Last updated: April 30, 2026
What is CA2933403 and what does it cover?
CA2933403 is a Canadian patent titled “COMPOSITIONS COMPRISING DILIGENTLY MANUFACTURED GRANULES AND PROCESSES FOR THEIR PREPARATION” (inventors: Ravindra S. Chhabra et al.; assignee: Janssen Pharmaceutica N.V.) (Canada Patent CA2933403).
The patent is centered on solid oral dose formulations built from granules that are manufactured under defined process and quality parameters. The scope is directed to:
- Granule-based compositions intended for oral administration.
- Granule manufacturing processes that control critical parameters affecting quality attributes of the final dosage form.
- Resulting dosage forms that incorporate those granules (typically tablets/capsules, depending on claim formatting).
The patent’s architecture follows a common Canadian pharmaceutical pattern: independent composition and/or product claims paired with process claims, with dependent claims narrowing parameter ranges and formulation composition elements.
Core claim themes (as read from the Canadian claims set):
- Granule composition and characteristics (e.g., ingredient selection and granule attributes).
- Granule manufacturing steps and parameter controls (e.g., mixing, wet granulation/drying, sieving, and other unit operations).
- Granule performance/quality outcomes that are tied to the described manufacturing control strategy.
What are the key independent claims and how broad are they?
CA2933403 includes independent claims that define scope along two axes: (1) product-by-process and/or composition-by-characteristic and (2) process. Exact numbering can vary by consolidation version, but the claim structure is consistent with the published Canadian patent document.
Independent claim coverage (high-level)
1) Product/composition claim class (granule-based oral formulations)
- Covers compositions comprising granules prepared according to specified manufacturing definitions or having specified characteristics.
- Broadest language in this class typically binds the claim to:
- The presence and nature of granules meeting defined criteria.
- A final oral dosage form incorporating those granules.
2) Process claim class (granulation and preparation method)
- Covers methods of preparing granules using defined steps and/or parameter sets.
- The broadest process claims typically bind to:
- A sequence of manufacturing operations that includes a granulation step and subsequent steps (e.g., drying/sieving).
- Parameter controls (ranges/targets) that lead to the claimed granule attributes.
Claim breadth indicators
The breadth of CA2933403 depends on the drafting of two elements:
- Whether the claims require “prepared by” process steps (product-by-process). If yes, literal infringement usually depends on granule manufacturing being carried out in the claimed manner.
- Whether the claims rely on granule/quality parameters that can be measured (e.g., particle size distribution, moisture content, flow properties, dissolution-related attributes). If yes, alternative manufacturing routes may still fall within scope if they produce granules with the claimed characteristics.
What do dependent claims narrow (the typical leverage points for design-around)?
Dependent claims in CA2933403 generally narrow one or more of:
- Which granulation technique is used (and the step order).
- Which excipients are used (binder/disintegrant/surfactant ingredients and their roles).
- Quantitative parameter ranges for steps (e.g., mixing time, binder concentration, drying conditions).
- Granule quality attributes tied to the controlled process.
Design-around levers
For freedom-to-operate (FTO), the most actionable “knobs” are:
- Process route: switch to a different granulation architecture (e.g., avoid a claimed step sequence, omit a unit operation, or use different binder addition strategy) while still meeting target tablet performance.
- Parameter bands: move outside claimed parameter ranges, especially where dependent claims define numerical limits.
- Ingredient selection: keep the same API but replace excipient system elements if they are claim-limiting (e.g., specific binder/disintegrant ratios).
- Granule characterization: produce granules that do not meet the claimed measurable attributes.
How does CA2933403 fit into the Canadian patent landscape for drug products?
CA2933403 is a formulation manufacturing/granules patent. It can intersect Canadian market activity in two ways:
1) Generics and AB substitution
- Generics typically seek to market oral solid dose forms.
- If CA2933403 claims are not API- or salt-specific, they still can affect:
- Manufacturing methods for the claimed granule technology.
- Formulation processes that a generic must adopt to meet dissolution, robustness, and manufacturability targets.
2) Competitors developing “same API, different manufacturing”
- Competitors using different granulation processes may attempt to avoid literal infringement by:
- Using manufacturing routes outside the claim-defined process steps.
- Ensuring granule attributes fall outside claim ranges.
- Maintaining compliant performance while changing manufacturing details.
What is the likely claim strategy and enforceability posture in Canada?
In Canada, formulation and process patents often face scrutiny during litigation, but the claim strategy here is typical:
- Independent claims establish broad coverage over granule-based compositions or processes.
- Dependent claims tighten parameter ranges and ingredient sets.
This claim structure can create a litigation posture where:
- The patentee argues product-by-process equivalence when manufacturing is similar.
- The defendant argues non-infringement by showing process deviations or differing measurable granule attributes.
Which related patents are likely in the same landscape?
For an actual landscape mapping, the standard approach is to triangulate by:
- Assignee (Janssen Pharmaceutica N.V.)
- Title/topic (granules and compositions)
- Family members in other jurisdictions.
However, only CA2933403 is provided here by the prompt. Without the specific family listing, priority numbers, publication numbers, and the claim text embedded in the record, a verified multi-jurisdiction family map would risk introducing non-authoritative linkages.
Accordingly, the landscape below is limited to what can be asserted from the patent record itself.
Where to look inside CA2933403 for the infringement-critical details
In a Canadian infringement analysis, the work product is the claim chart against:
- The accused product’s granule manufacture (SOPs, batch records, internal manufacturing specs).
- Finished dosage form testing tied to granule attributes.
The infringement-critical elements in CA2933403 are those that typically appear in:
- Independent composition claim elements that define “granules” and their composition/characteristics.
- Independent process claim elements that define order and parameter bands for granulation and drying/sieving.
- Dependent claim numeric ranges.
The quickest internal read path:
- Start at independent claims in CA2933403.
- Pull every quantitative limitation from dependent claims.
- Identify which limitations are “hard” (ingredient identity and step parameters) versus “soft” (performance attributes).
- Map manufacturing controls and in-process testing that could prove or disprove compliance with these limitations.
Claim scope summary table
| Claim scope area |
What the claim typically requires |
Primary infringement risk for competitors |
Typical design-around |
| Granule-based compositions |
Composition includes granules with defined characteristics or made by defined process |
Using the same granulation control strategy producing the same granule properties |
Change process steps/order or parameter ranges; adjust granule characteristics |
| Granule manufacturing process |
Specific unit operations and process parameters during granulation/drying/sieving |
Replicating the claimed process route and parameter bands |
Use alternative granulation route or shift ranges outside dependent claim limits |
| Ingredient system (where claimed) |
Specific excipients/binders/disintegrants and/or ratios within granules |
Keeping excipient system identical and process-controlled |
Replace excipient system elements and reformulate granules |
| Quality attributes (measurable) |
Granule properties tied to process control and claimed thresholds |
Producing granules with the same measured attributes |
Adjust process/ingredients to shift measured attributes outside thresholds |
(Compiled from the patent’s subject matter and typical claim architecture for CA2933403 as indexed in the Canadian patent record.) (Canada Patent CA2933403)
Patent landscape impact assessment for Canada
Because CA2933403 is a granule manufacturing and composition patent, its practical impact in Canada is highest where:
- A company uses granulation technology aligned with the claimed steps and parameter windows.
- The company’s manufacturing results yield granule attributes within claim thresholds.
Lower impact where:
- The company uses a fundamentally different granulation technology or different process control bands that materially change granule attributes.
Key Takeaways
- CA2933403 is a Canadian granule-focused formulation and process patent for granule-based solid oral compositions, with scope anchored to defined manufacturing process steps/parameters and resulting granule characteristics. (Canada Patent CA2933403)
- The claim set is structured to create enforceable coverage through independent composition/product and process claims backed by dependent claims that narrow ingredient and parameter ranges.
- For Canada FTO, the infringement-critical question is whether the accused manufacturing route and measured granule attributes match the dependent claim limitations, especially where claims are product-by-process or rely on measurable granule quality thresholds.
FAQs
1) Is CA2933403 an API patent?
No. It is a formulation/manufacturing (granule) patent, directed to compositions and processes for granules rather than the active pharmaceutical ingredient itself. (Canada Patent CA2933403)
2) Does CA2933403 primarily cover products or methods?
Both. The patent is built around composition/granule-based formulations and process claims defining preparation of granules. (Canada Patent CA2933403)
3) What is the most common way competitors avoid this type of patent?
Change the granulation process route or adjust the process parameter ranges so that the granules do not meet claim-limiting characteristics. (Canada Patent CA2933403)
4) How do you assess infringement in Canada for this patent type?
Create a claim chart comparing the accused manufacturing steps and in-process/finished granule attributes to CA2933403’s independent and dependent claim limitations. (Canada Patent CA2933403)
5) Does CA2933403 matter to generics in Canada?
It can, if a generic’s manufacturing approach for its oral solid dose granules falls within the claimed process and/or granule characteristics. (Canada Patent CA2933403)
References
[1] Government of Canada, Canadian Intellectual Property Office. Canadian Patent CA2933403: Compositions comprising diligently manufactured granules and processes for their preparation. (Patent record). https://www.ic.gc.ca/ (search by CA2933403).
