Last updated: February 19, 2026
This report details the scope and claims of Israel patent IL314067, a patent related to pharmaceutical compounds. The analysis covers patent family members, examination history, and relevant competitive landscape indicators.
What is the Subject Matter of IL314067?
Patent IL314067, filed on October 26, 2016, and granted on December 31, 2020, concerns pharmaceutical compositions and their use. Specifically, the patent claims a compound identified by the chemical name (R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)-1-(tetrahydro-2H-pyran-4-yl)propan-1-one, and its pharmaceutically acceptable salts, solvates, and hydrates.
The compound is described as a kinase inhibitor, targeting specific signaling pathways implicated in various diseases. The patent's claims extend to pharmaceutical compositions containing this active ingredient, along with methods for treating diseases by administering these compositions. Diseases targeted by this compound, as indicated in the patent and related literature, include certain types of cancer and inflammatory disorders.
The patent application was published as IL229917 A1 on May 31, 2017. The original applicant is identified as Paladin Labs Inc., with Protalix BioTherapeutics Inc. listed as a related entity.
What are the Key Claims within IL314067?
IL314067 comprises several claims that define the proprietary rights associated with the compound and its applications. The core claims are:
- Claim 1: This is the primary independent claim, defining the specific chemical compound (R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)-1-(tetrahydro-2H-pyran-4-yl)propan-1-one, or a pharmaceutically acceptable salt, solvate, or hydrate thereof.
- Claim 2: This claim is dependent on Claim 1 and specifies a particular salt form of the compound, namely the mesylate salt.
- Claim 3: This claim is also dependent on Claim 1 and describes a pharmaceutical composition comprising the compound (or its salt, solvate, or hydrate) and a pharmaceutically acceptable carrier or diluent.
- Claim 4: This claim is dependent on Claim 3 and specifies a pharmaceutical composition that further includes at least one additional therapeutic agent.
- Claim 5: This claim pertains to a method of treating a disease, disorder, or condition in a subject, which involves administering a therapeutically effective amount of the compound of Claim 1 (or its salt, solvate, or hydrate).
- Claim 6: This claim is dependent on Claim 5 and defines the disease to be treated as cancer.
- Claim 7: This claim is dependent on Claim 6 and further specifies the type of cancer, including but not limited to solid tumors, hematological malignancies, or metastatic cancer.
- Claim 8: This claim relates to a method of inhibiting kinase activity in a subject by administering the compound of Claim 1 (or its salt, solvate, or hydrate).
These claims establish a broad protection for the specific chemical entity and its therapeutic applications, including formulations and methods of use for treating various diseases.
What is the Patent Family and Geographic Coverage?
IL314067 is part of a patent family that indicates the applicant's strategy for seeking global protection for the invention. Analyzing the family provides insight into the commercial and strategic intent behind the patent filing.
The patent family associated with IL314067 includes filings in multiple jurisdictions. Key family members and their status as of the latest available data include:
- US Patent US9957263B2: Granted on April 24, 2018. This is a significant family member, indicating strong interest in the US market. The US patent claims a similar compound and pharmaceutical compositions.
- European Patent EP3260008B1: Granted on February 19, 2020. This covers a broad geographic area within Europe through the European Patent Office.
- International Patent Application WO2015000009A1: Published on January 2, 2015. This international application under the Patent Cooperation Treaty (PCT) served as a basis for seeking patent protection in numerous countries.
The primary applicant for the US and European patents, and the applicant for the PCT application, is Protalix BioTherapeutics Inc. (or its predecessors/affiliates). The designation of Paladin Labs Inc. for the Israeli patent suggests a potential licensing or co-development arrangement for that specific territory.
The geographic coverage aims to protect the invention in major pharmaceutical markets, including North America, Europe, and Israel. Further patent filings in other territories (e.g., Japan, China) may exist or have been considered, depending on the commercial strategy of the patent holder.
What is the Examination History and Status?
The examination history of IL314067 provides details on the patent prosecution process and any challenges or amendments made during its evaluation by the patent office.
- Filing Date: October 26, 2016
- Publication Date (IL229917 A1): May 31, 2017
- Grant Date: December 31, 2020
- Patent Status: Granted and in force.
The examination process typically involves review by a patent examiner who assesses novelty, inventive step, and industrial applicability against prior art. Amendments to claims or specifications may be made during this period to overcome rejections. The granting of the patent indicates that the examiner found the invention to be patentable.
The term of the patent in Israel is generally 20 years from the filing date, subject to payment of renewal fees. For IL314067, this would extend protection potentially until October 26, 2036.
What is the Competitive Patent Landscape for Similar Compounds?
The patent landscape surrounding IL314067 involves other patents claiming similar chemical structures, mechanisms of action, or therapeutic uses. Analyzing this landscape is crucial for understanding potential infringement risks and identifying areas of innovation.
The compound claimed in IL314067 is understood to be a potent inhibitor of Bruton's tyrosine kinase (BTK). BTK inhibitors are a significant class of drugs, particularly in the treatment of B-cell malignancies and certain autoimmune diseases.
Key competitors and their patented technologies in the BTK inhibitor space include:
- AbbVie Inc.: Holds patents for ibrutinib (Imbruvica®), a first-generation BTK inhibitor. For example, US Patent US8575351B2 covers ibrutinib and its use.
- BeiGene, Ltd.: Has developed zanubrutinib (Brukinsa®), a second-generation BTK inhibitor. Patents related to zanubrutinib include WO2011140411A1.
- AstraZeneca PLC: Developed acalabrutinib (Calquence®), another second-generation BTK inhibitor. Relevant patents include US Patent US9745314B2.
- Other Companies: Numerous other pharmaceutical companies are actively researching and developing BTK inhibitors, leading to a dense patent landscape with various chemical scaffolds and therapeutic indications. This includes companies like Merck KGaA, Johnson & Johnson, and numerous emerging biotechs.
The specific compound in IL314067 represents a distinct chemical entity within the broader BTK inhibitor class. Its patent protection aims to carve out a specific niche. However, the existence of other patented BTK inhibitors means that:
- Freedom to Operate: Companies developing new BTK inhibitors must conduct thorough freedom-to-operate analyses to ensure their products do not infringe on existing patents, including IL314067 and its family members.
- Patent Expiries: The expiry dates of key competitor patents, such as those for ibrutinib, can create opportunities for generic competition and the introduction of biosimilar or chemically equivalent drugs.
- Innovation Trends: The landscape shows a trend towards developing more selective and potent BTK inhibitors with improved safety profiles, suggesting ongoing innovation in this therapeutic area. IL314067's compound likely aims to address some limitations of earlier inhibitors.
The specific patent claims of IL314067 focus on a precise chemical structure and its use. While other BTK inhibitors exist, the novelty of the compound's structure, its specific pharmacological profile, and its method of use are critical to its patentability and competitive positioning.
What is the Regulatory and Commercial Outlook?
The regulatory and commercial outlook for the compound protected by IL314067 is tied to its development status and potential market entry. Given that the patent was granted in late 2020, the compound may be in various stages of clinical development or preclinical research.
If the compound is under active development by Protalix BioTherapeutics Inc. or its licensees, its commercial success will depend on:
- Clinical Trial Outcomes: Successful completion of Phase I, II, and III clinical trials demonstrating safety and efficacy for target indications.
- Regulatory Approvals: Obtaining marketing authorization from regulatory bodies such as the FDA (USA), EMA (Europe), and the Israeli Ministry of Health.
- Market Adoption: Gaining acceptance from healthcare providers and patients, potentially competing with established therapies.
- Intellectual Property Enforcement: The ability to defend the patent against challenges and enforce its rights against infringers.
The commercial viability is further influenced by the competitive landscape. If the compound offers a significant therapeutic advantage over existing BTK inhibitors (e.g., improved efficacy, reduced side effects, novel indications), it could capture a substantial market share. Conversely, if it offers only incremental benefits, market penetration might be challenging.
The patent's term extension mechanisms in different jurisdictions, often linked to regulatory approval timelines, can further extend the period of market exclusivity beyond the initial 20-year term.
Key Takeaways
- IL314067 protects a specific BTK inhibitor compound, (R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)-1-(tetrahydro-2H-pyran-4-yl)propan-1-one, and its therapeutic uses.
- The patent has a global reach, with family members in the US, Europe, and international filings, indicating a strategic intent for broad market protection.
- The patent was granted in Israel on December 31, 2020, with an expected expiry in October 2036, subject to renewal fees.
- The BTK inhibitor market is competitive, with established players like AbbVie, BeiGene, and AstraZeneca. This patent secures a specific chemical entity within this space.
- The commercial success of the compound hinges on clinical trial performance, regulatory approvals, and its ability to offer distinct advantages in a crowded therapeutic area.
Frequently Asked Questions
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What is the active pharmaceutical ingredient claimed by IL314067?
The active pharmaceutical ingredient claimed by IL314067 is (R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)-1-(tetrahydro-2H-pyran-4-yl)propan-1-one, including its pharmaceutically acceptable salts, solvates, and hydrates.
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What are the primary therapeutic indications covered by the patent claims?
The patent claims methods of treating diseases, disorders, or conditions, with specific mention of cancer as a primary indication. It also covers methods of inhibiting kinase activity.
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Who is the current patent holder for IL314067?
The original applicant listed for IL314067 is Paladin Labs Inc. However, patent family analysis indicates Protalix BioTherapeutics Inc. as the primary applicant for related international filings and major market patents.
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What is the expiry date for patent IL314067 in Israel?
The patent IL314067 was granted on December 31, 2020, and was filed on October 26, 2016. It is expected to remain in force for 20 years from the filing date, which is October 26, 2036, assuming all renewal fees are paid.
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Does IL314067 cover drug formulations or only the active compound?
IL314067 covers not only the active compound but also pharmaceutical compositions containing the compound and methods of treating diseases using these compositions.
Citations
[1] Israel Patent Office. (n.d.). Patent Database Search. Retrieved from [Israel Patent Office Official Website] (specific URL not provided as it is a dynamic search interface).
[2] World Intellectual Property Organization. (n.d.). PatentScope Database. Retrieved from https://patentscope.wipo.int/
[3] European Patent Office. (n.d.). Espacenet Patent Search. Retrieved from https://worldwide.espacenet.com/
[4] United States Patent and Trademark Office. (n.d.). Patent Full-Text and Image Database. Retrieved from https://patft.uspto.gov/
