DCT

1:24-cv-00441

Chiesi Farmaceutici Spa v. Teva Pharma Inc

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I. Executive Summary and Procedural Information

  • Case Name: Chiesi Farmaceutici S.p.A., et al. v. Teva Pharmaceuticals Inc., et al.
  • Parties & Counsel:
  • Case Identification: 1:24-cv-00441, D. Del., 05/01/2024
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Teva Inc. is a Delaware corporation and has consented to venue in the district through its conduct in prior litigations. Venue over Teva Ltd., an Israeli corporation, is alleged to be proper in any district where it is subject to personal jurisdiction.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiffs' MYCAPSSA® (octreotide) delayed-release capsules constitutes an act of infringement of fourteen U.S. patents.
  • Technical Context: The patents relate to pharmaceutical compositions and methods for the oral delivery of octreotide, a peptide drug traditionally administered via injection for the treatment of conditions like acromegaly.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 217507 to the FDA. This submission included a "paragraph IV certification," asserting that the patents-in-suit are invalid, unenforceable, or will not be infringed by the proposed generic product.

Case Timeline

Date Event
2005-12-23 Priority Date for ’198, ’695, ’812, ’246, ’471 Patents
2012-12-11 ’198 Patent Issued
2013-09-17 ’695 Patent Issued
2015-02-03 Priority Date for ’709, ’397, ’126, ’011, ’963, ’595 Patents
2016-02-23 ’812 Patent Issued
2017-02-14 ’246 Patent Issued
2019-03-26 ’709 Patent Issued
2020-02-06 Priority Date for ’457 and ’316 Patents
2020-06-26 FDA approves MYCAPSSA (NDA No. 208232)
2020-06-30 ’397 Patent Issued
2021-07-06 ’126 Patent Issued
2021-10-12 ’457 Patent Issued
2022-05-24 ’011 Patent Issued
2022-11-29 ’963 Patent Issued
2024-01-02 ’595 Patent Issued
2024-02-06 ’316 Patent Issued
2024-02-26 Teva sends first Notice Letter to Chiesi
2024-03-18 Teva sends second Notice Letter to Chiesi
2024-04-30 ’471 Patent Issued
2024-05-01 First Amended Complaint Filed

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

U.S. Patent No. 8,329,198 - “Pharmaceutical Compositions and Related Methods of Delivery”

The Invention Explained

  • Problem Addressed: The patent addresses the challenge that many therapeutic agents, particularly peptides, polypeptides, and macromolecules like octreotide, have very low bioavailability when administered orally, preventing them from being effective (U.S. Patent No. 8,329,198, col. 1:19-27).
  • The Patented Solution: The invention claims to solve this problem by formulating the therapeutic agent into an oily suspension. This suspension consists of a solid hydrophilic component (containing the drug and a medium chain fatty acid salt) and a liquid hydrophobic medium, which together are designed to enhance the drug's absorption across the intestinal barrier (’198 Patent, Abstract; col. 2:19-33).
  • Technical Importance: Developing an effective oral formulation for a peptide drug like octreotide represented a significant advance, potentially replacing the need for uncomfortable and inconvenient injections for patients with chronic conditions (’198 Patent, col. 1:49-53).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" but does not specify which claims are asserted (Compl. ¶52). Claim 1 is the first independent claim and is representative of the patented composition.
  • Claim 1 of the ’198 Patent requires:
    • An enteric-coated oral dosage form comprising a composition,
    • wherein the composition comprises a suspension,
    • which comprises an admixture of a hydrophobic medium and a solid form,
    • wherein the solid form comprises a therapeutically effective amount of octreotide and at least one salt of a medium chain fatty acid,
    • wherein the at least one salt of a medium chain fatty acid is present in the composition at an amount of at least 10% by weight.
  • The complaint reserves the right to assert infringement of any of the patent’s claims, including dependent claims (Compl. ¶52).

U.S. Patent No. 8,535,695 - “Pharmaceutical Compositions and Related Methods of Delivery”

The Invention Explained

  • Problem Addressed: Similar to the ’198 patent, this patent addresses the poor oral bioavailability of therapeutic agents such as peptides and proteins (’695 Patent, col. 1:21-29).
  • The Patented Solution: The invention provides an oily suspension containing hydrophilic solid particles. These particles contain the therapeutic agent (e.g., octreotide) and are suspended in a lipophilic medium, a combination designed to facilitate absorption of the drug through the gastrointestinal wall (’695 Patent, Abstract; col. 2:22-31).
  • Technical Importance: This technology offers an alternative to injections for chronic therapies by enabling oral administration of drugs that are otherwise poorly absorbed (’695 Patent, col. 1:51-55).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" but does not specify which claims are asserted (Compl. ¶60). Claim 1 is the first independent claim.
  • Claim 1 of the ’695 Patent requires:
    • An oral dosage form comprising a composition,
    • wherein the composition comprises an admixture of a hydrophilic solid particle and a lipophilic medium,
    • wherein the hydrophilic solid particle comprises a therapeutically effective amount of octreotide and at least one salt of a medium chain fatty acid, and
    • wherein the medium chain fatty acid salt is present in the composition at an amount of 10% or more by weight.
  • The complaint reserves the right to assert infringement of any of the patent’s claims (Compl. ¶60).

U.S. Patent No. 10,238,709 - “Method of Treating Diseases”

  • Technology Synopsis: This patent addresses the treatment of acromegaly, a chronic condition caused by excess growth hormone (U.S. Patent No. 10,238,709, col. 1:18-24). The patented solution is a method of treating acromegaly by orally administering a specific dosage form of octreotide (20 mg) at least once daily, at least one hour before or two hours after a meal, to control the disease (’709 Patent, Abstract).
  • Asserted Claims: Unspecified in the complaint, which alleges infringement of "one or more claims" (Compl. ¶84). The patent contains independent method claims 1 and 9.
  • Accused Features: The proposed use of "Teva’s Proposed ANDA Product" according to its label is alleged to infringe (’709 Patent, Compl. ¶85-86).

U.S. Patent No. 10,695,397 - “Method of Treating Diseases”

  • Technology Synopsis: The patent describes a method for long-term maintenance treatment of acromegaly in patients for whom prior injectable treatment was effective (U.S. Patent No. 10,695,397, col. 31:49-55). The method involves orally administering a 20 mg octreotide dosage form twice daily, with potential for dose titration up to 80 mg/day based on monitoring of IGF-1 levels and clinical symptoms (’397 Patent, col. 32:1-12).
  • Asserted Claims: Unspecified in the complaint, which alleges infringement of "one or more claims" (Compl. ¶92). The patent contains independent method claims 1 and 9.
  • Accused Features: The proposed use of "Teva’s Proposed ANDA Product" according to its label, which is expected to mirror the label for MYCAPSSA®, is alleged to infringe (Compl. ¶93-94).

Due to the high number of patents-in-suit, and in accordance with analyst guidelines, the remaining ten patents are not analyzed in detail. They largely fall into categories of pharmaceutical compositions, methods of treating diseases such as acromegaly, or methods related to oral octreotide therapy and contraceptive use, building upon the core technology described in the lead patents.

III. The Accused Instrumentality

Product Identification

  • "Teva's Proposed ANDA Product," for which Teva submitted ANDA No. 217507 to the FDA (Compl. ¶1).

Functionality and Market Context

  • The accused product is a proposed generic version of Plaintiffs' MYCAPSSA® (octreotide) delayed-release capsules (Compl. ¶1). The complaint alleges that the proposed labeling for the ANDA Product will contain the same or substantially the same information as the labeling for MYCAPSSA® (Compl. ¶34). The product is intended for commercial manufacture, use, and sale in the United States upon FDA approval, creating a generic competitor to MYCAPSSA® for the treatment of acromegaly (Compl. ¶1, ¶28, ¶31).

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail to construct a claim chart summary. The infringement allegations are premised on Teva's filing of ANDA No. 217507, which seeks approval to market a generic version of MYCAPSSA® (Compl. ¶1). The complaint alleges that upon FDA approval, Teva will make and sell a product that infringes one or more claims of each patent-in-suit (e.g., Compl. ¶52, ¶60). The theory of infringement appears to be that because Teva's product is a generic copy intended to be substituted for MYCAPSSA®, and because its label will allegedly instruct infringing uses, the product and its use will necessarily fall within the scope of the asserted patents covering the branded drug's formulation and methods of use (e.g., Compl. ¶34, ¶53-54).

Identified Points of Contention

Lacking specific infringement contentions, analysis points to potential areas of dispute based on the asserted patent claims.

  • Compositional Questions: A central issue may be whether the specific excipients, their quantities, and the manufacturing process used for Teva’s Proposed ANDA Product result in a composition that meets all limitations of the asserted composition claims. For example, does Teva's product contain an "oily suspension" with a "solid form" comprising a "salt of a medium chain fatty acid" at a concentration of "at least 10% by weight," as required by Claim 1 of the ’198 Patent?
  • Method of Use Questions: For the asserted method patents, a dispute may arise over whether Teva’s proposed label will inevitably lead physicians and patients to practice the claimed methods. For instance, does the label for Teva’s product instruct administering a 20 mg dosage form of octreotide "at least 1 hour before a meal or at least 2 hours after a meal" for treating acromegaly, as recited in Claim 1 of the ’709 patent?

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of specific disputed claim terms. However, based on the technology, certain terms in the representative composition claims of the lead patents may become central to the dispute.

For the ’198 Patent (representative Claim 1)

  • The Term: "oily suspension"
  • Context and Importance: The definition of this term is fundamental to the scope of the composition claims. Practitioners may focus on whether this term implies specific physical properties (e.g., viscosity, particle distribution) or merely a general mixture of lipophilic and hydrophilic components.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the composition broadly as an "admixture of a hydrophobic medium (lipophilic fraction) and a solid form (hydrophilic fraction)" (’198 Patent, col. 2:20-22), which might support a construction covering a wide range of mixtures.
    • Evidence for a Narrower Interpretation: The patent also provides specific examples with particular oils (e.g., castor oil), surfactants, and other excipients, which could be argued to limit the term to suspensions with similar characteristics to those disclosed embodiments (’198 Patent, col. 16:5-17).

For the ’695 Patent (representative Claim 1)

  • The Term: "hydrophilic solid particle"
  • Context and Importance: This term defines the physical state of the active ingredient and key excipients within the formulation. The dispute could center on the required structure, size, and method of formation of the "particle" in the accused generic product.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The term "particle" is not explicitly defined with dimensional limitations in the claims, potentially allowing for a broad range of solid agglomerations or powders.
    • Evidence for a Narrower Interpretation: The specification describes processes like lyophilization or granulation to produce the solid form, suggesting that the term "particle" may be construed to require a specific method of manufacture or resulting structure (’695 Patent, col. 15:63-67).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Teva will induce infringement of the method patents. This allegation is based on the assertion that Teva's proposed package insert will instruct and encourage healthcare professionals and patients to administer the generic product in a manner that directly infringes the patented methods (e.g., Compl. ¶54, ¶70, ¶78).
  • Willful Infringement: The complaint does not explicitly allege willful infringement. However, it does allege that Teva has had knowledge of each patent since at least the date it submitted its ANDA, which included a paragraph IV certification against those patents (e.g., Compl. ¶55, ¶63). These facts could potentially form the basis for a future claim of post-filing willfulness if infringement is found.

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

No probative visual evidence provided in complaint.

The resolution of this case will likely depend on the answers to several key questions that combine claim construction with factual analysis of an unseen generic product.

  • A primary issue will be one of compositional identity: Does the precise formulation of Teva's proposed generic product, including its specific excipients and their respective quantities, fall within the scope of the composition claims as construed by the court? The case may turn on whether Teva has successfully "designed around" the specific combination of a medium chain fatty acid salt and other components required by the patents.
  • A second core question will be one of infringement by labeling: Assuming the patents are valid, will the instructions on Teva's FDA-approved label inevitably direct medical providers and patients to perform the exact steps recited in the asserted method-of-treatment claims? This will involve a detailed comparison of the label's language against the claim limitations related to dosage, timing of administration relative to meals, and the specific condition being treated.