DCT
1:25-cv-00928
Novartis Pharma Corp v. Teva Pharma Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Novartis Pharmaceuticals Corporation (Delaware)
- Defendant: Teva Pharmaceuticals, Inc. (Delaware), Teva Pharmaceuticals USA, Inc. (Delaware), and Teva Pharmaceutical Industries Ltd. (Israel)
- Plaintiff’s Counsel: McCarter & English, LLP; Williams & Connolly LLP
- Case Identification: 1:25-cv-00928, D. Del., 07/24/2025
- Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because the Teva entities are incorporated in Delaware or, in the case of the Israeli parent company, are subject to personal jurisdiction in the district.
- Core Dispute: Plaintiff alleges that Defendant’s planned generic version of the cancer drug Mekinist® will infringe five patents related to specific pharmaceutical compositions of the drug trametinib dimethyl sulfoxide.
- Technical Context: The technology concerns pharmaceutical formulations for trametinib, a MEK inhibitor used to treat certain melanomas, focusing on stability, solubility, and bioavailability through specific excipients, particle sizes, and solvate forms.
- Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA with a “Paragraph IV” certification, asserting that the patents-in-suit are invalid, unenforceable, or will not be infringed by its proposed generic product.
Case Timeline
| Date | Event |
|---|---|
| 2010-12-20 | Priority Date for ’304, ’706, ’941, and ’021 Patents |
| 2013-11-12 | U.S. Patent No. 8,580,304 Issued |
| 2015-10-13 | U.S. Patent No. 9,155,706 Issued |
| 2016-03-01 | U.S. Patent No. 9,271,941 Issued |
| 2016-07-26 | U.S. Patent No. 9,399,021 Issued |
| 2025-06-09 | Teva Notifies Novartis of ANDA Filing |
| 2025-07-24 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,580,304 - “Pharmaceutical Composition”
The Invention Explained
- Problem Addressed: The patent describes challenges in formulating the active compound, noting that it can revert to an insoluble form when exposed to moisture, suffer from slow dissolution from solid dosage forms, and exhibit photo-instability. (’304 Patent, col. 4:3-9).
- The Patented Solution: The invention provides a solid oral pharmaceutical composition of trametinib dimethyl sulfoxide solvate that uses specific formulation parameters—such as excipients that are substantially free of water, controlled particle size, and limitations on the amount of unsolvated drug—to improve stability and achieve a desirable pharmacokinetic profile for effective treatment. (’304 Patent, col. 5:1-35; Abstract).
- Technical Importance: This formulation approach addresses critical manufacturing and therapeutic delivery issues for a low-solubility active pharmaceutical ingredient, aiming to ensure consistent dosing, bioavailability, and stability on a commercial scale. (’304 Patent, col. 4:10-15).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claim 8. (Compl. ¶54).
- Independent Claim 1 requires:
- A pharmaceutical tablet comprising an amount of the drug N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide dimethyl sulfoxide solvate.
- The tablet contains from about 25% to about 89% by weight of one or more excipients.
- The amount of unsolvated drug does not exceed about 20%.
- At least 50% of the drug particles have a particle size of 30 micron or less.
- The complaint reserves the right to assert additional claims. (Compl. ¶61).
U.S. Patent No. 9,155,706 - “Pharmaceutical Composition”
The Invention Explained
- Problem Addressed: The patent addresses the same formulation challenges as the ’304 Patent, including the compound's tendency to desolvate into an insoluble form, its slow dissolution, and its photo-instability, all of which can negatively impact in vivo administration. (’706 Patent, col. 4:3-9).
- The Patented Solution: The invention provides a solid oral pharmaceutical composition of the trametinib dimethyl sulfoxide solvate where the drug particles are micronized, with at least 50% having a particle size of 30 microns or less. This approach aims to improve the exposure and absorption profile of the drug upon administration. (’706 Patent, col. 5:4-13; Abstract).
- Technical Importance: Micronization is a key technique for improving the bioavailability of poorly soluble drugs by increasing the surface area available for dissolution, thereby enhancing the consistency and efficacy of the therapeutic. (’706 Patent, col. 36:43-50).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claim 8. (Compl. ¶78).
- Independent Claim 1 requires:
- A pharmaceutical tablet comprising an amount of the drug N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide dimethyl sulfoxide solvate.
- Wherein at least 50% of the drug particles have a particle size of 30 microns or less.
- Wherein the drug particles are micronized.
- The complaint reserves the right to assert additional claims. (Compl. ¶84).
U.S. Patent No. 9,271,941 - “Pharmaceutical Composition”
- Technology Synopsis: This patent covers pharmaceutical tablets containing trametinib dimethyl sulfoxide solvate with specific formulation characteristics to ensure stability and bioavailability. The claims focus on tablets containing about 25% to 89% by weight of excipients that are substantially free of water and/or have at least 50% of drug particles with a particle size of 30 microns or less. (’941 Patent, col. 42:50-col. 43:4).
- Asserted Claims: Independent claim 1 and dependent claim 8. (Compl. ¶101).
- Accused Features: Teva’s ANDA Product is alleged to be a pharmaceutical tablet containing the claimed solvate, formulated with excipients that are substantially free of water, and having at least 50% of its drug particles sized at 30 microns or less. (Compl. ¶¶102-104).
U.S. Patent No. 9,399,021 - “Pharmaceutical Composition”
- Technology Synopsis: This patent covers pharmaceutical tablets containing trametinib dimethyl sulfoxide solvate where the drug particles are micronized and/or at least 50% of the particles have a size of 30 microns or less. This invention aims to address poor drug exposure and absorption by controlling particle size to enhance dissolution. (’021 Patent, col. 5:4-13).
- Asserted Claims: Independent claim 1 and dependent claim 8. (Compl. ¶124).
- Accused Features: Teva’s ANDA Product is alleged to be a pharmaceutical tablet containing the claimed solvate wherein the drug particles are micronized and have a particle size of 30 microns or less for at least 50% of the particles. (Compl. ¶¶125-127).
III. The Accused Instrumentality
- Product Identification: Defendant’s Abbreviated New Drug Application (“ANDA”) No. 220040 product (“Teva’s ANDA Product”), which is a proposed generic version of Mekinist® (trametinib dimethyl sulfoxide) tablets in 0.5 mg and 2 mg dosages. (Compl. ¶3).
- Functionality and Market Context: The accused product is an anticancer medication indicated for the treatment of certain types of melanoma. (Compl. ¶44). By filing an ANDA, Defendant seeks FDA approval to market a generic equivalent to Plaintiff’s branded drug, Mekinist®, prior to the expiration of the patents-in-suit. (Compl. ¶3). The act of filing the ANDA for a product that, if approved, would meet the limitations of the patents-in-suit constitutes a statutory act of infringement. (Compl. ¶59). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
’304 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a pharmaceutical tablet comprising ... N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)...]phenyl}acetamide dimethyl sulfoxide solvate... | Teva’s ANDA Product is a pharmaceutical tablet that contains trametinib dimethyl sulfoxide solvate. | ¶55 | col. 41:21-30 |
| wherein... the tablet contains from about 25% to about 89% by weight of one or more excipients... | Teva’s ANDA Product contains from about 25% to about 89% by weight of one or more excipients. | ¶56 | col. 41:31-35 |
| the amount of unsolvated drug does not exceed about 20%... | The amount of unsolvated drug in Teva’s ANDA Product does not exceed about 20%. | ¶57 | col. 42:29-32 |
| at least 50% of the drug particles have a particle size of 30 micron or less. | At least 50% of the drug particles in Teva’s ANDA Product have a particle size of 30 micron or less. | ¶58 | col. 42:49-51 |
- Identified Points of Contention:
- Scope Questions: The case may raise questions regarding the scope of the term "about" as it applies to the claimed ranges for excipient weight (25-89%) and unsolvated drug amount (not exceeding 20%). The interpretation of this term could be central to determining literal infringement.
- Technical Questions: A key factual question will be whether Teva’s ANDA Product, which is not publicly available, actually meets the claimed particle size and unsolvated drug limitations. (Compl. ¶46). The litigation will depend on discovery into the precise physical and chemical characteristics of the accused product.
’706 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a pharmaceutical tablet comprising ... N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)...]phenyl}acetamide dimethyl sulfoxide solvate... | Teva’s ANDA Product is a pharmaceutical tablet that contains trametinib dimethyl sulfoxide solvate. | ¶79 | col. 42:1-10 |
| wherein at least 50% of the drug particles have a particle size of 30 microns or less... | At least 50% of the drug particles in Teva’s ANDA Product have a particle size of 30 microns or less. | ¶80 | col. 42:11-13 |
| and wherein the drug particles are micronized. | The drug particles are micronized in Teva’s ANDA Product. | ¶81 | col. 42:14-15 |
- Identified Points of Contention:
- Scope Questions: The dispute may focus on the definition of "micronized." While the patent provides a definition related to particle size reduction, the parties could contest whether Teva's process for manufacturing its active pharmaceutical ingredient constitutes "micronization" as understood in the art and described in the patent.
- Technical Questions: As with the ’304 Patent, infringement will depend on whether Teva’s ANDA Product actually has the particle size distribution required by the claim. The complaint’s allegations are made "on information and belief," indicating that this is a question to be resolved through discovery.
V. Key Claim Terms for Construction
The Term: "substantially free of water" (from asserted patents, e.g., '941 Patent, Claim 1)
Context and Importance: This term is central to the patents' claimed solution for improving the stability of the drug solvate, which is sensitive to moisture. Practitioners may focus on this term because its definition will determine whether a generic formulation with trace amounts of water infringes. The dispute will likely concern how much moisture is permissible before an excipient is no longer "substantially free" of water.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The use of "substantially" suggests the patentee did not intend a completely anhydrous standard, allowing for some minor or incidental amount of water that does not materially affect the invention's stability objective.
- Evidence for a Narrower Interpretation: The patent specification provides a specific example, stating that "it is contemplated that the excipient could contain minor amounts of water, for example: about 5% by weight or less, suitably about 2.5% by weight of less, suitably about 1% by weight of less." (’941 Patent, col. 22:65-col. 23:2). A defendant may argue this language limits the term to these specified low percentages.
The Term: "micronized" (from asserted patents, e.g., '706 Patent, Claim 1)
Context and Importance: Micronization is key to achieving the claimed bioavailability and dissolution profile. The infringement analysis will hinge on whether Teva's manufacturing process for its drug substance falls within the patent’s definition of this term.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A plaintiff might argue that any process that achieves the claimed particle size distribution (at least 50% of particles are 30 microns or less) inherently satisfies the "micronized" limitation, as the term is functionally defined by its result.
- Evidence for a Narrower Interpretation: The specification explicitly defines the term: "By the term micronized, as used herein, is meant the standard usage in the art that the drug particles are processed, for example by milling, bashing and/or grinding, to significantly reduce particle size over those produced naturally during chemical synthesis." (’706 Patent, col. 36:35-42). A defendant could argue that its particle size is achieved through crystallization control or another method not involving "milling, bashing and/or grinding," and thus its particles are not "micronized" even if they meet the size requirement.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Teva plans and intends to actively induce infringement upon ANDA approval. (Compl. ¶¶63, 86, 109, 132). This allegation is based on the assertion that Teva's proposed product labeling will direct and encourage physicians and patients to use the generic product in a manner that infringes the patents. (Compl. ¶¶62, 85, 108, 131). The complaint alleges Teva is acting with knowledge of the patents and a specific intent to infringe. (Compl. ¶¶63, 86).
- Willful Infringement: The complaint does not contain a formal count for willful infringement. However, it alleges that Teva had knowledge of the patents-in-suit via the FDA's Orange Book listing and Teva's own notice letter, and that it "knowingly and deliberately challenged Novartis's patent rights." (Compl. ¶¶18, 51, 63-64). These allegations could potentially support a future claim for enhanced damages or a finding of an exceptional case for attorneys' fees under 35 U.S.C. § 285, which is requested in the prayer for relief. (Prayer for Relief ¶e).
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this case will likely depend on the answers to two primary questions:
- A core issue will be one of definitional scope: How will the court construe claim terms with inherent flexibility, such as "about" and "substantially free of water"? The degree of numerical precision required by these terms will be critical in determining whether Teva’s product, which may be formulated to the edge of the claimed ranges, literally infringes.
- A key evidentiary question will be one of technical proof: What are the actual, measured physical characteristics of Teva's ANDA product? As the product is not yet on the market, the case will turn on technical evidence obtained through discovery regarding its particle size distribution, percentage of unsolvated drug, and the specific processes used to manufacture it, particularly whether those processes constitute "micronization" as defined in the patents.