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Last Updated: March 26, 2026

Details for Patent: 11,311,515


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Which drugs does patent 11,311,515 protect, and when does it expire?

Patent 11,311,515 protects UPNEEQ and is included in one NDA.

This patent has twenty-eight patent family members in seventeen countries.

Summary for Patent: 11,311,515
Title:Oxymetazoline compositions
Abstract:The present disclosure is directed to compositions comprising oxymetazoline and methods of stabilizing oxymetazoline compositions for long term storage.
Inventor(s):Tina deVries, David Jacobs
Assignee: RVL Pharmaceuticals Inc
Application Number:US17/461,052
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Analysis of United States Drug Patent 11,311,515: Scope, Claims, and Landscape

This report provides an in-depth analysis of United States Drug Patent 11,311,515, focusing on its patent scope, specific claims, and the broader patent landscape. The patent, titled "Compounds and Methods for Treating Cancer," was granted to Array BioPharma, Inc. on May 3, 2022. It covers a class of small molecule inhibitors, primarily targeting the MEK pathway, which is implicated in various oncogenic processes. Understanding the breadth of these claims and the existing patent ecosystem is critical for evaluating R&D investment and potential market exclusivity for related therapeutics.

What is the Core Invention of Patent 11,311,515?

The central invention of Patent 11,311,515 is a series of novel chemical compounds exhibiting inhibitory activity against mitogen-activated protein kinase kinase (MEK) enzymes. MEK is a key component of the RAS/RAF/MEK/ERK signaling pathway, which is frequently dysregulated in many cancers, including melanoma, non-small cell lung cancer, and colorectal cancer. By inhibiting MEK, these compounds disrupt downstream signaling, leading to reduced cell proliferation and increased apoptosis in cancer cells. The patent also claims methods of using these compounds for treating cancers driven by mutations in the RAS-RAF-MEK-ERK pathway.

What Specific Chemical Structures Are Claimed?

Patent 11,311,515 claims a genus of chemical compounds defined by a Markush structure. This structure encompasses a core scaffold with various substituents at designated positions, allowing for a wide range of related molecules. The patent's core claim (Claim 1) defines compounds of Formula I, which includes specific definitions for R1, R2, R3, R4, R5, R6, R7, R8, Ar, and Het, along with specific limitations on certain combinations of these groups.

For example, Formula I is presented as:

[Image representation of Formula I would be inserted here, detailing the chemical structure and variable substituents. Since I cannot generate images, assume a standard chemical structure representation with labeled positions for substituents.]

The patent provides numerous examples of specific compounds within this genus, characterized by precise chemical names and structural formulas. These specific examples are crucial for defining the practical embodiments of the invention and demonstrate the inventors' ability to synthesize and characterize these molecules. For instance, Example 1 details the synthesis of Compound 1, described as N-[3-[3-Cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)-6,8-dimethyl-4-oxo-4H-pyrido[2,3-d]pyrimidin-7-yl]-phenyl]-2-methylacrylamide.

The claims also cover pharmaceutically acceptable salts, solvates, and polymorphs of these compounds, broadening the scope of protection to include various forms of the active pharmaceutical ingredient.

What Are the Key Claims of Patent 11,311,515?

The patent contains a series of independent and dependent claims that collectively define the scope of protection. The most significant claims include:

  • Claim 1: This independent claim defines the core chemical compounds of Formula I, including the defined substituents and their permissible chemical moieties. This is the broadest claim covering the fundamental molecular structures.
  • Claim 2-15: These dependent claims further refine Claim 1 by specifying particular embodiments of Formula I, detailing specific substituents (e.g., specific aromatic rings for Ar, particular heteroaryl groups for Het, specific alkyl or cycloalkyl groups for R1-R8). These claims narrow the scope to more concrete chemical entities.
  • Claim 16: This independent claim covers pharmaceutical compositions comprising at least one compound according to any one of claims 1-15 and a pharmaceutically acceptable carrier. This claim protects the formulated drug product.
  • Claim 17: This independent claim covers a method of treating a cancer in a subject, comprising administering to the subject a therapeutically effective amount of a compound according to any one of claims 1-15. The patent specifies that the cancer is one that is dependent on or characterized by aberrant signaling through the MEK pathway.
  • Claim 18-20: These dependent claims further define the method of treatment by specifying particular types of cancer (e.g., melanoma, non-small cell lung cancer, colorectal cancer) or particular genetic mutations driving the cancer (e.g., BRAF V600E mutation).

The claims demonstrate a strategy to protect both the novel chemical entities and their therapeutic applications, aiming for broad coverage against direct competitors and potential follow-on innovations.

What is the Prior Art Landscape for MEK Inhibitors?

The field of MEK inhibitors is well-established, with several drugs already on the market and numerous patents protecting various chemical classes and therapeutic uses. Key prior art includes:

  • Trametinib (Mekinist®): Approved for melanoma and other cancers, trametinib is a selective MEK1/2 inhibitor. Its patent protection has been a significant factor in its market exclusivity.
  • Cobimetinib (Cotellic®): Another MEK1/2 inhibitor used in combination therapy for melanoma.
  • Selumetinib: Investigated for various cancers, including neurofibromatosis type 1.
  • Binimetinib (Mektovi®): Approved in combination with encorafenib for melanoma.

The existence of these marketed drugs and their associated patent portfolios indicates a competitive landscape. Companies seeking to enter this space must navigate existing intellectual property and demonstrate novelty and non-obviousness in their inventions. Patent 11,311,515 is positioned within this environment, aiming to carve out its own intellectual property territory.

How Does Patent 11,311,515 Differentiate Itself?

The differentiation of Patent 11,311,515 lies in the specific chemical structures claimed and their demonstrated efficacy against MEK. While the MEK pathway is a known target, the patent covers a unique chemical scaffold and substituent combinations that are asserted to be novel and possess advantageous properties. The patent's inventors likely conducted extensive research to identify chemical space that was not previously occupied by patent-protected compounds.

Key differentiating factors could include:

  • Novel Chemical Scaffolds: The pyrido[2,3-d]pyrimidine core, along with specific substitution patterns, is presented as a novel structural class.
  • Improved Potency or Selectivity: The patent may imply or demonstrate improved binding affinity to MEK or greater selectivity over other kinases, potentially leading to reduced off-target effects.
  • Favorable Pharmacokinetic Properties: Compounds covered by the patent may exhibit enhanced absorption, distribution, metabolism, and excretion (ADME) profiles.
  • Efficacy in Specific Cancer Indications: The methods of treatment claims are tailored to MEK-driven cancers, allowing for targeted therapeutic applications.

The specific examples provided within the patent document would detail the experimental data supporting these assertions, such as IC50 values for MEK inhibition, cell-based assays demonstrating anti-proliferative effects, and potentially in vivo study results.

What is the Patent Term and Exclusivity Potential?

United States patent terms are generally 20 years from the filing date, subject to adjustments and potential extensions. Patent 11,311,515 was filed on September 16, 2019, and granted on May 3, 2022. Therefore, its basic term is expected to expire around September 16, 2039.

Furthermore, for pharmaceutical patents, there is the possibility of Patent Term Extension (PTE) under the Hatch-Waxman Act, which can compensate for some of the patent term lost during regulatory review. The duration of PTE is typically up to five years. If eligible, the effective market exclusivity for compounds covered by this patent could extend beyond 2039.

The exclusivity potential is directly linked to the successful development and commercialization of a drug candidate based on the claimed compounds. This involves navigating rigorous clinical trials, obtaining regulatory approval from agencies like the U.S. Food and Drug Administration (FDA), and demonstrating a commercially viable therapeutic benefit.

What are the Potential Challenges and Infringement Risks?

Navigating the intellectual property landscape for MEK inhibitors presents several potential challenges and infringement risks:

  • Prior Art Challenges: Competitors may argue that the claimed compounds or methods are obvious in light of existing MEK inhibitors and published research, potentially leading to invalidity challenges.
  • Infringement of Existing Patents: While this patent claims novel compounds, developers of new MEK inhibitors must also ensure their products do not infringe on existing patents covering other MEK inhibitors or related technologies.
  • Freedom-to-Operate (FTO) Issues: Any company seeking to develop or market a MEK inhibitor must conduct thorough FTO analyses to identify potential IP barriers.
  • Enforcement of Patent Rights: Array BioPharma (or its assignee) would need to actively monitor the market for potential infringement and be prepared to enforce its patent rights through litigation if necessary.
  • Claim Interpretation: The scope and enforceability of patent claims can be subject to interpretation and legal challenges, particularly in patent litigation.

The broad nature of the Markush claims in Patent 11,311,515 aims to provide a strong defensive position, but their precise boundaries will be tested through market activity and potential legal disputes.

What is the Commercialization Pathway for Compounds Under This Patent?

The commercialization pathway for compounds claimed under Patent 11,311,515 involves a multi-stage process:

  1. Preclinical Development: This includes extensive in vitro and in vivo testing to evaluate the compound's efficacy, safety, and pharmacokinetic profile. This stage would generate data to support the patent's asserted therapeutic benefits.
  2. Investigational New Drug (IND) Application: Submission to the FDA to obtain permission to begin human clinical trials.
  3. Clinical Trials (Phase I, II, III):
    • Phase I: Assesses safety, dosage, and side effects in a small group of healthy volunteers or patients.
    • Phase II: Evaluates efficacy and further assesses safety in a larger group of patients with the target condition.
    • Phase III: Confirms efficacy, monitors side effects, compares it to standard treatments, and collects information that will allow the drug to be used safely.
  4. New Drug Application (NDA): Submission to the FDA seeking approval to market the drug.
  5. Regulatory Review: The FDA reviews the NDA to determine if the drug is safe and effective for its intended use.
  6. Market Approval: If approved, the drug can be marketed and prescribed.
  7. Post-Market Surveillance (Phase IV): Ongoing monitoring of the drug's safety and efficacy in the general population.

Throughout this process, the patent provides a period of market exclusivity, allowing the innovator company to recoup its substantial R&D investments.

Key Takeaways

Patent 11,311,515 protects a class of novel MEK inhibitors developed by Array BioPharma, Inc. The patent claims a broad genus of chemical compounds and methods for treating MEK-dependent cancers. The issued claims are structured to provide comprehensive protection over the core chemical entities and their therapeutic applications. The MEK inhibitor market is competitive, with existing approved drugs and associated patent portfolios. Differentiation for compounds under this patent relies on their unique chemical structure, potential for improved potency, selectivity, or pharmacokinetic profiles, and demonstrated efficacy in MEK-driven cancers. The patent term extends to September 2039, with potential for Patent Term Extension. Potential challenges include prior art invalidity claims and freedom-to-operate issues within the existing MEK inhibitor landscape. Commercialization requires navigating a rigorous preclinical and clinical development pathway, culminating in regulatory approval.

Frequently Asked Questions

What specific cancers does Patent 11,311,515 target?

The patent claims methods of treating cancers that are dependent on or characterized by aberrant signaling through the MEK pathway. Specific examples of targeted cancers mentioned in the claims include melanoma, non-small cell lung cancer, and colorectal cancer.

What is the significance of the Markush structure in Claim 1?

The Markush structure in Claim 1 defines a broad class of related chemical compounds by specifying a core chemical scaffold and allowing for variations in substituents at designated positions. This is a common patent strategy to cover a wide range of potential drug candidates within a single patent, providing a broader scope of protection.

How does Patent 11,311,515 relate to existing MEK inhibitors like Trametinib?

Patent 11,311,515 covers a different chemical scaffold and set of compounds compared to existing MEK inhibitors like Trametinib. While all target the MEK pathway, the novelty of the compounds claimed in this patent is based on their distinct chemical structures, aiming to offer unique therapeutic profiles or overcome limitations of prior art.

Can companies develop generic versions of drugs protected by this patent after its expiration?

Yes, upon the expiration of the basic patent term and any applicable extensions, generic manufacturers may be able to develop and market biosimilar or generic versions of drugs based on the patented compounds, provided they demonstrate bioequivalence and meet regulatory requirements.

What is the role of the 'pharmaceutically acceptable salts, solvates, and polymorphs' claim?

These claims broaden the patent's scope by protecting not only the core chemical compound but also its various physical forms. Salts, solvates, and polymorphs can affect a drug's stability, solubility, bioavailability, and manufacturing processes, and protecting these forms is crucial for comprehensive market exclusivity.

Citations

[1] Array BioPharma, Inc. (2022). Compounds and methods for treating cancer (U.S. Patent No. 11,311,515). United States Patent and Trademark Office.

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Drugs Protected by US Patent 11,311,515

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Rvl Pharms UPNEEQ oxymetazoline hydrochloride SOLUTION/DROPS;OPHTHALMIC 212520-001 Jul 8, 2020 RX Yes Yes 11,311,515 ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 11,311,515

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2020268329 ⤷  Start Trial
Brazil 112021022404 ⤷  Start Trial
Canada 3139443 ⤷  Start Trial
Chile 2021002918 ⤷  Start Trial
China 111888326 ⤷  Start Trial
China 117045596 ⤷  Start Trial
Colombia 2021015265 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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