposed within" it. For the '402 Patent, a question may arise as to whether barium sulfate "mixed into the core of the implant" meets the limitation of being "encapsulated in the biocompatible component" (Compl. ¶ E.1, p. 7).
V. Key Claim Terms for Construction
- The Term: "hollow interior" ('401 Patent, Claim 1)
- Context and Importance: The construction of this term is critical because the accused Nexplanon® implant is a solid rod, not a hollow tube (Compl. ¶ A, p. 2). A narrow construction would likely support a finding of non-infringement, while a broad or functional interpretation would be necessary for an infringement theory to proceed.
- Evidence for a Broader Interpretation: The patent does not provide an explicit definition for the term, which may allow a party to argue for a functional interpretation where a porous solid matrix that contains and elutes a drug serves the same purpose as a hollow structure.
- Evidence for a Narrower Interpretation: The specification explicitly discloses and depicts a "hollow tube 18 having a cylindrical cavity 20" (’401 Patent, col. 16:21-23; FIG. 2). This specific embodiment strongly supports a literal interpretation of the term as a physically empty space or cavity within the strand.
- The Term: "encapsulated in" ('402 Patent, Claim 1)
- Context and Importance: The complaint states that barium sulfate is "added" and "mix[ed]" into the core of the Nexplanon® implant (Compl. ¶ E.1, p. 7). Whether this configuration meets the "encapsulated in" limitation will be a point of dispute. Practitioners may focus on this term to determine if a simple mixture is sufficient or if a more discrete containment structure is required.
- Evidence for a Broader Interpretation: A party could argue that "encapsulated in" simply means "enclosed within," and thus individual particles of barium sulfate are enclosed by the surrounding polymer matrix.
- Evidence for a Narrower Interpretation: The patent’s background discusses conventional radioactive seeds that take the "form of a capsule encapsulating a radioisotope" (’402 Patent, col. 1:53-54). This language, referencing a distinct capsule structure, may be used to argue that "encapsulated" requires a discrete boundary between the radiopaque material and the biocompatible component, rather than a simple mixture.
VI. Other Allegations
- Indirect Infringement: The complaint seeks a declaratory judgment of non-infringement for both direct and indirect infringement but, as a DJ complaint, does not plead facts that would support an indirect infringement claim against itself (Compl. ¶¶ 30-31).
- Willful Infringement: The complaint makes no allegations related to willfulness. However, it establishes Merck's pre-suit knowledge of the patents-in-suit through its description of the prior infringement action filed by Microspherix in June 2017 and a subsequent letter from Microspherix's counsel (Compl. ¶ 6, p. 5; ¶ 8). This history would form the basis for any potential willfulness claim by Microspherix.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of technological scope: can claims originating from a patent specification focused entirely on localized cancer brachytherapy be validly construed to cover a systemic, hormonal contraceptive implant, an application the patent specification contrasts with its own invention? This question implicates fundamental patent law doctrines of written description and enablement.
- A key claim construction question will be one of structural definition: does the accused Nexplanon® implant—a solid polymer rod with dispersed agents—meet claim limitations requiring a "hollow interior" with an agent "disposed within," as recited in the '401 patent, or is there a dispositive mismatch between the claimed structure and the accused product?