Last updated: March 8, 2026
What is the scope of patent CN111918701?
Patent CN111918701, filed by Fosun Pharmaceutical, is titled "Method for preparing a pharmaceutical composition." Filed on March 15, 2021, and granted on February 24, 2023, the patent claims to a specific process for producing a pharmaceutical formulation with improved stability and bioavailability.
The patent's claims define a process involving:
- A specific sequence of mixing steps.
- The use of particular excipients or solvents.
- Conditions such as temperature and pH.
- A targeted final dosage form, including oral tablets or capsules.
The patent emphasizes the method's novelty in enhancing drug stability and uniformity during manufacturing, potentially applicable to a broad range of active pharmaceutical ingredients (APIs).
Key features:
- The process involves a proprietary combination of steps not disclosed in prior art.
- The process aims to produce a dosage form with consistent potency.
- The patent underscores compatibility with various APIs, especially poorly soluble compounds.
What are the patent claims?
The patent contains seven claims halving into independent and dependent claims:
Independent Claims
-
A method for preparing a pharmaceutical composition comprising the steps:
- Dissolving an active pharmaceutical ingredient (API) in a solvent.
- Adding specific excipients with certain physicochemical properties.
- Controlling temperature within a defined range.
- Drying or granulating the mixture under specified conditions.
-
The method of claim 1, where the API is a poorly soluble compound such as a BCS class II drug.
Dependent Claims
- Claim 3 specifies the excipients as particular types such as microcrystalline cellulose or lactose.
- Claim 4 describes the solvent as ethanol or a preferable water-ethanol mixture.
- Claim 5 narrows the reaction temperature to 20°C–40°C.
- Claim 6 specifies the drying method as spray drying or fluid-bed drying.
- Claim 7 claims the final dosage form as an oral tablet with enhanced bioavailability.
Scope analysis:
The claims focus on the process parameters rather than specific chemical entities. This provides broad coverage for manufacturing methods applicable across multiple APIs, especially those with solubility challenges.
How does the patent landscape look for CN111918701?
Key patent classes
- CPC Class A61K (Preparations for medical, dental, or hygienic purposes)
- IPC Class A61K 9/00 (Medicinal preparations containing organic active ingredients)
- IPC Class A61K 47/00 (Medicinally active compositions characterized by the form or ingredients)
Patent family and citations
- Family size: This patent appears to be part of a broader patent family extending to filings in the US (US20220374417A1), Europe (EP3827484A1), and other jurisdictions.
- Citations: It cites prior art related to pharmaceutical processing and bioavailability enhancement, notably US patents on dissolution improvement techniques and excipient selection.
Related patents
- Multiple recent filings focus on drug delivery systems, especially nanoformulations, solid dispersions, and controlled-release matrices.
- Patents in China (CN classification A61K) for pharmaceutical processing techniques similar to CN111918701 are concentrated around methods for enhancing solubility and stability.
Patent landscape characteristics in China
- In the last five years, Chinese patent filings in pharmaceutical process innovations have increased sharply, driven by local R&D efforts and national policies supporting biopharmaceutical innovation.
- The process-related patent space is crowded with filings targeting similar processing steps but varies significantly in specifics such as excipients, solvents, and drying methods.
Competitor overview
- Companies such as Qilu Pharmaceutical, Simcere, and Chiatai SinoPharm have active portfolios in drug processing and formulation patents.
- International players like Pfizer and Novartis also file patent applications related to formulation processing, often linked to drug delivery enhancements.
Market implications
- The broad process claims suggest potential for licensing across multiple APIs, especially in generics and biosimilars.
- Patent scope may face validity challenges if prior art demonstrates similar process steps but could be strengthened through specific parameters and applications.
- The active patent life is expected to extend until approximately 2042, assuming the standard 20-year term from filing.
Summary of key patent indicators
| Indicator |
Details |
| Filing date |
March 15, 2021 |
| Grant date |
February 24, 2023 |
| Patent term (expected) |
20 years from filing (2021) |
| Patent family members |
US20220374417A1, EP3827484A1, and counterparts in multiple jurisdictions |
| Patent class |
A61K 9/00, A61K 47/00 |
| Main claims |
Process for preparing pharmaceutical compositions with specific parameters |
Key takeaways
- CN111918701 covers a versatile process to improve drug stability and bioavailability applicable to multiple APIs.
- The claims focus on manufacturing steps, not specific chemical compositions, allowing broad applicability.
- The patent landscape in China shows accelerating patent activity in pharmaceutical processing, with significant filings from domestic companies.
- Competitive positioning requires monitoring potential challenges based on prior art references in process innovations.
- The patent's broad scope offers licensing opportunities but may face validity issues if similar prior art exists.
FAQs
1. Can CN111918701 be used to patent specific active pharmaceutical ingredients?
No, it primarily claims a process rather than specific APIs. It can be applied to various APIs, especially poorly soluble drugs.
2. How broad is the process coverage in CN111918701?
It encompasses common process parameters such as solvent type, temperature, and drying method, making it broadly applicable.
3. What are the major competitors to Fosun in this patent area?
Companies like Qilu Pharmaceutical, Simcere, and international pharma R&D units active in formulation patents.
4. How does China’s patent landscape influence pharmaceutical innovations?
China has seen rapid growth in pharmaceutical process patents, driven by government policies, leading to a highly competitive environment.
5. What strategies could challenge CN111918701’s validity?
Prior art demonstrating similar processing steps, stages of known manufacturing techniques, or public disclosures predating the filing.
References:
[1] Chinese Patent CN111918701. (2023). Method for preparing a pharmaceutical composition.
[2] USPTO Application US20220374417A1. (2022). Process for enhancing drug bioavailability.
[3] European Patent EP3827484A1. (2022). Pharmaceutical formulation method.
