Veloxis Pharmaceuticals, Inc. v. Accord Healthcare et al.

Veloxis Pharmaceuticals, Inc., a specialty pharmaceutical company committed to improving the lives of transplant patients, initiated this patent infringement lawsuit. Veloxis, a subsidiary of Asahi Kasei, develops and commercializes medications, with its flagship product being ENVARSUS XR® (tacrolimus extended-release tablets), an immunosuppressant used to prevent organ rejection in kidney transplant patients. The defendants, Accord Healthcare, Inc. and its parent company Intas Pharmaceuticals, Ltd., are generic drug manufacturers. Accord Healthcare operates as a large-scale provider of generic pharmaceuticals in the United States, while Intas is an Indian multinational pharmaceutical company focused on generic therapeutic drugs. The core of the dispute revolved around Accord's Abbreviated New Drug Application (ANDA) No. 217255, through which it sought FDA approval to market generic 0.75 mg, 1 mg, and 4 mg extended-release tacrolimus tablets, directly competing with Veloxis's branded ENVARSUS XR®.

Veloxis asserted seven U.S. patents: 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. These patents collectively cover the extended-release formulation of tacrolimus, its clinical use, formulation variants, dosing methods, and manufacturing processes as embodied in the ENVARSUS XR® product. The case was filed in the U.S. District Court for the District of Delaware (Case No. 1:22-cv-00909), a prominent venue for patent litigation, particularly Hatch-Waxman actions, known for its specialized docket and established jurisprudence in pharmaceutical disputes. The presiding judge was U.S. District Judge Joshua D. Wolson.

This litigation is notable as a standard Hatch-Waxman patent infringement action, triggered by Accord's Paragraph IV certification, which signaled their intent to launch a generic version of ENVARSUS XR® before the expiration of Veloxis's patents. The case concluded successfully for Veloxis with a stipulated consent judgment and permanent injunction entered on January 24, 2024, preventing Accord and Intas from commercializing their ANDA product until the expiration of all seven patents-in-suit. While the consent judgment preserved Accord's Paragraph IV certification and did not block FDA approval, it effectively enjoined commercialization. No specific, directly linked parallel PTAB IPRs were identified for this particular case in the search results.

Key Legal Developments and Outcome in Veloxis Pharmaceuticals, Inc. v. Accord Healthcare et al.

The patent infringement litigation, Veloxis Pharmaceuticals, Inc. v. Accord Healthcare et al., Case No. 1:22-cv-00909 in the District of Delaware, was initiated by Veloxis Pharmaceuticals, Inc. against Accord Healthcare and Intas concerning patent 10,864,199. The case concluded with a dismissal with prejudice via a consent judgment on January 24, 2024.

Chronological Legal Developments:

• Filing & Initial Pleadings (2022-07-07): Veloxis Pharmaceuticals, Inc. filed its complaint on July 7, 2022, asserting infringement of U.S. Patent No. 10,864,199. The complaint stemmed from Accord Healthcare's Paragraph IV certification for its Abbreviated New Drug Application (ANDA) No. 217255, seeking FDA approval to market a generic version of a product covered by the asserted patent before its expiration.

  • Answer & Counterclaims (2022-09-09): Defendants Accord Healthcare, Inc. and Intas Pharmaceuticals, Inc. filed their Answer and Counterclaims on September 9, 2022 (Docket Entry 11). In their answer, defendants admitted to sending a Paragraph IV Certification letter for ANDA No. 217255, which implicated the '199 patent, among others.

• Pre-Trial Motions of Substance:

  • Motion for Protective Order (2023-09-08): Defendants filed a motion for a protective order (ECF No. 91) which was denied by the court on September 8, 2023. The motion sought to avoid in-person depositions, but the court ruled that the discovery Veloxis sought was not unreasonable or disproportionate, and the defendants, operating in an industry prone to litigation in the U.S., should expect to participate in such discovery. The order mandated that defendants make noticed witnesses available for in-person depositions, citing technological challenges with remote depositions as a justification for the in-person requirement.

• Claim Construction (Markman): There is no indication from available public records that the case reached the claim construction (Markman) stage before its dismissal.

• Discovery Milestones: The denial of the Defendants' Motion for a Protective Order on September 8, 2023, was a significant discovery milestone, compelling in-person depositions and indicating active discovery efforts by the plaintiff.

• Trial Events, Verdict, and Post-Trial Motions: The case was dismissed prior to reaching trial, and therefore, no trial events, verdict, or post-trial motions occurred.

• Final Disposition – Dismissal with Prejudice (2024-01-24): The case was terminated on January 24, 2024, when the parties filed a consent judgment. This judgment resulted in the dismissal of the case with prejudice and enjoined Accord and Intas from infringing the patents-in-suit until their expiration.

• Parallel PTAB IPR/PGR Proceedings: A search of the USPTO Patent Trial and Appeal Board (PTAB) database for U.S. Patent No. 10,864,199 reveals no instituted or concluded IPR or PGR proceedings related to this patent. There was no direct impact from PTAB proceedings on the litigation.## Key Legal Developments and Outcome in Veloxis Pharmaceuticals, Inc. v. Accord Healthcare et al.

The patent infringement litigation, Veloxis Pharmaceuticals, Inc. v. Accord Healthcare et al., Case No. 1:22-cv-00909 in the District of Delaware, was initiated by Veloxis Pharmaceuticals, Inc. against Accord Healthcare and Intas concerning patent 10,864,199. The case concluded with a dismissal with prejudice via a consent judgment on January 24, 2024.

Chronological Legal Developments:

• Filing & Initial Pleadings (2022-07-07): Veloxis Pharmaceuticals, Inc. filed its complaint on July 7, 2022, asserting infringement of U.S. Patent No. 10,864,199. The complaint stemmed from Accord Healthcare's Paragraph IV certification for its Abbreviated New Drug Application (ANDA) No. 217255, seeking FDA approval to market a generic version of a product covered by the asserted patent before its expiration.

  • Answer & Counterclaims (2022-09-09): Defendants Accord Healthcare, Inc. and Intas Pharmaceuticals, Inc. filed their Answer and Counterclaims on September 9, 2022 (Docket Entry 11). In their answer, defendants admitted to sending a Paragraph IV Certification letter for ANDA No. 217255, which implicated the '199 patent, among others.

• Pre-Trial Motions of Substance:

  • Motion for Protective Order (2023-09-08): Defendants filed a motion for a protective order (ECF No. 91) which was denied by the court on September 8, 2023. The motion sought to avoid in-person depositions, but the court ruled that the discovery Veloxis sought was not unreasonable or disproportionate, and the defendants, operating in an industry prone to litigation in the U.S., should expect to participate in such discovery. The order mandated that defendants make noticed witnesses available for in-person depositions, citing technological challenges with remote depositions as a justification for the in-person requirement.

• Claim Construction (Markman): There is no indication from available public records that the case reached the claim construction (Markman) stage before its dismissal.

• Discovery Milestones: The denial of the Defendants' Motion for a Protective Order on September 8, 2023, was a significant discovery milestone, compelling in-person depositions and indicating active discovery efforts by the plaintiff.

• Trial Events, Verdict, and Post-Trial Motions: The case was dismissed prior to reaching trial, and therefore, no trial events, verdict, or post-trial motions occurred.

• Final Disposition – Dismissal with Prejudice (2024-01-24): The case was terminated on January 24, 2024, when the parties filed a consent judgment. This judgment resulted in the dismissal of the case with prejudice and enjoined Accord and Intas from infringing the patents-in-suit until their expiration.

• Parallel PTAB IPR/PGR Proceedings: A search of the USPTO Patent Trial and Appeal Board (PTAB) database for U.S. Patent No. 10,864,199 reveals no instituted or concluded IPR or PGR proceedings related to this patent. There was no direct impact from PTAB proceedings on the litigation.

The plaintiff, Veloxis Pharmaceuticals, Inc., was represented by attorneys from Morris, Nichols, Arsht & Tunnell LLP.

The counsel of record for Veloxis Pharmaceuticals, Inc. were:

• Jack B. Blumenfeld

  • Role: Likely lead or local counsel. In Delaware District Court cases, attorneys from Morris, Nichols, Arsht & Tunnell LLP frequently serve as local counsel given their prominence in the state.
  • Firm and office location: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE.
  • Relevant experience: Jack Blumenfeld is a well-known patent litigator, particularly in Hatch-Waxman cases, with extensive experience in the District of Delaware. He is consistently recognized for his work in intellectual property law.

• Jeremy A. Tigan

  • Role: Likely lead or local counsel.
  • Firm and office location: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE.
  • Relevant experience: Jeremy Tigan is also an experienced patent litigator with Morris, Nichols, Arsht & Tunnell LLP, often appearing in Hatch-Waxman and other intellectual property disputes in the District of Delaware. He is also listed as counsel for Veloxis in other related cases.

Counsel of Record for Defendants Accord Healthcare and Intas in Veloxis Pharmaceuticals, Inc. v. Accord Healthcare et al.

In Veloxis Pharmaceuticals, Inc. v. Accord Healthcare et al., Case No. 1:22-cv-00909, the defendants, Accord Healthcare, Inc. and Intas Pharmaceuticals Ltd., were represented by attorneys from McAndrews, Held & Malloy, Ltd., serving as "Of Counsel," and local counsel from a Delaware firm.

Here is a breakdown of the identified counsel:

From McAndrews, Held & Malloy, Ltd. (Chicago, IL office):

• Alejandro "Alex" Menchaca - Of Counsel
  • Firm: McAndrews, Held & Malloy, Ltd. (Chicago, IL)
  • Experience: Shareholder with extensive experience in patent, trademark, and related law, focusing on ANDA litigation and counseling. He has presented on "Skinny Labeling and Induced Infringement" and "Overcoming Obviousness in the Hatch Waxman Space." He was recognized by Best Lawyers in America for Litigation - Intellectual Property, Litigation - Patent, and Patent Law.
• Ben J. Mahon - Of Counsel
  • Firm: McAndrews, Held & Malloy, Ltd. (Chicago, IL)
  • Experience: Partner focusing on patent litigation, particularly in biological, chemical, and pharmaceutical arts, with significant experience in district court litigation, inter partes review (IPR) proceedings, and Federal Circuit appeals. He has led trial teams to judgments of invalidity for patents covering abuse-proof formulations.
• Aaron F. Barkoff - Of Counsel
  • Firm: McAndrews, Held & Malloy, Ltd. (Chicago, IL)
  • Experience: Patent litigator specializing in pharmaceutical and biotechnology patent law with impressive trial experience in Hatch-Waxman litigation, representing both large pharmaceutical and generic drug companies. He has a strong technical background in biochemistry and deep understanding of FDA regulatory issues.

Local Counsel:

• Kelly E. Farnan - Local Counsel
  • Firm: (Specific Delaware firm not explicitly stated in the provided snippets for this case, but her listing on a docket entry for a Delaware District Court case indicates her role as local counsel.)
  • Experience: Kelly Farnan is an attorney admitted to practice in the District of Delaware (Bar #4395). Her role as local counsel in this significant Hatch-Waxman case suggests experience in Delaware federal court proceedings, particularly in patent litigation.

While other attorneys from McAndrews, Held & Malloy, Ltd. such as Rajendra A. Chiplunkar and Bradley P. Loren, are known to represent Accord Healthcare in other Hatch-Waxman cases in the District of Delaware, the specific docket entry (Document 11) for Veloxis Pharmaceuticals, Inc. v. Accord Healthcare et al., Case No. 1:22-cv-00909 lists Aaron F. Barkoff, Alejandro Menchaca, and Ben J. Mahon as "Of Counsel" from McAndrews. There is no explicit mention of Daignault Iyer LLP or Ronald M. Daignault as counsel of record in the provided direct docket information for this specific case, though Daignault Iyer LLP does represent Accord/Intas in generic drug Hatch-Waxman litigation generally.