DCT

1:18-cv-01588

Galderma Laboratories LP v. Sun Pharmaceutical Industries Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-01588, D. Del., 02/08/2019
  • Venue Allegations: Venue is alleged to be proper in Delaware because Defendants have purposefully availed themselves of the district by, among other things, committing the tortious act of filing a New Drug Application (NDA) that will lead to foreseeable harm to Plaintiffs in Delaware, intending to market and sell the accused product in the state, maintaining a designated agent in Delaware, and previously submitting to the court's jurisdiction.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an NDA seeking FDA approval for a generic 40 mg doxycycline tablet product constitutes an act of infringement of a patent covering a method of treating rosacea with a low dose of doxycycline.
  • Technical Context: The technology concerns pharmaceutical methods for treating inflammatory skin conditions, such as rosacea, using a low, sub-antimicrobial dose of a tetracycline-class drug to achieve an anti-inflammatory effect while avoiding the side effects associated with long-term antibiotic use.
  • Key Procedural History: This case is related to a prior litigation between the same parties in the same court (the "Sun I Action"), which concerned related patents and the same accused product and which proceeded to a bench trial in December 2018. The patent-in-suit in the current action issued in August 2018 and was subsequently listed in the FDA's Orange Book. Defendants then amended their NDA to file a Paragraph IV certification against the new patent, triggering this lawsuit.

Case Timeline

Date Event
2001-04-05 U.S. Patent No. 10,058,564 Priority Date
2016-09-14 Sun sends First Notice Letter for related patents
2016-10-27 Plaintiffs commence Sun I Action
2016-11-21 Sun files Answer & Counterclaims in Sun I Action
2017-01-09 Plaintiffs file Answer to Counterclaims in Sun I Action
2018-08-28 U.S. Patent No. 10,058,564 issues
2018-09-25 '564 Patent listed in FDA Orange Book
2018-10-15 Plaintiffs file original complaint in current action
2018-12-10 Sun I Action bench trial begins
2019-01-11 Sun sends Second Notice Letter for '564 Patent
2019-01-31 Sun files Answer & Counterclaims in current action
2019-02-08 First Amended Complaint filed

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.

The Invention Explained

  • Problem Addressed: The patent's background describes the conventional treatment of acne with systemically-administered tetracycline antibiotics, which are typically given at high doses to inhibit microbial growth ('564 Patent, col. 4:52-64). This long-term, high-dose administration can lead to undesirable side effects, including the disruption of healthy intestinal flora and the development of antibiotic-resistant bacteria ('564 Patent, col. 5:43-48).
  • The Patented Solution: The invention is a method of treating inflammatory skin disorders, like acne and rosacea, by administering a low, "sub-antibiotic" dose of a tetracycline compound, such as doxycycline ('564 Patent, Abstract). This low dose is asserted to be sufficient to provide a therapeutic anti-inflammatory benefit (e.g., reducing lesions) but low enough to have "substantially no antibiotic activity," thereby avoiding the side effects of conventional high-dose antibiotic therapy ('564 Patent, col. 5:56-62).
  • Technical Importance: This method seeks to decouple the known anti-inflammatory properties of tetracyclines from their antimicrobial properties, potentially offering a safer profile for long-term management of chronic inflammatory skin conditions ('564 Patent, col. 5:49-54).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" of the '564 Patent (Compl. ¶31). Independent claim 1 is representative of the core invention.
  • Independent Claim 1 recites:
    • A method for treating papules and pustule of rosacea in a human in need thereof,
    • the method comprising administering orally to said human doxycycline, or a pharmaceutically acceptable salt thereof,
    • in an amount that is 5 mg to 40 mg total daily dose of doxycycline
    • without administering a bisphosphonate compound.
  • The complaint does not explicitly limit its allegations to independent claims, thereby preserving the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Sun's NDA Product," identified as a 40 mg doxycycline tablet for which Defendants seek FDA approval via New Drug Application (NDA) No. 209259 (Compl. ¶¶ 5, 22).

Functionality and Market Context

  • The complaint alleges that Sun's NDA Product is a generic version of Plaintiffs' ORACEA® (doxycycline, USP) 40 mg Capsules (Compl. ¶¶ 18, 21-22). The act of infringement alleged under the Hatch-Waxman Act is Defendants' submission of the NDA seeking approval to market this product for a therapeutic use that allegedly falls within the scope of the '564 patent's claims, prior to the patent's expiration (Compl. ¶29). The product is intended for oral administration to treat the inflammatory lesions of rosacea, positioning it as a direct competitor to Plaintiffs' branded product (Compl. ¶¶ 5, 18).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges infringement under 35 U.S.C. § 271(e)(2) based on the submission of the NDA (Compl. ¶29). The following chart summarizes the likely infringement theory for claim 1 based on the descriptions in the complaint.

'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 complaint alleges Sun filed NDA No. 209259 for its product, which is a generic version of ORACEA®, a drug indicated for treating the inflammatory lesions of rosacea. The proposed use in the NDA constitutes the claimed "method." ¶¶5, 18, 29 col. 5:49-54
the method comprising administering orally to said human doxycycline, or a pharmaceutically acceptable salt thereof, Sun's NDA Product is described as a "doxycycline tablet product" intended for oral administration. ¶5 col. 6:5-8
in an amount that is 5 mg to 40 mg total daily dose of doxycycline The accused product is a "40 mg doxycycline tablet," which corresponds to the dosage recited in the claim. The proposed label in the NDA would specify a daily dose falling within the claimed range. ¶5 col. 8:36-38
without administering a bisphosphonate compound. Infringement of this negative limitation is premised on the accused product's proposed label not instructing or requiring co-administration of a bisphosphonate compound. ¶29 col. 7:12-24
  • Identified Points of Contention:
    • Scope Questions: A central issue in Hatch-Waxman litigation is whether the method that will be described on the proposed label of the generic product falls within the scope of the asserted patent claims. The dispute will likely focus on the precise language of Sun's proposed label for its NDA Product and whether it directs physicians and patients to perform each step of the claimed method.
    • Technical Questions: While the complaint alleges the accused product is a 40 mg doxycycline tablet, the ultimate proof of infringement for the dosage element will depend on the "total daily dose" instructions in the product's final approved labeling. Any ambiguity in the label's dosing instructions could become a point of contention.

V. Key Claim Terms for Construction

  • The Term: "treating"

  • Context and Importance: In an action based on an NDA filing, infringement is assessed by comparing the asserted claims to the uses described in the proposed product labeling. The definition of "treating" is critical because Defendants may argue that their proposed label describes a use or outcome that does not meet the patent's definition of the term.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes effective treatment as "a reduction or inhibition of the blemishes and lesions associated with acne" ('564 Patent, col. 6:41-43), suggesting a general improvement rather than a specific clinical endpoint.
    • Evidence for a Narrower Interpretation: A party could argue the term should be limited by the results disclosed in the patent's clinical trial example, which reports specific percentage reductions in comedones and inflammatory lesions ('564 Patent, col. 20:49-55).

  • The Term: "without administering a bisphosphonate compound"

  • Context and Importance: The scope of this negative limitation is fundamental to the infringement analysis. Practitioners may focus on this term because it is a clear attempt by the patentee to distinguish the invention, and the parties will dispute what is required to prove that the accused method meets this limitation.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent’s abstract and detailed description simply state the method is performed "without administering a bisphosphonate compound" ('564 Patent, Abstract; col. 1:55-57), which may support an interpretation that the mere absence of a requirement for co-administration on the accused product's label is sufficient for infringement.
    • Evidence for a Narrower Interpretation: The specification contains an explicit section disclaiming bisphosphonates ('564 Patent, col. 7:12-24). A party could argue this emphatic carve-out implies that the limitation requires more than mere silence on a product label, perhaps applying only where bisphosphonates are contraindicated or where a label explicitly instructs against their use.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that by filing its NDA, Sun has induced infringement of the '564 patent under 35 U.S.C. § 271(e)(2) (Compl. ¶30). The factual basis for knowledge and intent includes Sun's receipt of notice letters regarding the patent family and its participation in prior litigation on related patents (Compl. ¶¶ 5, 23, 27). The complaint also anticipates claims for future inducement of infringement under 35 U.S.C. § 271(b) should the product be commercially launched (Compl. ¶31).
  • Willful Infringement: The complaint does not contain an explicit allegation of willful infringement.

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

  • A core issue will be one of label-based infringement: Will the specific instructions for use on the proposed label of Sun's 40 mg doxycycline NDA Product direct physicians and patients to perform a method that meets every positive and negative limitation of an asserted claim of the '564 patent?
  • A key legal and evidentiary question will be one of negative limitation scope: Is the absence of an instruction to co-administer a bisphosphonate on the accused product's proposed label sufficient to meet the "without administering a bisphosphonate compound" limitation, or does the claim require a more explicit disavowal?