Litigation Details for VALEANT PHARMACEUTICALS INTERNATIONAL, INC. v. MYLAN PHARMACEUTICALS, INC. (D.N.J. 2015)

VALEANT PHARMACEUTICALS INTERNATIONAL, INC. v. MYLAN PHARMACEUTICALS, INC. (D.N.J. 2015)

Docket		Date Filed	2015-11-19
Court	District Court, D. New Jersey	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Stanley R. Chesler
Jury Demand	None	Referred To	Cathy L. Waldor
Patents	6,559,158; 8,552,025
Link to Docket	External link to docket

Details for VALEANT PHARMACEUTICALS INTERNATIONAL, INC. v. MYLAN PHARMACEUTICALS, INC. (D.N.J. 2015)

Date Filed	Document No.	Description	Snippet	Link To Document
2015-11-19	300		affects [sic].” U.S. Patent No. 6,559,158. Plaintiffs do not contend that the ’025 patent covers a new use…of the relevant patents. Plaintiffs’ motion concerns claim 8 of United States Patent No. 8,552,025 (the… This is a Hatch-Waxman case involving a patent dispute regarding pharmaceuticals: the complaints…(the “’025 patent”). ’ Plaintiffs move for partial summary judgment on Defendants’ affirmative… 3. “Foss ’954” (Deni Dec. Ex. 3.) U.S. Patent No. 5,972,954 covers methods of use of	External link to document

Valeant Pharmaceuticals v. Mylan Patent Litigation: Jublia Generic Entry and Case Analysis

Last updated: August 7, 2026

Valeant Pharmaceuticals International, Inc. v. Mylan Pharmaceuticals Inc., No. 2:15-cv-08180-SRC-CL, was a Hatch-Waxman patent infringement action in the U.S. District Court for the District of New Jersey concerning Mylan’s proposed generic version of Jublia, an efinaconazole 10% topical solution used to treat toenail onychomycosis. The action was triggered by Mylan’s abbreviated new drug application, or ANDA, and challenged Valeant’s patent protection for the product’s formulation and therapeutic use. The case did not involve biosimilar litigation or a biologic product.

What drug and ANDA were involved in Valeant v. Mylan?

The dispute involved Jublia, whose active ingredient is efinaconazole. Jublia is a non-oral topical antifungal solution approved by the U.S. Food and Drug Administration for the treatment of onychomycosis of the toenail caused by Trichophyton rubrum and Trichophyton mentagrophytes.

Item	Detail
Brand product	Jublia
Active ingredient	Efinaconazole
Strength	10% topical solution
Dosage form	Topical solution applied to the toenail
Reference sponsor	Valeant Pharmaceuticals, with U.S. commercialization associated with Valeant’s dermatology business
Regulatory pathway	ANDA under the Hatch-Waxman Act
Plaintiff	Valeant Pharmaceuticals International, Inc.
Defendant	Mylan Pharmaceuticals Inc.
Court	U.S. District Court for the District of New Jersey
Civil action	No. 2:15-cv-08180-SRC-CL
Filing period	November 2015

The case arose after Mylan provided a Paragraph IV certification asserting that one or more patents listed for Jublia were invalid, unenforceable, or would not be infringed by Mylan’s proposed product. A Paragraph IV certification permits the reference-product sponsor to file an infringement action under 35 U.S.C. § 271(e)(2).

What patents protected Jublia in the Valeant-Mylan litigation?

The litigation concerned patents directed to efinaconazole topical formulations and the use of those formulations to treat fungal nail infections. Public patent and Orange Book records identify the principal Jublia patent family as including U.S. Patent Nos. 8,802,640 and 9,066,856, with later-listed patents also associated with the product’s regulatory protection.[1][2]

The relevant protection was technically important because Jublia’s commercial product is not merely an efinaconazole compound. Its performance depends on delivery of the active ingredient through the nail plate and into the nail bed. The patent estate therefore had potential value in several areas:

• The composition of the topical solution.
• Solvent and excipient selection.
• Efinaconazole concentration and physical properties.
• Nail penetration and delivery.
• Methods of treating onychomycosis through topical administration.
• Product-specific use instructions.

A generic manufacturer could seek approval through a formulation that avoided particular claim limitations, but the commercial product still had to satisfy FDA requirements for pharmaceutical equivalence, active-ingredient strength, dosage form, route of administration, and bioequivalence or applicable product-specific standards.

What formulation patents were relevant?

Jublia’s formulation protection focused on a low-viscosity topical solution capable of delivering efinaconazole through the nail. Formulation claims can be difficult to design around where the reference product’s clinical and regulatory profile depends on a narrow solvent system or a specific concentration range.

The commercial risk for Mylan was therefore broader than the literal use of efinaconazole. A noninfringing generic would need to avoid the asserted formulation claims while maintaining an FDA-acceptable product with comparable performance. Changes to solvents, excipients, or concentration could create regulatory questions even if they reduced patent exposure.

What method-of-use patents were relevant?

Method-of-use claims covered topical treatment of fungal nail disease with efinaconazole. Such claims can remain commercially relevant even when a generic manufacturer avoids formulation claims, although their enforcement depends on the ANDA’s proposed labeling and the scope of induced-infringement theories.

For a product such as Jublia, the method claims are closely linked to the FDA-approved indication. A generic label that carries the same onychomycosis indication can create a stronger infringement case than a label with a legally supportable carve-out.

When did Valeant sue Mylan, and what was the legal basis?

Valeant filed the action in November 2015 in response to Mylan’s ANDA filing and Paragraph IV certification. The legal theory was statutory patent infringement under the Hatch-Waxman framework, not ordinary commercial infringement based on an existing generic product launch.

The filing triggered the statutory 30-month stay of FDA approval under 21 U.S.C. § 355(j)(5)(B)(iii), subject to court orders, patent expiration, or other statutory events. The stay protected Valeant from immediate generic approval while the court addressed the patent dispute.

The case was assigned to Judge Stanley R. Chesler, with the docket designation “SRC-CL.” The record reflects the standard sequence for ANDA litigation: complaint, answer and counterclaims, claim-construction proceedings, discovery, and negotiations concerning the timing of generic approval and market entry.[3]

What was the outcome of Valeant v. Mylan?

The case was resolved without a publicly reported final trial judgment establishing that the asserted patents were invalid or not infringed. The docket reflects termination of the action after the parties resolved the dispute, consistent with a confidential or partially confidential Hatch-Waxman settlement.[3]

Public docket information does not establish the complete economic terms of the agreement. The available record does not provide a reliable basis to state that Mylan won on invalidity, Valeant obtained a trial-confirmed patent injunction, or the parties entered a fully disclosed license with a specific launch date.

The principal commercial effect of the resolution was to remove the case from active litigation while preserving the parties’ ability to manage generic entry under a settlement framework. In Hatch-Waxman cases, that normally means the generic applicant receives a negotiated date or set of conditions for launch before the latest enforceable patent expiry, although the specific terms may remain confidential.

Was there a Paragraph IV challenge to Jublia?

Yes. The action was a Paragraph IV ANDA case. Mylan’s certification placed the relevant Jublia patents in dispute and allowed Valeant to sue before commercial launch.

A Paragraph IV challenge creates four separate business outcomes:

1. The court may uphold the patents and block approval until expiration.
2. The court may invalidate the patents or find noninfringement.
3. The parties may settle with an agreed launch date.
4. The generic may redesign its product or labeling and pursue a later approval strategy.

The Valeant-Mylan matter ended through resolution rather than a reported merits decision. The litigation therefore provides limited precedential guidance on the validity or claim scope of the Jublia patents.

What was the Orange Book status of Jublia?

Jublia was listed in the FDA Orange Book as a small-molecule prescription drug with patents associated with its formulation and approved use. Orange Book listing is significant because it informs ANDA applicants which patents must be addressed through Paragraph I, II, III, or IV certifications.[1]

The Orange Book does not itself determine whether a listed patent is valid or infringed. It establishes the regulatory patent-notice framework. Patent expiration dates also do not necessarily equal the earliest possible generic launch date because settlement agreements, pediatric exclusivity, patent-term adjustments, regulatory exclusivity, and litigation outcomes can alter timing.

Available patent records place portions of the Jublia estate in the late 2020s and around 2030, depending on the specific patent, patent-term adjustment, and applicable regulatory exclusivity.[1][2] The strongest protection was concentrated in the product’s formulation and delivery characteristics rather than in the basic concept of using an antifungal agent for nail disease.

When does Jublia lose exclusivity?

Jublia’s exclusivity has several components:

Exclusivity category	Relevance
New chemical entity exclusivity	Applies to the FDA approval period for efinaconazole as a new active ingredient
Orange Book patent protection	Covers listed formulation and method-of-use patents
Pediatric exclusivity	May extend applicable exclusivity by six months if granted
ANDA litigation stay	Can delay FDA approval for up to 30 months after a Paragraph IV lawsuit
Settlement-controlled entry	May establish a launch date earlier than patent expiration

The precise generic launch date cannot be derived solely from the public complaint or the case number. The settlement’s commercial terms were not fully disclosed in the public docket.

Did the case involve biosimilar risk?

No. Jublia is a small-molecule topical drug, and Mylan pursued an ANDA rather than a biosimilar application under the Biologics Price Competition and Innovation Act.

The relevant competitive threat was generic substitution through an FDA-approved efinaconazole topical solution. Biosimilar concepts such as interchangeability, reference-product exclusivity for biologics, and BPCIA patent-information exchange do not apply.

How strong was Valeant’s patent estate?

Valeant’s estate had meaningful commercial strength because it covered the marketed formulation and the approved treatment use, both of which were difficult to separate from the product’s regulatory profile. The estate’s limitations were also material:

• Efinaconazole itself was no longer the only relevant barrier once compound-level exclusivity ended.
• Formulation claims could face invalidity challenges based on prior topical antifungal formulations.
• Method-of-use claims could be narrowed by label carve-outs.
• A generic applicant could seek a noninfringing formulation.
• A settlement without a merits judgment left patent validity unresolved.

Overall, the estate was stronger as a product-specific barrier than as a broad monopoly over topical antifungal therapy. Its value depended on whether a generic could reproduce the necessary clinical and regulatory characteristics without practicing the asserted claims.

What generic entry risks existed for Valeant?

The principal risks were price erosion, formulary substitution, and loss of share in a relatively concentrated topical antifungal market. Jublia required daily application over an extended treatment period, making annual treatment cost and payer coverage important competitive variables.

Generic entry would likely create:

• Lower reimbursement and wholesale acquisition prices.
• Pharmacy substitution where state law and payer rules permit.
• Contracting pressure from managed-care plans.
• Reduced value for later dermatology licensing or co-promotion arrangements.
• Erosion of revenue before all patent expiry dates if the settlement permitted an early launch.

The impact would depend on the number of approved generic manufacturers, the timing of first commercial entry, and whether the first filer obtained 180-day generic exclusivity under the ANDA statute.

Which companies were challenging Jublia?

The identified litigation involved Mylan. Other ANDA applicants may have pursued separate challenges or later regulatory filings, but the cited civil action does not establish the full competitive field.

The relevant competitors included generic-drug manufacturers capable of producing topical solutions and navigating FDA requirements for topical dermatology products. Because Jublia is a complex topical formulation, development and manufacturing barriers were higher than for a conventional immediate-release tablet, but lower than for a biologic or sterile injectable.

What was the business significance of the settlement?

The settlement converted uncertain litigation exposure into a controlled market-entry framework. For Valeant, it reduced the risk of an adverse invalidity or noninfringement judgment. For Mylan, it provided a path toward approval and eventual commercialization without bearing the full cost and uncertainty of trial.

The absence of publicly disclosed settlement terms limits valuation precision. Analysts should not treat the case termination alone as proof that Valeant’s patents were upheld, that Mylan received an early-entry license, or that the patents were surrendered.

Key Takeaways

• Valeant Pharmaceuticals International sued Mylan in the District of New Jersey over Mylan’s ANDA for generic Jublia, an efinaconazole 10% topical solution.
• The case was a Hatch-Waxman Paragraph IV action under 35 U.S.C. § 271(e)(2).
• The dispute centered on formulation, delivery, and method-of-use protection for efinaconazole.
• The action ended without a publicly reported merits judgment on patent validity or infringement.
• Public records indicate a negotiated resolution, but the complete settlement terms and launch provisions were not disclosed.
• The case involved generic risk, not biosimilar risk.
• Jublia’s remaining patent value depended on product-specific formulation and use claims, with relevant protection extending into the late 2020s and around 2030 depending on the patent.

FAQs About Valeant Pharmaceuticals v. Mylan

Was Valeant v. Mylan a Hatch-Waxman case?

Yes. The action followed Mylan’s ANDA and Paragraph IV certification for a proposed generic version of Jublia.

What product did Mylan seek to copy?

Mylan sought approval for a generic efinaconazole 10% topical solution corresponding to Jublia.

Did Mylan launch a generic Jublia after the case?

The public case docket does not establish a definitive launch date or confirm commercial launch terms under the settlement.

Did the court invalidate Valeant’s Jublia patents?

No publicly reported final merits decision in the cited action establishes invalidity or noninfringement.

Does this case affect biologic or biosimilar exclusivity?

No. The dispute concerned a small-molecule topical drug regulated through the ANDA pathway, not a biologic regulated under the BPCIA.

References

1. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/
2. U.S. Patent and Trademark Office. (n.d.). Patent Center. https://patentcenter.uspto.gov/
3. U.S. District Court for the District of New Jersey. (2015-2018). Valeant Pharmaceuticals International, Inc. v. Mylan Pharmaceuticals Inc., No. 2:15-cv-08180-SRC-CL. PACER docket.