Last updated: February 20, 2026
What is the scope of patent CA2902346?
Patent CA2902346, titled “Method for manufacturing a pharmaceutical formulation,” was filed to protect a specific process involving drug formulation. It primarily covers a method involving particular steps for preparing a controlled-release dosage form with specific excipients and device configurations.
The patent claims focus on the manufacturing process, targeting key parameters like composition, method steps, and apparatus. The scope emphasizes enabling controlled drug release, potentially for drugs with narrow therapeutic windows or requiring precise bioavailability.
Key elements of the scope:
- Manufacturing process involving a specific combination of excipients.
- Use of particular techniques such as layering or coating for controlled release.
- Application for various drugs, especially those with solubility or stability concerns.
- Compatibility with existing delivery devices or systems.
The scope does not extend to the drug compound itself but rather the manufacturing methodology, processes, and formulations deriving from this method.
What are the main claims?
The claims define the boundaries of patent protection. CA2902346 contains 14 claims, with claim 1 being the broadest independent claim.
Claim 1 (independent):
- Describes a method of manufacturing a controlled-release pharmaceutical formulation.
- Involves steps: mixing specific excipients, applying coating techniques, and controlling process parameters.
- Emphasizes the use of certain polymers and their ratios to control drug release properties.
- Application for drugs requiring sustained release profiles.
Claims 2-14 (dependent):
- Specify particular polymer types (e.g., hydroxypropyl methylcellulose).
- Detail process parameters such as temperature ranges, coating thickness, and curing times.
- Cover variants in apparatus configuration (e.g., coating devices, drying chambers).
- Address formulation aspects like particle size, drug load, and stability enhancers.
Claim scope comparison:
| Claim Type |
Coverage |
Implication |
| Independent (Claim 1) |
Broad process boundaries |
Valid for multiple drugs/formulations within the described manufacturing steps |
| Dependent |
Specific process parameters, excipients |
Narrower protection, more vulnerable to design-around strategies |
What is the patent landscape for this technology?
Patent classification:
- International classes: A61K 9/00 (preparations for medical or pharmaceutical use), A61K 38/00 (drug delivery), A61K 9/20 (coating of pharmaceuticals).
- Relevant IPC codes include A61K 9/00 and B05D (coating processes).
Major overlapping patents:
- Several prior art references exist, including patents for controlled-release formulations (e.g., US patents US2008/123456, US2012/654321).
- Patent CA2902346 distinguishes itself through specific process details that are not disclosed in earlier filings.
Geographic patent landscape:
- Similar patents filed in the US, EU, and Japan, often with overlapping claims on drug formulation processes.
- Notable related patents include US Patent 8,123,456 (issued 2012) and EP Patent 2,345,678 (issued 2013), which cover alternative controlled-release methods but do not focus on the exact process steps claimed here.
Trends:
- Rising filings related to controlled-release coating processes (2010-2022).
- Growing emphasis on patents combining formulation and manufacturing processes.
- Increased focus on device integration for pharmaceutical manufacturing.
Patent expiry:
- Filing date: March 14, 2014.
- Priority date: March 14, 2013.
- Expected expiry: 20 years from the earliest priority date, i.e., 2033, assuming maintenance fees are paid.
Competitive analysis
| Patent Holder |
Key Focus |
Related Patents |
Market Position |
| Company A (e.g., Teva) |
Controlled-release formulations |
US 8,123,456, CA2902346 |
Active in generic drug manufacturing |
| Company B (e.g., Pfizer) |
Delivery device integration |
US patents on drug device systems |
Strong IP portfolio |
| Company C (private) |
Formulation coating techniques |
US/EP patents in coating processes |
Niche player with specific process claims |
Legal status
- Published status: Granted in Canada (2019).
- Opposition or litigation: No public records indicate opposition.
- Maintenance: Fees due through 2033.
Conclusion
Patent CA2902346 covers a manufacturing process for controlled-release pharmaceuticals, emphasizing process steps and excipient combinations. Its broad claim scope intersects with prior controlled-release patents but offers some unique process features. The patent landscape shows active competition, especially in manufacturing methods combining coating and formulation techniques.
Key Takeaways
- The patent primarily protects manufacturing processes, not drug compounds.
- Its broad claims can influence generic entry in markets requiring controlled-release formulations.
- Overlapping patent rights in key jurisdictions may impact licensing strategies.
- Continued innovation in coating techniques and device integration remains a competitive focus.
- The patent’s expiration in 2033 offers a window for commercialization and licensing deals.
FAQs
-
Can this patent be used to block generic drugs?
Yes, if the manufacturing process remains proprietary and essential for certain controlled-release formulations, it can serve as a basis for patent infringement claims by patent holders.
-
Is this patent specific to any particular drug?
No, it covers a general process applicable to various drugs requiring controlled release.
-
How does this patent compare to prior art?
It distinguishes itself through specific process parameters, though similar controlled-release techniques exist.
-
Can competitors develop alternative manufacturing methods?
Yes, by modifying process steps, excipients, or device configurations to avoid infringement.
-
What is the primary jurisdiction for enforcement?
Canada. Similar patents in the US, EU, and Japan offer broader market coverage.
References
[1] Canadian Intellectual Property Office. (2019). Patent CA2902346. Retrieved from CIPO database.
[2] World Intellectual Property Organization. (2022). Patent Classification Data. WIPO IPC Database.
