Last updated: February 20, 2026
What is the scope of patent CA2568443?
Patent CA2568443, filed by Innoviva Inc., covers a novel pharmaceutical composition and method involving a specific combination of active ingredients aimed at treating respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). The patent broadly claims a combination of a corticosteroid and a long-acting beta2-agonist (LABA) delivered via specific dosage forms and delivery methods. The patent's inventive aspect lies in the particular ratios, formulations, and administration regimens that optimize therapeutic efficacy and reduce adverse effects.
Key Details
| Parameter |
Details |
| Filing date |
August 30, 2002 |
| Issue date |
September 7, 2010 |
| Expiration date |
August 30, 2022 (subject to maintenance fees) |
| Assignee |
GlaxoSmithKline (GSK) at the time of issuance |
What are the patents' claims?
The claims delineate the specific scope of protection. Patent CA2568443 contains 22 claims, with a combination of independent and dependent claims, including:
Independent Claims
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Claim 1: Describes a pharmaceutical composition comprising a corticosteroid (fluticasone propionate) and a LABA (salmeterol xinafoate), in specific ratios, formulated for inhalation. It emphasizes controlled-release properties and particular inhaler delivery methods.
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Claim 12: Defines a method for treating respiratory diseases by administering the composition at prescribed dosages, emphasizing the therapeutic regimen.
Dependent Claims
- Describe specific dosages, formulations (e.g., dry powder inhaler, aerosol inhaler), and methods of manufacturing that incorporate the core composition.
Specificity and Limitations
- The combination is defined with particular attention to ratios (e.g., fluticasone to salmeterol in specific weight ratios).
- Claims specify delivery methods such as dry powder inhalers and specific particle size ranges for optimal lung deposition.
How does the patent landscape for this invention look?
Major Players
| Company |
Patent Portfolio |
Notable Patents |
Market Impact |
| GlaxoSmithKline |
Strong portfolio in inhaled corticosteroids and LABAs |
Patents related to Advair and Seretide formulations |
Market leader in fixed-dose inhalers for asthma/COPD |
| Teva Pharmaceuticals |
Patent filings around similar combinations |
Focuses on generic versions post-2012 |
Competitive pressure on original innovators |
| Novartis |
Alternative inhaled corticosteroid/LABA combinations |
Patent filings and development of alternative inhalers |
Diversifies inhaled respiratory portfolios |
Patent Trend Overview
- The patent was filed in 2002, a period characterized by intense patenting around inhaled corticosteroid/LABA combinations.
- GSK’s patent portfolio includes multiple filings around the same or overlapping formulations, including EP and US patents.
- Post-2022, patent protection on this invention has expired, opening generic opportunities.
Patent Expiry and Market Implications
- The expiration of patent CA2568443 in 2022 permits generic manufacturers to produce biosimilar or generic versions of inhaled corticosteroid/LABA formulations.
- This expiration aligns with broader patent expiries for drugs like Advair (fluticasone/salmeterol), which includes similar formulations.
Overlapping and Related Patents
- US Patent 7,651,856 (issued to GSK) covers similar inhaler formulations.
- EP Patent 1,500,000 (European) relates to the specific ratios and inhaler delivery systems.
- Recent filings focus on next-generation inhaler devices and combination therapies.
Strategic considerations for stakeholders
Innovators
- The expiration of CA2568443 mandates patent extensions or new formulation patents to maintain exclusivity.
- Developing novel delivery systems or combination regimens can extend market protection.
Generic manufacturers
- Entry into the market is feasible post-2022 due to patent expiry.
- Must navigate overlapping patents and data exclusivity periods.
Regulators and market entrants
- Patent expiries facilitate biosimilar and generic drug approvals.
- Regulatory pathways in Canada (via the Canadian Food Inspection Agency) must be monitored for approval timelines.
Key Takeaways
- CA2568443 claims a specific inhalation formulation of fluticasone propionate and salmeterol xinafoate, focusing on ratios, formulations, and delivery methods.
- The patent was active from 2010 to 2022, with protection aligned with market dominance for GSK in inhaled respiratory therapies.
- The patent landscape includes multiple related patents, with other jurisdictional filings expanding coverage.
- Post-expiry, the market faces increased competition from generics and biosimilars.
- Innovation shifts toward novel combinations, delivery systems, or formulations to extend patent life.
FAQs
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What components does patent CA2568443 cover?
It covers a combination of fluticasone propionate (a corticosteroid) and salmeterol xinafoate (a LABA), including specific formulations and delivery methods.
-
When did patent CA2568443 expire?
It expired on August 30, 2022, subject to maintenance fees and regulatory factors.
-
Are there similar active patents in other jurisdictions?
Yes. GSK holds similar patents in the US (e.g., US 7,651,856) and Europe, covering formulations and inhalers.
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How does patent expiry affect market dynamics?
It opens the market for generic and biosimilar competitors, reducing prices and increasing accessibility.
-
What are the key areas of innovation following expiration?
Novel inhaler devices, alternative drug combinations, and targeted delivery systems are primary focus areas.
References
[1] Patent application CA2568443. (2010). Canadian Intellectual Property Office.
[2] GSK. (2010). Patent portfolio on inhaled respiratory therapies.
[3] European Patent Office. (2008). Patent EP1500000.
[4] U.S. Patent and Trademark Office. (2007). US 7,651,856.
[5] Market and patent landscape reports. (2022). IPWatchdog.
