United States Patent 8,841,310: Scope, Claims, and Landscape Analysis

This report provides a detailed analysis of United States Patent 8,841,310, focusing on its patent scope, specific claims, and the competitive landscape. The patent, granted on September 16, 2014, to Genentech, Inc., covers "METHODS FOR TREATING HER2-POSITIVE BREAST CANCER" and is associated with the therapeutic antibody pertuzumab.

What is the Subject Matter of US Patent 8,841,310?

US Patent 8,841,310 claims methods for treating HER2-positive breast cancer using pertuzumab, a humanized monoclonal antibody. The invention addresses the need for improved treatment strategies, particularly for patients who have received prior HER2-targeted therapy.

The core of the patent's subject matter lies in the specific therapeutic regimen and patient population. It defines treatment protocols involving the administration of pertuzumab in combination with other anti-cancer agents.

What Are the Key Claims of US Patent 8,841,310?

The patent contains several independent and dependent claims that define the scope of protection. The independent claims are crucial for understanding the breadth of the invention.

Claim 1, a representative independent claim, reads:

"1. A method of treating a subject having HER2-positive breast cancer, the method comprising administering to the subject an effective amount of a humanized anti-HER2 antibody, wherein the antibody binds to subdomain II of HER2." [1]

Key elements within this and other claims include:

Therapeutic Target: HER2-positive breast cancer. This specifies the disease state for which the method is intended.
Active Agent: A humanized anti-HER2 antibody. This defines the class of therapeutic compounds.
Binding Specificity: The antibody binds to subdomain II of HER2. This is a critical structural and functional limitation, distinguishing it from antibodies binding to other HER2 domains.
Administration: Administering an effective amount. This refers to a dosage sufficient to achieve a therapeutic effect.
Patient Population: The claims often specify patient subgroups, such as those who have received prior HER2-targeted therapy, including trastuzumab. For instance, claim 13 states: "13. The method of claim 1, wherein the subject has previously been treated with trastuzumab." [1]
Combination Therapy: Several claims define treatment regimens that include pertuzumab in conjunction with other chemotherapeutic agents. Claim 15 specifies: "15. The method of claim 14, wherein the other anti-cancer agent is selected from the group consisting of a taxane, a platinum-based chemotherapeutic agent, an anthracycline, and capecitabine." [1]

The patent's claims are structured to cover specific therapeutic uses and patient scenarios, thereby carving out a distinct market position for pertuzumab in the treatment of HER2-positive breast cancer.

How Does the Patent Define "HER2-Positive Breast Cancer"?

The patent defines "HER2-positive breast cancer" through established diagnostic criteria commonly used in clinical practice. While not explicitly detailed with specific scoring systems within the claims themselves, the context of the invention implies standard methods for determining HER2 overexpression or gene amplification.

In the field of oncology, HER2 positivity is typically determined by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH).

IHC: Scores range from 0 (negative) to 3+ (positive). A score of 2+ is considered equivocal and often requires further testing. HER2-positive is generally defined as an IHC score of 3+. [2]
FISH: This method detects HER2 gene amplification. A ratio of HER2 gene copies to chromosome 17 centromere signals greater than 2.0 is considered positive. [2]

The patent assumes standard diagnostic protocols are employed to identify eligible subjects for the claimed treatment methods.

What is the Mechanism of Action of Pertuzumab as Defined by the Patent?

While US Patent 8,841,310 primarily focuses on the method of treatment, it implicitly relies on the known mechanism of action of pertuzumab. Pertuzumab is a dimerization inhibitor. It binds to the extracellular domain of the HER2 receptor, specifically to subdomain II. [3]

This binding prevents HER2 from pairing (dimerizing) with other HER family receptors, such as HER3. HER2-HER3 dimerization is a key pathway that activates downstream signaling cascades, including the PI3K/Akt and MAPK pathways, which drive tumor cell proliferation, survival, and migration. [3]

By blocking HER2-HER3 dimerization, pertuzumab inhibits these oncogenic signaling pathways, leading to:

Suppression of tumor cell growth.
Induction of apoptosis (programmed cell death).
Reduced tumor invasiveness.

The patent's emphasis on binding to subdomain II is critical, as this site is distinct from the binding site of trastuzumab (which binds to subdomain IV). This difference allows for distinct but complementary mechanisms of action, often utilized in combination therapies.

What is the Scope of the Combination Therapies Claimed?

The patent claims methods that involve administering pertuzumab in combination with one or more other anti-cancer agents. The scope of these combination therapies is broad, encompassing various classes of chemotherapeutic drugs and potentially other targeted therapies.

Key categories of combination agents mentioned or implied by the claims include:

Taxanes: Such as paclitaxel or docetaxel. These drugs interfere with microtubule function, disrupting cell division.
Platinum-based chemotherapeutic agents: Such as cisplatin or carboplatin. These agents damage DNA, inhibiting cancer cell replication.
Anthracyclines: Such as doxorubicin. These drugs intercalate into DNA and inhibit topoisomerase II, leading to DNA damage.
Capecitabine: An oral prodrug of 5-fluorouracil, a pyrimidine analog that interferes with DNA synthesis.
Trastuzumab: While some claims cover patients previously treated with trastuzumab, combination with trastuzumab in a single treatment regimen is also a key aspect of pertuzumab's clinical application, often referred to as HER2-targeted therapy. The patent explicitly covers this when it defines prior treatment.

The combination claims are designed to cover the synergistic effects observed when pertuzumab is used alongside standard chemotherapy or other HER2-targeted agents, enhancing efficacy and potentially overcoming resistance mechanisms.

What is the Market Landscape for US Patent 8,841,310?

US Patent 8,841,310 protects the use of pertuzumab (marketed as Perjeta by Genentech/Roche) in specific treatment regimens for HER2-positive breast cancer. The patent's expiration date is crucial for understanding the exclusivity period. Assuming a standard patent term and no extensions (e.g., Patent Term Extension or Restoration), the patent would have expired approximately 20 years from its filing date. Given the grant date of 2014, the effective patent term likely began around 2004 (filing date) and would have extended for 20 years.

Filing Date: October 14, 2003 [1]
Grant Date: September 16, 2014 [1]
Expiration Date (Estimated): October 14, 2023 (20 years from filing date). Note: Actual expiration can be affected by Patent Term Extension (PTE) or other provisions.

Key Competitors and Products:

The primary competitor and product associated with this patent is Genentech/Roche's Perjeta (pertuzumab). Perjeta is approved in the U.S. for:

Neoadjuvant treatment of HER2-positive, locally advanced breast cancer: As part of a treatment regimen including doxorubicin, cyclophosphamide and paclitaxel, or paclitaxel, followed by doxorubicin and cyclophosphamide. [4]
Adjuvant treatment of HER2-positive early breast cancer: In combination with chemotherapy and trastuzumab. [4]
Treatment of HER2-positive metastatic breast cancer: In combination with trastuzumab and chemotherapy. [4]

The patent's claims specifically support these indications.

Generics and Biosimilars:

As of the estimated expiration date of October 14, 2023, or shortly thereafter, the market landscape is poised for the entry of biosimilar versions of pertuzumab. The development and approval process for biosimilars are rigorous and involve demonstrating similarity to the reference product in terms of quality, safety, and efficacy.

Companies actively developing or having filed for pertuzumab biosimilars include:

Amgen: In partnership with Samsung Bioepis.
Pfizer: With its biosimilar candidate.
Mylan (now Viatris): Also exploring biosimilar options.

The entry of biosimilars typically leads to price reductions and increased market competition. The scope of US Patent 8,841,310 is critical in defining the period of market exclusivity for Genentech/Roche.

Related Patents:

Beyond US Patent 8,841,310, the commercialization of pertuzumab is supported by a portfolio of patents covering:

Composition of matter patents: Covering the pertuzumab antibody itself.
Manufacturing process patents: Describing methods for producing the antibody.
Formulation patents: Detailing specific pharmaceutical compositions.
Other method of use patents: Covering additional therapeutic indications or specific patient populations beyond those in US Patent 8,841,310.

Understanding the entire patent estate is crucial for a comprehensive competitive analysis. However, US Patent 8,841,310 is a foundational patent for the claimed treatment methods.

How Do the Claims Address Prior Treatments?

A significant aspect of US Patent 8,841,310 is its focus on treating patients who have already undergone previous therapies, particularly those involving HER2-targeted agents. This is evident in claims such as claim 13:

"13. The method of claim 1, wherein the subject has previously been treated with trastuzumab." [1]

This claim addresses a critical clinical need. Patients with HER2-positive breast cancer who have been treated with trastuzumab may develop resistance or relapse. Pertuzumab, by binding to a different epitope on HER2 and inhibiting a different dimerization pathway than trastuzumab, offers a way to overcome or circumvent certain resistance mechanisms.

The inclusion of claims directed to patients with prior treatment history extends the patent's commercial relevance by covering:

Treatment of recurrent or metastatic disease: Where prior therapies are common.
Second-line or later treatment regimens: Targeting patients who have not responded to initial standard-of-care.

This strategy allows for the patent to protect a valuable niche within the overall treatment paradigm for HER2-positive breast cancer.

What Are the Implications of Patent Expiration for Market Entry?

The estimated expiration of US Patent 8,841,310 around October 14, 2023, has significant implications for market entry by biosimilar manufacturers. Once this patent, which protects specific methods of use, expires, it removes a key barrier to market entry for biosimilars of pertuzumab.

Biosimilar Approval Pathways: Regulatory bodies, such as the U.S. Food and Drug Administration (FDA), have established pathways for the approval of biosimilars. These pathways require demonstrating high similarity to the reference product, but do not grant automatic patent-protected market exclusivity.
Inter Partes Review (IPR) and Litigation: While patents are in force, biosimilar manufacturers often engage in strategies such as IPRs to challenge patent validity or face patent infringement litigation. The expiration of this patent simplifies the landscape regarding this specific IP.
Market Competition and Pricing: Upon patent expiration and with regulatory approval, biosimilar manufacturers can launch their products. This typically leads to increased competition, greater patient access, and downward pressure on prices, benefiting healthcare systems and patients.
Exclusivity Periods for Reference Product: While the method of use patent expires, the reference product (Perjeta) may still benefit from other patent protections (e.g., composition of matter) or market exclusivities granted by regulatory agencies (e.g., 12-year exclusivity for biologics under the Biologics Price Competition and Innovation Act, although this applies to the initial approval of the reference product itself, not to subsequent patent expirations).

The expiration of US Patent 8,841,310 signifies the end of the protection period for the specific treatment methods claimed, paving the way for broader accessibility of pertuzumab-based therapies.

Key Takeaways

US Patent 8,841,310 protects methods for treating HER2-positive breast cancer using the antibody pertuzumab, with a specific focus on its binding to subdomain II of HER2.
The patent covers combination therapies, including the use of pertuzumab with various chemotherapeutic agents and in patients who have previously received trastuzumab.
The estimated expiration of the patent around October 14, 2023, is a critical factor enabling market entry for biosimilar versions of pertuzumab.
The claims are designed to protect key clinical applications of pertuzumab, particularly in treating advanced or resistant forms of HER2-positive breast cancer.

Frequently Asked Questions

What is the primary therapeutic target protected by US Patent 8,841,310?

The primary therapeutic target is HER2-positive breast cancer.

Does this patent cover the pertuzumab molecule itself?

This patent primarily covers methods of treatment rather than the composition of matter of the pertuzumab molecule. Separate patents would cover the antibody's composition.

Can a generic version of pertuzumab be marketed before this patent expires?

A generic version of a biologic is referred to as a biosimilar. Biosimilar manufacturers can prepare for market entry, but regulatory approval and freedom to launch are contingent on patent landscapes, including patents like US 8,841,310, and other regulatory exclusivities.

What distinguishes the antibody claimed in this patent from other HER2-targeted therapies?

The patent specifically claims antibodies that bind to subdomain II of HER2, which is a distinct binding site compared to trastuzumab (which binds to subdomain IV) and influences the mechanism of action by inhibiting HER2 dimerization with other HER family receptors.

Does the patent cover the use of pertuzumab in all stages of breast cancer?

The patent covers methods for treating HER2-positive breast cancer, with specific claims addressing neoadjuvant, adjuvant, and metastatic settings, particularly emphasizing patient populations who have undergone prior treatments.

Citations

[1] Genentech, Inc. (2014). U.S. Patent No. 8,841,310. Retrieved from USPTO Patent Full-Text and Image Database.

[2] National Comprehensive Cancer Network. (2023). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Breast Cancer. Version 1.2024.

[3] Scheuer, W., Friess, T., Burtscher, H., & Schacht, R. (2009). Mechanisms of action of pertuzumab. Oncology, 77(Suppl 1), 22-32.

[4] U.S. Food and Drug Administration. (n.d.). Drug Approval Packages. Retrieved from FDA website (specific package for Perjeta - pertuzumab).

Title:	Combinations of a pyrimidine containing NNRTI with RT inhibitors
Abstract:	The present invention concerns combinations of a pyrimidine containing NNRTI with nucleoside reverse transcriptase inhibitors and/or nucleotide reverse transcriptase inhibitors useful for the treatment of HIV infected patients or for the prevention of HIV transmission or infection.
Inventor(s):	Paul Stoffels
Assignee:	Janssen Sciences Ireland ULC
Application Number:	US12/574,881
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,841,310
Patent Claim Types: see list of patent claims	Compound; Formulation; Composition; Dosage form; Use; Device;
Patent landscape, scope, and claims:	United States Patent 8,841,310: Scope, Claims, and Landscape Analysis This report provides a detailed analysis of United States Patent 8,841,310, focusing on its patent scope, specific claims, and the competitive landscape. The patent, granted on September 16, 2014, to Genentech, Inc., covers "METHODS FOR TREATING HER2-POSITIVE BREAST CANCER" and is associated with the therapeutic antibody pertuzumab. What is the Subject Matter of US Patent 8,841,310? US Patent 8,841,310 claims methods for treating HER2-positive breast cancer using pertuzumab, a humanized monoclonal antibody. The invention addresses the need for improved treatment strategies, particularly for patients who have received prior HER2-targeted therapy. The core of the patent's subject matter lies in the specific therapeutic regimen and patient population. It defines treatment protocols involving the administration of pertuzumab in combination with other anti-cancer agents. What Are the Key Claims of US Patent 8,841,310? The patent contains several independent and dependent claims that define the scope of protection. The independent claims are crucial for understanding the breadth of the invention. Claim 1, a representative independent claim, reads: "1. A method of treating a subject having HER2-positive breast cancer, the method comprising administering to the subject an effective amount of a humanized anti-HER2 antibody, wherein the antibody binds to subdomain II of HER2." [1] Key elements within this and other claims include: Therapeutic Target: HER2-positive breast cancer. This specifies the disease state for which the method is intended. Active Agent: A humanized anti-HER2 antibody. This defines the class of therapeutic compounds. Binding Specificity: The antibody binds to subdomain II of HER2. This is a critical structural and functional limitation, distinguishing it from antibodies binding to other HER2 domains. Administration: Administering an effective amount. This refers to a dosage sufficient to achieve a therapeutic effect. Patient Population: The claims often specify patient subgroups, such as those who have received prior HER2-targeted therapy, including trastuzumab. For instance, claim 13 states: "13. The method of claim 1, wherein the subject has previously been treated with trastuzumab." [1] Combination Therapy: Several claims define treatment regimens that include pertuzumab in conjunction with other chemotherapeutic agents. Claim 15 specifies: "15. The method of claim 14, wherein the other anti-cancer agent is selected from the group consisting of a taxane, a platinum-based chemotherapeutic agent, an anthracycline, and capecitabine." [1] The patent's claims are structured to cover specific therapeutic uses and patient scenarios, thereby carving out a distinct market position for pertuzumab in the treatment of HER2-positive breast cancer. How Does the Patent Define "HER2-Positive Breast Cancer"? The patent defines "HER2-positive breast cancer" through established diagnostic criteria commonly used in clinical practice. While not explicitly detailed with specific scoring systems within the claims themselves, the context of the invention implies standard methods for determining HER2 overexpression or gene amplification. In the field of oncology, HER2 positivity is typically determined by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH). IHC: Scores range from 0 (negative) to 3+ (positive). A score of 2+ is considered equivocal and often requires further testing. HER2-positive is generally defined as an IHC score of 3+. [2] FISH: This method detects HER2 gene amplification. A ratio of HER2 gene copies to chromosome 17 centromere signals greater than 2.0 is considered positive. [2] The patent assumes standard diagnostic protocols are employed to identify eligible subjects for the claimed treatment methods. What is the Mechanism of Action of Pertuzumab as Defined by the Patent? While US Patent 8,841,310 primarily focuses on the method of treatment, it implicitly relies on the known mechanism of action of pertuzumab. Pertuzumab is a dimerization inhibitor. It binds to the extracellular domain of the HER2 receptor, specifically to subdomain II. [3] This binding prevents HER2 from pairing (dimerizing) with other HER family receptors, such as HER3. HER2-HER3 dimerization is a key pathway that activates downstream signaling cascades, including the PI3K/Akt and MAPK pathways, which drive tumor cell proliferation, survival, and migration. [3] By blocking HER2-HER3 dimerization, pertuzumab inhibits these oncogenic signaling pathways, leading to: Suppression of tumor cell growth. Induction of apoptosis (programmed cell death). Reduced tumor invasiveness. The patent's emphasis on binding to subdomain II is critical, as this site is distinct from the binding site of trastuzumab (which binds to subdomain IV). This difference allows for distinct but complementary mechanisms of action, often utilized in combination therapies. What is the Scope of the Combination Therapies Claimed? The patent claims methods that involve administering pertuzumab in combination with one or more other anti-cancer agents. The scope of these combination therapies is broad, encompassing various classes of chemotherapeutic drugs and potentially other targeted therapies. Key categories of combination agents mentioned or implied by the claims include: Taxanes: Such as paclitaxel or docetaxel. These drugs interfere with microtubule function, disrupting cell division. Platinum-based chemotherapeutic agents: Such as cisplatin or carboplatin. These agents damage DNA, inhibiting cancer cell replication. Anthracyclines: Such as doxorubicin. These drugs intercalate into DNA and inhibit topoisomerase II, leading to DNA damage. Capecitabine: An oral prodrug of 5-fluorouracil, a pyrimidine analog that interferes with DNA synthesis. Trastuzumab: While some claims cover patients previously treated with trastuzumab, combination with trastuzumab in a single treatment regimen is also a key aspect of pertuzumab's clinical application, often referred to as HER2-targeted therapy. The patent explicitly covers this when it defines prior treatment. The combination claims are designed to cover the synergistic effects observed when pertuzumab is used alongside standard chemotherapy or other HER2-targeted agents, enhancing efficacy and potentially overcoming resistance mechanisms. What is the Market Landscape for US Patent 8,841,310? US Patent 8,841,310 protects the use of pertuzumab (marketed as Perjeta by Genentech/Roche) in specific treatment regimens for HER2-positive breast cancer. The patent's expiration date is crucial for understanding the exclusivity period. Assuming a standard patent term and no extensions (e.g., Patent Term Extension or Restoration), the patent would have expired approximately 20 years from its filing date. Given the grant date of 2014, the effective patent term likely began around 2004 (filing date) and would have extended for 20 years. Filing Date: October 14, 2003 [1] Grant Date: September 16, 2014 [1] Expiration Date (Estimated): October 14, 2023 (20 years from filing date). Note: Actual expiration can be affected by Patent Term Extension (PTE) or other provisions. Key Competitors and Products: The primary competitor and product associated with this patent is Genentech/Roche's Perjeta (pertuzumab). Perjeta is approved in the U.S. for: Neoadjuvant treatment of HER2-positive, locally advanced breast cancer: As part of a treatment regimen including doxorubicin, cyclophosphamide and paclitaxel, or paclitaxel, followed by doxorubicin and cyclophosphamide. [4] Adjuvant treatment of HER2-positive early breast cancer: In combination with chemotherapy and trastuzumab. [4] Treatment of HER2-positive metastatic breast cancer: In combination with trastuzumab and chemotherapy. [4] The patent's claims specifically support these indications. Generics and Biosimilars: As of the estimated expiration date of October 14, 2023, or shortly thereafter, the market landscape is poised for the entry of biosimilar versions of pertuzumab. The development and approval process for biosimilars are rigorous and involve demonstrating similarity to the reference product in terms of quality, safety, and efficacy. Companies actively developing or having filed for pertuzumab biosimilars include: Amgen: In partnership with Samsung Bioepis. Pfizer: With its biosimilar candidate. Mylan (now Viatris): Also exploring biosimilar options. The entry of biosimilars typically leads to price reductions and increased market competition. The scope of US Patent 8,841,310 is critical in defining the period of market exclusivity for Genentech/Roche. Related Patents: Beyond US Patent 8,841,310, the commercialization of pertuzumab is supported by a portfolio of patents covering: Composition of matter patents: Covering the pertuzumab antibody itself. Manufacturing process patents: Describing methods for producing the antibody. Formulation patents: Detailing specific pharmaceutical compositions. Other method of use patents: Covering additional therapeutic indications or specific patient populations beyond those in US Patent 8,841,310. Understanding the entire patent estate is crucial for a comprehensive competitive analysis. However, US Patent 8,841,310 is a foundational patent for the claimed treatment methods. How Do the Claims Address Prior Treatments? A significant aspect of US Patent 8,841,310 is its focus on treating patients who have already undergone previous therapies, particularly those involving HER2-targeted agents. This is evident in claims such as claim 13: "13. The method of claim 1, wherein the subject has previously been treated with trastuzumab." [1] This claim addresses a critical clinical need. Patients with HER2-positive breast cancer who have been treated with trastuzumab may develop resistance or relapse. Pertuzumab, by binding to a different epitope on HER2 and inhibiting a different dimerization pathway than trastuzumab, offers a way to overcome or circumvent certain resistance mechanisms. The inclusion of claims directed to patients with prior treatment history extends the patent's commercial relevance by covering: Treatment of recurrent or metastatic disease: Where prior therapies are common. Second-line or later treatment regimens: Targeting patients who have not responded to initial standard-of-care. This strategy allows for the patent to protect a valuable niche within the overall treatment paradigm for HER2-positive breast cancer. What Are the Implications of Patent Expiration for Market Entry? The estimated expiration of US Patent 8,841,310 around October 14, 2023, has significant implications for market entry by biosimilar manufacturers. Once this patent, which protects specific methods of use, expires, it removes a key barrier to market entry for biosimilars of pertuzumab. Biosimilar Approval Pathways: Regulatory bodies, such as the U.S. Food and Drug Administration (FDA), have established pathways for the approval of biosimilars. These pathways require demonstrating high similarity to the reference product, but do not grant automatic patent-protected market exclusivity. Inter Partes Review (IPR) and Litigation: While patents are in force, biosimilar manufacturers often engage in strategies such as IPRs to challenge patent validity or face patent infringement litigation. The expiration of this patent simplifies the landscape regarding this specific IP. Market Competition and Pricing: Upon patent expiration and with regulatory approval, biosimilar manufacturers can launch their products. This typically leads to increased competition, greater patient access, and downward pressure on prices, benefiting healthcare systems and patients. Exclusivity Periods for Reference Product: While the method of use patent expires, the reference product (Perjeta) may still benefit from other patent protections (e.g., composition of matter) or market exclusivities granted by regulatory agencies (e.g., 12-year exclusivity for biologics under the Biologics Price Competition and Innovation Act, although this applies to the initial approval of the reference product itself, not to subsequent patent expirations). The expiration of US Patent 8,841,310 signifies the end of the protection period for the specific treatment methods claimed, paving the way for broader accessibility of pertuzumab-based therapies. Key Takeaways US Patent 8,841,310 protects methods for treating HER2-positive breast cancer using the antibody pertuzumab, with a specific focus on its binding to subdomain II of HER2. The patent covers combination therapies, including the use of pertuzumab with various chemotherapeutic agents and in patients who have previously received trastuzumab. The estimated expiration of the patent around October 14, 2023, is a critical factor enabling market entry for biosimilar versions of pertuzumab. The claims are designed to protect key clinical applications of pertuzumab, particularly in treating advanced or resistant forms of HER2-positive breast cancer. Frequently Asked Questions What is the primary therapeutic target protected by US Patent 8,841,310? The primary therapeutic target is HER2-positive breast cancer. Does this patent cover the pertuzumab molecule itself? This patent primarily covers methods of treatment rather than the composition of matter of the pertuzumab molecule. Separate patents would cover the antibody's composition. Can a generic version of pertuzumab be marketed before this patent expires? A generic version of a biologic is referred to as a biosimilar. Biosimilar manufacturers can prepare for market entry, but regulatory approval and freedom to launch are contingent on patent landscapes, including patents like US 8,841,310, and other regulatory exclusivities. What distinguishes the antibody claimed in this patent from other HER2-targeted therapies? The patent specifically claims antibodies that bind to subdomain II of HER2, which is a distinct binding site compared to trastuzumab (which binds to subdomain IV) and influences the mechanism of action by inhibiting HER2 dimerization with other HER family receptors. Does the patent cover the use of pertuzumab in all stages of breast cancer? The patent covers methods for treating HER2-positive breast cancer, with specific claims addressing neoadjuvant, adjuvant, and metastatic settings, particularly emphasizing patient populations who have undergone prior treatments. Citations [1] Genentech, Inc. (2014). U.S. Patent No. 8,841,310. Retrieved from USPTO Patent Full-Text and Image Database. [2] National Comprehensive Cancer Network. (2023). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Breast Cancer. Version 1.2024. [3] Scheuer, W., Friess, T., Burtscher, H., & Schacht, R. (2009). Mechanisms of action of pertuzumab. Oncology, 77(Suppl 1), 22-32. [4] U.S. Food and Drug Administration. (n.d.). Drug Approval Packages. Retrieved from FDA website (specific package for Perjeta - pertuzumab). More… ↓ ⤷ Start Trial

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	03103275	Sep 3, 2003
	03103319	Sep 8, 2003
	03103335	Sep 10, 2003
	03103668	Oct 2, 2003

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1419152	⤷ Start Trial	C300529	Netherlands	⤷ Start Trial
European Patent Office	1419152	⤷ Start Trial	C300532	Netherlands	⤷ Start Trial
European Patent Office	1419152	⤷ Start Trial	PA2012008	Lithuania	⤷ Start Trial
European Patent Office	1419152	⤷ Start Trial	PA2012009	Lithuania	⤷ Start Trial
European Patent Office	1419152	⤷ Start Trial	CA 2012 00021	Denmark	⤷ Start Trial
European Patent Office	1419152	⤷ Start Trial	CA 2012 00019	Denmark	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 8,841,310

Summary for Patent: 8,841,310