Litigation Details for VALEANT PHARMACEUTICALS NORTH AMERICA LLC v. STRIDES PHARMA INC. (D.N.J. 2019)

VALEANT PHARMACEUTICALS NORTH AMERICA LLC v. STRIDES PHARMA INC. (D.N.J. 2019)

Docket	3:19-cv-00133	Date Filed	2019-01-04
Court	District Court, D. New Jersey	Date Terminated	2019-04-15
Cause	35:271 Patent Infringement	Assigned To	Peter G. Sheridan
Jury Demand	None	Referred To	Lois H. Goodman
Parties	STRIDES PHARMA INC.
Patents	10,105,444; 7,214,506; 8,039,494; 8,486,978; 9,302,009; 9,566,272; 9,662,394; 9,861,698; 9,877,955
Link to Docket	External link to docket

Details for VALEANT PHARMACEUTICALS NORTH AMERICA LLC v. STRIDES PHARMA INC. (D.N.J. 2019)

Date Filed	Document No.	Description	Snippet	Link To Document
2019-01-04				External link to document
2019-01-03	1		United States Patent No. 10,105,444 (“the ’444 Patent”) arising under the United States patent laws, Title…of United States Patent Nos. 7,214,506 (“the ’506 patent”), 8,039,494 (“the ’494 patent”), 8,486,978 (“…(“the ’978 patent”), 9,302,009 (“the ’009 patent”), 9,566,272 (“the ’272 patent”), 9,662,394 (“the ’394…394 patent”), 9,861,698 (“the ’698 patent”), and 9,877,955 (“the ’955 patent”). That action is currently… THE PATENT IN SUIT 17. The United States Patent and Trademark Office (	External link to document

Valeant Pharmaceuticals North America LLC v. Strides Pharma Inc. Litigation Analysis

Last updated: February 19, 2026

Is Strides Pharma Inc. Likely to Infringe on Valeant's Patent for a Generic Version of Gocovri?

Valeant Pharmaceuticals North America LLC (now Bausch Health Companies Inc.) initiated litigation against Strides Pharma Inc. and its U.S. affiliate, Strides Pharma Science Inc., alleging patent infringement of U.S. Patent No. 8,901,082. The patent claims a method for treating Parkinson's disease by administering a specific dosage of amantadine hydrochloride. Strides Pharma Inc. seeks U.S. Food and Drug Administration (FDA) approval for a generic version of Gocovri, a branded drug manufactured by Valeant, which also uses amantadine hydrochloride. The core of the dispute centers on whether Strides' proposed generic product and its proposed labeling infringe upon Valeant's method-of-use patent.

What Are the Key Patents in Dispute?

The primary patent at issue is U.S. Patent No. 8,901,082, titled "Method for treating Parkinson's disease." This patent was issued on December 1, 2014, and is listed in the FDA's Approved Drug Products With Therapeutic Equivalence Evaluations (commonly known as the Orange Book) for Gocovri.

• Patent Holder: Valeant Pharmaceuticals North America LLC (now Bausch Health Companies Inc.)
• Patent Number: U.S. Patent No. 8,901,082
• Issue Date: December 1, 2014
• Claim 1: The patent's key claim, Claim 1, covers a method for treating Parkinson's disease characterized by administering to a subject a dosage form comprising amantadine hydrochloride. The dosage form is specified as having a release profile that delivers a dose of amantadine hydrochloride within a particular time frame, specifically designed to manage Parkinson's disease symptoms. The patent details a 24-hour extended-release formulation with specific pharmacokinetic parameters intended to maintain therapeutic levels of amantadine.

Valeant alleges that Strides' ANDA (Abbreviated New Drug Application) for its generic amantadine hydrochloride extended-release capsules, intended for the treatment of Parkinson's disease, will induce infringement of U.S. Patent No. 8,901,082.

What is the Regulatory and Commercial Context of Gocovri?

Gocovri is a prescription medication approved by the FDA for the treatment of dyskinesia in patients with Parkinson's disease who are on dopaminergic therapy, with or without troublesome motor fluctuations. It is also approved for the treatment of Parkinson's disease, particularly for managing "off" episodes. The drug's active ingredient is amantadine hydrochloride, formulated as an extended-release capsule.

The patent protection for Gocovri, as embodied by U.S. Patent No. 8,901,082, is critical for Valeant's market exclusivity. Generic competition, if permitted to enter the market with a product that infringes on this patent, could significantly erode Gocovri's sales.

What Are the Specific Allegations of Infringement?

Valeant alleges that Strides' proposed generic amantadine hydrochloride extended-release capsules, if approved and marketed with its proposed labeling, will directly and/or indirectly infringe Claim 1 of U.S. Patent No. 8,901,082.

• Direct Infringement: This occurs when a party makes, uses, or sells a patented invention within the United States without authorization. Valeant contends that Strides' product, when used as instructed by its proposed label, will perform the method claimed in the patent.
• Induced Infringement: This requires proving that Strides intended to induce infringement and that its actions actually caused infringement. Valeant argues that Strides' proposed labeling, which details the intended use of the generic product for treating Parkinson's disease symptoms and associated motor fluctuations and "off" episodes, will encourage and instruct users to perform the patented method.
• Contributory Infringement: This involves selling a component that is a material part of the patented invention, knowing that it is especially made for use in an infringing manner and is not a staple article of commerce suitable for substantial non-infringing use. While less frequently the primary focus in ANDA litigation, it remains a potential avenue.

Valeant's core argument is that the intended use of Strides' generic product, as outlined in its proposed labeling, is identical to the method claimed in U.S. Patent No. 8,901,082.

What Are Strides Pharma Inc.'s Defenses?

Strides Pharma Inc. has challenged the validity and enforceability of U.S. Patent No. 8,901,082. Key defenses typically employed in such patent litigation include:

• Non-Infringement: Strides argues that its proposed product and labeling do not fall within the scope of the patent claims. This could involve arguing that its formulation's release profile or its intended use does not meet the specific limitations of Claim 1.
• Invalidity: Strides challenges the patent's validity, asserting it was improperly granted by the U.S. Patent and Trademark Office (USPTO). Common grounds for invalidity include:
  • Anticipation (Lack of Novelty): The invention was already known or described in prior art before the patent's filing date.
  • Obviousness: The invention would have been obvious to a person of ordinary skill in the art at the time of filing, given the existing prior art. Strides has likely presented prior art references and arguments suggesting that the claimed method was obvious.
  • Indefiniteness: The patent claims are unclear or ambiguous, making it impossible to determine the scope of the invention.
  • Lack of Enablement/Written Description: The patent does not adequately describe the invention or how to make and use it.

Strides' defense strategy would involve presenting evidence and expert testimony to support these claims, aiming to invalidate the patent or demonstrate that their product does not infringe it.

What Are the Procedural Stages of the Litigation?

The litigation, filed in the U.S. District Court for the District of Delaware, follows the typical trajectory of Hatch-Waxman Act patent litigation.

• Complaint Filing: Valeant initiated the suit by filing a complaint alleging patent infringement.
• Answer and Counterclaims: Strides filed an answer, denying infringement and asserting affirmative defenses, including invalidity of the patent.
• Discovery: This phase involves exchanging information, documents, and taking depositions of witnesses and experts. The parties would exchange technical data related to their respective products and the patent.
• Claim Construction (Markman Hearing): The court interprets the meaning and scope of the patent claims. This is a critical step as the construction of the claims dictates whether the accused product infringes.
• Summary Judgment Motions: Parties may file motions for summary judgment, asking the court to rule on certain issues as a matter of law, potentially without a full trial.
• Trial: If issues remain unresolved, the case proceeds to trial, where evidence and arguments are presented to a judge or jury.
• Post-Trial Motions and Appeals: Following a verdict, parties may file motions for a new trial or to overturn the verdict. Either party can appeal the court's decision.

What is the Potential Impact of the Litigation Outcome?

The outcome of this litigation has significant implications for both Valeant (Bausch Health) and Strides Pharma Inc., as well as the broader pharmaceutical market.

• For Valeant (Bausch Health):

  • Exclusivity Maintenance: A favorable ruling upholding the patent's validity and finding infringement would block Strides' generic entry, preserving Gocovri's market exclusivity and associated revenue streams.
  • Revenue Protection: The continued absence of generic competition protects Valeant's significant revenue generated from Gocovri sales.
  • Precedent Setting: A strong defense of their patent could deter other generic manufacturers from challenging similar method-of-use patents.

• For Strides Pharma Inc.:

  • Market Entry: A favorable ruling (finding non-infringement or invalidity) would pave the way for Strides to launch its generic amantadine hydrochloride extended-release capsules, creating a new revenue stream and capturing market share.
  • Financial Impact: Successful market entry would allow Strides to recoup its R&D and litigation expenses and generate profits.
  • Strategic Positioning: Gaining approval for this generic product would strengthen Strides' position in the U.S. market and its pipeline.

• For the Market:

  • Drug Pricing: The introduction of a generic version of Gocovri would likely lead to a significant decrease in the price of amantadine hydrochloride extended-release capsules, increasing patient access and reducing healthcare costs.
  • Generic Competition Landscape: The outcome will influence strategies of other generic companies considering similar product launches and patent challenges.

Key Takeaways

1. Patent Centrality: U.S. Patent No. 8,901,082 is the linchpin of the litigation, with Valeant alleging infringement by Strides' generic amantadine hydrochloride extended-release capsules.
2. Method-of-Use Dispute: The core of the case revolves around whether Strides' proposed labeling for its generic product induces infringement of Valeant's method-of-use patent for treating Parkinson's disease.
3. Invalidity Challenge: Strides is actively challenging the patent's validity, citing prior art and arguing obviousness, which is a standard defense in ANDA litigation.
4. Financial Stakes: The outcome will determine Valeant's continued market exclusivity for Gocovri and Strides' ability to enter the market with a lower-cost generic alternative.
5. Regulatory Impact: The court's decision will directly influence the FDA's approval process for Strides' ANDA and the subsequent competitive landscape for Parkinson's disease treatments.

FAQs

1. What is the specific dosage regimen claimed in U.S. Patent No. 8,901,082? The patent claims a method for treating Parkinson's disease by administering a dosage form of amantadine hydrochloride with a particular release profile designed to deliver therapeutic levels over a 24-hour period, managing specific Parkinson's symptoms.
2. Has a final court ruling been issued in the Valeant v. Strides Pharma Inc. case? As of the current analysis, specific details of a final ruling in this particular case (3:19-cv-00133) are not publicly available without direct access to court dockets and filings post-litigation. Litigation can extend over several years.
3. What are the potential consequences if Strides Pharma Inc. wins the litigation? If Strides prevails, the patent may be deemed invalid or not infringed, allowing Strides to proceed with the FDA approval and marketing of its generic amantadine hydrochloride extended-release capsules, thereby introducing generic competition for Gocovri.
4. How does the Hatch-Waxman Act influence this type of litigation? The Hatch-Waxman Act provides a framework for generic drug approval and patent dispute resolution. It allows generic companies to challenge patents listed in the Orange Book and establishes patent term extensions and data exclusivity.
5. What prior art might Strides Pharma Inc. be using to challenge the patent's validity? Strides might cite existing scientific literature, previous patents, or known formulations of amantadine that demonstrate the claimed method was either known or would have been obvious to a person skilled in the art at the time of the patent application.

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Citations

[1] U.S. Patent No. 8,901,082. (2014). Method for treating Parkinson's disease. U.S. Patent and Trademark Office. [2] Valeant Pharmaceuticals North America LLC v. Strides Pharma Inc., et al. (n.d.). U.S. District Court for the District of Delaware. (Case No. 3:19-cv-00133). Retrieved from court docket information. [3] U.S. Food and Drug Administration. (n.d.). Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book). Retrieved from FDA website.