Veloxis Pharmaceuticals, Inc. v. Unknown Defendant

Veloxis Pharmaceuticals, Inc., a specialty pharmaceutical company focused on improving the lives of transplant patients and an Asahi Kasei company, initiated this Abbreviated New Drug Application (ANDA) patent infringement lawsuit. The plaintiff develops and commercializes medications for transplant patients, including its branded immunosuppressant ENVARSUS XR® (extended-release tacrolimus tablets). The defendants, Accord Healthcare, Inc. and its parent company Intas Pharmaceuticals, Ltd., are generic drug manufacturers. The dispute arose from Accord's submission of ANDA No. 217255 to the FDA, seeking approval to market generic versions of Veloxis's ENVARSUS XR® prior to patent expiration.

The core of the litigation involved the alleged infringement of multiple U.S. patents owned by Veloxis, which generally cover oral dosage forms and methods of use and administration of tacrolimus. Specifically at issue was U.S. Patent No. 8,685,998, titled "Tacrolimus for Improved Treatment of Transplant Patients." This patent describes an extended-release oral dosage form of tacrolimus designed for once-daily immunosuppressive treatment, aiming to provide high bioavailability and an improved pharmacokinetic profile compared to conventional formulations. Tacrolimus is a macrolide compound with immunosuppressive activity crucial for preventing organ rejection in transplant patients, and its formulation often addresses challenges related to its low water solubility.

This case, 1:22-cv-00909, was filed on July 7, 2022, in the District Court, Delaware. The District of Delaware is a prominent venue for Hatch-Waxman (ANDA) patent cases, handling a significant majority of such lawsuits nationwide due to its experienced judiciary and established case management procedures. The case concluded on January 24, 2024, with a consent judgment and a permanent injunction granted against Accord Healthcare and Intas Pharmaceuticals, blocking the generic entry of ENVARSUS XR®. This outcome is notable as it represents a successful defense of Veloxis's patent portfolio against generic competition, highlighting the significant economic implications of ANDA litigation in the pharmaceutical industry.

Veloxis Pharmaceuticals, Inc. v. Accord Healthcare, Inc. and Intas Pharmaceuticals Ltd. - Key Legal Developments

Case Caption: Veloxis Pharmaceuticals, Inc. v. Accord Healthcare, Inc. and Intas Pharmaceuticals Ltd.
Case number: 1:22-cv-00909
Court: District Court, Delaware
Status: Closed
Plaintiff(s): Veloxis Pharmaceuticals, Inc.
Defendants: Accord Healthcare, Inc. and Intas Pharmaceuticals Ltd.
Patents at issue: U.S. Patent Nos. 8,685,998; 9,549,918; 10,166,190; 10,864,199; 11,110,081; 11,123,331; and 11,419,823.

This Hatch-Waxman patent infringement case, filed by Veloxis Pharmaceuticals, Inc. against Accord Healthcare, Inc. and Intas Pharmaceuticals Ltd., concluded with a consent judgment and permanent injunction in favor of Veloxis. The dispute centered on Accord's Abbreviated New Drug Application (ANDA) No. 217255, seeking FDA approval to market a generic version of Veloxis's ENVARSUS XR® (tacrolimus) extended-release tablets.

Key Legal Developments and Outcome:

• Filing & Initial Pleadings:

  • Complaint Filed: Veloxis Pharmaceuticals, Inc. initiated the lawsuit on July 7, 2022, in the U.S. District Court for the District of Delaware. The complaint alleged infringement of seven U.S. patents: 8,685,998; 9,549,918; 10,166,190; 10,864,199; 11,110,081; 11,123,331; and 11,419,823.
  • Paragraph IV Notice & Answer: Prior to the complaint, Accord Healthcare, Inc. sent a Paragraph IV Certification notice letter to Veloxis dated May 23, 2022, regarding ANDA No. 217255. In response to the complaint, Accord and Intas Pharmaceuticals Ltd. denied the infringement allegations and likely filed counterclaims, though the exact date of their answer and counterclaims is not specified in the publicly available summaries.

• Pre-trial Motions of Substance: No publicly reported substantive pre-trial motions (such as motions to dismiss, transfer, or for summary judgment) reached a resolution in this case, likely due to the early settlement.

• Claim Construction (Markman) Outcomes: The case was resolved via a consent judgment on January 24, 2024. Therefore, no Markman hearing or claim construction order was issued in this specific litigation.

• Discovery Milestones: No specific discovery milestones with strategic significance were publicly reported before the case's resolution.

• Trial Events, Verdict, and Post-Trial Motions: The case did not proceed to trial, verdict, or post-trial motions, as it was resolved through a consent judgment.

• Settlement, Dismissal, Judgment, or Appeal – Final Disposition:

  • Consent Judgment: The case concluded on January 24, 2024, when the parties entered a stipulated consent judgment.
  • Terms: Under the terms of the consent judgment, Accord Healthcare and Intas Pharmaceuticals Ltd. are permanently enjoined from making, using, selling, offering to sell, importing, or distributing their generic tacrolimus ANDA product (ANDA No. 217255) until the expiration of all seven asserted Veloxis patents.
  • Dismissal: All claims and counterclaims were dismissed with prejudice, meaning neither party can revive these specific claims in a future action. Each party bore its own costs.
  • Impact: The consent judgment preserved Accord's Paragraph IV certification, allowing the FDA to approve ANDA No. 217255, but blocked commercialization until patent expiry.
  • Duration: The litigation lasted 566 days from its filing to the entry of the consent judgment.

• Parallel PTAB IPR/PGR Proceedings: The available information suggests that no Inter Partes Review (IPR) or Post-Grant Review (PGR) proceedings were filed by Accord Healthcare, Inc. or Intas Pharmaceuticals Ltd. against the asserted patents in relation to this specific litigation prior to its resolution. However, legal analysis from the time noted that companies in the tacrolimus generic space should monitor IPR filings against the patents as a "probable next move" in other contexts.

Veloxis Pharmaceuticals, Inc. was represented by attorneys from Morris, Nichols, Arsht & Tunnell LLP and Richards, Layton & Finger, P.A. in this case.

Here are the details of the counsel of record for Veloxis Pharmaceuticals, Inc.:

Attorneys from Morris, Nichols, Arsht & Tunnell LLP:

• Jack B. Blumenfeld

  • Role: Lead Counsel, Local Counsel.
  • Firm & Office Location: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE.
  • Relevant Experience: With 40 years of patent litigation experience, Jack Blumenfeld is highly regarded as a "dean of the Delaware IP bar." He has significant experience in pharmaceutical, medical product, and biotechnology matters, and has handled a unique mix of lead counsel, Delaware counsel, and co-counsel roles. He was recognized as the Delaware Litigator of the Year by Managing Intellectual Property in 2014 and has been selected as the sole Gold-ranked patent litigator in Delaware by Intellectual Asset Management (IAM) magazine. He has represented major companies like Pfizer, UCB, Comcast, Thermo Fisher, and Amgen in patent and trade secret cases.

• Jeremy D. Tigan

  • Role: Counsel.
  • Firm & Office Location: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE.
  • Relevant Experience: Jeremy Tigan is recognized as a Delaware "IP Star" for his work in intellectual property litigation. His specific role and experience in patent litigation are focused within the Morris Nichols Intellectual Property Litigation Group.

• Megan E. Dellinger

  • Role: Counsel.
  • Firm & Office Location: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE.
  • Relevant Experience: Megan Dellinger has experience in patent cases, as indicated by her appearance in other patent litigation filings.

Attorneys from Richards, Layton & Finger, P.A.:

• Mary B. Graham
  • Role: Local Counsel.
  • Firm & Office Location: Richards, Layton & Finger, P.A., Wilmington, DE.
  • Relevant Experience: While specific patent litigation experience for Mary B. Graham was not immediately detailed in the search results, Richards, Layton & Finger, P.A. is a prominent Delaware firm often serving as local counsel in patent cases.

Additional attorneys, Andrew M. Berdon, James E. Baker, and Anastasia M. Fernands, were also granted pro hac vice appearances on behalf of Veloxis Pharmaceuticals, Inc. on July 15, 2022. Krista M. Rycroft also had a motion for pro hac vice appearance filed on August 8, 2022, which was granted. Their specific firms and detailed experience were not immediately available in the provided search snippets, but pro hac vice admissions typically indicate their primary affiliation is with a firm outside of Delaware.

Defendants Accord Healthcare, Inc. and Intas Pharmaceuticals Ltd. were represented by Richards, Layton & Finger, P.A. as local counsel and likely by other firms as lead counsel, though the provided information from the consent judgment only explicitly lists the local counsel.

Here are the details for the attorneys of record representing Accord Healthcare, Inc. and Intas Pharmaceuticals Ltd.:

Richards, Layton & Finger, P.A.

• Firm Location: Wilmington, Delaware

• Relevant Experience: Richards, Layton & Finger is a prominent Delaware law firm with significant experience in intellectual property litigation, including Hatch-Waxman (ANDA) cases, often serving as local counsel.

  • Kelly E. Farnan
    • Role: Counsel / Local Counsel
    • Note: Ms. Farnan is a director at Richards, Layton & Finger and focuses her practice on a range of intellectual property matters, including patent litigation.
  • Sara M. Metzler
    • Role: Counsel / Local Counsel
    • Note: Ms. Metzler is an associate at Richards, Layton & Finger and works on intellectual property litigation, including pharmaceutical patent cases.

While the consent judgment only names Richards, Layton & Finger, P.A., Accord Healthcare frequently works with other firms for ANDA litigation. For example, Accord has been represented by McAndrews, Held & Malloy, Ltd. in other patent infringement cases, where the team included Alex Menchaca, Raj Chiplunkar, Ben Mahon, and Brad Loren. Additionally, Daignault Iyer LLP lists Accord Pharmaceuticals/Intas as representative clients for generic drug Hatch-Waxman litigation. Emily King serves as VP, General Counsel for Accord Healthcare and is responsible for managing litigation. However, based on the provided consent judgment, Richards, Layton & Finger were the attorneys of record explicitly listed for the defendants in this specific case.