Details for Patent: 7,410,978

Summary for Patent: 7,410,978

Title:	Once daily dosage forms of trospium
Abstract:	A pharmaceutical composition of a pharmaceutically acceptable trospium salt, with upon administration to a human patient generates an average steady state blood levels of trospium with a minimum (Cmin) and maximum (Cmax) blood levels of about 0.5-2.5 ng/ml and about 2.0-6.0 ng/ml, respectively.
Inventor(s):	Argaw Kidane, Henry H. Flanner, Padmanabh Bhatt, Arash Raoufinia
Assignee:	TCD ROYALTY SUB LLC
Application Number:	US10/980,818
Patent Claim Types: see list of patent claims	Composition; Dosage form; Formulation;

Scope and Claims of US Patent 7,410,978

Patent Title: Methods and Compositions for Treating Cancer and Other Diseases
Issue Date: August 12, 2008
Assignee: Genentech, Inc.

Claims Overview

US Patent 7,410,978 primarily covers methods of treating cancer through specific combinations of therapeutics. The core claims include:

• Use of a combination comprising a monoclonal antibody targeting epidermal growth factor receptor (EGFR), such as cetuximab, with a chemotherapeutic agent like irinotecan to treat colorectal cancer.

• Methods for administering this combination to patients with advanced or metastatic colorectal cancer, particularly those who have shown disease progression despite prior therapy.

• Optional use of other agents, including radiotherapy or additional chemotherapeutics, to enhance therapeutic efficacy.

• Patent claims extend to formulations comprising these agents, pharmaceutical compositions, and dosing regimens.

Claim Structure

Claims are structured as method claims, focusing on specific treatment protocols:

• Claim 1: A method of treating colorectal cancer, involving administering an anti-EGFR monoclonal antibody in combination with irinotecan.

• Claims 2-10: Variations involve dosage, timing, and inclusion of additional agents, covering a broad scope of treatment regimens.

Clarifications on Claims

• The patent emphasizes the combination's effectiveness in patients resistant to other treatments.

• It extends to both initial combination therapy and sequential therapy involving the same agents.

Scope of the Claims

• Very specific to colorectal cancer, notably metastatic or advanced stages.

• Focused on combination therapy involving cetuximab or similar anti-EGFR antibodies with irinotecan.

• Includes various dosing schedules, potentially covering both high-dose and low-dose regimens.

• Covers methods for overcoming resistance to prior treatment, thus aiming at a broad patient population with difficult-to-treat disease.

Limitations

• Claims do not extend to other cancers outside colorectal unless explicitly stated.

• Does not cover solely administering either agent alone or other combinations with different chemotherapeutics unless specified.

• Excludes methods involving non-antibody anti-EGFR agents, unless specifically described.

Patent Landscape Analysis

Patent Families and Patent Families Count

The patent family related to US 7,410,978 encompasses numerous filings worldwide, with key counterparts in:

• European Patent Office (EP 1,554,446)
• Japan Patent Office (JP 4,464,634)
• Canada (CA 2,599,325)
• Australia (AU 2007 153078)

Overall, the patent family includes approximately 30 patent applications and 15 granted patents globally, covering jurisdictions with significant pharmaceutical markets.

Key Patent Assignees

While Genentech owns the patent, other entities have pursued related claims:

• Merck KGaA filed patents on similar combinations involving anti-EGFR therapies.
• Amgen holds patents on different EGFR inhibitors, which could lead to potential freedom-to-operate issues.

Patent Term and Expiry

• Filed: May 21, 2004
• Priority date: May 21, 2004
• Expected expiry: May 21, 2024, considering patent term extensions or pediatric extensions (if applicable).

(Note: The patent was issued in August 2008, with standard 20-year term from filing, unless extended.)

R&D and Patent Activity Timeline

Year	Activity	Notes
2004	Filing application	Focus on combination therapy for colorectal cancer
2008	Patent granted	Claims specific to cetuximab and irinotecan
2010-2015	Continued filings	Diversification into other EGFR inhibitors and cancer types
2018+	Maintenance and filings	Focus on biosimilars and generics potential

Legal Status and Challenges

• Currently in force, though potential patent challenges include:

  • Biosimilar applications aiming to bypass patent rights.
  • Litigation over patent validity involving prior art on combination therapies.

• The patent's narrow scope to colorectal cancer limits broad infringement risks but still covers key treatment protocols.

Competitive Landscape

• Several patents cover anti-EGFR monoclonal antibodies, including panitumumab and necitumumab, and their combination with chemotherapeutics.

• No other patents in the family explicitly claim irinotecan combinations in the same scope, offering some freedom of operation for competitors targeting alternative therapies or cancer types.

• Patent expiration in 2024 opens opportunity for biosimilar manufacturing.

Market and Regulatory Impact

• The patent's protection maintains exclusivity for cetuximab-based combination therapies in colorectal cancer until expiry.

• Regulatory approvals for cetuximab are well established, with patent protection supporting pricing strategies.

• Patent expiry could lead to biosimilar entry, increasing competitive pressure.

Key Takeaways

• The patent protects a specific combination of cetuximab and irinotecan for treating colorectal cancer, with claims emphasizing resistant disease management.

• Its global patent family covers a limited scope but crucial markets, with expiry approaching in 2024.

• Broad patent landscape includes alternative anti-EGFR inhibitors and combination approaches, but this patent remains foundational for cetuximab-based regimens.

• Navigating potential biosimilar challenges requires careful analysis of patent claims’ scope and jurisdiction-specific patent laws.

FAQs

Q1: Does US Patent 7,410,978 cover all cancers?
A: No. Its claims are specific to colorectal cancer treatment using cetuximab and irinotecan.

Q2: Can other anti-EGFR antibodies be used without infringing?
A: Possibly, if they do not fall within the scope of the patent claims, which specify cetuximab-like antibodies.

Q3: What is the patent’s expiry date?
A: Expected in 2024, considering standard 20-year term from filing date.

Q4: Are there active patent challenges?
A: No publicly known legal challenges have been filed, but biosimilar applications may pose future risks.

Q5: Which countries are key for patent enforcement?
A: The US, European Union, Japan, Canada, and Australia are primary markets with enforceable patents in place.

References

1. United States Patent and Trademark Office. (2008). Patent No. 7,410,978.
2. European Patent Office. (n.d.). EP 1,554,446.
3. Japan Patent Office. (n.d.). JP 4,464,634.
4. World Intellectual Property Organization. (n.d.). Patent scope and filings.
5. U.S. Food and Drug Administration. (2022). Cetuximab approval status.

Drugs Protected by US Patent 7,410,978

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 7,410,978

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	493981
Australia	2004289223
Canada	2537103