Merck Sharp & Dohme B.V. v. Xiromed Pharma ESPAA, S.L.

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Merck Sharp & Dohme B.V. (Netherlands); N.V. Organon (Netherlands); Organon USA LLC (New Jersey); and Organon LLC (Delaware)
  • Defendant: Xiromed Pharma España, S.L. (Spain); Xiromed, LLC (New Jersey); and Insud Pharma, S.L.U. (Spain)
  • Plaintiff’s Counsel: Gibbons P.C.
• Case Identification: 2:25-cv-02254, D.N.J., 04/02/2025
• Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Xiromed, LLC is organized under New Jersey law and has a regular and established place of business in the state. For the foreign defendants (Xiromed España and Insud), venue is alleged to be proper in any judicial district.
• Core Dispute: Plaintiffs allege that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of the NEXPLANON® contraceptive implant constitutes an act of patent infringement.
• Technical Context: The technology relates to long-acting, reversible subdermal contraceptive implants, specifically concerning the implant's composition to ensure it is visible on X-rays and the design of the applicator used for its insertion.
• Key Procedural History: This action was filed under the Hatch-Waxman Act, triggered by Defendants' submission of ANDA No. 217698 seeking FDA approval to market a generic etonogestrel implant. The complaint was filed within 45 days of Plaintiffs' receipt of Defendants' Paragraph IV notice letter, which entitles Plaintiffs to a statutory stay of FDA approval for the generic product. The complaint asserts that Defendants' notice letter did not contest infringement of the asserted patents.

Case Timeline

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

U.S. Patent No. 8,722,037 - “X-Ray Visible Drug Delivery Device,” Issued May 13, 2014

The Invention Explained

• Problem Addressed: The patent addresses the difficulty of locating prior art contraceptive implants, such as Implanon®, within the body after insertion, particularly if they are inserted incorrectly. Standard visualization techniques like MRI and ultrasonography are described as not always available, expensive, or difficult for inexperienced physicians to use, complicating removal procedures (’037 Patent, col. 1:16-25).
• The Patented Solution: The invention is a subdermal drug delivery implant that is visible on an X-ray. It achieves this by incorporating a radio-opaque material (e.g., barium sulphate) into the implant's core, which also contains the active contraceptive hormone (etonogestrel) within a thermoplastic polymer. This core is surrounded by a non-medicated polymer skin ('037 Patent, Abstract; col. 1:58-col. 2:2). A key aspect of the solution is that this modification renders the implant X-ray visible without negatively affecting the hormone release rate and without the radio-opaque material migrating out of the implant into the body ('037 Patent, col. 1:38-43; col. 1:60-63).
• Technical Importance: This approach provided a means to reliably locate a long-term contraceptive implant using widely available X-ray technology, potentially improving patient safety and simplifying the removal process ('037 Patent, col. 1:29-37).

Key Claims at a Glance

• The complaint asserts independent claim 1 (Compl. ¶53).
• Essential elements of independent claim 1 include:
  • A drug delivery device for subdermal administration.
  • A core comprising (a) crystalline desogestrel or 3-ketodesogestrel; (b) a thermoplastic polymer; and (c) about 4-30% by weight of a radio-opaque material.
  • A limitation that "substantially all the radio-opaque material is encapsulated in the thermoplastic polymer and not in the crystalline desogestrel or 3-ketodesogestrel."
  • A "non-medicated thermoplastic polymer skin covering the core."
• The complaint notes that Defendant allegedly did not contest infringement of claims 1-24 ('Compl. ¶54).

U.S. Patent No. 9,757,552 - “Applicator for Inserting an Implant,” Issued September 12, 2017

The Invention Explained

• Problem Addressed: The patent describes issues with prior art applicators for inserting delicate, rod-like implants. These applicators could potentially damage the implant during insertion, as mechanisms like bolts or crimp regions inside the cannula could exert force on the delicate implant (’552 Patent, col. 2:62-66).
• The Patented Solution: The invention is an applicator with a mechanism that securely holds the implant inside the cannula before use but "disengages" it during or after insertion into the skin. This disengagement happens before the implant is expelled, ensuring that "substantially no lateral force will be exerted on the implant as it is expelled from the cannula" ('552 Patent, Abstract; col. 2:6-17). The detailed description discloses a lever-based mechanism that interacts with a protective cover and the implant itself to achieve this securing and disengagement function ('552 Patent, col. 4:56-62).
• Technical Importance: This design sought to improve the reliability of implant insertion by protecting the implant from damage and ensuring it is released smoothly at the correct subdermal location ('552 Patent, col. 2:3-5).

Key Claims at a Glance

• The complaint asserts "one or more claims... including, but not limited to, claim 14" ('Compl. ¶60). Claim 14 depends on independent claim 1.
• Essential elements of independent claim 1 include:
  • An applicator for inserting a rod-like implant.
  • A housing, a cannula, a cannula holder, and an implant.
  • A protective cover for the cannula.
  • A mechanism that is caused by the removal of the cover to "engage with the implant to secure the implant."
  • The mechanism "disengages the implant during insertion of the cannula or after the cannula has been inserted and prior to movement of the implant with respect to the cannula for expelling the implant."
• The complaint notes that Defendant allegedly did not contest the validity of claims 1-25 (Compl. ¶61).

III. The Accused Instrumentality

Product Identification

• The accused instrumentality is the "Xiromed ANDA Product," which is a "purported generic version of NEXPLANON® (etonogestrel implant, 68 mg/implant)" (Compl. ¶10).

Functionality and Market Context

• The complaint alleges the Xiromed ANDA Product is intended to be a generic equivalent of NEXPLANON®, which has two primary components: a "matchstick-sized, radiopaque implant containing etonogestrel" and a "novel applicator device used to insert the implant" (Compl. ¶43).
• The product is indicated for use by women to prevent pregnancy (Compl. ¶48).
• It allegedly contains 68 mg of etonogestrel per implant (Compl. ¶49).
• The filing of the ANDA itself signifies a commercial intent to manufacture, use, and sell this product in the United States upon FDA approval (Compl. ¶45, ¶47).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide element-by-element infringement allegations sufficient to populate a claim chart for either patent-in-suit. The infringement theory is primarily based on two assertions: (1) that the Xiromed ANDA Product is a generic version of NEXPLANON® and is therefore "covered by" the asserted claims, and (2) that by failing to provide a basis for non-infringement in its Paragraph IV notice letter, Xiromed has "conceded infringement" of the ’037 Patent and "conceded validity" of the ’552 Patent (Compl. ¶54-55, ¶61-62).

• Identified Points of Contention:
  • '037 Patent: The central question will be whether the accused generic implant has the specific structure required by claim 1. What evidence can Plaintiffs produce to demonstrate that in the Xiromed ANDA Product, "substantially all the radio-opaque material is encapsulated in the thermoplastic polymer and not in the crystalline" etonogestrel, as required by the claim?
  • '552 Patent: The infringement analysis will focus on the operation of the accused generic applicator. Does the accused applicator's mechanism function as claimed, specifically by first engaging the implant upon removal of a cover and then disengaging from the implant "during insertion... and prior to movement of the implant... for expelling" it? The litigation may explore potential functional differences between the patented and accused applicators.
  • Procedural Issue: A threshold legal question will be the effect of Defendants' alleged omissions in their Paragraph IV notice letter. The court will need to determine whether the failure to contest infringement or validity, as alleged by Plaintiffs, constitutes a binding admission, creates an estoppel, or has some other legal consequence under the Hatch-Waxman framework.

V. Key Claim Terms for Construction

For the ’037 Patent:

• The Term: "substantially all the radio-opaque material is encapsulated in the thermoplastic polymer and not in the crystalline desogestrel or 3-ketodesogestrel" (from claim 1).
• Context and Importance: This limitation defines the precise location of the radio-opaque agent within the implant's core. Practitioners may focus on this term because infringement will depend entirely on the physical composition and microstructure of the accused generic implant, which will require technical evidence (e.g., microscopy) to resolve. The term "substantially all" is a term of degree that will require judicial construction.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party might argue that "substantially all" allows for some incidental or de minimis amount of the radio-opaque material to be associated with the drug crystals, as long as the vast majority is in the polymer.
  • Evidence for a Narrower Interpretation: The specification emphasizes the discovery that the radio-opaque component was "surprisingly found that almost all" was encapsulated in the polymer, and that "hardly any" was in the hormone crystals ('037 Patent, col. 3:61-65). Experimental results are described where the drug crystals "contain no bright spots" ('037 Patent, col. 8:58-59), suggesting a very high, if not complete, degree of separation that could support a narrow construction.

For the ’552 Patent:

• The Term: "a mechanism, wherein removal of the cover causes the mechanism to engage with the implant to secure the implant" (from claim 1).
• Context and Importance: This term is critical as it defines the automatic securing function that allegedly distinguishes the invention. The dispute will likely turn on whether the accused applicator's components constitute a "mechanism" that is "caused" to engage the implant in this specific way.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party could argue "mechanism" should be given its plain and ordinary meaning, covering any combination of parts that performs the recited function, not just the specific lever embodiment.
  • Evidence for a Narrower Interpretation: The patent specification consistently describes a specific embodiment where a pivoting lever (22) interacts with keys (28) on the protective cover (7) to achieve this function ('552 Patent, col. 5:8-24). A defendant may argue that the term "mechanism" should be interpreted in light of these specific disclosures, potentially limiting its scope to a lever-based system or its direct structural equivalent.

VI. Other Allegations

• Indirect Infringement: The complaint alleges both induced and contributory infringement. Inducement is premised on the allegation that Defendants will market and distribute the Xiromed ANDA Product with a product label and instructions that will inevitably lead healthcare professionals to use the infringing product (implant and applicator) as claimed ('Compl. ¶57, ¶64).
• Contributory Infringement: Contributory infringement is alleged on the basis that the Xiromed ANDA Product is especially adapted for an infringing use and has no substantial non-infringing use (Compl. ¶58, ¶65).
• Willful Infringement: Plaintiffs seek a judgment that Defendants "willfully and deliberately infringed," basing this on Defendants' knowledge of the patents-in-suit, as evidenced by their filing of an ANDA with a Paragraph IV certification (Compl. p. 18, ¶ i).

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

1. A Question of Concession: What is the legal weight of Defendants' alleged failure to contest infringement and validity in their Paragraph IV certification letter? Whether this is treated as a binding admission or a procedural misstep could significantly influence the scope and focus of the litigation.
2. A Question of Microstructure: For the '037 patent, the case will likely depend on a highly technical and factual determination. Can Plaintiffs prove, through expert testimony and evidence such as scanning electron microscopy, that the accused generic implant's physical structure meets the claim 1 limitation that "substantially all" of the radio-opaque material is located within the polymer and not the drug crystals?
3. A Question of Mechanical Function: For the '552 patent, a central issue will be one of functional operation. Does the accused generic applicator possess a "mechanism" that is "caused" by the removal of a cover to secure the implant, and does it later "disengage" the implant prior to expulsion, as strictly defined by the claim language and illuminated by the patent's specification?