Untitled case

The patent infringement case 1:24-cv-00882 in the Delaware District Court involves a dispute between Genzyme Corporation as the plaintiff and Sarepta Therapeutics, Inc. and Sarepta Therapeutics Three, LLC as the defendants. Genzyme Corporation is a wholly-owned subsidiary of Sanofi, a global pharmaceutical company, making them an operating company. Sarepta Therapeutics is also an operating company focused on gene therapy, specifically for Duchenne muscular dystrophy (DMD).

The core of the litigation centers on Sarepta's commercial gene therapy product, Elevidys® (delandistrogene moxeparvovec-rokl), which is used to treat Duchenne muscular dystrophy. Genzyme alleges that Sarepta's manufacturing and sale of Elevidys® infringes its patents. The initial complaint asserted infringement of U.S. Patent No. 7,704,721 (the "'721 patent") and U.S. Patent No. 9,051,542 (the "'542 patent"). The '721 patent claims manufacturing methods for preventing aggregation of recombinant adeno-associated virus (rAAV) virions, while the '542 patent claims a composition for the storage of purified rAAV vector particles. Genzyme later amended its complaint to include five additional patents: U.S. Patent Nos. 12,031,894, 12,013,326, 11,698,377, 12,123,880, and 12,298,313, which are directed to methods to characterize or analyze preparations of recombinant viral particles, often using analytical ultracentrifugation.

The case is proceeding in the U.S. District Court for the District of Delaware under Judge Richard G. Andrews, with Magistrate Judge Sherry R. Fallon also involved. Delaware remains a prominent venue for patent litigation, particularly for pharmaceutical and technology firms, largely due to the high number of companies incorporated in the state and the judiciary's extensive experience and specialized expertise in complex patent cases. The case is notable as it involves competing pharmaceutical companies in the rapidly developing field of gene therapy for Duchenne muscular dystrophy, a significant and high-value market, with Sarepta reporting substantial net revenue from Elevidys®. Furthermore, Sarepta Therapeutics has initiated multiple inter partes review (IPR) proceedings at the Patent Trial and Appeal Board (PTAB) challenging the validity of Genzyme's asserted patents, some of which have already been denied institution. This IPR linkage and the direct competition between two major players in the gene therapy space underscore the case's industry impact.

Here's a summary of the key legal developments and outcomes for the patent infringement litigation Genzyme Corporation v. Sarepta Therapeutics, Inc. et al., Case No. 1:24-cv-00882, in the District of Delaware, involving US Patent No. 7,704,721 and other related patents. The case remains active.

Key Legal Developments:

• Filing & Initial Pleadings:

  • Complaint Filed (2024-07-26): Plaintiff Genzyme Corporation, a wholly-owned subsidiary of Sanofi, filed a patent infringement lawsuit against Sarepta Therapeutics, Inc. and Sarepta Therapeutics Three, LLC (collectively, "Sarepta"). Genzyme alleged that Sarepta's manufacture and sale of Elevidys® (delandistrogene moxeparvovec-rokl), a gene therapy for Duchenne muscular dystrophy, infringed U.S. Patent Nos. 7,704,721 and 9,051,542. Genzyme sought judgments of infringement (including willful infringement), damages (including treble damages), and attorneys' fees.
  • Second Amended Complaint (2025-05-27): Genzyme filed an Unopposed Motion for Leave to File a Second Amended Complaint, which the Court granted. This amended complaint added five new patents to the litigation: U.S. Patent Nos. 12,031,894; 12,013,326; 11,698,377; 12,123,880; and 12,298,313.
  • Amended Scheduling Order (2025-05-29): Following the addition of new patents, the parties filed a joint stipulation to amend the scheduling order to allow adequate time for disclosures and discovery related to the additional patents.

• Pre-trial motions of substance:

  • Specific motions to dismiss or transfer are not explicitly detailed in the available search results beyond the general progression of the case. The deferral of a claim construction argument until summary judgment suggests that summary judgment motions are anticipated but not yet filed or ruled upon.

• Claim Construction (Markman) Outcomes:

  • Joint Claim Construction Brief (D.I. 138, 145): A sealed Joint Claim Construction Brief (JCCB) and its redacted version were filed.
  • Order on JCCB (2026-04-20): Judge Richard G. Andrews ordered the parties to file a conforming redacted brief due to over-redaction. The Court deferred consideration of the argument that "without significant aggregation" is indefinite until, at the earliest, summary judgment, and adopted Plaintiff's proposed construction for this term. The order specified that the Markman hearing would only address the terms "the pH of the composition is between 7.5 and 8.0" and "preventing aggregation."
  • Oral Order on Disputed Terms (2026-04-22): The Court ruled on two of the four disputed terms in the JCCB, deferring rulings on the remaining two.
  • Claim Construction Order (2026-04-27): A Claim Construction Order was signed by Judge Andrews.

• Discovery Milestones with Strategic Significance:

  • The extension of the case schedule in May 2025 to accommodate disclosures and discovery for the five additional patents indicates a strategic adjustment to the discovery phase.
  • Sarepta's awareness of patent '542 as of August 22, 2023, and patent '721 as of July 26, 2024, came to light through Genzyme's first set of interrogatories (Interrogatory No. 6), which Sarepta responded to on April 4, 2025.

• Trial Events, Verdict, and Post-trial Motions:

  • As of May 20, 2026, the case is active and has recently concluded claim construction. No trial events, verdicts, or post-trial motions have occurred.

• Settlement, Dismissal, Judgment, or Appeal:

  • The case is currently active and ongoing in the District of Delaware. There is no information available regarding settlement, dismissal, judgment, or appeal at this stage.

• Parallel PTAB IPR/PGR Proceedings:

  • IPR2026-00314: An Inter Partes Review (IPR) proceeding, IPR2026-00314, related to the district court case 1:24-cv-00882, had an Institution Decision: Deny issued on May 6, 2026. This denial indicates that the PTAB did not proceed with a full review of the challenged patent claims in this specific IPR. The effect of this on the district court litigation would be that the claims challenged in this IPR can proceed to litigation without the PTAB's validity findings.
  • News articles mentioning the initial complaint also noted that there were other IPRs and litigations involving Elevidys®, such as Sarepta Therapeutics, Inc. v. Trustees of The University of Pennsylvania, IPR2024-00580 (awaiting Institution Decision at that time) and Regenxbio Inc. v. Sarepta Therapeutics, Inc., No. 1:23-cv-00667 (D. Del.) (stayed pending IPR2024-00580). However, the specific impact of these on this particular 1:24-cv-00882 case is not fully detailed in the provided search results.

Genzyme Corporation, the plaintiff in the patent infringement case 1:24-cv-00882 in the Delaware District Court, is represented by counsel from Dechert LLP and local counsel from Morris, Nichols, Arsht & Tunnell LLP.

The counsel of record for Genzyme Corporation are:

Lead Counsel (Dechert LLP)

• Katherine A. Helm (Lead Counsel)
  • Firm & Office: Dechert LLP, New York, NY.
  • Experience Note: Ms. Helm is experienced in patent litigation, listed as "of counsel" in court filings for Genzyme.
• Noah M. Leibowitz (Lead Counsel)
  • Firm & Office: Dechert LLP, New York, NY.
  • Experience Note: Mr. Leibowitz is experienced in patent litigation, listed as "of counsel" in court filings for Genzyme.
• Martin J. Black (Lead Counsel)
  • Firm & Office: Dechert LLP, New York, NY.
  • Experience Note: Mr. Black is involved in patent infringement litigation for Genzyme.
• Sharon K. Gagliardi (Lead Counsel)
  • Firm & Office: Dechert LLP, New York, NY.
  • Experience Note: Ms. Gagliardi is involved in patent infringement litigation for Genzyme.
• Jonathan D. Loeb (Lead Counsel)
  • Firm & Office: Dechert LLP, New York, NY.
  • Experience Note: Mr. Loeb is involved in patent infringement litigation for Genzyme.
• Amanda K. Antons (Lead Counsel)
  • Firm & Office: Dechert LLP, New York, NY.
  • Experience Note: Ms. Antons is involved in patent infringement litigation for Genzyme.

Local Counsel (Morris, Nichols, Arsht & Tunnell LLP)

• Rodger D. Smith II (Local Counsel)
  • Firm & Office: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE.
  • Experience Note: Morris Nichols is a prominent patent litigation firm in Delaware, frequently serving as local counsel in complex patent cases and representing clients in over a third of IP cases in the District of Delaware.
• Derek J. Fahnestock (Local Counsel)
  • Firm & Office: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE.
  • Experience Note: Mr. Fahnestock is involved in patent litigation, and his firm is known for its extensive experience in the District of Delaware.
• Megan E. Dellinger (Local Counsel)
  • Firm & Office: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE.
  • Experience Note: Ms. Dellinger is involved in patent litigation, and her firm is known for its extensive experience in the District of Delaware.

Defendants Sarepta Therapeutics, Inc. and Sarepta Therapeutics Three, LLC are represented by a team of attorneys from several firms.

Lead Counsel:

• M. David Weingarten, Ph.D. - Lead Counsel

  • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Atlanta, GA)
  • Experience: Dr. Weingarten focuses on patent litigation, post-grant trial proceedings, and patent prosecution with a diverse chemistry and life sciences practice. He is representing Sarepta in this defensive patent litigation concerning Elevidys® and related inter partes reviews (IPRs). He has a Ph.D. in organic chemistry and is recognized for his mastery of intricate case details and deep understanding of chemistry issues in both large pharma and small biotech contexts.

• John D. Livingstone - Lead Counsel

  • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Atlanta, GA)
  • Experience: Finnegan is a leading IP law firm with extensive experience in biologics, patent litigation, and post-grant proceedings, frequently representing pharmaceutical companies.

Local Counsel (Delaware):

• Derek J. Fahnestock - Local Counsel

  • Firm: Morris, Nichols, Arsht & Tunnell LLP (Wilmington, DE)
  • Experience: Mr. Fahnestock frequently represents clients as lead or Delaware counsel in the District of Delaware, handling patent infringement, trade secrets, and other litigation matters across various technologies, including medical devices, pharmaceuticals, and semiconductors. Morris Nichols is recognized as a premier patent litigation firm in Delaware and has handled more patent litigation cases than any other Delaware firm in the past five years.

• Megan E. Dellinger - Local Counsel

  • Firm: Morris, Nichols, Arsht & Tunnell LLP (Wilmington, DE)
  • Experience: Morris Nichols has a strong intellectual property litigation practice, often representing branded pharmaceutical companies in infringement litigation and handling complex patent disputes.

• Rodger D. Smith II - Local Counsel

  • Firm: Morris, Nichols, Arsht & Tunnell LLP (Wilmington, DE)
  • Experience: Morris Nichols is highly regarded for its patent litigation work in Delaware and is regularly engaged for local counsel duties in complex patent matters.

The defendants are also represented by attorneys from Quinn Emanuel Urquhart & Sullivan, LLP.

• Andrew M. Berdon

  • Firm: Quinn Emanuel Urquhart & Sullivan, LLP (New York, NY)

• Robert B. Wilson

  • Firm: Quinn Emanuel Urquhart & Sullivan, LLP (New York, NY)

• Anne S. Toker

  • Firm: Quinn Emanuel Urquhart & Sullivan, LLP (New York, NY)

• Anastasia M. Fernands

  • Firm: Quinn Emanuel Urquhart & Sullivan, LLP (New York, NY)