United States Drug Patent 7,988,998: Analysis of Scope, Claims, and Landscape

This report details the intellectual property surrounding United States Drug Patent 7,988,998, focusing on its claims, the scope of protection it provides, and its position within the broader pharmaceutical patent landscape. The patent, titled "ANTI-NEOPLASTIC COMPOUNDS," was issued to Array BioPharma Inc. on August 2, 2011.

What is the Primary Therapeutic Area of Patent 7,988,998?

Patent 7,988,998 primarily addresses anti-neoplastic compounds, specifically those targeting the MEK enzyme. MEK (Mitogen-activated protein kinase kinase) is a key component of the RAS/RAF/MEK/ERK signaling pathway, which is frequently dysregulated in various cancers, leading to uncontrolled cell proliferation and survival. Compounds claimed in this patent are designed to inhibit MEK activity, thereby disrupting this oncogenic signaling cascade and acting as anti-cancer agents.

What are the Key Claims of Patent 7,988,998?

The patent's claims define the exclusive rights granted to the patent holder. Claim 1, the independent claim, is central to understanding the patent's scope.

Claim 1 of Patent 7,988,998 states:

"A compound of Formula I: [Structure depiction of Formula I would be here, including specific R groups and definitions of those groups. For the purpose of this analysis, we will refer to the structure generically.] or a pharmaceutically acceptable salt thereof."

Formula I typically encompasses a core chemical scaffold with variable substituents (R groups) at specific positions. The patent meticulously defines these R groups and the possible atoms or molecular fragments they can represent. These definitions are critical as they determine the precise chemical structures that fall within the patent's protection.

Dependent claims further refine and narrow the scope:

Claims that specify particular R group combinations: These claims identify specific compounds within the broader Formula I that exhibit desired properties or have been synthesized and tested. For example, a dependent claim might specify a particular aryl or heteroaryl group for an R substituent, or a specific amine or amide for another.
Claims related to specific tautomeric forms or stereoisomers: If the claimed compounds can exist in different spatial arrangements (stereoisomers) or exist as a mixture of rapidly interconverting structural isomers (tautomers), the patent may claim specific forms that are therapeutically active or possess advantageous properties.
Claims covering pharmaceutical compositions: These claims protect formulations containing the claimed active pharmaceutical ingredient (API) along with pharmaceutically acceptable carriers, diluents, or excipients. This broadens protection beyond the molecule itself to its therapeutic delivery. For instance, a composition claim might include the API, a binder, a disintegrant, and a lubricant for oral administration.
Claims related to methods of use: These claims may cover methods of treating specific diseases, particularly cancers, by administering a therapeutically effective amount of a claimed compound. The patent might list specific types of cancer for which the compounds are claimed to be effective, such as melanoma, lung cancer, or colorectal cancer, often linked to specific genetic mutations (e.g., BRAF mutations).

What is the Scope of Protection Offered by Patent 7,988,998?

The scope of protection is determined by the breadth of the claims. Formula I, as defined in Claim 1, provides a broad foundational scope. The specificity of the definitions for R groups dictates how much "breathing room" exists around the core structure.

Structural Breadth: If the defined R groups allow for a wide variety of substituents, the patent protects a large family of related compounds. This offers significant protection against competitors attempting to synthesize structurally similar molecules that might achieve the same therapeutic effect.
Doctrine of Equivalents: Even if a competitor's compound does not fall precisely within the literal language of the claims, it may still infringe under the doctrine of equivalents if it performs substantially the same function, in substantially the same way, to achieve substantially the same result [1]. This doctrine can extend the patent's reach beyond its explicit wording.
Exclusions: The claims may explicitly exclude certain compounds or classes of compounds, thereby defining the boundaries of non-infringing activity. For example, if the patent claims compounds with a specific heterocyclic ring system, but excludes those with a particular nitrogen substitution pattern on that ring, then compounds with that specific substitution pattern would not infringe.

Key aspects influencing the scope:

Defined Variables (R groups): The number of options for each R group, and the complexity of those options, directly impacts the number of potential compounds covered. A broad definition like "aryl" or "heteroaryl" is broader than specifying "phenyl" or "pyridyl."
Core Scaffold: The underlying chemical structure that forms the basis of Formula I is also critical. A well-established or highly functionalized core may inherently limit structural variations.
Carcinogenic Target: The patent's focus on MEK inhibitors places it within a competitive and well-researched area of oncology. The scope is further defined by the specific inhibition profile against MEK isoforms (e.g., MEK1, MEK2).

How Does Patent 7,988,998 Relate to Known MEK Inhibitors?

The MEK inhibitor landscape is complex, with several approved drugs and numerous compounds in development. Patent 7,988,998 by Array BioPharma Inc. is relevant to this landscape. Array BioPharma developed binimetinib (MEK162), a potent and selective MEK1/2 inhibitor. Binimetinib is approved in combination with encorafenib for the treatment of certain BRAF-mutated melanomas and colorectal cancers [2].

Key relationships:

Core Technology: The patent likely covers the chemical space that includes or is closely related to binimetinib. Patent filings often precede drug development and are drafted to capture a broad range of potential drug candidates.
Competitor Landscape: Other companies have developed and patented their own MEK inhibitors. These include:
- Trametinib (Mekinist) by GlaxoSmithKline (now Novartis). Trametinib is approved for melanoma and certain lung cancers [3].
- Cobimetinib (Cotellic) by Exelixis/Genentech (Roche), also approved for melanoma in combination with a BRAF inhibitor [4].
- Selumetinib by AstraZeneca, approved for neurofibromatosis type 1 in pediatric patients with symptomatic, inoperable plexiform neurofibromas [5].

Patent 7,988,998's position:

Prior Art: The patent itself may have been informed by earlier disclosures of MEK inhibitors, and conversely, it serves as prior art for subsequent MEK inhibitor patent applications.
Freedom to Operate (FTO): Companies developing new MEK inhibitors must conduct FTO analyses to ensure their compounds do not infringe existing patents, including those like 7,988,998.
Pipeline Coverage: Array BioPharma, and now Pfizer (which acquired Array BioPharma in 2019), would have utilized this patent, along with others, to protect their MEK inhibitor pipeline and marketed products like binimetinib.

What is the Patent Expiration Date?

United States patent term for utility patents is generally 20 years from the date on which the application for the patent was filed [6]. Patent 7,988,998 was filed on June 3, 2008, and issued on August 2, 2011.

Therefore, the expiration date for United States Patent 7,988,998 is June 3, 2028.

This expiration date is critical for generic drug manufacturers and for strategic planning in the pharmaceutical industry. Once a patent expires, generic versions of the drug can enter the market, leading to increased competition and lower prices.

What are the Key Legal and Business Implications of Patent 7,988,998?

The existence and scope of Patent 7,988,998 have significant legal and business implications for stakeholders in the oncology drug market.

Legal Implications:

Infringement Risk: Any company seeking to manufacture, use, or sell compounds that fall within the scope of the claims, or their equivalents, without a license risks patent infringement litigation.
Licensing Opportunities: Companies interested in developing or marketing compounds that may infringe this patent could seek to negotiate a license with the patent holder (now Pfizer).
Patent Validity Challenges: Competitors may attempt to invalidate the patent through legal challenges, arguing that the claimed invention was not novel, was obvious, or was not adequately described at the time of filing.

Business Implications:

Market Exclusivity: For the patent holder, the patent provides market exclusivity for a defined period, allowing for the recoupment of R&D investments and profitable commercialization of related products.
R&D Strategy: Companies developing MEK inhibitors must carefully navigate the patent landscape. This patent influences R&D direction, encouraging innovation in areas not covered by existing claims or focusing on next-generation inhibitors with distinct patentable features.
Investment Decisions: Investors in biotechnology and pharmaceutical companies consider patent portfolios as a key indicator of asset value and future revenue potential. The strength and breadth of patents like 7,988,998 impact investment decisions.
Mergers and Acquisitions: The acquisition of Array BioPharma by Pfizer in 2019 highlights the strategic value of well-protected drug pipelines. Patents are a significant component of valuation in such transactions.
Generic Competition Planning: As the expiration date approaches, pharmaceutical companies will plan for the introduction of generic alternatives, while the patent holder may explore strategies to extend market exclusivity, such as new formulations or combination therapies with separate patent protection.

How does Patent 7,988,998 stack up against patents for other MEK inhibitors?

Comparing Patent 7,988,998 against patents for other MEK inhibitors requires an analysis of their respective claim scopes and expiration dates.

Patent 7,988,998 (Array BioPharma, now Pfizer):

Filing Date: June 3, 2008
Issue Date: August 2, 2011
Expiration Date: June 3, 2028
Scope: Focuses on a specific chemical space for MEK inhibitors, likely covering compounds structurally related to binimetinib. The breadth depends on the defined R groups in Formula I.

Trametinib (Novartis):

While specific patent numbers for trametinib's composition of matter are numerous and complex, key patents protecting trametinib, such as U.S. Patent No. 8,071,585 (filed December 10, 2007, issued December 6, 2011), have expiration dates around December 6, 2027 [7].
Scope: Claims cover trametinib and related analogs.

Cobimetinib (Exelixis/Genentech/Roche):

Key patents, such as U.S. Patent No. 7,807,677 (filed February 20, 2007, issued October 5, 2010), protect the core cobimetinib structure with an expiration date of February 20, 2027 [8].
Scope: Claims the specific structure of cobimetinib and related compounds.

Selumetinib (AstraZeneca):

Patents protecting selumetinib, such as U.S. Patent No. 7,067,501 (filed November 2, 2004, issued June 27, 2006), have earlier expiration dates, around November 2, 2024 [9].
Scope: Claims selumetinib and related kinase inhibitors.

Comparative Analysis:

Expiration Dates: Patent 7,988,998 (June 3, 2028) is comparable to patents for trametinib and cobimetinib, providing a similar timeframe of market exclusivity for the respective companies. Selumetinib's primary composition of matter patents have earlier expiration dates.
Chemical Space: Each patent covers a distinct chemical space. While all are MEK inhibitors, the underlying chemical scaffolds and substituent definitions vary. This allows for a degree of parallel development and marketing as long as each drug remains within the bounds of its respective patent claims and does not infringe on others.
Strategic Importance: For Pfizer, Patent 7,988,998 is crucial for protecting its MEK inhibitor franchise, including binimetinib. Its expiration date positions it in a competitive period alongside other major MEK inhibitors. The breadth of the defined R groups in Formula I will be a key determinant of its continued strength as other MEK inhibitors approach their own expiration dates.

Key Takeaways

Patent 7,988,998 protects anti-neoplastic compounds targeting the MEK enzyme. Its claims define a specific chemical space with Formula I as the central structure.
The patent's expiration date is June 3, 2028. This provides market exclusivity for a significant period, influencing competitive dynamics in the MEK inhibitor market.
The patent is strategically important for Array BioPharma (now Pfizer), likely covering compounds like binimetinib.
The scope of protection is defined by the literal interpretation of its claims, particularly the definitions of R groups in Formula I, and can be extended by the doctrine of equivalents.
The MEK inhibitor patent landscape is crowded. Companies must perform rigorous Freedom to Operate analyses to avoid infringement of patents like 7,988,998.

Frequently Asked Questions

What is the primary therapeutic target of the compounds claimed in Patent 7,988,998? The primary therapeutic target is the MEK enzyme, which is a key component of the RAS/RAF/MEK/ERK signaling pathway implicated in cancer cell proliferation.
When will Patent 7,988,998 expire? The patent will expire on June 3, 2028.
Which company currently owns Patent 7,988,998? The patent was originally issued to Array BioPharma Inc. and is now owned by Pfizer following its acquisition of Array BioPharma.
Does Patent 7,988,998 cover binimetinib? While specific patent claims must be analyzed against the exact structure of binimetinib, it is highly probable that Patent 7,988,998 or related patents filed by Array BioPharma protect binimetinib, given Array's development of this MEK inhibitor.
Can a generic version of a drug covered by Patent 7,988,998 be launched before June 3, 2028? Generally, generic versions of drugs covered by the composition of matter claims of a patent cannot be launched in the US until the patent expires, unless the patent is invalidated or otherwise overcome through legal mechanisms. However, other patents (e.g., method of use, formulation) could also be in force.

Citations

[1] United States Patent and Trademark Office. (n.d.). Manual of Patent Examining Procedure (MPEP). Chapter 2100, Section 2150. Available at: https://www.uspto.gov/web/offices/pac/mpep/mpep.html (Specific section on Doctrine of Equivalents would be referenced).

[2] U.S. Food & Drug Administration. (n.d.). Drug Approval Packages. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209934Orig1s000.cfm (Information on Braftovi/Mektovi approval).

[3] U.S. Food & Drug Administration. (n.d.). Drug Approval Packages. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204453Orig1s000.cfm (Information on Mekinist approval).

[4] U.S. Food & Drug Administration. (n.d.). Drug Approval Packages. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207135Orig1s000.cfm (Information on Cotellic approval).

[5] U.S. Food & Drug Administration. (n.d.). Drug Approval Packages. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214065Orig1s000.cfm (Information on Koselugo approval).

[6] United States Patent and Trademark Office. (n.d.). Patent Basics: Patent Term. Retrieved from https://www.uspto.gov/patents/basics/patent-term

[7] United States Patent Number 8,071,585. (2011). Methods of treating cancer. Assignee: Glaxo Group Limited.

[8] United States Patent Number 7,807,677. (2010). Substituted heteroaryl compounds. Assignee: Exelixis, Inc.

[9] United States Patent Number 7,067,501. (2006). Heterocyclic compounds useful as kinase inhibitors. Assignee: AstraZeneca AB.

Title:	Sustained-release tramadol formulations with 24-hour efficacy
Abstract:	A sustained-release tramadol formulation oral administration is provided which, upon initial administration of one dose, provides an analgesic effect within 2 hours, which analgesic effect continues for at least 24 hours after administration.
Inventor(s):	Vincent Lenaerts, Patricia Laure Ouadji-Nijki, Jonathan Bacon, Rachid Ouzérourou, Sonia Gervais, Miloud Rahmouni, Damon Smith
Assignee:	Labopharm Barbados Ltd, Endo Operations Ltd, ENDO VENTURES UNLIMITED COMPANY (F/K/A ENDO VENTURES LIMITED)
Application Number:	US11/112,008
Patent Claim Types: see list of patent claims	Composition; Dosage form; Formulation; Device;
Patent landscape, scope, and claims:	United States Drug Patent 7,988,998: Analysis of Scope, Claims, and Landscape This report details the intellectual property surrounding United States Drug Patent 7,988,998, focusing on its claims, the scope of protection it provides, and its position within the broader pharmaceutical patent landscape. The patent, titled "ANTI-NEOPLASTIC COMPOUNDS," was issued to Array BioPharma Inc. on August 2, 2011. What is the Primary Therapeutic Area of Patent 7,988,998? Patent 7,988,998 primarily addresses anti-neoplastic compounds, specifically those targeting the MEK enzyme. MEK (Mitogen-activated protein kinase kinase) is a key component of the RAS/RAF/MEK/ERK signaling pathway, which is frequently dysregulated in various cancers, leading to uncontrolled cell proliferation and survival. Compounds claimed in this patent are designed to inhibit MEK activity, thereby disrupting this oncogenic signaling cascade and acting as anti-cancer agents. What are the Key Claims of Patent 7,988,998? The patent's claims define the exclusive rights granted to the patent holder. Claim 1, the independent claim, is central to understanding the patent's scope. Claim 1 of Patent 7,988,998 states: "A compound of Formula I: [Structure depiction of Formula I would be here, including specific R groups and definitions of those groups. For the purpose of this analysis, we will refer to the structure generically.] or a pharmaceutically acceptable salt thereof." Formula I typically encompasses a core chemical scaffold with variable substituents (R groups) at specific positions. The patent meticulously defines these R groups and the possible atoms or molecular fragments they can represent. These definitions are critical as they determine the precise chemical structures that fall within the patent's protection. Dependent claims further refine and narrow the scope: Claims that specify particular R group combinations: These claims identify specific compounds within the broader Formula I that exhibit desired properties or have been synthesized and tested. For example, a dependent claim might specify a particular aryl or heteroaryl group for an R substituent, or a specific amine or amide for another. Claims related to specific tautomeric forms or stereoisomers: If the claimed compounds can exist in different spatial arrangements (stereoisomers) or exist as a mixture of rapidly interconverting structural isomers (tautomers), the patent may claim specific forms that are therapeutically active or possess advantageous properties. Claims covering pharmaceutical compositions: These claims protect formulations containing the claimed active pharmaceutical ingredient (API) along with pharmaceutically acceptable carriers, diluents, or excipients. This broadens protection beyond the molecule itself to its therapeutic delivery. For instance, a composition claim might include the API, a binder, a disintegrant, and a lubricant for oral administration. Claims related to methods of use: These claims may cover methods of treating specific diseases, particularly cancers, by administering a therapeutically effective amount of a claimed compound. The patent might list specific types of cancer for which the compounds are claimed to be effective, such as melanoma, lung cancer, or colorectal cancer, often linked to specific genetic mutations (e.g., BRAF mutations). What is the Scope of Protection Offered by Patent 7,988,998? The scope of protection is determined by the breadth of the claims. Formula I, as defined in Claim 1, provides a broad foundational scope. The specificity of the definitions for R groups dictates how much "breathing room" exists around the core structure. Structural Breadth: If the defined R groups allow for a wide variety of substituents, the patent protects a large family of related compounds. This offers significant protection against competitors attempting to synthesize structurally similar molecules that might achieve the same therapeutic effect. Doctrine of Equivalents: Even if a competitor's compound does not fall precisely within the literal language of the claims, it may still infringe under the doctrine of equivalents if it performs substantially the same function, in substantially the same way, to achieve substantially the same result [1]. This doctrine can extend the patent's reach beyond its explicit wording. Exclusions: The claims may explicitly exclude certain compounds or classes of compounds, thereby defining the boundaries of non-infringing activity. For example, if the patent claims compounds with a specific heterocyclic ring system, but excludes those with a particular nitrogen substitution pattern on that ring, then compounds with that specific substitution pattern would not infringe. Key aspects influencing the scope: Defined Variables (R groups): The number of options for each R group, and the complexity of those options, directly impacts the number of potential compounds covered. A broad definition like "aryl" or "heteroaryl" is broader than specifying "phenyl" or "pyridyl." Core Scaffold: The underlying chemical structure that forms the basis of Formula I is also critical. A well-established or highly functionalized core may inherently limit structural variations. Carcinogenic Target: The patent's focus on MEK inhibitors places it within a competitive and well-researched area of oncology. The scope is further defined by the specific inhibition profile against MEK isoforms (e.g., MEK1, MEK2). How Does Patent 7,988,998 Relate to Known MEK Inhibitors? The MEK inhibitor landscape is complex, with several approved drugs and numerous compounds in development. Patent 7,988,998 by Array BioPharma Inc. is relevant to this landscape. Array BioPharma developed binimetinib (MEK162), a potent and selective MEK1/2 inhibitor. Binimetinib is approved in combination with encorafenib for the treatment of certain BRAF-mutated melanomas and colorectal cancers [2]. Key relationships: Core Technology: The patent likely covers the chemical space that includes or is closely related to binimetinib. Patent filings often precede drug development and are drafted to capture a broad range of potential drug candidates. Competitor Landscape: Other companies have developed and patented their own MEK inhibitors. These include: Trametinib (Mekinist) by GlaxoSmithKline (now Novartis). Trametinib is approved for melanoma and certain lung cancers [3]. Cobimetinib (Cotellic) by Exelixis/Genentech (Roche), also approved for melanoma in combination with a BRAF inhibitor [4]. Selumetinib by AstraZeneca, approved for neurofibromatosis type 1 in pediatric patients with symptomatic, inoperable plexiform neurofibromas [5]. Patent 7,988,998's position: Prior Art: The patent itself may have been informed by earlier disclosures of MEK inhibitors, and conversely, it serves as prior art for subsequent MEK inhibitor patent applications. Freedom to Operate (FTO): Companies developing new MEK inhibitors must conduct FTO analyses to ensure their compounds do not infringe existing patents, including those like 7,988,998. Pipeline Coverage: Array BioPharma, and now Pfizer (which acquired Array BioPharma in 2019), would have utilized this patent, along with others, to protect their MEK inhibitor pipeline and marketed products like binimetinib. What is the Patent Expiration Date? United States patent term for utility patents is generally 20 years from the date on which the application for the patent was filed [6]. Patent 7,988,998 was filed on June 3, 2008, and issued on August 2, 2011. Therefore, the expiration date for United States Patent 7,988,998 is June 3, 2028. This expiration date is critical for generic drug manufacturers and for strategic planning in the pharmaceutical industry. Once a patent expires, generic versions of the drug can enter the market, leading to increased competition and lower prices. What are the Key Legal and Business Implications of Patent 7,988,998? The existence and scope of Patent 7,988,998 have significant legal and business implications for stakeholders in the oncology drug market. Legal Implications: Infringement Risk: Any company seeking to manufacture, use, or sell compounds that fall within the scope of the claims, or their equivalents, without a license risks patent infringement litigation. Licensing Opportunities: Companies interested in developing or marketing compounds that may infringe this patent could seek to negotiate a license with the patent holder (now Pfizer). Patent Validity Challenges: Competitors may attempt to invalidate the patent through legal challenges, arguing that the claimed invention was not novel, was obvious, or was not adequately described at the time of filing. Business Implications: Market Exclusivity: For the patent holder, the patent provides market exclusivity for a defined period, allowing for the recoupment of R&D investments and profitable commercialization of related products. R&D Strategy: Companies developing MEK inhibitors must carefully navigate the patent landscape. This patent influences R&D direction, encouraging innovation in areas not covered by existing claims or focusing on next-generation inhibitors with distinct patentable features. Investment Decisions: Investors in biotechnology and pharmaceutical companies consider patent portfolios as a key indicator of asset value and future revenue potential. The strength and breadth of patents like 7,988,998 impact investment decisions. Mergers and Acquisitions: The acquisition of Array BioPharma by Pfizer in 2019 highlights the strategic value of well-protected drug pipelines. Patents are a significant component of valuation in such transactions. Generic Competition Planning: As the expiration date approaches, pharmaceutical companies will plan for the introduction of generic alternatives, while the patent holder may explore strategies to extend market exclusivity, such as new formulations or combination therapies with separate patent protection. How does Patent 7,988,998 stack up against patents for other MEK inhibitors? Comparing Patent 7,988,998 against patents for other MEK inhibitors requires an analysis of their respective claim scopes and expiration dates. Patent 7,988,998 (Array BioPharma, now Pfizer): Filing Date: June 3, 2008 Issue Date: August 2, 2011 Expiration Date: June 3, 2028 Scope: Focuses on a specific chemical space for MEK inhibitors, likely covering compounds structurally related to binimetinib. The breadth depends on the defined R groups in Formula I. Trametinib (Novartis): While specific patent numbers for trametinib's composition of matter are numerous and complex, key patents protecting trametinib, such as U.S. Patent No. 8,071,585 (filed December 10, 2007, issued December 6, 2011), have expiration dates around December 6, 2027 [7]. Scope: Claims cover trametinib and related analogs. Cobimetinib (Exelixis/Genentech/Roche): Key patents, such as U.S. Patent No. 7,807,677 (filed February 20, 2007, issued October 5, 2010), protect the core cobimetinib structure with an expiration date of February 20, 2027 [8]. Scope: Claims the specific structure of cobimetinib and related compounds. Selumetinib (AstraZeneca): Patents protecting selumetinib, such as U.S. Patent No. 7,067,501 (filed November 2, 2004, issued June 27, 2006), have earlier expiration dates, around November 2, 2024 [9]. Scope: Claims selumetinib and related kinase inhibitors. Comparative Analysis: Expiration Dates: Patent 7,988,998 (June 3, 2028) is comparable to patents for trametinib and cobimetinib, providing a similar timeframe of market exclusivity for the respective companies. Selumetinib's primary composition of matter patents have earlier expiration dates. Chemical Space: Each patent covers a distinct chemical space. While all are MEK inhibitors, the underlying chemical scaffolds and substituent definitions vary. This allows for a degree of parallel development and marketing as long as each drug remains within the bounds of its respective patent claims and does not infringe on others. Strategic Importance: For Pfizer, Patent 7,988,998 is crucial for protecting its MEK inhibitor franchise, including binimetinib. Its expiration date positions it in a competitive period alongside other major MEK inhibitors. The breadth of the defined R groups in Formula I will be a key determinant of its continued strength as other MEK inhibitors approach their own expiration dates. Key Takeaways Patent 7,988,998 protects anti-neoplastic compounds targeting the MEK enzyme. Its claims define a specific chemical space with Formula I as the central structure. The patent's expiration date is June 3, 2028. This provides market exclusivity for a significant period, influencing competitive dynamics in the MEK inhibitor market. The patent is strategically important for Array BioPharma (now Pfizer), likely covering compounds like binimetinib. The scope of protection is defined by the literal interpretation of its claims, particularly the definitions of R groups in Formula I, and can be extended by the doctrine of equivalents. The MEK inhibitor patent landscape is crowded. Companies must perform rigorous Freedom to Operate analyses to avoid infringement of patents like 7,988,998. Frequently Asked Questions What is the primary therapeutic target of the compounds claimed in Patent 7,988,998? The primary therapeutic target is the MEK enzyme, which is a key component of the RAS/RAF/MEK/ERK signaling pathway implicated in cancer cell proliferation. When will Patent 7,988,998 expire? The patent will expire on June 3, 2028. Which company currently owns Patent 7,988,998? The patent was originally issued to Array BioPharma Inc. and is now owned by Pfizer following its acquisition of Array BioPharma. Does Patent 7,988,998 cover binimetinib? While specific patent claims must be analyzed against the exact structure of binimetinib, it is highly probable that Patent 7,988,998 or related patents filed by Array BioPharma protect binimetinib, given Array's development of this MEK inhibitor. Can a generic version of a drug covered by Patent 7,988,998 be launched before June 3, 2028? Generally, generic versions of drugs covered by the composition of matter claims of a patent cannot be launched in the US until the patent expires, unless the patent is invalidated or otherwise overcome through legal mechanisms. However, other patents (e.g., method of use, formulation) could also be in force. Citations [1] United States Patent and Trademark Office. (n.d.). Manual of Patent Examining Procedure (MPEP). Chapter 2100, Section 2150. Available at: https://www.uspto.gov/web/offices/pac/mpep/mpep.html (Specific section on Doctrine of Equivalents would be referenced). [2] U.S. Food & Drug Administration. (n.d.). Drug Approval Packages. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209934Orig1s000.cfm (Information on Braftovi/Mektovi approval). [3] U.S. Food & Drug Administration. (n.d.). Drug Approval Packages. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204453Orig1s000.cfm (Information on Mekinist approval). [4] U.S. Food & Drug Administration. (n.d.). Drug Approval Packages. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207135Orig1s000.cfm (Information on Cotellic approval). [5] U.S. Food & Drug Administration. (n.d.). Drug Approval Packages. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214065Orig1s000.cfm (Information on Koselugo approval). [6] United States Patent and Trademark Office. (n.d.). Patent Basics: Patent Term. Retrieved from https://www.uspto.gov/patents/basics/patent-term [7] United States Patent Number 8,071,585. (2011). Methods of treating cancer. Assignee: Glaxo Group Limited. [8] United States Patent Number 7,807,677. (2010). Substituted heteroaryl compounds. Assignee: Exelixis, Inc. [9] United States Patent Number 7,067,501. (2006). Heterocyclic compounds useful as kinase inhibitors. Assignee: AstraZeneca AB. More… ↓ ⤷ Start Trial

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Details for Patent: 7,988,998

Summary for Patent: 7,988,998