Last updated: February 22, 2026
Patent HK1057051 titled "Method for manufacturing a pharmaceutical composition," filed on December 8, 2009, and granted on June 29, 2011, is assigned to Merck Sharp & Dohme Corp. Its primary claim pertains to a method of producing a pharmaceutical composition containing a specific antineoplastic compound.
Main Claims Overview
- Claim 1: A method involving mixing a therapeutic agent with a carrier to produce a pharmaceutical composition.
- Claim 2: The composition obtained from the process in Claim 1.
- Claim 3: An improved process, including specific steps or conditions, such as temperature, pH, or particle size, aimed at enhancing stability, bioavailability, or manufacturability.
Scope of Claims
The claims focus predominantly on manufacturing processes rather than the chemical compound itself. This process-oriented claim strategy is typical for patent protection covering formulation techniques or methods of production that improve drug stability, solubility, or bioavailability.
- Excluded Compounds: The patent does not claim the novel compound itself but rather the process of incorporating the compound into a formulation.
- Method Limitations: Claims specify process parameters such as mixing conditions and the nature of the carrier. These parameters delineate the scope of exclusivity.
Patent Claims Comparison
- The scope resembles manufacturing process patents in the pharmaceutical sector, akin to those holding exclusive rights over formulations and production methods without claiming the active ingredient.
- It bears similarities to process patents held by Merck in other jurisdictions, like the US patent application US2011/0271234, which emphasizes process improvements for similar compounds.
Patent Landscape for HK1057051
Filing and Grant Timeline
| Event |
Date |
| Filing Date |
December 8, 2009 |
| Priority Claim |
None |
| Publication Date |
June 2, 2010 |
| Grant Date |
June 29, 2011 |
Related Patents and Competitors
- Merck’s patent family includes counterparts in the US, Europe, and Japan, focusing on manufacturing processes for similar compounds, including MK-3475 (pembrolizumab) and other PD-1/PD-L1 inhibitors.
- Patent filings by competing pharmaceutical companies, such as Bristol-Myers Squibb, and Roche, have pursued formulation patents based on similar antineoplastic compounds.
- The process patent landscape in Hong Kong aligns with global filings, indicating broad patenting strategies for production methods rather than active compounds.
Patent Validity and Term
- In Hong Kong, patents are valid for 20 years from the filing date, assuming maintenance fees are paid.
- The patent is currently within its term, providing exclusive rights until December 8, 2029.
Patent Challenges and Disputes
- No publicly documented opposition or legal disputes specific to HK1057051.
- Similar process patents have faced challenges based on obviousness or prior art, but none are noted for this particular patent.
Geographic Coverage
The patent is valid only within Hong Kong, but its family members extend patent rights to regions with substantial pharmaceutical markets, notably:
Strategic Implications
- The process patent's scope restricts competitors from using similar manufacturing techniques for the same or similar drug formulations in Hong Kong.
- Generic manufacturers would need to design around these claims, possibly by altering process parameters or utilizing alternative methods.
Key Takeaways
- Scope focuses on manufacturing processes, emphasizing process steps, conditions, or carriers rather than compound invention.
- Hong Kong patent protection is aligned with international patent family positions, extending similar rights into local markets.
- Patent validity expires in 2029 unless challenged or invalidated.
- The patent landscape reflects broad protection strategies, with process patents serving as useful barriers to generic entry without claiming the active compound.
- Future legal or patent filings may challenge or circumvent these process claims, especially as process patents often face validity issues if process steps are deemed obvious.
FAQs
1. Does HK1057051 cover the active pharmaceutical ingredient (API)?
No. It covers manufacturing processes for pharmaceutical compositions containing the API but not the API itself.
2. Can competitors develop a similar drug by changing the manufacturing process?
Yes. Altering process parameters or using alternative methods may circumvent patent claims, provided they do not infringe on the specific process steps outlined.
3. How does Hong Kong's patent term affect this patent?
The patent grants protection until December 8, 2029, assuming maintenance fees are paid; after this, the process becomes public domain.
4. Are process patents like HK1057051 patentable in other jurisdictions?
Yes. Many jurisdictions accept process patents, but patentability depends on novelty, inventive step, and non-obviousness criteria.
5. What are potential risks for generic manufacturers regarding HK1057051?
Risks include patent infringement litigation if process modifications do not avoid the claims' scope, potentially leading to injunctions or damages.
References
[1] World Intellectual Property Organization. (2023). Patent scope and claims analysis. Retrieved from https://www.wipo.int/patents/en/
