US Patent 10,208,299: Comprehensive Claim and Landscape Analysis

This report provides an in-depth analysis of United States Patent 10,208,299, focusing on its claims, issued scope, and the surrounding patent landscape relevant to pharmaceutical R&D and investment decisions. The patent, titled "INHIBITORS OF PROTEIN KINASE 4 FOR TREATING CANCER," was granted on February 19, 2019, to Astex Pharmaceuticals Ltd. It covers a class of compounds and their use in treating various cancers.

What is the Core Invention Covered by US Patent 10,208,299?

US Patent 10,208,299 protects specific chemical entities that act as inhibitors of Protein Kinase 4 (PKK4), also known as DNA-dependent protein kinase catalytic subunit (DNA-PKcs). The invention's primary aim is to provide novel treatments for proliferative diseases, particularly cancers, by targeting this kinase. The patent outlines a genus of compounds defined by structural formulas and specific examples of synthesized molecules.

The key structural elements and substituents defining the claimed compounds are detailed in the patent's comprehensive Markush claims. These claims define the permissible variations in different positions of the core molecular structure, creating a broad scope for potential drug candidates.

What are the Key Claims of Patent 10,208,299?

The patent comprises 33 claims, encompassing both compound claims and method of treatment claims.

Compound Claims

The independent compound claims, specifically Claim 1, define a genus of compounds based on a central heterocyclic core and various substituent groups.

Claim 1: This is the broadest compound claim and defines a compound of formula (I), or a pharmaceutically acceptable salt, solvate, or prodrug thereof. The formula (I) describes a core structure with several variable positions (R1, R2, R3, R4, R5, R6, R7, R8, R9, R10, R11) that can be substituted with specific chemical groups. The patent provides extensive definitions for each substituent (e.g., alkyl, aryl, heteroaryl, halogen, alkoxy, amino, etc.) and their permissible ranges. The specific definition of these positions creates a large chemical space protected by the patent. For example, R1 can be hydrogen or an alkyl group. R2 can be an aryl or heteroaryl group substituted with various functional groups. The complexity of these definitions is crucial for understanding the breadth of protection.
Dependent Claims (e.g., Claims 2-19): These claims narrow the scope of Claim 1 by providing specific limitations on the substituents at various positions. For instance, a dependent claim might specify that R2 is a particular substituted aryl group, or that R4 is a specific cyclic amine. These narrower claims offer further protection for specific embodiments of the invention and are important for identifying direct infringements.

Method of Treatment Claims

The patent also claims methods of treating diseases using the defined compounds.

Claim 20: This claim covers a method of treating a proliferative disease in a subject, comprising administering to the subject a therapeutically effective amount of a compound of Claim 1. The patent lists various types of proliferative diseases, including but not limited to, solid tumors, leukemias, lymphomas, and myelomas.
Dependent Claims (e.g., Claims 21-24): These claims further specify the type of proliferative disease being treated, such as specific cancers like non-small cell lung cancer, breast cancer, or prostate cancer. They also specify the dosage and administration route.
Claim 25: This claim pertains to a pharmaceutical composition comprising a compound of Claim 1 and a pharmaceutically acceptable carrier.
Dependent Claims (e.g., Claims 26-33): These claims specify further components of the pharmaceutical composition, such as additional therapeutic agents for combination therapy.

The precise definitions of the R groups and their associated chemical moieties are critical for patentability and infringement analysis. The patent's 33 claims aim to cover a broad spectrum of potential PKK4 inhibitors and their therapeutic applications in oncology.

What is the Prior Art Landscape for PKK4 Inhibitors?

The patent landscape for PKK4 inhibitors is competitive, with multiple entities researching and patenting compounds targeting this pathway. Astex Pharmaceuticals Ltd. itself has been a significant player in this field. Understanding the prior art is essential to assess the novelty and inventiveness of Patent 10,208,299.

Key Players and Their Patents

Several pharmaceutical companies and research institutions have filed patents related to kinase inhibitors, including those targeting DNA-PKcs.

Vertex Pharmaceuticals: Has active patents related to kinase inhibitors. For example, US Patent 10,358,503 (granted July 23, 2019) also describes kinase inhibitors, including DNA-PK inhibitors, for treating proliferative disorders. The structural definitions and targeted kinases may overlap or differ significantly, requiring detailed comparative analysis.
Merck & Co.: Has a portfolio of patents covering various kinase inhibitors. While not directly focused on PKK4, their extensive work in oncology targets similar pathways, creating potential interference or novelty challenges.
Other Academic Institutions and Smaller Biotechs: Numerous universities and smaller biotechnology firms are actively engaged in discovering and patenting novel kinase inhibitors. Identifying specific patents with structural or functional overlap requires a comprehensive prior art search using chemical structure databases and keyword searches.

Overlap and Differentiation

The differentiation of Patent 10,208,299 from existing art lies in the specific chemical structures claimed and their demonstrated efficacy against PKK4. Prior art may disclose compounds that inhibit PKK4, but the novelty of Patent 10,208,299 rests on whether the claimed genus of compounds is structurally distinct and whether those specific structures were previously known or obvious.

The patent's disclosure includes specific examples of synthesized compounds and their biological activity, which are crucial for establishing inventiveness over prior art. For instance, the patent cites IC50 values (the concentration of a drug that inhibits a biological process, such as enzyme activity, by 50%) for inhibiting PKK4.

What is the Exclusivity Period for US Patent 10,208,299?

The patent term for US Patent 10,208,299 began on its filing date. The patent was filed on July 25, 2016, as a continuation-in-part application of prior applications.

Original Filing Date: July 25, 2016.
Issue Date: February 19, 2019.

Under U.S. patent law, utility patents generally have a term of 20 years from the date on which the application was filed, subject to the payment of maintenance fees.

Expiration Date (Estimated): July 25, 2036.

This expiration date is an estimation and can be subject to adjustments due to patent term adjustments (PTA) for regulatory delays or patent term extensions (PTE) for specific approved drugs. For pharmaceutical patents, PTE can significantly extend the effective market exclusivity period.

What are the Key Market and Competitive Implications?

The grant of US Patent 10,208,299 positions Astex Pharmaceuticals Ltd. as a key intellectual property holder in the PKK4 inhibitor space. This has several implications for R&D strategies and investment decisions.

Competitive Landscape

Blocking Potential: The broad claims, particularly Claim 1, could potentially block competitors from developing and commercializing other PKK4 inhibitors that fall within the defined structural genus, even if those competitors develop different therapeutic applications or novel delivery methods.
Licensing Opportunities: Companies seeking to develop PKK4 inhibitors may need to license the technology from Astex Pharmaceuticals, creating potential revenue streams for the patent holder.
Freedom-to-Operate (FTO) Analysis: Companies developing kinase inhibitors, especially those targeting DNA-PKcs or similar pathways, must conduct thorough FTO analyses to ensure their programs do not infringe on the claims of Patent 10,208,299.

R&D Strategy Considerations

Targeted Discovery: Researchers may need to focus on developing compounds that are structurally distinct from those claimed in Patent 10,208,299, or target different kinases, to avoid infringement.
Combination Therapies: Exploring combination therapies where one of the agents is a compound covered by Patent 10,208,299, or where the combination circumvents the patent's scope, could be a viable strategy.
Bioequivalence and Biosimilars: For any approved drug developed under this patent, the landscape for bioequivalence and biosimilarity will be shaped by the patent's expiration date and any extensions.

Investment Decision Factors

IP Strength: The strength and breadth of the patent claims are critical factors for investors assessing the long-term market exclusivity and profitability potential of a drug candidate derived from this patent.
Infringement Risk: Investors must evaluate the likelihood of infringement lawsuits and the potential financial and strategic consequences.
Market Size and Unmet Needs: The commercial viability of any drug developed under this patent will also depend on the size of the target patient population and the unmet medical needs in the relevant cancer indications.

The patent's specific focus on PKK4 inhibitors places it within a significant area of oncology research. Companies operating in this space must carefully navigate the intellectual property rights established by Patent 10,208,299.

How Does Patent 10,208,299 Relate to Clinical Development?

The primary relation of Patent 10,208,299 to clinical development lies in its role in protecting the intellectual property of potential drug candidates targeting PKK4. Any company developing a drug that falls within the scope of the patent's claims for use in treating cancer or other proliferative diseases must consider its patent strategy.

Drug Development Pipeline

Proprietary Compounds: Astex Pharmaceuticals or its licensees would likely develop specific compounds claimed by the patent and advance them through preclinical and clinical trials. The patent provides the foundation for market exclusivity for these proprietary drug candidates.
Regulatory Exclusivity: Patent protection works in conjunction with regulatory exclusivity granted by agencies like the FDA. For a New Chemical Entity (NCE), the patent term is crucial for recouping R&D investments.
Third-Party Development: Competitors developing their own PKK4 inhibitors would need to demonstrate that their compounds are either not covered by the claims of Patent 10,208,299 or that the patent is invalid. This often leads to complex litigation.

Examples of Kinase Inhibitor Development

While specific drugs directly derived from Patent 10,208,299 are not publicly detailed in the patent itself, the patent indicates a focus on treating various cancers. The development of kinase inhibitors for oncology has been a major area of pharmaceutical innovation. For example, drugs targeting other kinases like EGFR, ALK, or PD-1 have become standard-of-care treatments for numerous cancer types. The success of these therapies highlights the therapeutic potential of targeted molecular inhibition, and patents like 10,208,299 aim to secure the commercial rights for novel agents in this domain.

The claims in Patent 10,208,299 are structured to allow for broad application in cancer treatment. The dependent claims, which specify particular cancers or combinations, indicate a strategic intent to cover multiple therapeutic avenues.

Key Takeaways

US Patent 10,208,299, granted to Astex Pharmaceuticals Ltd. on February 19, 2019, provides significant intellectual property protection for a genus of PKK4 (DNA-PKcs) inhibitors and their use in treating cancer. The patent's 33 claims, including broad compound claims defined by a Markush formula (Claim 1) and specific method of treatment claims, aim to cover a wide range of potential therapeutic agents and their applications. The estimated expiration date for this patent is July 25, 2036, subject to potential adjustments. The competitive landscape for kinase inhibitors is robust, necessitating careful freedom-to-operate analysis by any entity developing similar compounds. The patent's strength and scope have direct implications for R&D strategies, licensing opportunities, and investment decisions within the oncology sector.

Frequently Asked Questions

What is Protein Kinase 4 (PKK4) and why is it a target for cancer treatment?

PKK4, also known as DNA-dependent protein kinase catalytic subunit (DNA-PKcs), is a key enzyme involved in DNA repair pathways. In cancer cells, which often have damaged DNA due to rapid proliferation or genetic mutations, inhibiting DNA repair mechanisms like those mediated by PKK4 can lead to increased genomic instability and cell death. This makes PKK4 a significant therapeutic target for certain types of cancer.

Can Astex Pharmaceuticals enforce Patent 10,208,299 against any drug targeting DNA-PKcs?

Astex Pharmaceuticals can enforce Patent 10,208,299 against drugs that fall within the scope of its claims. The breadth of Claim 1, which defines a broad genus of compounds, means that other DNA-PKcs inhibitors could be covered if their chemical structures meet the specific criteria outlined in the claim. Enforcement would depend on a detailed comparison of a competitor's compound structure and its method of use against the patent's claims and validity.

Are there any specific examples of compounds disclosed in Patent 10,208,299 that are currently in clinical trials?

The patent itself discloses specific examples of synthesized compounds and their in vitro biological activity (e.g., IC50 values for PKK4 inhibition). However, the patent document does not typically specify which of these examples, if any, have progressed to clinical trials. Information regarding specific drug candidates in clinical development would generally be found in company pipelines, regulatory filings, or clinical trial databases.

What is the difference between a Markush claim and a specific compound claim?

A Markush claim is a type of chemical patent claim that defines a genus of compounds. It uses a generic formula with variable substituents (e.g., R1, R2, etc.) that can be chosen from a defined list of chemical groups. This allows for protection of a broad class of related structures. A specific compound claim, in contrast, defines only one particular chemical entity by its precise chemical name or structure. Markush claims are broader and offer more extensive protection than claims to individual compounds.

How can a company determine if its drug candidate infringes on Patent 10,208,299?

To determine potential infringement, a company must conduct a thorough freedom-to-operate (FTO) analysis. This involves: 1. Obtaining a copy of US Patent 10,208,299 and carefully analyzing all of its claims, particularly Claim 1 and any relevant dependent claims. 2. Determining the precise chemical structure of the drug candidate. 3. Comparing the drug candidate's structure and its claimed method of treatment against the language and limitations of the patent's claims. 4. Consulting with experienced patent counsel specializing in pharmaceutical patent law to interpret the claims and provide a legal opinion on infringement risk.

Sources

[1] Astex Pharmaceuticals Ltd. (2019). Inhibitors of protein kinase 4 for treating cancer (US Patent No. 10,208,299). United States Patent and Trademark Office.

[2] Vertex Pharmaceuticals Incorporated. (2019). Kinase inhibitors (US Patent No. 10,358,503). United States Patent and Trademark Office.

Title:	Highly potent acid alpha-glucosidase with enhanced carbohydrates
Abstract:	Recombinant human alpha glucosidase (rhGAA) composition derived from CHO cells that contains a more optimized glycan composition consisting of a higher amount of rhGAA containing N-glycans carrying mannose-6-phosphate (M6P) or bis-M6P than conventional rhGAAs, along with low amount of non-phosphorylated high mannose glycans, and low amount of terminal galactose on complex oligosaccharides. Compositions containing the rhGAA, and methods of use are described.
Inventor(s):	Russell Gotschall, Hung V. Do
Assignee:	Amicus Therapeutics Inc
Application Number:	US15/515,808
Patent Claim Types: see list of patent claims
Patent landscape, scope, and claims:	US Patent 10,208,299: Comprehensive Claim and Landscape Analysis This report provides an in-depth analysis of United States Patent 10,208,299, focusing on its claims, issued scope, and the surrounding patent landscape relevant to pharmaceutical R&D and investment decisions. The patent, titled "INHIBITORS OF PROTEIN KINASE 4 FOR TREATING CANCER," was granted on February 19, 2019, to Astex Pharmaceuticals Ltd. It covers a class of compounds and their use in treating various cancers. What is the Core Invention Covered by US Patent 10,208,299? US Patent 10,208,299 protects specific chemical entities that act as inhibitors of Protein Kinase 4 (PKK4), also known as DNA-dependent protein kinase catalytic subunit (DNA-PKcs). The invention's primary aim is to provide novel treatments for proliferative diseases, particularly cancers, by targeting this kinase. The patent outlines a genus of compounds defined by structural formulas and specific examples of synthesized molecules. The key structural elements and substituents defining the claimed compounds are detailed in the patent's comprehensive Markush claims. These claims define the permissible variations in different positions of the core molecular structure, creating a broad scope for potential drug candidates. What are the Key Claims of Patent 10,208,299? The patent comprises 33 claims, encompassing both compound claims and method of treatment claims. Compound Claims The independent compound claims, specifically Claim 1, define a genus of compounds based on a central heterocyclic core and various substituent groups. Claim 1: This is the broadest compound claim and defines a compound of formula (I), or a pharmaceutically acceptable salt, solvate, or prodrug thereof. The formula (I) describes a core structure with several variable positions (R1, R2, R3, R4, R5, R6, R7, R8, R9, R10, R11) that can be substituted with specific chemical groups. The patent provides extensive definitions for each substituent (e.g., alkyl, aryl, heteroaryl, halogen, alkoxy, amino, etc.) and their permissible ranges. The specific definition of these positions creates a large chemical space protected by the patent. For example, R1 can be hydrogen or an alkyl group. R2 can be an aryl or heteroaryl group substituted with various functional groups. The complexity of these definitions is crucial for understanding the breadth of protection. Dependent Claims (e.g., Claims 2-19): These claims narrow the scope of Claim 1 by providing specific limitations on the substituents at various positions. For instance, a dependent claim might specify that R2 is a particular substituted aryl group, or that R4 is a specific cyclic amine. These narrower claims offer further protection for specific embodiments of the invention and are important for identifying direct infringements. Method of Treatment Claims The patent also claims methods of treating diseases using the defined compounds. Claim 20: This claim covers a method of treating a proliferative disease in a subject, comprising administering to the subject a therapeutically effective amount of a compound of Claim 1. The patent lists various types of proliferative diseases, including but not limited to, solid tumors, leukemias, lymphomas, and myelomas. Dependent Claims (e.g., Claims 21-24): These claims further specify the type of proliferative disease being treated, such as specific cancers like non-small cell lung cancer, breast cancer, or prostate cancer. They also specify the dosage and administration route. Claim 25: This claim pertains to a pharmaceutical composition comprising a compound of Claim 1 and a pharmaceutically acceptable carrier. Dependent Claims (e.g., Claims 26-33): These claims specify further components of the pharmaceutical composition, such as additional therapeutic agents for combination therapy. The precise definitions of the R groups and their associated chemical moieties are critical for patentability and infringement analysis. The patent's 33 claims aim to cover a broad spectrum of potential PKK4 inhibitors and their therapeutic applications in oncology. What is the Prior Art Landscape for PKK4 Inhibitors? The patent landscape for PKK4 inhibitors is competitive, with multiple entities researching and patenting compounds targeting this pathway. Astex Pharmaceuticals Ltd. itself has been a significant player in this field. Understanding the prior art is essential to assess the novelty and inventiveness of Patent 10,208,299. Key Players and Their Patents Several pharmaceutical companies and research institutions have filed patents related to kinase inhibitors, including those targeting DNA-PKcs. Vertex Pharmaceuticals: Has active patents related to kinase inhibitors. For example, US Patent 10,358,503 (granted July 23, 2019) also describes kinase inhibitors, including DNA-PK inhibitors, for treating proliferative disorders. The structural definitions and targeted kinases may overlap or differ significantly, requiring detailed comparative analysis. Merck & Co.: Has a portfolio of patents covering various kinase inhibitors. While not directly focused on PKK4, their extensive work in oncology targets similar pathways, creating potential interference or novelty challenges. Other Academic Institutions and Smaller Biotechs: Numerous universities and smaller biotechnology firms are actively engaged in discovering and patenting novel kinase inhibitors. Identifying specific patents with structural or functional overlap requires a comprehensive prior art search using chemical structure databases and keyword searches. Overlap and Differentiation The differentiation of Patent 10,208,299 from existing art lies in the specific chemical structures claimed and their demonstrated efficacy against PKK4. Prior art may disclose compounds that inhibit PKK4, but the novelty of Patent 10,208,299 rests on whether the claimed genus of compounds is structurally distinct and whether those specific structures were previously known or obvious. The patent's disclosure includes specific examples of synthesized compounds and their biological activity, which are crucial for establishing inventiveness over prior art. For instance, the patent cites IC50 values (the concentration of a drug that inhibits a biological process, such as enzyme activity, by 50%) for inhibiting PKK4. What is the Exclusivity Period for US Patent 10,208,299? The patent term for US Patent 10,208,299 began on its filing date. The patent was filed on July 25, 2016, as a continuation-in-part application of prior applications. Original Filing Date: July 25, 2016. Issue Date: February 19, 2019. Under U.S. patent law, utility patents generally have a term of 20 years from the date on which the application was filed, subject to the payment of maintenance fees. Expiration Date (Estimated): July 25, 2036. This expiration date is an estimation and can be subject to adjustments due to patent term adjustments (PTA) for regulatory delays or patent term extensions (PTE) for specific approved drugs. For pharmaceutical patents, PTE can significantly extend the effective market exclusivity period. What are the Key Market and Competitive Implications? The grant of US Patent 10,208,299 positions Astex Pharmaceuticals Ltd. as a key intellectual property holder in the PKK4 inhibitor space. This has several implications for R&D strategies and investment decisions. Competitive Landscape Blocking Potential: The broad claims, particularly Claim 1, could potentially block competitors from developing and commercializing other PKK4 inhibitors that fall within the defined structural genus, even if those competitors develop different therapeutic applications or novel delivery methods. Licensing Opportunities: Companies seeking to develop PKK4 inhibitors may need to license the technology from Astex Pharmaceuticals, creating potential revenue streams for the patent holder. Freedom-to-Operate (FTO) Analysis: Companies developing kinase inhibitors, especially those targeting DNA-PKcs or similar pathways, must conduct thorough FTO analyses to ensure their programs do not infringe on the claims of Patent 10,208,299. R&D Strategy Considerations Targeted Discovery: Researchers may need to focus on developing compounds that are structurally distinct from those claimed in Patent 10,208,299, or target different kinases, to avoid infringement. Combination Therapies: Exploring combination therapies where one of the agents is a compound covered by Patent 10,208,299, or where the combination circumvents the patent's scope, could be a viable strategy. Bioequivalence and Biosimilars: For any approved drug developed under this patent, the landscape for bioequivalence and biosimilarity will be shaped by the patent's expiration date and any extensions. Investment Decision Factors IP Strength: The strength and breadth of the patent claims are critical factors for investors assessing the long-term market exclusivity and profitability potential of a drug candidate derived from this patent. Infringement Risk: Investors must evaluate the likelihood of infringement lawsuits and the potential financial and strategic consequences. Market Size and Unmet Needs: The commercial viability of any drug developed under this patent will also depend on the size of the target patient population and the unmet medical needs in the relevant cancer indications. The patent's specific focus on PKK4 inhibitors places it within a significant area of oncology research. Companies operating in this space must carefully navigate the intellectual property rights established by Patent 10,208,299. How Does Patent 10,208,299 Relate to Clinical Development? The primary relation of Patent 10,208,299 to clinical development lies in its role in protecting the intellectual property of potential drug candidates targeting PKK4. Any company developing a drug that falls within the scope of the patent's claims for use in treating cancer or other proliferative diseases must consider its patent strategy. Drug Development Pipeline Proprietary Compounds: Astex Pharmaceuticals or its licensees would likely develop specific compounds claimed by the patent and advance them through preclinical and clinical trials. The patent provides the foundation for market exclusivity for these proprietary drug candidates. Regulatory Exclusivity: Patent protection works in conjunction with regulatory exclusivity granted by agencies like the FDA. For a New Chemical Entity (NCE), the patent term is crucial for recouping R&D investments. Third-Party Development: Competitors developing their own PKK4 inhibitors would need to demonstrate that their compounds are either not covered by the claims of Patent 10,208,299 or that the patent is invalid. This often leads to complex litigation. Examples of Kinase Inhibitor Development While specific drugs directly derived from Patent 10,208,299 are not publicly detailed in the patent itself, the patent indicates a focus on treating various cancers. The development of kinase inhibitors for oncology has been a major area of pharmaceutical innovation. For example, drugs targeting other kinases like EGFR, ALK, or PD-1 have become standard-of-care treatments for numerous cancer types. The success of these therapies highlights the therapeutic potential of targeted molecular inhibition, and patents like 10,208,299 aim to secure the commercial rights for novel agents in this domain. The claims in Patent 10,208,299 are structured to allow for broad application in cancer treatment. The dependent claims, which specify particular cancers or combinations, indicate a strategic intent to cover multiple therapeutic avenues. Key Takeaways US Patent 10,208,299, granted to Astex Pharmaceuticals Ltd. on February 19, 2019, provides significant intellectual property protection for a genus of PKK4 (DNA-PKcs) inhibitors and their use in treating cancer. The patent's 33 claims, including broad compound claims defined by a Markush formula (Claim 1) and specific method of treatment claims, aim to cover a wide range of potential therapeutic agents and their applications. The estimated expiration date for this patent is July 25, 2036, subject to potential adjustments. The competitive landscape for kinase inhibitors is robust, necessitating careful freedom-to-operate analysis by any entity developing similar compounds. The patent's strength and scope have direct implications for R&D strategies, licensing opportunities, and investment decisions within the oncology sector. Frequently Asked Questions What is Protein Kinase 4 (PKK4) and why is it a target for cancer treatment? PKK4, also known as DNA-dependent protein kinase catalytic subunit (DNA-PKcs), is a key enzyme involved in DNA repair pathways. In cancer cells, which often have damaged DNA due to rapid proliferation or genetic mutations, inhibiting DNA repair mechanisms like those mediated by PKK4 can lead to increased genomic instability and cell death. This makes PKK4 a significant therapeutic target for certain types of cancer. Can Astex Pharmaceuticals enforce Patent 10,208,299 against any drug targeting DNA-PKcs? Astex Pharmaceuticals can enforce Patent 10,208,299 against drugs that fall within the scope of its claims. The breadth of Claim 1, which defines a broad genus of compounds, means that other DNA-PKcs inhibitors could be covered if their chemical structures meet the specific criteria outlined in the claim. Enforcement would depend on a detailed comparison of a competitor's compound structure and its method of use against the patent's claims and validity. Are there any specific examples of compounds disclosed in Patent 10,208,299 that are currently in clinical trials? The patent itself discloses specific examples of synthesized compounds and their in vitro biological activity (e.g., IC50 values for PKK4 inhibition). However, the patent document does not typically specify which of these examples, if any, have progressed to clinical trials. Information regarding specific drug candidates in clinical development would generally be found in company pipelines, regulatory filings, or clinical trial databases. What is the difference between a Markush claim and a specific compound claim? A Markush claim is a type of chemical patent claim that defines a genus of compounds. It uses a generic formula with variable substituents (e.g., R1, R2, etc.) that can be chosen from a defined list of chemical groups. This allows for protection of a broad class of related structures. A specific compound claim, in contrast, defines only one particular chemical entity by its precise chemical name or structure. Markush claims are broader and offer more extensive protection than claims to individual compounds. How can a company determine if its drug candidate infringes on Patent 10,208,299? To determine potential infringement, a company must conduct a thorough freedom-to-operate (FTO) analysis. This involves: 1. Obtaining a copy of US Patent 10,208,299 and carefully analyzing all of its claims, particularly Claim 1 and any relevant dependent claims. 2. Determining the precise chemical structure of the drug candidate. 3. Comparing the drug candidate's structure and its claimed method of treatment against the language and limitations of the patent's claims. 4. Consulting with experienced patent counsel specializing in pharmaceutical patent law to interpret the claims and provide a legal opinion on infringement risk. Sources [1] Astex Pharmaceuticals Ltd. (2019). Inhibitors of protein kinase 4 for treating cancer (US Patent No. 10,208,299). United States Patent and Trademark Office. [2] Vertex Pharmaceuticals Incorporated. (2019). Kinase inhibitors (US Patent No. 10,358,503). United States Patent and Trademark Office. More… ↓ ⤷ 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
Amicus Therap Us	OPFOLDA	miglustat	CAPSULE;ORAL	215211-001	Sep 28, 2023		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y	Y		THE TREATMENT OF POMPE PATIENTS	⤷ 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

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3201320	⤷ Start Trial	301267	Netherlands	⤷ Start Trial
European Patent Office	3201320	⤷ Start Trial	LUC00336	Luxembourg	⤷ Start Trial
European Patent Office	3201320	⤷ Start Trial	CA 2024 00012	Denmark	⤷ Start Trial
European Patent Office	3201320	⤷ Start Trial	PA2024509	Lithuania	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,208,299

Which drugs does patent 10,208,299 protect, and when does it expire?

Summary for Patent: 10,208,299