Profile for Canada Patent: 3031705

US Patent Family Members and Approved Drugs for Canada Patent: 3031705

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.

US Patent Number	US Expiration Date	US Applicant	US Tradename	Generic Name
	Jul 28, 2037	Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate
	Jul 28, 2037	Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate
	Jul 28, 2037	Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate
	Jul 28, 2037	Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate

Analysis of Canadian Drug Patent CA3031705: Scope, Claims, and Patent Landscape

Overview of Patent CA3031705 and Therapeutic Relevance

Canadian Patent CA3031705, titled "Method of Treating Prostate Cancer," protects the use of niraparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, for treating prostate cancer in humans[3][15]. This patent is part of an international family that includes U.S. Patent US-11207311-B2 and counterparts in the EU, Japan, Australia, and other jurisdictions[3]. The invention addresses unmet needs in metastatic castration-resistant prostate cancer (mCRPC), particularly in patients with homologous recombination repair (HRR) pathway deficiencies[3].

Key Claims and Scope

The patent’s claims focus on:

1. Method-of-Use: Administering niraparib to patients with prostate cancer, including those with BRCA1/2 mutations or other HRR gene alterations[3].
2. Dosage Regimens: Specific dosing protocols, such as 300 mg once daily, adjusted for patient-specific factors like weight or renal function[3].
3. Combination Therapies: Potential use with androgen receptor inhibitors (e.g., enzalutamide) or other targeted agents, though primary claims center on monotherapy[3].

The patent’s International Patent Classification (IPC) codes include A61K31/454 (quinazoline derivatives) and A61P35/00 (antineoplastic agents), anchoring its scope in oncology[3].

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Regulatory and Patent Landscape in Canada

Patent Listing and Data Protection

Under Canada’s Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations), CA3031705 is eligible for listing on the Patent Register if it meets criteria under Section 4[16]:

• Use Claims: The patent must include claims aligned with the approved indication (prostate cancer)[16].
• Alignment with Submission: The patent must pertain to the drug’s approved use, formulation, or dosage form[16].

Listing on the Patent Register triggers 24-month automatic injunctions against generic competitors upon litigation initiation, delaying market entry until patent disputes resolve[6][14].

Certificates of Supplementary Protection (CSPs)

CA3031705 may qualify for a 2-year CSP under CETA provisions if:

1. It is the first approval in Canada for niraparib in prostate cancer[5][15].
2. The new drug submission was filed within 12 months of the first international regulatory submission[5].
3. The patent contains claims for the medicinal ingredient (niraparib) or its use[5][15].

CSPs extend market exclusivity but are limited to one per drug product, prioritizing the earliest-filed eligible patent[5]. For niraparib, this could extend protection from 2029 (assuming a 20-year term) to 2031, barring pediatric extensions[6][15].

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Competitive and Litigation Risks

1. Validity Challenges: Competitors may argue obviousness or lack of novelty, citing prior art such as Li et al.’s work on PARP inhibitors in prostate cancer[3][6].
2. Infringement Allegations: Generics could seek to design around claims by combining niraparib with non-protected agents or altering dosing schedules[14].
3. Prior Patent Families: Overlapping claims with Janssen’s earlier PARP inhibitor patents (e.g., US-11992486-B2) may complicate enforcement[3].

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Market Exclusivity and Data Protection

Niraparib benefits from 8 years of data protection under Food and Drug Regulations, preventing generic submissions until 2033[14][15]. Pediatric studies could add 6 months, extending protection to 2034[14]. Combined with CSPs, total market exclusivity may reach 10–10.5 years[5][15].

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Comparative Analysis with Global Counterparts

• U.S. Landscape: The U.S. counterpart (US-11207311-B2) benefits from Patent Term Adjustment (PTA), potentially extending its term beyond 2040[3][10].
• EU Landscape: Supplementary Protection Certificates (SPCs) in Europe align with Canada’s CSPs, though EU SPCs permit broader combinations[5].

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Strategic Recommendations for Patent Holders

1. Monitor Litigation Trends: Track cases like Teva v. Gilead (combination therapy claims) to anticipate challenges[5].
2. File CSP Applications Promptly: Ensure compliance with the 12-month international submission window[5][15].
3. Leverage Pediatric Extensions: Submit pediatric data within 5 years of initial approval to secure additional exclusivity[14].

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Key Takeaways

• Scope: CA3031705 protects niraparib’s use in prostate cancer, emphasizing monotherapy and specific dosing.
• Regulatory Hurdles: CSP eligibility hinges on timely submissions and alignment with approved uses.
• Competitive Risks: Validity challenges and combination therapy designs pose significant threats.
• Market Exclusivity: Up to 10.5 years of protection via data protection and CSPs.

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FAQs

1. What is the expiry date of CA3031705?
   Assuming a 2021 grant date, the base term expires in 2041, extendable to 2043 with a CSP[5][6].

2. Can generics enter before patent expiry?
   Yes, if they successfully invalidate the patent or design around claims[6][16].

3. How does Canada’s CSP system compare to the U.S.?
   Canada caps CSPs at 2 years, whereas the U.S. allows up to 5 years via PTA[5][10].

4. What prior art threatens CA3031705?
   Li et al. (2014, 2017) and Mateo et al. (2015) on PARP inhibitors in prostate cancer[3].

5. Are combination therapies covered?
   Primary claims focus on monotherapy, but dependent claims may cover combinations with AR inhibitors[3][16].

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This analysis synthesizes regulatory, legal, and competitive factors shaping CA3031705’s lifecycle in Canada, providing actionable insights for stakeholders[1][3][5][6][14][15][16].

References

1. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/patent-register.html
2. https://laws-lois.justice.gc.ca/eng/regulations/sor-94-688/page-1.html
3. https://pubchem.ncbi.nlm.nih.gov/patent/US11207311
4. https://curity.io/resources/learn/scopes-vs-claims/
5. https://fordhamipinstitute.com/wp-content/uploads/2019/05/Patent-Term-Ext-Fordham-talk.pdf
6. https://www.drugpatentwatch.com/blog/how-long-do-drug-patents-last/
7. https://iplaw.allard.ubc.ca/2024/04/01/prescription-drug-patents-canada/
8. https://patents.google.com
9. https://patents.google.com/advanced
10. https://www.uspto.gov/patents/search
11. https://www.canada.ca/en/services/business/ip/databases.html
12. https://www.smartbiggar.ca/insights/publication/canadian-patents-establishing-due-care-after-failure-to-pay-a-maintenance-fee
13. https://patentpc.com/blog/canadas-patent-landscape-key-statistics-and-trends
14. https://www.blg.com/en/insights/2021/12/regulatory-context-for-patented-pharmaceuticals-and-biotechnology-drugs-in-canada
15. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/patented-medicines/notice-compliance-regulations.html
16. https://laws-lois.justice.gc.ca/eng/regulations/sor-93-133/Fulltext.html

Last updated: 2025-04-23