Genzyme Corporation v. Novartis Gene Therapies, Inc.

Genzyme Corporation, a biotechnology company known for developing therapies for rare diseases and a subsidiary of Sanofi, initiated this patent infringement lawsuit. The plaintiff Genzyme Corporation, along with Aventis Inc., is asserting six patents related to recombinant adeno-associated virus (AAV) vector technology. The defendant, Novartis Gene Therapies, Inc. (formerly AveXis and a subsidiary of Novartis AG), is a biotechnology company focused on developing gene therapies for rare neurological genetic disorders. Novartis Gene Therapies' accused product is Zolgensma (onasemnogene abeparvovec-xioi), a gene therapy for spinal muscular atrophy (SMA), which was, at one point, considered the world's most expensive drug.

The asserted patent, US9051542, generally covers compositions and methods designed to prevent the aggregation of AAV vectors. AAV vectors are a crucial biological delivery platform used in gene therapy, and preventing their aggregation is important for the efficacy and safety of such treatments. The case was filed in the District Court for the District of Delaware, with Judge Richard G. Andrews presiding. The District of Delaware is a prominent venue for patent litigation, largely because many major U.S. technology and pharmaceutical companies, including many defendants, are incorporated there, making it a mandatory venue for such suits following the TC Heartland Supreme Court decision. The court also has an experienced bench in patent law, which contributes to its role as a high-volume patent forum.

This case is notable due to the high-stakes nature of the involved technologies and products within the gene therapy industry, particularly concerning Zolgensma, a significant breakthrough drug for spinal muscular atrophy. The litigation also involved multiple patent infringement actions and parallel inter partes review (IPR) proceedings at the Patent Trial and Appeal Board (PTAB). While the prompt states the case is active, public records indicate that the case was dismissed with prejudice in February 2024 after 796 days of litigation, with the parties bearing their own costs. The dismissal followed a settlement after several patents were invalidated during claim construction, others found not literally infringed, and IPRs were instituted.

The litigation "Genzyme Corporation v. Novartis Gene Therapies, Inc." (1:21-cv-01736) in the District Court for the District of Delaware involved Genzyme Corporation and Aventis Inc. (Plaintiffs) asserting six patents related to recombinant adeno-associated virus (AAV) vector technology against Novartis Gene Therapies, Inc., Novartis Pharmaceuticals Corporation, and Novartis AG (Defendants). The asserted patents included US7125717B2, US7846729B2, US8093054B2, US7785888B2, US6596535B1, and US9051542B2, all in connection with Novartis's Zolgensma gene therapy product.

Here are the key legal developments and the outcome of the litigation:

Filing & Initial Pleadings:

• Complaint Filed: Genzyme Corporation and Aventis Inc. filed the patent infringement lawsuit on December 10, 2021, in the District of Delaware. The initial complaint asserted six patents, including the '542 patent.

Pre-trial Motions of Substance:

• Motion to Dismiss (Novartis AG): Defendant Novartis AG filed a motion to dismiss under Federal Rule of Civil Procedure 12(b)(2) for lack of personal jurisdiction.
  • Outcome: On February 13, 2023, the District Court for the District of Delaware, presided over by Judge Richard G. Andrews, granted Novartis AG's motion to dismiss for lack of personal jurisdiction.

Claim Construction (Markman) Outcomes:

• Markman Hearing: The court addressed claim construction for multiple terms across the six asserted patents, including the '542 patent.
  • Outcome: On August 18, 2023, Judge Richard G. Andrews issued a Memorandum Opinion providing claim constructions for terms in the asserted patents. According to Novartis's counsel, the case settled after four patents were invalidated during claim construction, and five patents were found not literally infringed. While the specific impact on the '542 patent from the Markman order is not detailed in the available snippets beyond its inclusion in the opinion, the broader outcome indicates significant rulings favoring the defendants.

Parallel PTAB IPR Proceedings:

• IPR Petitions Filed: Novartis Gene Therapies, Inc. and Novartis Pharmaceuticals Corporation filed multiple inter partes review (IPR) petitions challenging claims of US Patent 9051542. Specifically, IPR2023-00608 and IPR2023-00609 were filed against the '542 patent.
• Disclaimer of Claims: In its preliminary response to the IPR petitions, Genzyme Corporation, the Patent Owner, stated that it had disclaimed claims 1 and 2 of the '542 patent. As a result, only claims 5 and 6 of the '542 patent remained at issue in the IPR proceedings.
• Denial of Institution (IPR2023-00608 & IPR2023-00609): On August 30, 2023, the Patent Trial and Appeal Board (PTAB) denied institution of inter partes review for both IPR2023-00608 and IPR2023-00609. The PTAB determined that Novartis had not demonstrated a reasonable likelihood of success in proving that either claim 5 or claim 6 of the '542 patent was unpatentable. The PTAB also noted concerns regarding Novartis filing two petitions challenging only four claims of the '542 patent, considering it placed a substantial and unnecessary burden on the Board.

Final Disposition:

• Dismissal with Prejudice: The case was closed on February 14, 2024, via a joint stipulation under Federal Rule of Civil Procedure 41(a)(1)(A)(ii). All claims asserted by any party were dismissed with prejudice, meaning Genzyme cannot refile the same patent claims against Novartis.
• Settlement: The dismissal with prejudice, combined with each side agreeing to bear its own attorneys' fees and costs, the withdrawal of all pending motions, and a waiver of all appeal rights, is structurally consistent with a confidential settlement, such as a licensing or cross-licensing arrangement. Novartis's counsel also explicitly stated that "The case settled after four patents were invalidated during claim construction, five patents found not literally infringed, and institution of multiple IPRs."
• Outcome Summary: The litigation lasted 796 days, which is longer than the median patent case in the District of Delaware, suggesting substantive engagement before resolution.

The patent infringement case Genzyme Corporation v. Novartis Gene Therapies, Inc., Case No. 1:21-cv-01736, originally filed in the District Court for the District of Delaware, was dismissed with prejudice on February 14, 2024, via a joint stipulation between the parties. The parties agreed to bear their own fees and costs. Therefore, the case is no longer active.

The counsel of record representing the plaintiffs, Genzyme Corporation and Aventis Inc., included attorneys from the following firms:

1. WILKS LAW, LLC (Wilmington, Delaware)

• David E. Wilks
  • Role: Local Counsel
  • Firm & Office: Wilks Law, LLC, Wilmington, DE
  • Note: Appears as counsel for plaintiffs in multiple docket entries in the District of Delaware.
• Scott B. Czerwonka
  • Role: Local Counsel
  • Firm & Office: Wilks Law, LLC, Wilmington, DE
  • Note: Appears as counsel for plaintiffs in multiple docket entries in the District of Delaware.
• D. Charles Vavala
  • Role: Local Counsel
  • Firm & Office: Wilks Law, LLC, Wilmington, DE
  • Note: Signed documents as "Attorneys for Plaintiffs Genzyme Corporation and Aventis Inc."

2. MCDONNELL BOEHNEN HULBERT & BERGHOFF LLP (Chicago, Illinois)

• Paul H. Berghoff
  • Role: Lead Counsel (argued claim construction)
  • Firm & Office: McDonnell Boehnen Hulbert & Berghoff LLP, Chicago, IL
  • Note: Experienced in patent litigation, including arguing claim construction in this case.
• Joshua R. Rich
  • Role: Lead Counsel (argued claim construction)
  • Firm & Office: McDonnell Boehnen Hulbert & Berghoff LLP, Chicago, IL
  • Note: Experienced in patent litigation, including arguing claim construction in this case.
• John Conour, Ph.D.
  • Role: Lead Counsel
  • Firm & Office: McDonnell Boehnen Hulbert & Berghoff LLP, Chicago, IL
  • Note: Holds a Ph.D., indicating a technical background often relevant in patent litigation.
• George T. Lyons, III
  • Role: Lead Counsel
  • Firm & Office: McDonnell Boehnen Hulbert & Berghoff LLP, Chicago, IL
  • Note: Listed as an attorney for plaintiffs.
• Bryan G. Helwig, Ph.D.
  • Role: Lead Counsel
  • Firm & Office: McDonnell Boehnen Hulbert & Berghoff LLP, Chicago, IL
  • Note: Holds a Ph.D., indicating a technical background often relevant in patent litigation.
• Alexandra E. MacKenzie
  • Role: Lead Counsel
  • Firm & Office: McDonnell Boehnen Hulbert & Berghoff LLP, Chicago, IL
  • Note: Listed as an attorney for plaintiffs.
• Daniel Gonzalez (Jr.)
  • Role: Lead Counsel
  • Firm & Office: McDonnell Boehnen Hulbert & Berghoff LLP, Chicago, IL
  • Note: Listed as an attorney for plaintiffs.
• James L. Lovsin
  • Role: Lead Counsel
  • Firm & Office: McDonnell Boehnen Hulbert & Berghoff LLP, Chicago, IL
  • Note: Listed as an attorney for plaintiffs.
• Margot M. Wilson
  • Role: Lead Counsel (argued claim construction)
  • Firm & Office: McDonnell Boehnen Hulbert & Berghoff LLP, Chicago, IL
  • Note: Experienced in patent litigation, including arguing claim construction in this case.

No specific in-house counsel for Genzyme Corporation were listed as counsel of record in the publicly available docket entries for this specific litigation. In-house counsel typically manage the litigation strategy and coordinate with outside counsel rather than appearing directly as counsel of record in court.

The defendant, Novartis Gene Therapies, Inc., was represented by several attorneys and firms in this patent infringement case.

Here is a breakdown of the counsel of record for the defendant(s):

Lead Counsel:

• John D. Livingstone

  • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner LLP, Atlanta, GA.
  • Note: Mr. Livingstone is a nationally recognized first-chair trial lawyer specializing in complex pharmaceutical, chemical, and biotechnology patent litigation before U.S. district courts, the U.S. International Trade Commission (ITC), and the U.S. Court of Appeals for the Federal Circuit. He also serves as lead counsel in post-grant proceedings before the Patent Trial and Appeal Board (PTAB). He successfully led Novartis against Genzyme's multiple patent infringement actions and IPR proceedings related to recombinant adeno-associated virus vector technology, resulting in a settlement after several patents were invalidated or found not literally infringed.

• Megan L. Meyers

  • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner LLP, Atlanta, GA.
  • Note: Ms. Meyers successfully defended Novartis against Genzyme's multiple patent infringement actions and inter partes review (IPR) proceedings concerning AAV vector technology in Zolgensma®. She has extensive experience in patent litigation, including preliminary injunction proceedings and Abbreviated New Drug Application (ANDA) litigation for pharmaceutical drug products.

• Shannon Patrick

  • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner LLP, Atlanta, GA.
  • Note: Shannon Patrick was part of the Finnegan team representing Novartis in this high-stakes gene therapy patent dispute.

• M. David Weingarten, Ph.D.

  • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner LLP, Atlanta, GA.
  • Note: Dr. Weingarten was listed as Of Counsel for the defendants in the February 2024 dismissal document.

• Amanda K. Murphy, Ph.D.

  • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner LLP, London, United Kingdom.
  • Note: Dr. Murphy successfully defended Novartis in this case, which involved multiple patent infringement actions and IPR proceedings. She has a background as a former law clerk to the Honorable S. Jay Plager on the U.S. Court of Appeals for the Federal Circuit and serves as an adjunct professor teaching patent prosecution.

• Cora Holt

  • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner LLP, Washington, DC.

• Michael Galgano

  • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner LLP, Washington, DC.

• Christopher W. Weber, Ph.D.

  • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner LLP, Washington, DC.

• Emily Gabranski

  • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner LLP, Washington, DC.

• Marta Garcia Daneshvar

  • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner LLP, Boston, MA.

Local Counsel:

• Kelly E. Farnan

  • Firm: Richards, Layton & Finger, P.A., Wilmington, DE.
  • Note: Ms. Farnan is a highly regarded trial lawyer focusing on complex commercial and intellectual property litigation, particularly patent disputes, in Delaware's state and federal courts. She has been recognized as Managing IP's Delaware Litigator of the Year multiple times.

• Daniel M. Silver

  • Firm: McCarter & English, LLP, Wilmington, DE.
  • Note: Mr. Silver has represented Novartis in various patent litigation matters in the District of Delaware.

• Alexandra M. Joyce

  • Firm: McCarter & English, LLP, Wilmington, DE.

Of Counsel:

• Richard D. Batchelder, Jr.
  • Firm: Ropes & Gray LLP, Boston, MA.
  • Note: Mr. Batchelder is a Senior Counsel at Ropes & Gray with nearly 30 years of experience in high-stakes litigation, including significant contractual and indemnification disputes for life sciences and healthcare clients.

In-House Counsel:

While specific in-house counsel for Novartis Gene Therapies, Inc. on this particular case are not explicitly listed in the search results as counsel of record, Novartis has a robust in-house legal team. Karen L. Hale is the Chief Legal & Compliance Officer for Novartis, leading global security, legal, and ethics, risk, and compliance functions, and brings over 20 years of experience in the global pharmaceutical industry. Novartis's legal team is known for its expertise in healthcare and pharmaceutical sectors.