DCT

2:20-cv-02751

Merck Sharp & Dohme BV v. Teva Pharma USA Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:20-cv-02751, D.N.J., 03/12/2020
  • Venue Allegations: Venue is alleged to be proper as to Teva USA because it has a regular and established place of business in New Jersey. Venue is alleged to be proper as to Teva Pharmaceutical Industries Limited because it is a foreign entity.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the anesthetic reversal agent Bridion® (sugammadex) constitutes an act of infringement of a patent covering the sugammadex compound.
  • Technical Context: The technology concerns modified cyclodextrins, which are complex sugar-based molecules designed to act as chemical chelating agents that selectively capture and inactivate other drug molecules, specifically neuromuscular blocking agents used during surgery.
  • Key Procedural History: The patent-in-suit is a reissue of an earlier patent. The complaint notes that the U.S. Patent and Trademark Office has determined the patent is eligible for a five-year patent term extension (PTE), extending its expiration to 2026. The lawsuit was triggered by Teva's submission of an ANDA with a Paragraph IV certification, asserting that its generic product would not infringe or that the patent-in-suit is invalid or unenforceable.

Case Timeline

Date Event
1999-11-29 ’733 Patent Priority Date
2003-12-30 Original U.S. Patent No. 6,670,340 Issued
2014-01-28 U.S. Reissue Patent No. RE44,733 Issued
2015-12-15 FDA approves Plaintiffs' Bridion® (sugammadex) New Drug Application
2020-01-31 Teva sends Paragraph IV Notice Letter to Merck
2020-02-04 USPTO issues Notice of Final Determination on PTE for '733 Patent
2020-03-12 Complaint Filed

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

  • Patent Identification: U.S. Reissue Patent No. RE44,733, "6-Mercapto-Cyclodextrin Derivatives: Reversal Agents For Drug-Induced Neuromuscular Block," issued January 28, 2014.
  • The Invention Explained:
    • Problem Addressed: The patent addresses the need to safely and effectively reverse drug-induced neuromuscular blockade (temporary muscle paralysis) following surgery ('733 Patent, col. 1:19-24). Traditional reversal agents, such as anticholinesterases, work by increasing levels of the neurotransmitter acetylcholine. This mechanism can cause significant side effects, including cardiovascular complications, and is not reliably effective in cases of very deep ("profound") blockade ('733 Patent, col. 2:1-26).
    • The Patented Solution: The invention is a new class of chemical agents based on modified cyclodextrins. Instead of affecting neurotransmitter levels, these molecules act as "chemical chelators" that directly find, encapsulate, and thereby inactivate the neuromuscular blocking drug molecules circulating in the patient's plasma ('733 Patent, col. 2:27-34; Abstract). This novel mechanism is designed to provide rapid reversal with fewer side effects ('733 Patent, col. 2:35-44).
    • Technical Importance: This approach represented a new paradigm for reversing anesthesia, moving from indirect physiological manipulation to direct chemical sequestration of the blocking agent, which the complaint alleges was a "significant advance in the field of anesthesiology" (Compl. ¶39).
  • Key Claims at a Glance:
    • The complaint asserts infringement of "one or more claims of the '733 patent, including at least claim 1" (Compl. ¶51).
    • Independent Claim 1 recites:
      • A 6-mercapto-cyclodextrin derivative having a specific chemical structure (Formula I);
      • Wherein the cyclodextrin ring size is defined by variables "m" and "n" such that "m+n=7" or "8";
      • Having a linker group "R" that is a "(C1-6)alkylene" or a phenylene-based structure;
      • Having a terminal functional group "X" selected from a list including "COOH" (a carboxylic acid);
      • The claim includes a negative limitation, specifying it is "with the exclusion of" a list of eight specific, previously known cyclodextrin compounds.

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is Teva's proposed generic "sugammadex injection, 200 mg/2 mL," which is the subject of ANDA No. 214126 submitted to the FDA (Compl. ¶8).
  • Functionality and Market Context: The complaint alleges that Teva's product contains "sugammadex as an active ingredient" (Compl. ¶47). Sugammadex is the active ingredient in Merck's branded product, Bridion®, and is described as a "modified cyclodextrin that acts by directly encapsulating, binding, and inactivating" neuromuscular blocking agents (Compl. ¶38). Teva's product is intended for the same indication: the reversal of neuromuscular blockade in adults undergoing surgery (Compl. ¶44). The complaint notes that Teva is "the leading generic drug company in the United States" (Compl. ¶21).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint alleges that Teva’s submission of its ANDA constitutes an act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶53). The core of the infringement allegation is that the active ingredient in Teva's proposed product, sugammadex, is a chemical compound that falls within the scope of the asserted claims of the ’733 Patent (Compl. ¶51).

RE44,733 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A 6-mercapto-cyclodextrin derivative having the general formula I ... wherein m is 0-7 and n is 1-8 and m+n=7 or 8 The complaint alleges Teva's product contains sugammadex, which is identified as 6-per-deoxy-6-per-(2-carboxyethyl)thio-γ-cyclodextrin, a γ-cyclodextrin derivative where m+n=8. ¶35, ¶51 col. 4:40-43
R is (C1-6)alkylene... The sugammadex compound contains an ethyl group as the "R" linker, which is a "(C1-6)alkylene". ¶35, ¶51 col. 4:20-27
X is COOH... The sugammadex compound contains a "COOH" (carboxy) group as the "X" terminal group. ¶35, ¶51 col. 3:19-22
or pharmaceutically acceptable salts thereof The accused product is a sugammadex injection, and the claims cover the compound or its pharmaceutically acceptable salts. ¶8, ¶47 col. 3:23-24
with the exclusion of [list of 8 compounds] The complaint implicitly alleges that sugammadex, the active ingredient in Teva's product, is not one of the eight specifically excluded compounds. ¶51 col. 3:25-49
  • Identified Points of Contention:
    • Validity vs. Infringement: In a Hatch-Waxman case involving a generic version of a patented compound, the primary dispute is often over patent validity rather than literal infringement. Teva's Paragraph IV certification asserts that the ’733 patent is "invalid, unenforceable, and/or will not be infringed" (Compl. ¶46). The central question for the court will likely be whether Teva can prove by clear and convincing evidence that the asserted claims are invalid as anticipated or obvious in light of prior art.
    • Scope Questions: A potential point of contention may arise from the negative limitation in Claim 1. The analysis will require a precise chemical comparison between Teva's proposed product and the eight specifically excluded compounds to confirm that Teva's product does not fall within the carved-out subject matter.

V. Key Claim Terms for Construction

While the complaint does not identify specific claim construction disputes, the structure of the claims suggests certain terms will be critical.

  • The Term: "with the exclusion of" [list of eight specific chemical compounds]

  • Context and Importance: This negative limitation is fundamental to the scope of Claim 1. Both infringement and validity analyses will depend on the precise chemical identity of these eight compounds. Practitioners may focus on this term because if Teva's product, or a prior art reference, is found to be one of these eight compounds, it would be dispositive of non-infringement or invalidity, respectively.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: A party might argue for a broad reading of the names of the excluded compounds to capture not just the exact structure but also closely related isomers or salts, if the naming convention allows for such ambiguity.
    • Evidence for a Narrower Interpretation: The patent lists the excluded compounds with specific chemical names (e.g., 6-per-deoxy-6-per-(carboxymethylthio)-β-cyclodextrin) and cites publications where they are described ('733 Patent, col. 3:28-49). A party would argue that the scope of the exclusion is strictly limited to the exact molecular structures disclosed in those references, with no room for equivalents or close variants.

  • The Term: "(C1-6)alkylene"

  • Context and Importance: This term defines the linker "R" connecting the cyclodextrin core to the terminal group "X". Its construction is important for defining the breadth of the chemical genus covered by the claim.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification provides a broad, conventional definition: "a branched or straight chain bivalent carbon radical containing 1-6 carbon atoms" and provides a non-exhaustive list of examples, including "methylene, ethylene..., propylene," etc. ('733 Patent, col. 4:20-27). This language supports a broad interpretation covering all chemical linkers meeting that definition.
    • Evidence for a Narrower Interpretation: A party seeking to narrow the claim might argue that the specific examples provided in the patent, such as the "(2-carboxyethyl)" group of sugammadex (Example 4), which uses an ethylene linker, suggest that the invention is focused on short, straight-chain linkers, potentially limiting the effective scope of the term.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement, stating that Teva will knowingly and intentionally "accompany the Teva ANDA Products with a product label or product insert that will include instructions for using or administering" the product in an infringing manner (Compl. ¶58). It is alleged that following these instructions for the approved medical use would directly infringe the ’733 patent’s method claims (Compl. ¶57).
  • Willful Infringement: The complaint alleges that Teva's infringement is willful, based on the allegation that Teva acted "with full knowledge of the '733 patent and without a reasonable basis for believing that they would not be liable for direct infringement" (Compl. ¶63).

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

The dispute as framed by the complaint centers on Teva’s challenge to Merck’s patent rights for its successful drug, Bridion®. The outcome will likely depend on the court's resolution of two central questions:

  • A core issue will be one of patent validity: given that the ’733 patent is a reissue and has undergone examination for a patent term extension, will Teva be able to present clear and convincing evidence that the asserted claims covering the sugammadex compound are invalid over the prior art?
  • A key question of claim scope will be the interpretation of the patent's negative limitations: does the precise chemical structure of any relevant prior art reference, or Teva's proposed generic product itself, fall squarely within the definition of one of the eight compounds expressly excluded from the scope of Claim 1?