DCT

1:19-cv-00440

Galderma Laboratories LP v. Amneal Pharma LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-00440, D. Del., 03/01/2019
  • Venue Allegations: Venue is asserted based on Defendant Amneal Pharmaceuticals, LLC being a Delaware corporation and on Defendants' alleged tortious acts of infringement under 35 U.S.C. § 271(e)(2) that will cause foreseeable harm to Plaintiffs in Delaware.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) for a generic 40 mg doxycycline oral capsule product constitutes an act of infringement of a patent covering low-dose methods for treating rosacea.
  • Technical Context: The technology concerns pharmaceutical methods for treating dermatological conditions using tetracycline-class drugs at dosages low enough to provide therapeutic benefit without significant antibiotic effects, thereby avoiding common side effects of long-term antibiotic use.
  • Key Procedural History: The complaint notes that the parties were previously involved in litigation (the "Amneal II Action") over the same ANDA, where a court found that Amneal infringed claims of different, related patents. The patent-in-suit in the present case issued after the judgment in that prior action and was subsequently listed in the FDA's Orange Book for Plaintiffs' ORACEA® product.

Case Timeline

Date Event
2001-04-05 '564 Patent Priority Date
2016-02-17 Amneal sends Paragraph IV notice letter regarding related patents
2018-02-01 Bench trial held in prior "Amneal II Action" (approximate date)
2018-08-27 Court issues judgment in "Amneal II Action"
2018-08-28 '564 Patent Issue Date
2018-09-25 '564 Patent listed in FDA Orange Book
2019-03-01 Complaint Filing Date

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

U.S. Patent No. 10,058,564 - "Methods of Treating Acne"

  • Patent Identification: U.S. Patent No. 10,058,564, "Methods of Treating Acne," issued August 28, 2018. (Compl. ¶21).

The Invention Explained

  • Problem Addressed: The patent describes the problem that conventional antibiotic treatments for acne require high doses of tetracyclines, which can lead to undesirable side effects, including the disruption of healthy microbial flora and the emergence of antibiotic-resistant bacteria. (’564 Patent, col. 3:42-51).
  • The Patented Solution: The invention is a method of treating inflammatory skin conditions by systemically administering a tetracycline compound (e.g., doxycycline) at a "sub-antibiotic" dose. (’564 Patent, col. 3:52-56). This low dose is asserted to be effective in treating the condition through non-antibiotic mechanisms, such as reducing the number of comedones, while avoiding the negative side effects associated with conventional higher-dose antibiotic therapy. (’564 Patent, Abstract; col. 4:1-5).
  • Technical Importance: This approach seeks to decouple the anti-inflammatory benefits of tetracyclines from their antimicrobial effects, offering a potential path for long-term management of chronic skin conditions without contributing to the public health problem of antibiotic resistance. (’564 Patent, col. 3:45-51).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" of the '564 patent without specifying them. (Compl. ¶33). The independent claims are 1 and 7.
  • Independent Claim 1: A method of treating papules and pustules of rosacea by orally administering doxycycline in a total daily dose of 5 mg to 40 mg, without co-administering a bisphosphonate compound.
  • Independent Claim 7: A method of treating papules and pustules of rosacea by orally administering doxycycline in a total daily dose of 5 mg to 40 mg, where the treatment results in "no reduction of skin microflora during a six-month treatment."

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the submission and maintenance of Abbreviated New Drug Application (ANDA) No. 203278 to the U.S. Food and Drug Administration (FDA). (Compl. ¶24). This is a statutory act of infringement under 35 U.S.C. § 271(e)(2).

Functionality and Market Context

  • The ANDA seeks approval to market a "40 mg doxycycline oral capsule product." (Compl. ¶6).
  • The proposed indication for the generic product is the "treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients," which is the same indication as Plaintiffs' branded drug, ORACEA® Capsules. (Compl. ¶6, ¶25).
  • The complaint alleges that by filing the ANDA, Defendants seek to secure FDA approval to manufacture and sell their generic product prior to the expiration of the ’564 patent. (Compl. ¶24).

IV. Analysis of Infringement Allegations

The complaint provides a "notice pleading" of infringement, asserting that the future marketing of the product described in Amneal's ANDA will infringe the '564 patent. No probative visual evidence provided in complaint. A summary of the infringement theory for Claim 1 can be constructed as follows.

'564 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating papules and pustule of rosacea in a human in need thereof... The ANDA product is proposed for the indication of "treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients." ¶6 col. 4:50
...the method comprising administering orally to said human doxycycline, or a pharmaceutically acceptable salt thereof... The ANDA product is an "oral capsule" containing doxycycline. ¶6 col. 5:6-8
...in an amount that is 5 mg to 40 mg total daily dose of doxycycline... The ANDA is for a "40 mg doxycycline oral capsule product," which falls within the claimed dosage range. ¶6 col. 7:33-35
...without administering a bisphosphonate compound. The ANDA product is for a doxycycline formulation; the complaint contains no allegation that it is or would be co-administered with a bisphosphonate. ¶6, ¶24 col. 7:12-24
  • Identified Points of Contention:
    • Scope Questions: A potential dispute may arise from the fact that the patent is titled "Methods of Treating Acne" and its specification focuses extensively on acne, while the asserted independent claims are directed to "rosacea." A court may need to consider whether the patent's disclosure provides adequate written description and enablement to support the full scope of claims for rosacea, a clinically distinct condition.
    • Technical Questions: For Claim 7, a key factual question is whether the administration of Amneal's proposed 40 mg product would, in fact, result in "no reduction of skin microflora." Answering this question would likely require analysis of Amneal's clinical data from its ANDA submission and competing expert testimony on the pharmacological effects of its specific formulation.

V. Key Claim Terms for Construction

  • The Term: "treating papules and pustule of rosacea"

  • Context and Importance: Practitioners may focus on this term because the patent's validity could be challenged on the grounds that its specification, which is heavily centered on "acne" and its characteristics (e.g., comedones), does not adequately describe or enable the invention as claimed for "rosacea."

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: Plaintiffs may argue that the term should be given its plain and ordinary meaning. They may point to the specification's explicit identification of "acne rosacea" as a type of acne to be treated, suggesting the inventor contemplated the condition. (’564 Patent, col. 4:50).
    • Evidence for a Narrower Interpretation: Defendants may argue that the patent's disclosure is overwhelmingly focused on features of acne vulgaris (e.g., comedones, P. acnes bacteria) that are not the primary characteristics of rosacea. They could contend that the isolated mention of "acne rosacea" is insufficient to support claims for the broader condition of rosacea, raising questions of written description under § 112. (’564 Patent, col. 2:37-43, 2:53-58).

  • The Term: "no reduction of skin microflora" (from Claim 7)

  • Context and Importance: This negative limitation is central to the infringement analysis for Claim 7 and embodies the "sub-antimicrobial" concept of the invention. The dispute will turn on whether Amneal's product meets this requirement.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: Plaintiffs could point to the clinical study results described in the patent, which allegedly showed "no reduction of skin microflora" compared to placebo, to argue the term means no statistically significant change in key bacterial counts. (’564 Patent, col. 20:56-60).
    • Evidence for a Narrower Interpretation: Defendants could argue that the term requires a showing of absolutely no decrease in any component of the skin's complex microbiome, and that any measurable decrease, however small, would place their product outside the claim scope. They might also argue the term is indefinite due to the inherent variability of "skin microflora."

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that if Amneal's product is launched, Amneal would induce infringement under 35 U.S.C. § 271(b). (Compl. ¶33). This allegation is based on the premise that Amneal’s product labeling and marketing materials would instruct physicians and patients to use the product in a manner that directly practices the claimed method.
  • Willful Infringement: The complaint does not explicitly use the word "willful." However, it alleges facts that could form the basis for such a claim, noting that Amneal continues to seek approval for its ANDA product even after the '564 patent was issued and listed in the Orange Book, and after a court found the same ANDA to infringe related patents. (Compl. ¶28, ¶29). These allegations suggest Defendants had knowledge of the patent and the asserted infringement.

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

  • A core issue will be one of validity and claim scope: Does the patent's detailed description, with its focus on the pathology of acne, provide sufficient written description and enablement to support the validity of claims directed to the treatment of rosacea?
  • A key evidentiary question will be one of infringement and functional equivalence: Can Plaintiffs prove that Amneal's proposed product, if marketed, will meet all claim limitations, particularly the functional requirement in Claim 7 of causing "no reduction of skin microflora"?
  • The litigation history between the parties raises a critical question regarding intent: Given the prior adjudication of infringement for related patents covering the same ANDA product, will Amneal’s continued pursuit of FDA approval in the face of the newly issued '564 patent be deemed to constitute willful infringement?