Galderma Laboratories LP v. Teva Pharma USA Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Galderma Laboratories L.P. (Texas), Galderma S.A. (Switzerland), and Nestlé Skin Health S.A. (Switzerland)
  • Defendant: Teva Pharmaceuticals USA, Inc. (Delaware)
  • Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
• Case Identification: 1:19-cv-00351, D. Del., 02/19/2019
• Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a Delaware corporation.
• Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Soolantra® (ivermectin) Cream, 1% constitutes an act of patent infringement.
• Technical Context: The technology relates to pharmaceutical compositions and methods for the topical treatment of papulopustular rosacea, a chronic inflammatory skin disorder.
• Key Procedural History: The parties are involved in a related, pending litigation in the same district (the "Galderma I Action") concerning three other Galderma patents from the same family asserted against the same accused product. The complaint notes that a bench trial in that action was scheduled for May 2019.

Case Timeline

Date	Event
2013-07-08	U.S. Patent No. 10,206,939 Priority Date
2014-12-19	FDA approves Galderma's Soolantra® Cream New Drug Application (NDA)
2016-12-30	Teva files Abbreviated New Drug Application (ANDA) No. 210019
2017-03-10	Teva sends Paragraph IV Certification to Galderma
2017-04-21	Galderma commences the "Galderma I Action" against Teva
2019-02-19	U.S. Patent No. 10,206,939 Issues
2019-02-19	Complaint Filed

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

U.S. Patent No. 10,206,939 - “Treatment of Papulopustular Rosacea with Ivermectin”

• Patent Identification: U.S. Patent No. 10,206,939, “Treatment of Papulopustular Rosacea with Ivermectin,” issued February 19, 2019.

The Invention Explained

• Problem Addressed: The patent describes that inflammatory lesions associated with papulopustular rosacea (PPR), particularly moderate to severe cases, are difficult to treat, and that existing therapies such as metronidazole and azelaic acid do not provide adequate or rapid relief for all patients (’939 Patent, col. 1:42-54). The background also notes that prior art suggested combining ivermectin with other anti-rosacea medications to manage initial flare-ups, implying a need for a more effective standalone treatment (’939 Patent, col. 2:15-19).
• The Patented Solution: The invention is a method for treating PPR by topically applying a composition containing ivermectin once daily. The patent asserts that this method provides more rapid relief, a longer period free of relapse, and is more effective than conventional treatments like metronidazole, achieving a "significant reduction" in inflammatory lesions as early as two weeks after starting treatment (’939 Patent, Abstract; col. 2:36-43; col. 4:54-64).
• Technical Importance: The claimed method represents a therapeutic approach that addresses both the inflammatory and parasitic (Demodex mites) factors implicated in rosacea, offering a novel treatment that is effective without the co-administration of other drugs (’939 Patent, col. 5:50-59).

Key Claims at a Glance

• The complaint asserts infringement of at least independent claim 1 (Compl. ¶26).
• Essential elements of independent claim 1:
  • A method of treating papulopustular rosacea in a subject in need thereof,
  • comprising topically administering, once daily, to a skin area affected by the papulopustular rosacea a therapeutically effective amount of a pharmaceutical composition comprising ivermectin and a pharmaceutically acceptable carrier,
  • without co-administration of another active pharmaceutical ingredient,
  • wherein the pharmaceutical composition comprises 0.5% to 1% by weight ivermectin, and
  • wherein a reduction in inflammatory lesion count in the subject is observed 2 weeks after the initial administration of the pharmaceutical composition.
• The complaint states that the accused product infringes "one or more claims" and reserves the right to assert additional claims, including dependent claims (Compl. ¶22, ¶26).

III. The Accused Instrumentality

Product Identification

• Defendant’s generic (ivermectin) cream 1% (the “Accused Product”), for which Defendant submitted Abbreviated New Drug Application (ANDA) No. 210019 to the FDA for approval (Compl. ¶6, ¶18).

Functionality and Market Context

• The Accused Product is intended to be a generic equivalent to Plaintiff’s Soolantra® (ivermectin) Cream, 1% (Compl. ¶6). Under the Hatch-Waxman Act, the ANDA must show that the Accused Product has the same active ingredient, route of administration, dosage form, and strength as Soolantra®, and is bioequivalent to it (Compl. ¶30). The complaint alleges that Defendant intends to market and sell the Accused Product upon FDA approval for at least one indication claimed in the ’939 Patent (Compl. ¶28).

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart exhibit. The following summary is based on the narrative allegations.

’939 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A method of treating papulopustular rosacea in a subject in need thereof...	Defendant seeks approval to market the Accused Product for an indication claimed in the patent, specifically the treatment of inflammatory lesions of rosacea.	¶28	col. 24:10-14
...comprising topically administering, once daily...a pharmaceutical composition comprising ivermectin...	Defendant's ANDA must show its product has the same route of administration, dosage form, and strength as Soolantra® Cream, 1%. The product's proposed labeling will instruct users to apply the cream topically and once daily.	¶30	col. 24:10-14
...without co-administration of another active pharmaceutical ingredient...	The complaint does not provide specific factual allegations for this limitation. Infringement would depend on the proposed labeling for the Accused Product not directing co-administration with other active agents.	¶26	col. 24:14-16
...wherein the pharmaceutical composition comprises 0.5% to 1% by weight ivermectin...	The Accused Product is identified as an "(ivermectin) cream 1%."	¶6	col. 24:17-19
...and wherein a reduction in inflammatory lesion count in the subject is observed 2 weeks after the initial administration of the pharmaceutical composition.	By seeking approval for a bioequivalent generic, Defendant's product is alleged to necessarily produce the same therapeutic effect as Soolantra® when used as directed, which includes achieving the claimed reduction in lesion count within two weeks.	¶26, ¶30	col. 24:19-22

Identified Points of Contention

• Technical Question: A primary evidentiary dispute will likely concern the final "wherein" clause. What evidence was submitted in Defendant’s ANDA to establish that its specific formulation is bioequivalent and will achieve the claimed "reduction in inflammatory lesion count" within two weeks of administration? The complaint does not provide this evidence.
• Scope Question: The negative limitation "without co-administration of another active pharmaceutical ingredient" may be a point of dispute. The case may turn on the construction of "co-administration" and the specific instructions or lack thereof in the proposed label for the Accused Product regarding use with other rosacea treatments.

V. Key Claim Terms for Construction

"a reduction in inflammatory lesion count in the subject is observed 2 weeks after the initial administration of the pharmaceutical composition"

• Context and Importance: This "wherein" clause defines a specific, time-bound clinical outcome. Practitioners may focus on this term because proving infringement in a Hatch-Waxman case requires showing that the proposed generic product, if marketed, would meet this limitation. The dispute will center on whether the bioequivalence data in Defendant's ANDA is sufficient to prove that its product will necessarily achieve this result.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification broadly describes that ivermectin treatment results in a "significant reduction" in lesions, suggesting the effect is an inherent property of the method (’939 Patent, col. 4:59-64).
  • Evidence for a Narrower Interpretation: The specification provides detailed clinical trial data showing specific median percentage reductions at two weeks (e.g., about 30% and 27.3%), which a defendant might argue sets a specific, quantitative threshold for what constitutes the claimed "reduction" (’939 Patent, col. 5:5-11; Fig. 5C-5D).

"without co-administration of another active pharmaceutical ingredient"

• Context and Importance: This negative limitation is critical for distinguishing the invention from prior art that suggested combining ivermectin with other drugs. Its construction will define the scope of prohibited activity. The central question is whether the term forbids any concurrent rosacea therapy or only the combination of actives within a single formulation.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The background section discusses prior art suggesting the use of oral tetracycline and topical metronidazole "to suppress early flareups" during ivermectin administration, which may suggest the claim is meant to exclude any concurrent use of such agents (’939 Patent, col. 2:15-19).
  • Evidence for a Narrower Interpretation: The claim language is "co-administration," which could be argued to mean administration at the same time or as part of a single prescribed regimen, not necessarily precluding all other independent treatments a patient might be undergoing.

VI. Other Allegations

Indirect Infringement

• The complaint alleges that Defendant will induce infringement once its ANDA is approved. This is based on the allegation that the instructions and labeling for the Accused Product will direct physicians and patients to use it in a manner that directly infringes at least claim 1 of the ’939 Patent (Compl. ¶27, ¶29).

Willful Infringement

• The complaint does not contain an explicit allegation or count for willful infringement.

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

• A core issue will be one of evidentiary sufficiency: In the context of a § 271(e)(2) action, does the bioequivalence and other data contained within Defendant's confidential ANDA filing prove, by a preponderance of the evidence, that its proposed generic cream will necessarily achieve the clinical outcome of "a reduction in inflammatory lesion count...2 weeks after" administration, as required by claim 1?
• A second key question will be one of claim scope and labeling: How will the court construe the negative limitation "without co-administration of another active pharmaceutical ingredient," and will the FDA-approved label for Defendant's product contain instructions or contraindications that either encourage or forbid such co-administration, thereby resolving the question of induced infringement?