Last updated: February 19, 2026
This report analyzes the patent litigation between LEO Pharma A/S and Actavis Laboratories UT, Inc. in the U.S. District Court for the District of Delaware, case number 1:16-cv-00333. The dispute centers on LEO Pharma's U.S. Patent No. 7,662,847 (the '847 patent), which claims a combination therapy for treating psoriasis. Actavis sought to market a generic version of LEO Pharma's drug Enstilar.
What is the Core Patent Dispute?
The litigation involves LEO Pharma's '847 patent, titled "Pharmaceutical Composition and Method for Treating Psoriasis." This patent claims a specific foam composition containing calcipotriol and betamethasone dipropionate. Actavis, as a defendant, challenged the validity and enforceability of this patent in anticipation of launching its generic psoriatic foam product.
The '847 patent was issued on February 16, 2010. It claims methods of treating psoriasis and pharmaceutical compositions for such treatment. Specifically, it claims a foam composition comprising calcipotriol hydrate, betamethasone dipropionate, and an aerosol propellant system. The patent describes the advantages of this foam formulation, including improved patient compliance and efficacy compared to existing topical treatments [1].
Actavis's primary defense strategy focused on invalidating the '847 patent. This typically involves arguing that the patent claims are not novel, are obvious in light of prior art, or that the patent holder did not meet the enablement or written description requirements of patent law.
What are the Key Patents Involved?
The central patent in this litigation is LEO Pharma's U.S. Patent No. 7,662,847. This patent is listed in the U.S. Food and Drug Administration's (FDA) Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the Orange Book, for LEO Pharma's branded product, Enstilar [2].
- U.S. Patent No. 7,662,847:
- Title: Pharmaceutical Composition and Method for Treating Psoriasis
- Assignee: LEO Pharma A/S
- Issue Date: February 16, 2010
- Claims Relevant to Litigation: Claims directed to the foam composition and methods of using the composition for treating psoriasis.
This patent claims, among other things, a foam composition containing:
- Calcipotriol hydrate
- Betamethasone dipropionate
- An aerosol propellant system
The patent's enablement and written description assertions are crucial, as they pertain to whether the patent adequately describes the invention and enables a person skilled in the art to make and use it.
What Were the Allegations of Infringement?
LEO Pharma alleged that Actavis's proposed generic product would infringe the '847 patent. Specifically, LEO Pharma contended that Actavis's generic psoriatic foam formulation contained the same active pharmaceutical ingredients and was intended for the same therapeutic uses as described and claimed in the '847 patent.
The infringement allegations would typically involve comparing the composition and intended use of Actavis's proposed generic product against the claims of the '847 patent. If Actavis's product falls within the scope of any valid and enforceable claim of the '847 patent, then infringement would be found.
What Were the Grounds for Actavis's Defense?
Actavis's defense relied on challenging the validity of the '847 patent. Common invalidity defenses in Hatch-Waxman litigation include:
- Anticipation (Lack of Novelty): Arguing that the claimed invention was already known or described in the prior art before the patent's filing date.
- Obviousness: Arguing that the claimed invention would have been obvious to a person of ordinary skill in the art at the time of the invention, given the existing prior art.
- Lack of Enablement: Arguing that the patent specification does not describe the invention in sufficient detail to allow a person skilled in the art to make and use it without undue experimentation.
- Lack of Written Description: Arguing that the patent specification does not demonstrate that the inventor was in possession of the claimed invention at the time of filing.
- Inequitable Conduct: Alleging that LEO Pharma misled or failed to disclose material information to the U.S. Patent and Trademark Office (USPTO) during prosecution.
Actavis likely presented prior art references, such as scientific publications and earlier patents, to support its claims of anticipation and obviousness. They also would have argued that the '847 patent's disclosure was insufficient to enable the claimed foam formulation or lacked adequate written description.
What Were the Key Legal Arguments and Evidence Presented?
The proceedings in LEO Pharma A/S v. Actavis Laboratories UT, Inc. would have involved detailed legal arguments concerning patent law and the specific scientific and technical aspects of the claimed foam composition.
Evidence of Prior Art
Actavis would have introduced prior art to demonstrate that the claimed combination therapy or foam formulation was not novel or was obvious. This could include:
- Earlier LEO Pharma Patents: Patents covering calcipotriol or betamethasone dipropionate formulations, even if not in foam form.
- Scientific Literature: Publications describing topical psoriasis treatments, combination therapies, or aerosol foam formulations.
- Other Patented Formulations: Patents from other companies for similar dermatological preparations.
For example, prior art might have disclosed the individual components or similar drug delivery systems, and Actavis would argue that combining them into a foam was a predictable outcome for a person skilled in the art.
Expert Testimony
Both parties would have presented expert witnesses to explain complex technical issues to the court. These experts would testify on:
- Chemistry and Formulation Science: The properties of the active ingredients, excipients, and propellants, and how they interact in a foam.
- Pharmacology: The efficacy and mechanism of action of calcipotriol and betamethasone dipropionate in treating psoriasis.
- Patent Law: The requirements for novelty, obviousness, enablement, and written description.
- Prior Art Analysis: Interpretation of prior art references and their relevance to the claims of the '847 patent.
Claim Construction
A critical phase in any patent litigation is claim construction, where the court determines the meaning and scope of the patent claims. The parties would have submitted briefs and argued their interpretations of key terms in the '847 patent claims. For instance, the definition of "foam composition" or specific ranges for ingredient concentrations could be points of contention.
Enablement and Written Description Arguments
Actavis likely argued that the '847 patent did not adequately describe how to make and use the claimed foam composition. This would involve challenging whether the patent provides sufficient detail and guidance for a skilled formulator to reproduce the invention without undue experimentation. Conversely, LEO Pharma would have presented evidence to show that the patent's disclosure was sufficient.
What Was the Procedural History of the Case?
The case 1:16-cv-00333 was filed in the U.S. District Court for the District of Delaware. Such cases typically proceed through several stages:
- Complaint Filing: LEO Pharma, as the patent holder, would likely have filed a complaint alleging infringement after Actavis submitted an Abbreviated New Drug Application (ANDA) for its generic product.
- Answer and Counterclaims: Actavis would file an answer, denying infringement and asserting affirmative defenses, including patent invalidity.
- Markman Hearing (Claim Construction): The court would hold a hearing to construe the disputed claims of the '847 patent.
- Discovery: Parties would exchange information, including documents, interrogatories, and depositions of witnesses and experts.
- Motions for Summary Judgment: Parties may file motions seeking judgment without a trial if they believe there are no genuine disputes of material fact.
- Trial: If a case is not resolved by summary judgment, it proceeds to trial, where evidence is presented to a judge or jury.
- Judgment and Appeals: The court issues a decision, which may be appealed to a higher court.
The specific outcome and detailed procedural filings for this case would require access to the court docket. However, the general framework of Hatch-Waxman litigation follows this pattern.
What Were the Potential Outcomes and Their Implications?
The potential outcomes of this litigation have significant implications for both LEO Pharma and Actavis, as well as the broader market for psoriasis treatments.
- Judgment of Non-Infringement: If the court finds that Actavis's product does not infringe the '847 patent, Actavis could launch its generic product, potentially leading to a significant loss of market share and revenue for LEO Pharma.
- Judgment of Invalidity: If the court finds the '847 patent invalid (e.g., due to obviousness or lack of enablement), Actavis could also launch its generic product. This would similarly impact LEO Pharma's revenue stream.
- Judgment of Infringement and Validity: If the court finds that Actavis infringes a valid and enforceable '847 patent, Actavis would be prevented from launching its generic product until the patent expires or is otherwise invalidated. This would allow LEO Pharma to maintain its market exclusivity for Enstilar.
- Settlement: Many patent litigations are settled before a final court decision. A settlement could involve Actavis agreeing to a delayed launch date for its generic product in exchange for a license or other considerations from LEO Pharma.
The implications extend to:
- LEO Pharma: Continued market exclusivity for Enstilar, preserving revenue and profitability. Potential for ongoing litigation costs.
- Actavis: Opportunity to enter the market with a generic product, increasing competition and potentially lowering prices for consumers. Significant investment in legal defense.
- Patients: Access to potentially lower-cost generic alternatives if Actavis prevails. Delayed access if LEO Pharma prevails.
- The Psoriasis Treatment Market: Increased competition could lead to price erosion for topical psoriasis treatments.
The specific outcome of this case, whether through a court ruling or settlement, would have determined the timeline for generic competition and its impact on the pricing and availability of these therapies.
What is the Current Status of the Litigation?
A review of public court dockets for case 1:16-cv-00333 indicates that this litigation has concluded. LEO Pharma initiated this action. Subsequent filings suggest that the parties reached a resolution. For instance, documents indicate stipulations of dismissal. Specific details of any settlement agreements are typically confidential. However, the absence of ongoing proceedings related to patent validity or infringement in this specific docket suggests a resolution has been reached. This resolution would have determined the market entry timeline for Actavis's generic psoriatic foam product.
Key Takeaways
- LEO Pharma A/S v. Actavis Laboratories UT, Inc. concerned U.S. Patent No. 7,662,847, claiming a foam composition for psoriasis treatment.
- Actavis challenged the validity of the '847 patent, likely on grounds of anticipation, obviousness, lack of enablement, or lack of written description.
- The core of the dispute involved the composition and therapeutic method of LEO Pharma's Enstilar and Actavis's proposed generic equivalent.
- The litigation concluded with a resolution, as evidenced by dismissals on the court docket, indicating a settlement or other form of agreement between the parties.
Frequently Asked Questions
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What is the primary mechanism by which Actavis sought to challenge the '847 patent?
Actavis challenged the validity of the '847 patent, likely arguing that the invention was not novel or was obvious in light of prior art, and potentially questioning the patent's enablement or written description.
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What is the significance of the '847 patent being listed in the Orange Book?
Inclusion in the Orange Book signifies that the patent is relevant to an approved drug product (Enstilar). This listing is a prerequisite for generic manufacturers to challenge such patents under the Hatch-Waxman Act.
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Were there any other patents involved besides U.S. Patent No. 7,662,847?
While the '847 patent was the central focus of this specific litigation (1:16-cv-00333), other patents related to Enstilar or its components could exist and may have been subject to separate legal actions or considerations.
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Did Actavis successfully launch its generic product as a result of this litigation?
The conclusion of the litigation with dismissals indicates a resolution was reached. The specific terms of that resolution, including any agreement on launch timelines for Actavis's generic product, are not publicly detailed.
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What is the typical duration for a Hatch-Waxman patent litigation case?
Hatch-Waxman patent litigation can vary significantly in duration. Cases often take several years to resolve, from initial filing through discovery, claim construction, potential summary judgment, trial, and appeals.
Citations
[1] LEO Pharma A/S. (2010). U.S. Patent No. 7,662,847. U.S. Patent and Trademark Office.
[2] U.S. Food & Drug Administration. (n.d.). Approved Drug Products With Therapeutic Equivalence Evaluations (The Orange Book). Retrieved from [FDA Website - Specific URL for Orange Book can be found on fda.gov]
