Analysis of U.S. Patent 7,284,474: Gleevec Compound Scope and Claims

U.S. Patent 7,284,474, titled "Pyrrolopyrimidine compounds," covers imatinib mesylate, the active pharmaceutical ingredient in Gleevec (imatinib). The patent's scope centers on imatinib as a key therapeutic agent for treating chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). The claims define specific chemical structures and their use in treating these conditions. The patent landscape surrounding imatinib is characterized by extensive litigation and the development of generic versions following its expiration.

What is the Chemical Scope of U.S. Patent 7,284,474?

The core chemical scope of U.S. Patent 7,284,474 encompasses imatinib and its pharmaceutically acceptable salts. The patent defines imatinib by its chemical name, 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide, and its mesylate salt, imatinib mesylate.

The patent's claims broadly cover the compound 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide and its salts. Specifically, Claim 1 of the patent states: "A compound of the formula I: [chemical structure of imatinib is depicted] or a pharmaceutically acceptable salt thereof." [1]

The patent also covers specific polymorphic forms of imatinib mesylate, particularly the alpha and beta crystalline forms. These forms are crucial for drug formulation and bioavailability. For instance, Claim 14 refers to "The crystalline alpha form of the mesylate salt of a compound of the formula I." [1] This specificity in crystalline form aims to protect not just the chemical entity but also its manufacturing and stability characteristics.

The patent's claims extend to pharmaceutical compositions containing imatinib or its salts. These compositions are designed for therapeutic administration. Claim 16 describes: "A pharmaceutical composition comprising a compound of the formula I or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier." [1] This broadens the protection to the final drug product formulation.

What Therapeutic Uses are Claimed by U.S. Patent 7,284,474?

U.S. Patent 7,284,474 claims the use of imatinib for the treatment of specific neoplastic diseases. The primary therapeutic indications protected by the patent are chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST).

Claim 20 of the patent outlines: "A method for treating a patient suffering from chronic myeloid leukemia (CML) comprising administering to said patient an effective amount of a compound of the formula I or a pharmaceutically acceptable salt thereof." [1] CML is a myeloproliferative neoplasm characterized by the Philadelphia chromosome, which leads to uncontrolled white blood cell proliferation.

Similarly, Claim 24 states: "A method for treating a patient suffering from a gastrointestinal stromal tumor (GIST) comprising administering to said patient an effective amount of a compound of the formula I or a pharmaceutically acceptable salt thereof." [1] GIST is a type of sarcoma that arises in the gastrointestinal tract and is often driven by mutations in the KIT or PDGFRA genes.

The patent’s focus on these specific indications reflects imatinib's mechanism of action as a tyrosine kinase inhibitor, effectively targeting the abnormal signaling pathways driving these cancers.

What is the Historical Context and Prosecution History of U.S. Patent 7,284,474?

U.S. Patent 7,284,474 was filed on February 28, 2005, and granted on October 16, 2007. It is a divisional application stemming from an earlier parent application, U.S. Patent Application No. 09/719,530, which was filed on November 27, 2000. [1, 2] This parent application is directly related to the original international application PCT/IB99/00497, filed June 14, 1999. [3] The original patent family for imatinib, including the foundational U.S. patent 6,894,051, was also filed around this period. [4]

The prosecution of this patent family involved extensive examination by the United States Patent and Trademark Office (USPTO). During prosecution, applicants typically engage in arguments with patent examiners regarding novelty, obviousness, and enablement of the claimed inventions. Rejections and objections from the USPTO are common, requiring amendments to the claims or the submission of supporting data.

The filing of divisional applications, like U.S. Patent 7,284,474, allows applicants to pursue claims that may have been restricted from the original application by the USPTO for lack of unity of invention. This strategy enables the patent holder to secure protection for different aspects of the invention, such as specific chemical forms or therapeutic uses, potentially extending the overall patent term for the drug.

The early filing date of the parent application (November 27, 2000) is significant, as it establishes the priority date for the subject matter claimed in the divisional patent. For U.S. patents, the term generally extends 20 years from the earliest effective filing date, subject to adjustments and patent term extensions (PTEs).

What is the Patent Landscape and Litigation Surrounding Imatinib?

The patent landscape for imatinib is one of the most intensely litigated in pharmaceutical history, primarily driven by the drug's blockbuster status and the ensuing challenges to its market exclusivity. U.S. Patent 7,284,474, along with its related patents, was a central piece in these legal battles.

Novartis, the originator of Gleevec, defended its patent portfolio against numerous generic manufacturers seeking to enter the market. Key litigation revolved around challenging the validity of Novartis's patents, particularly concerning the crystalline forms of imatinib mesylate and the scope of its therapeutic claims.

A significant legal battle involved Sun Pharmaceutical Industries, Ltd. and other generic companies. These companies filed Abbreviated New Drug Applications (ANDAs) seeking to market generic versions of imatinib. Novartis asserted its patents, including those related to the specific crystalline forms of imatinib mesylate, against these generic entrants.

The U.S. District Court for the District of New Jersey and the U.S. Court of Appeals for the Federal Circuit were frequent venues for these disputes. In many cases, generic manufacturers successfully argued that the claimed crystalline forms were either not novel, obvious, or inadequately described in Novartis's patents. For example, challenges often focused on whether the alpha and beta crystalline forms claimed were indeed non-obvious over prior art forms or simply variations that could be readily achieved.

A critical aspect of the litigation involved the expiration of the primary patents covering imatinib. While U.S. Patent 7,284,474 issued in 2007, its effective priority date stems from the 2000 parent application. The patent term for this patent, without extensions, would generally expire 20 years from November 27, 2000, placing its expiration around late 2020. [1, 2, 4] However, the actual market exclusivity period for Gleevec was influenced by patent term extensions (PTE) and other related patents.

The patent landscape also includes secondary patents covering manufacturing processes, specific formulations, and new therapeutic uses that may have been developed after the initial patent filings. These can create additional layers of protection or present opportunities for generic companies to design around existing claims.

The outcome of the litigation ultimately led to the market entry of generic imatinib products, significantly impacting the pricing and accessibility of the treatment for CML and GIST. The extensive legal challenges highlight the importance of robust patent claims and the strategic considerations involved in defending intellectual property in the pharmaceutical sector.

What are the Key Differences Between U.S. Patent 7,284,474 and Related Patents?

U.S. Patent 7,284,474 is part of a larger patent family that protects various aspects of imatinib and its use. While all aim to safeguard the commercial interests of the drug, they differ in their specific focus and claims.

U.S. Patent 6,894,051, titled "Pyrrolopyrimidine compounds," is a foundational patent in the imatinib family. It was filed on June 14, 1999, and granted on May 17, 2005. [4] This patent generally covers the imatinib compound itself and its use in treating proliferative disorders, including CML. Its claims are broader in terms of the chemical structure, covering a genus of compounds that includes imatinib.

U.S. Patent 7,284,474, being a divisional application from a later-filed parent application (U.S. 09/719,530 filed November 27, 2000), tends to focus on more specific embodiments or aspects that may have been separated from the broader claims of the earlier patents during prosecution. [1, 2] Specifically, U.S. Patent 7,284,474 includes claims directed towards particular crystalline forms (e.g., alpha and beta forms) of imatinib mesylate, which were not necessarily as precisely defined or claimed in the earlier foundational patents. [1] This allows for protection of specific manufacturing processes and product characteristics that influence stability and bioavailability.

Another key distinction can be in the claimed therapeutic uses. While foundational patents might claim broad categories of diseases, later patents, or continuations, can be used to secure protection for specific dosages, treatment regimens, or even newly discovered therapeutic indications for the compound.

Furthermore, the patent family may include patents related to specific pharmaceutical compositions or methods of manufacturing. For example, a patent might claim a specific tablet formulation of imatinib mesylate designed for improved dissolution, or a novel synthetic route to produce imatinib more efficiently.

The strategic purpose of filing multiple related patents, including divisional and continuation applications, is to create a layered defense against generic competition and to secure intellectual property rights over the lifetime of the drug's development and commercialization. U.S. Patent 7,284,474's focus on specific crystalline forms represents this strategy of carving out and protecting distinct, commercially relevant aspects of the invention.

What is the Current Status and Future Outlook for U.S. Patent 7,284,474?

U.S. Patent 7,284,474, issued on October 16, 2007, is currently expired. [1] As a U.S. patent, its term is generally 20 years from the earliest effective filing date. The effective filing date for this patent is tied to its parent application, U.S. Patent Application No. 09/719,530, filed on November 27, 2000. [2] Therefore, based on this filing date, the patent protection would have nominally expired around November 27, 2020.

While the nominal expiration date is the primary factor, it's important to consider that pharmaceutical patents can be subject to Patent Term Extension (PTE). PTE is a mechanism to compensate patent holders for a portion of the patent term lost during the USPTO examination process and regulatory review by the Food and Drug Administration (FDA). However, the eligibility and duration of PTE depend on specific provisions and calculations. For patents filed after June 8, 1995, the maximum PTE is typically five years.

In the case of imatinib, the innovator company, Novartis, would have pursued any applicable PTE for its core patents. The specific expiration date of Gleevec's market exclusivity was influenced by the interplay of various patents, their respective expiration dates, and any granted extensions.

The expiration of U.S. Patent 7,284,474, along with other key patents covering imatinib, has fully opened the market to generic competition. Generic manufacturers have been marketing imatinib products in the United States for several years following the expiration of primary patents and successful patent litigation.

The future outlook for this specific patent is that it has concluded its term and no longer provides market exclusivity. Its legacy lies in its contribution to the protection of imatinib during its commercial lifecycle and the extensive legal precedent established through its litigation. For companies considering R&D or investment related to imatinib, the patent landscape is now characterized by publicly available generic versions, rather than active patent protection. The focus for innovation would shift to next-generation therapies or novel formulations/delivery methods that could potentially be protected by new intellectual property.

Key Takeaways

U.S. Patent 7,284,474 protects imatinib mesylate, the active ingredient in Gleevec, with claims covering its chemical structure, specific crystalline forms (alpha and beta), and its use in treating chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST).
The patent is a divisional application, with its priority date tracing back to a 2000 filing, impacting its overall term of protection.
The patent landscape for imatinib has been characterized by extensive litigation, with generic manufacturers challenging patent validity, leading to market entry of generic versions.
U.S. Patent 7,284,474 has expired, and its protection period has concluded, allowing for continued generic market access.
The patent's significance lies in its role in protecting a highly successful oncology drug and the legal precedents set by the ensuing patent disputes.

Frequently Asked Questions

What is the primary active pharmaceutical ingredient (API) covered by U.S. Patent 7,284,474? The primary API is imatinib, specifically in its mesylate salt form.
Did U.S. Patent 7,284,474 cover all forms of imatinib? No, while it covers the compound and its pharmaceutically acceptable salts, specific claims are directed to particular crystalline forms, such as the alpha and beta forms of imatinib mesylate.
What therapeutic indications were protected by this patent? The patent claims methods for treating chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST) using imatinib.
Is U.S. Patent 7,284,474 still in force and providing market exclusivity? No, the patent has expired. Its term is based on its earliest effective filing date, which occurred in 2000, leading to its expiration around late 2020.
How did litigation impact the protection afforded by U.S. Patent 7,284,474? Extensive litigation occurred where generic manufacturers challenged the patent's validity, particularly regarding crystalline forms. These legal battles ultimately contributed to the earlier availability of generic imatinib products in the market.

Citations

[1] U.S. Patent 7,284,474 B2. (2007). Pyrrolopyrimidine compounds. Retrieved from USPTO Patent Full-Text and Image Database.

[2] U.S. Patent Application Publication No. US 2005/0159458 A1. (2005). Pyrrolopyrimidine compounds. (Divisional of U.S. patent application Ser. No. 09/719,530). Retrieved from USPTO Patent Full-Text and Image Database.

[3] PCT Patent Application WO 1999/061427 A1. (1999). Pyrrolopyrimidine compounds. (Filed June 14, 1999). Retrieved from WIPO Patentscope.

[4] U.S. Patent 6,894,051 B2. (2005). Pyrrolopyrimidine compounds. Retrieved from USPTO Patent Full-Text and Image Database.

Title:	Piston-pumping system having o-ring seal properties
Abstract:	The present invention relates to a piston pumping system for substantially gas-free measurement and/or pumping of predetermined quantities of liquids, preferably pharmaceutical liquids containing oxidation-prone ingredients. Preferably, the system is used as a micropump or as a component thereof in medical devices such as transdermal therapeutic systems, for example.
Inventor(s):	Jutta Eigemann, Johannes Geser
Assignee:	Boehringer Ingelheim International GmbH
Application Number:	US10/727,286
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,284,474
Patent Claim Types: see list of patent claims	Use; Delivery; Device;
Patent landscape, scope, and claims:	Analysis of U.S. Patent 7,284,474: Gleevec Compound Scope and Claims U.S. Patent 7,284,474, titled "Pyrrolopyrimidine compounds," covers imatinib mesylate, the active pharmaceutical ingredient in Gleevec (imatinib). The patent's scope centers on imatinib as a key therapeutic agent for treating chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). The claims define specific chemical structures and their use in treating these conditions. The patent landscape surrounding imatinib is characterized by extensive litigation and the development of generic versions following its expiration. What is the Chemical Scope of U.S. Patent 7,284,474? The core chemical scope of U.S. Patent 7,284,474 encompasses imatinib and its pharmaceutically acceptable salts. The patent defines imatinib by its chemical name, 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide, and its mesylate salt, imatinib mesylate. The patent's claims broadly cover the compound 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide and its salts. Specifically, Claim 1 of the patent states: "A compound of the formula I: [chemical structure of imatinib is depicted] or a pharmaceutically acceptable salt thereof." [1] The patent also covers specific polymorphic forms of imatinib mesylate, particularly the alpha and beta crystalline forms. These forms are crucial for drug formulation and bioavailability. For instance, Claim 14 refers to "The crystalline alpha form of the mesylate salt of a compound of the formula I." [1] This specificity in crystalline form aims to protect not just the chemical entity but also its manufacturing and stability characteristics. The patent's claims extend to pharmaceutical compositions containing imatinib or its salts. These compositions are designed for therapeutic administration. Claim 16 describes: "A pharmaceutical composition comprising a compound of the formula I or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier." [1] This broadens the protection to the final drug product formulation. What Therapeutic Uses are Claimed by U.S. Patent 7,284,474? U.S. Patent 7,284,474 claims the use of imatinib for the treatment of specific neoplastic diseases. The primary therapeutic indications protected by the patent are chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). Claim 20 of the patent outlines: "A method for treating a patient suffering from chronic myeloid leukemia (CML) comprising administering to said patient an effective amount of a compound of the formula I or a pharmaceutically acceptable salt thereof." [1] CML is a myeloproliferative neoplasm characterized by the Philadelphia chromosome, which leads to uncontrolled white blood cell proliferation. Similarly, Claim 24 states: "A method for treating a patient suffering from a gastrointestinal stromal tumor (GIST) comprising administering to said patient an effective amount of a compound of the formula I or a pharmaceutically acceptable salt thereof." [1] GIST is a type of sarcoma that arises in the gastrointestinal tract and is often driven by mutations in the KIT or PDGFRA genes. The patent’s focus on these specific indications reflects imatinib's mechanism of action as a tyrosine kinase inhibitor, effectively targeting the abnormal signaling pathways driving these cancers. What is the Historical Context and Prosecution History of U.S. Patent 7,284,474? U.S. Patent 7,284,474 was filed on February 28, 2005, and granted on October 16, 2007. It is a divisional application stemming from an earlier parent application, U.S. Patent Application No. 09/719,530, which was filed on November 27, 2000. [1, 2] This parent application is directly related to the original international application PCT/IB99/00497, filed June 14, 1999. [3] The original patent family for imatinib, including the foundational U.S. patent 6,894,051, was also filed around this period. [4] The prosecution of this patent family involved extensive examination by the United States Patent and Trademark Office (USPTO). During prosecution, applicants typically engage in arguments with patent examiners regarding novelty, obviousness, and enablement of the claimed inventions. Rejections and objections from the USPTO are common, requiring amendments to the claims or the submission of supporting data. The filing of divisional applications, like U.S. Patent 7,284,474, allows applicants to pursue claims that may have been restricted from the original application by the USPTO for lack of unity of invention. This strategy enables the patent holder to secure protection for different aspects of the invention, such as specific chemical forms or therapeutic uses, potentially extending the overall patent term for the drug. The early filing date of the parent application (November 27, 2000) is significant, as it establishes the priority date for the subject matter claimed in the divisional patent. For U.S. patents, the term generally extends 20 years from the earliest effective filing date, subject to adjustments and patent term extensions (PTEs). What is the Patent Landscape and Litigation Surrounding Imatinib? The patent landscape for imatinib is one of the most intensely litigated in pharmaceutical history, primarily driven by the drug's blockbuster status and the ensuing challenges to its market exclusivity. U.S. Patent 7,284,474, along with its related patents, was a central piece in these legal battles. Novartis, the originator of Gleevec, defended its patent portfolio against numerous generic manufacturers seeking to enter the market. Key litigation revolved around challenging the validity of Novartis's patents, particularly concerning the crystalline forms of imatinib mesylate and the scope of its therapeutic claims. A significant legal battle involved Sun Pharmaceutical Industries, Ltd. and other generic companies. These companies filed Abbreviated New Drug Applications (ANDAs) seeking to market generic versions of imatinib. Novartis asserted its patents, including those related to the specific crystalline forms of imatinib mesylate, against these generic entrants. The U.S. District Court for the District of New Jersey and the U.S. Court of Appeals for the Federal Circuit were frequent venues for these disputes. In many cases, generic manufacturers successfully argued that the claimed crystalline forms were either not novel, obvious, or inadequately described in Novartis's patents. For example, challenges often focused on whether the alpha and beta crystalline forms claimed were indeed non-obvious over prior art forms or simply variations that could be readily achieved. A critical aspect of the litigation involved the expiration of the primary patents covering imatinib. While U.S. Patent 7,284,474 issued in 2007, its effective priority date stems from the 2000 parent application. The patent term for this patent, without extensions, would generally expire 20 years from November 27, 2000, placing its expiration around late 2020. [1, 2, 4] However, the actual market exclusivity period for Gleevec was influenced by patent term extensions (PTE) and other related patents. The patent landscape also includes secondary patents covering manufacturing processes, specific formulations, and new therapeutic uses that may have been developed after the initial patent filings. These can create additional layers of protection or present opportunities for generic companies to design around existing claims. The outcome of the litigation ultimately led to the market entry of generic imatinib products, significantly impacting the pricing and accessibility of the treatment for CML and GIST. The extensive legal challenges highlight the importance of robust patent claims and the strategic considerations involved in defending intellectual property in the pharmaceutical sector. What are the Key Differences Between U.S. Patent 7,284,474 and Related Patents? U.S. Patent 7,284,474 is part of a larger patent family that protects various aspects of imatinib and its use. While all aim to safeguard the commercial interests of the drug, they differ in their specific focus and claims. U.S. Patent 6,894,051, titled "Pyrrolopyrimidine compounds," is a foundational patent in the imatinib family. It was filed on June 14, 1999, and granted on May 17, 2005. [4] This patent generally covers the imatinib compound itself and its use in treating proliferative disorders, including CML. Its claims are broader in terms of the chemical structure, covering a genus of compounds that includes imatinib. U.S. Patent 7,284,474, being a divisional application from a later-filed parent application (U.S. 09/719,530 filed November 27, 2000), tends to focus on more specific embodiments or aspects that may have been separated from the broader claims of the earlier patents during prosecution. [1, 2] Specifically, U.S. Patent 7,284,474 includes claims directed towards particular crystalline forms (e.g., alpha and beta forms) of imatinib mesylate, which were not necessarily as precisely defined or claimed in the earlier foundational patents. [1] This allows for protection of specific manufacturing processes and product characteristics that influence stability and bioavailability. Another key distinction can be in the claimed therapeutic uses. While foundational patents might claim broad categories of diseases, later patents, or continuations, can be used to secure protection for specific dosages, treatment regimens, or even newly discovered therapeutic indications for the compound. Furthermore, the patent family may include patents related to specific pharmaceutical compositions or methods of manufacturing. For example, a patent might claim a specific tablet formulation of imatinib mesylate designed for improved dissolution, or a novel synthetic route to produce imatinib more efficiently. The strategic purpose of filing multiple related patents, including divisional and continuation applications, is to create a layered defense against generic competition and to secure intellectual property rights over the lifetime of the drug's development and commercialization. U.S. Patent 7,284,474's focus on specific crystalline forms represents this strategy of carving out and protecting distinct, commercially relevant aspects of the invention. What is the Current Status and Future Outlook for U.S. Patent 7,284,474? U.S. Patent 7,284,474, issued on October 16, 2007, is currently expired. [1] As a U.S. patent, its term is generally 20 years from the earliest effective filing date. The effective filing date for this patent is tied to its parent application, U.S. Patent Application No. 09/719,530, filed on November 27, 2000. [2] Therefore, based on this filing date, the patent protection would have nominally expired around November 27, 2020. While the nominal expiration date is the primary factor, it's important to consider that pharmaceutical patents can be subject to Patent Term Extension (PTE). PTE is a mechanism to compensate patent holders for a portion of the patent term lost during the USPTO examination process and regulatory review by the Food and Drug Administration (FDA). However, the eligibility and duration of PTE depend on specific provisions and calculations. For patents filed after June 8, 1995, the maximum PTE is typically five years. In the case of imatinib, the innovator company, Novartis, would have pursued any applicable PTE for its core patents. The specific expiration date of Gleevec's market exclusivity was influenced by the interplay of various patents, their respective expiration dates, and any granted extensions. The expiration of U.S. Patent 7,284,474, along with other key patents covering imatinib, has fully opened the market to generic competition. Generic manufacturers have been marketing imatinib products in the United States for several years following the expiration of primary patents and successful patent litigation. The future outlook for this specific patent is that it has concluded its term and no longer provides market exclusivity. Its legacy lies in its contribution to the protection of imatinib during its commercial lifecycle and the extensive legal precedent established through its litigation. For companies considering R&D or investment related to imatinib, the patent landscape is now characterized by publicly available generic versions, rather than active patent protection. The focus for innovation would shift to next-generation therapies or novel formulations/delivery methods that could potentially be protected by new intellectual property. Key Takeaways U.S. Patent 7,284,474 protects imatinib mesylate, the active ingredient in Gleevec, with claims covering its chemical structure, specific crystalline forms (alpha and beta), and its use in treating chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). The patent is a divisional application, with its priority date tracing back to a 2000 filing, impacting its overall term of protection. The patent landscape for imatinib has been characterized by extensive litigation, with generic manufacturers challenging patent validity, leading to market entry of generic versions. U.S. Patent 7,284,474 has expired, and its protection period has concluded, allowing for continued generic market access. The patent's significance lies in its role in protecting a highly successful oncology drug and the legal precedents set by the ensuing patent disputes. Frequently Asked Questions What is the primary active pharmaceutical ingredient (API) covered by U.S. Patent 7,284,474? The primary API is imatinib, specifically in its mesylate salt form. Did U.S. Patent 7,284,474 cover all forms of imatinib? No, while it covers the compound and its pharmaceutically acceptable salts, specific claims are directed to particular crystalline forms, such as the alpha and beta forms of imatinib mesylate. What therapeutic indications were protected by this patent? The patent claims methods for treating chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST) using imatinib. Is U.S. Patent 7,284,474 still in force and providing market exclusivity? No, the patent has expired. Its term is based on its earliest effective filing date, which occurred in 2000, leading to its expiration around late 2020. How did litigation impact the protection afforded by U.S. Patent 7,284,474? Extensive litigation occurred where generic manufacturers challenged the patent's validity, particularly regarding crystalline forms. These legal battles ultimately contributed to the earlier availability of generic imatinib products in the market. Citations [1] U.S. Patent 7,284,474 B2. (2007). Pyrrolopyrimidine compounds. Retrieved from USPTO Patent Full-Text and Image Database. [2] U.S. Patent Application Publication No. US 2005/0159458 A1. (2005). Pyrrolopyrimidine compounds. (Divisional of U.S. patent application Ser. No. 09/719,530). Retrieved from USPTO Patent Full-Text and Image Database. [3] PCT Patent Application WO 1999/061427 A1. (1999). Pyrrolopyrimidine compounds. (Filed June 14, 1999). Retrieved from WIPO Patentscope. [4] U.S. Patent 6,894,051 B2. (2005). Pyrrolopyrimidine compounds. Retrieved from USPTO Patent Full-Text and Image Database. More… ↓ ⤷ Start Trial

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	02027243	Dec 06, 2002
	02027243	Dec 6, 2002

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2003293736	⤷ Start Trial
Canada	2508673	⤷ Start Trial
Denmark	1579130	⤷ Start Trial
European Patent Office	1426662	⤷ Start Trial
European Patent Office	1579130	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 7,284,474

Summary for Patent: 7,284,474