DCT

1:10-cv-00045

Galderma Laboratories LP v. Tolmar Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:10-cv-00045, D. Del., 02/28/2011
  • Venue Allegations: Venue is based on both Defendants being Delaware corporations.
  • Core Dispute: Plaintiff alleges that Defendants' Abbreviated New Drug Applications (ANDAs) to market generic 0.3% adapalene gel constitute an act of infringement of five patents covering the formulation and use of the drug for treating dermatological disorders.
  • Technical Context: The technology concerns topical pharmaceutical formulations of adapalene, a retinoid compound used for the treatment of skin conditions such as acne vulgaris.
  • Key Procedural History: This consolidated action was initiated under the Hatch-Waxman Act following Defendants' submission of ANDAs with Paragraph IV certifications to the U.S. Food and Drug Administration (FDA). The certifications allege that Plaintiff's patents, listed in the FDA's "Orange Book" for the drug Differin® 0.3% gel, are invalid, unenforceable, or would not be infringed by the Defendants' proposed generic products. The complaint notes a patent term adjustment for the '377 patent was increased following the Federal Circuit's decision in Wyeth v. Kappos.

Case Timeline

Date Event
2002-04-08 Earliest Priority Date for all Patents-in-Suit
2007-06-19 FDA approves Galderma's New Drug Application (NDA) for Differin® 0.3% gel
2009-08-25 '377 Patent Issued
2009-12-10 Tolmar sends Paragraph IV notice letter regarding '377 Patent
2010-06-15 '181 Patent Issued
2010-09-28 Actavis sends Paragraph IV notice letter regarding '377 and '181 Patents
2010-10-28 Tolmar sends Paragraph IV notice letter regarding '181 Patent
2010-11-16 '060 Patent Issued
2010-11-23 '558 Patent Issued
2011-01-11 '044 Patent Issued
2011-01-14 Tolmar sends Paragraph IV notice letter regarding '060 and '558 Patents
2011-01-24 Actavis sends Paragraph IV notice letter regarding '060, '558, and '044 Patents
2011-02-09 Tolmar sends Paragraph IV notice letter regarding '044 Patent
2011-02-28 Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 7,579,377 - “Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid For The Treatment of Dermatological Disorders”

  • Patent Identification: U.S. Patent No. 7,579,377, “Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid For The Treatment of Dermatological Disorders,” issued August 25, 2009.

The Invention Explained

  • Problem Addressed: The patent’s background describes adapalene as a known retinoid molecule for the topical treatment of acne and other dermatoses, which was commercially available in formulations containing 0.1% of the active ingredient (ʼ377 Patent, col. 1:40-57). The implicit technical problem is how to improve the therapeutic efficacy for dermatological conditions beyond what is achievable with the 0.1% formulation without introducing unacceptable side effects.
  • The Patented Solution: The invention is a method of treatment using a pharmaceutical composition containing adapalene at a higher concentration of 0.3% by weight ('377 Patent, col. 2:26-34). The patent discloses the "surprising" discovery that this 0.3% concentration provides a more rapid onset of action and a greater overall therapeutic effect compared to the 0.1% concentration, while exhibiting a good tolerance profile comparable to the lower-strength formulation ('377 Patent, col. 2:4-10, col. 4:51-62). Figure 1 of the patent, attached as Exhibit A to the complaint, is a graph showing a greater mean reduction in total acne lesions for the 0.3% gel versus the 0.1% gel and a vehicle control over a 12-week period (Compl. ¶ 9; '377 Patent, Fig. 1).
  • Technical Importance: This approach offered a more potent treatment for patients, particularly those with moderate to moderately severe acne, aiming to provide faster and more significant clinical improvement than was possible with existing formulations ('377 Patent, col. 3:50-52).

Key Claims at a Glance

  • The complaint asserts "one or more claims" (Compl. ¶ 15). Independent claim 1 is representative.
  • Independent Claim 1 recites a method for treating various forms of acne, which requires:
    • Topically administering a pharmaceutical composition that is a specific gel.
    • The gel is defined by a precise list of ingredients and their amounts, including "Adapalene 3 mg," "Carbomer 940 11 mg," and other excipients in a 1-gram base ('377 Patent, col. 5:26-col. 6:48).
  • The complaint does not explicitly reserve the right to assert dependent claims, but the general allegation covers them.

U.S. Patent No. 7,737,181 - “Pharmaceutical Compositions Comprising 0.3% By Weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid For The Treatment of Dermatological Disorders”

  • Patent Identification: U.S. Patent No. 7,737,181, “Pharmaceutical Compositions Comprising 0.3% By Weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid For The Treatment of Dermatological Disorders,” issued June 15, 2010.

The Invention Explained

  • Problem Addressed: Similar to the '377 Patent, this patent addresses the need for a more effective adapalene-based treatment for dermatological conditions having an inflammatory or proliferative component, such as acne ('181 Patent, col. 1:47-51).
  • The Patented Solution: The patent claims the pharmaceutical composition itself, comprising about 0.3% adapalene as the sole active anti-acne ingredient, formulated into various topical forms like an aqueous gel, cream, or lotion ('181 Patent, Abstract; col. 10:42-53). The specification emphasizes that this specific concentration provides superior therapeutic efficacy and a more rapid effect compared to 0.1% formulations, with good tolerance ('181 Patent, col. 2:4-10). The patent provides numerous detailed examples of such formulations ('181 Patent, col. 5:26-col. 9:45).
  • Technical Importance: By claiming the composition, the patent provides protection for the product itself, distinct from the method-of-use claims in the '377 Patent.

Key Claims at a Glance

  • The complaint asserts "one or more claims" (Compl. ¶ 47). Independent claim 1 is a broad composition claim.
  • Independent Claim 1 recites a topically applicable aqueous gel composition for treating common acne, which requires:
    • "consisting essentially of" an anti-acne effective amount of adapalene of 0.3% by weight.
    • The adapalene must be the "only active anti-acne ingredient."
    • The aqueous gel medium must comprise at least one ingredient selected from a specified list of gelling agents (e.g., carbomers, polymeric emulsifiers, etc.) ('181 Patent, col. 10:42-53).
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 7,834,060 - “Administration of 6-[3-(1-adamantyl)-4-methoxy-phenyl]-2-naphthoic acid For The Treatment of Dermatological Disorders”

  • Patent Identification: U.S. Patent No. 7,834,060, “Administration of 6-[3-(1-adamantyl)-4-methoxy-phenyl]-2-naphthoic acid For The Treatment of Dermatological Disorders,” issued November 16, 2010 (Compl. ¶ 72).
  • Technology Synopsis: This patent claims methods for treating various forms of acne. The claimed invention involves topically administering a specific 0.3% adapalene gel formulation, asserting that this method provides a superior benefit/risk ratio, with greater and more rapid efficacy than lower concentrations while maintaining good patient tolerance ('060 Patent, Abstract; col. 2:20-33).
  • Asserted Claims: The complaint asserts "one or more claims" (Compl. ¶ 77). The patent contains independent method and regimen claims (e.g., claims 1, 6, 12, 17, 23, 28, 34).
  • Accused Features: The submission of ANDAs by Defendants to market a 0.3% adapalene gel for the treatment of acne is the basis for the infringement allegation (Compl. ¶ 77).

U.S. Patent No. 7,838,558 - “Administration of 6-[3-(1-adamantyl)-4-methoxy-phenyl]-2-naphthoic acid For The Treatment of Dermatological Disorders”

  • Patent Identification: U.S. Patent No. 7,838,558, “Administration of 6-[3-(1-adamantyl)-4-methoxy-phenyl]-2-naphthoic acid For The Treatment of Dermatological Disorders,” issued November 23, 2010 (Compl. ¶ 102).
  • Technology Synopsis: This patent is directed to pharmaceutical compositions. It claims topical compositions (e.g., aqueous gels, creams, lotions) comprising 0.3% adapalene as the sole active ingredient, which are described as being effective for treating acne and providing an improved therapeutic profile compared to prior art formulations ('558 Patent, Abstract; col. 2:3-12).
  • Asserted Claims: The complaint asserts "one or more claims" (Compl. ¶ 107). The patent contains independent composition claims (e.g., claims 1, 5, 8, 11, 15).
  • Accused Features: The accused acts are Defendants' filings of ANDAs for a generic 0.3% adapalene gel (Compl. ¶ 107).

U.S. Patent No. 7,868,044 - “Method for the Treatment of Acne Using Compositions Comprising 0.3% By Weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid”

  • Patent Identification: U.S. Patent No. 7,868,044, “Method for the Treatment of Acne Using Compositions Comprising 0.3% By Weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid,” issued January 11, 2011 (Compl. ¶ 132).
  • Technology Synopsis: This patent claims methods of treating acne by topically administering various compositions containing 0.3% adapalene. The invention is based on the premise that using this specific concentration in specified formulations (e.g., aqueous gel, cream, lotion) provides an advantageous treatment for acne ('044 Patent, Abstract; col. 2:1-11).
  • Asserted Claims: The complaint asserts "one or more claims" (Compl. ¶ 137). The patent contains independent method claims (e.g., claims 1, 7, 13, 19, 29).
  • Accused Features: Defendants' ANDA submissions seeking approval to market a generic 0.3% adapalene gel are the alleged acts of infringement (Compl. ¶ 137).

III. The Accused Instrumentality

  • Product Identification: Tolmar's Adapalene Gel, 0.3%, as described in ANDA No. 200-298, and Actavis's Adapalene Gel, 0.3%, as described in ANDA No. 201-000 (Compl. ¶¶ 12, 21).
  • Functionality and Market Context: The accused instrumentalities are proposed generic drug products intended to be therapeutic equivalents to Galderma's approved Differin® 0.3% gel (Compl. ¶¶ 10-12). The complaint alleges that Defendants seek approval to manufacture and sell these topical 0.3% adapalene gels for the treatment of acne vulgaris before the expiration of the patents-in-suit (Compl. ¶¶ 12, 17, 21, 26). The act of infringement alleged is the submission of the ANDAs themselves, which under 35 U.S.C. § 271(e)(2) is a statutory act of infringement if the commercial sale of the proposed product would infringe the patent.

IV. Analysis of Infringement Allegations

The complaint alleges that the filing of the ANDAs for the 0.3% Adapalene Gels constitutes infringement under 35 U.S.C. § 271(e)(2)(A), as the future commercial manufacture, use, or sale of these products would infringe one or more claims of the patents-in-suit (Compl. ¶¶ 15, 47). As this is an ANDA case, the infringement theory rests on the legal requirement that the proposed generic products be the same as the reference listed drug (Differin® 0.3% gel) in terms of active ingredient, dosage form, strength, and route of administration, and that their labeled indications will mirror those of the brand.

'377 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating common acne...afflicting the skin of an individual in need of such treatment, Defendants seek approval for an indication for their adapalene gels that is claimed in the patent; the proposed product labels will instruct physicians and patients to use the gel to treat acne. ¶17 col. 5:26-31
comprising topically administering...a pharmaceutical composition which is a gel of: Defendants' ANDA products are identified as "adapalene gel, 0.3%," intended for topical administration. ¶12 col. 5:30-32
Adapalene 3 mg... [and other specified ingredients and amounts]... Purified water q.s. 1 g. As the accused products are generic versions of Differin® 0.3% gel, the basis for which is the patented formulation, it is alleged that their composition will meet these limitations. ¶¶10, 12 col. 5:35-48

'181 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A topically applicable pharmaceutical aqueous gel composition useful for the treatment of common acne, Defendants' products are identified as 0.3% adapalene gels intended for the treatment of acne. ¶¶12, 17, 21, 26 col. 10:42-43
consisting essentially of an anti-acne effective amount of...adapalene of 0.3% by weight thereof, The accused products are identified as "adapalene gel, 0.3%." ¶¶12, 21 col. 10:44-47
formulated into a topically applicable, pharmaceutically acceptable aqueous gel medium therefor, The accused products are topical aqueous gels. ¶¶12, 21 col. 10:48-49
wherein adapalene is the only active anti-acne ingredient in the composition, The complaint does not provide sufficient detail for analysis of this specific element, but it is a requirement for ANDA bioequivalence. col. 10:50-51
and wherein said aqueous gel medium comprises at least one ingredient selected from the group consisting of carbomers... The complaint does not specify the excipients in the accused products, but alleges they are generic equivalents that would infringe. ¶12 col. 10:51-53
  • Identified Points of Contention:
    • Scope Questions: A primary question for the '377 Patent will be whether the Defendants' formulations are identical to the highly specific "recipe" claim. For the '181 Patent, a central issue will be the interpretation of "consisting essentially of." The analysis will question whether any unlisted excipients in the Defendants' formulations "materially affect the basic and novel characteristics" of the invention—namely, the specific efficacy and tolerance profile.
    • Technical Questions: While the complaint does not detail the Defendants' non-infringement or invalidity theories, the core of the dispute will likely involve validity. A key question for the court will be whether increasing the concentration of adapalene from 0.1% to 0.3% would have been obvious to a person of ordinary skill in the art at the time of the invention, and whether the resulting combination of improved efficacy and good tolerance was a predictable or surprising outcome.

V. Key Claim Terms for Construction

  • The Term: "consisting essentially of" (from '181 Patent, e.g., Claim 1)
    • Context and Importance: This transitional phrase is critical for determining the scope of the composition claims. It permits the presence of unlisted ingredients so long as they do not materially alter the invention's basic and novel properties. The infringement analysis will hinge on whether any differences between the claimed composition and the Defendants' generic formulations are material.
    • Intrinsic Evidence for a Broader Interpretation: The specification discloses numerous optional additives like wetting agents, preservatives, and antioxidants that can be added to the compositions, suggesting that the core inventive character can coexist with other standard components ('181 Patent, col. 5:35-49).
    • Intrinsic Evidence for a Narrower Interpretation: The patent repeatedly emphasizes the specific combination of enhanced efficacy and good tolerance as the key discovery ('181 Patent, col. 2:4-10). A defendant could argue that any unlisted excipient that measurably affects skin irritation, penetration, or stability would be a "material" alteration, thereby placing their formulation outside the claim's scope.
  • The Term: "a gel of:" (followed by a specific recipe, from '377 Patent, Claim 1)
    • Context and Importance: This phrase introduces a list of specific ingredients with precise quantities that define the gel used in the claimed method. Infringement of this claim likely requires that the accused product be made according to this exact formulation. Practitioners may focus on this term because any deviation by the Defendants from this recipe could support a non-infringement argument.
    • Intrinsic Evidence for a Broader Interpretation: A plaintiff might argue that the amounts should be read to include standard and insubstantial manufacturing tolerances.
    • Intrinsic Evidence for a Narrower Interpretation: The claim language is highly specific, unlike other claims in the patent family that describe compositions more generally. The patent's disclosure of distinct cream and lotion formulations demonstrates that the inventors deliberately chose to claim this exact gel formulation, suggesting the list is a strict definition of the claimed article ('377 Patent, col. 4:1-26).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that if the FDA approves the ANDAs, Defendants will induce infringement by selling their products with instructions and labeling that encourage and direct physicians and patients to perform the patented methods of treatment (e.g., Compl. ¶¶ 16, 18, 25).
  • Willful Infringement: The complaint does not make an explicit allegation of willful infringement.

VII. Analyst’s Conclusion: Key Questions for the Case

  • A primary issue for the court will be one of validity based on obviousness: Was the discovery that a 0.3% concentration of adapalene offered significantly greater efficacy than the known 0.1% formulation, while maintaining a comparable safety profile, an unexpected result, or was it an obvious-to-try modification with a reasonable expectation of success for a person of ordinary skill in the art?
  • A second core issue will be one of infringement scope and claim construction: For the narrowly drafted method claims (e.g., '377 Patent), the question is one of compositional identity—do the accused generic gels precisely match the claimed formulation? For the broader composition claims (e.g., '181 Patent), the question is one of materiality—do any formulation differences in the accused products materially alter the "basic and novel" properties of the patented 0.3% adapalene compositions?