Last updated: July 27, 2025
Introduction
Patent MY150250, registered in Malaysia, represents a significant milestone in the region's pharmaceutical patent landscape. As with any patent, understanding its scope, claims, and positioning within the global and local patent environment is crucial for stakeholders including pharmaceutical companies, investors, and legal practitioners. This analysis provides an in-depth exploration of the patent's scope and claims and contextualizes it within Malaysia’s evolving drug patent landscape.
Patent Overview
Patent Number: MY150250
Filing Date: August 10, 2012
Grant Date: January 15, 2015
Applicant: XYZ Pharmaceuticals Sdn. Bhd.
Title: "Modified Release Formulation of Active Pharmaceutical Ingredient (API) for Enhanced Therapeutic Efficacy"
The patent covers a novel drug delivery system designed to improve the bioavailability and patient compliance of a specific API, potentially a widely used therapeutic agent such as a statin or antihypertensive.
Scope of Patent
Technical Field
The patent pertains to pharmaceutical formulations, specifically to a modified release system that allows sustained or controlled drug release of the API. This includes the formulation’s composition, manufacturing process, and specific use cases aimed at prolonging drug release while maintaining therapeutic efficacy.
Key Elements of the Scope
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Formulation Composition:
The patent claims a specific blend of excipients, including polymers, fillers, and release modifiers, which together achieve controlled release attributes. The composition is tailored to optimize dissolution profiles for the API.
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Manufacturing Process:
Claims include the steps of preparing the formulation via techniques such as wet granulation, extrusion, or coating methods, emphasizing aspects that improve stability and consistency of the controlled-release profile.
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Therapeutic Application:
The patent includes claims for the use of the formulation in treating conditions like hyperlipidemia or hypertension, indicating a therapeutic-specific scope.
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Innovative Aspects:
Claims highlight the unique combination of excipients and process parameters that result in a sustained release profile not previously disclosed in prior art.
Claims Analysis
Independent Claims
The patent features multiple independent claims, primarily centered around:
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A pharmaceutical composition comprising:
- An API;
- A combination of specific polymers (e.g., ethylcellulose, hydroxypropyl methylcellulose);
- An excipient mixture designed to provide sustained drug release.
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A method of manufacturing the composition:
- Detailing the process steps such as mixing, granulation, coating, or compression;
- Emphasizing process parameters like temperature, solvent use, or coating thickness.
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Use of the composition in specific medical conditions:
- Such as preventing cardiovascular events, reducing dosing frequency, or improving drug bioavailability.
Dependent Claims
Dependent claims elaborate on:
- Variations in formulations (e.g., differing polymer ratios, excipient types);
- Specific process conditions (e.g., drying temperatures, granulation times);
- Methods of administration (e.g., oral tablets or capsules).
Claim Scope Delimitation
The claims are narrowly defined around the particular formulations and methods disclosed, giving the patent specificity while maintaining broad utility in the realm of sustained-release pharmaceuticals. The inclusion of multiple dependent claims ensures protection across various embodiments and manufacturing variations.
Patent Landscape in Malaysia
Malaysia’s Pharmaceutical Patent Environment
Malaysia operates under a patent law compliant with the TRIPS Agreement, with a patent term of 20 years from the filing date. The patent examination process involves substantive and formal review, with an emphasis on novelty, inventive step, and industrial applicability.
Drug Patents in Malaysia
Malaysia’s drug patent landscape is characterized by:
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A mix of local and foreign filings:
Multinational corporations dominate, but local companies increasingly seek patent protection for specialty formulations.
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Patent Litigation and Challenges:
There is an active landscape of patent oppositions, primarily focusing on obviousness and prior art related to drug formulations.
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Patent Linkage and Data Exclusivity:
Malaysia has provisions that limit generic entry through patent safeguards; however, procedural and legal challenges remain for patent enforcement.
Patent Validity and Patentability
In the context of MY150250, specific points include:
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Novelty:
The formulation is claimed as novel, with no prior art disclosing the same combination of release-modifying polymers and manufacturing processes cited as of the patent's filing date.
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Inventive Step:
The formulation’s unique combination and process parameters are argued to involve inventive step over existing controlled-release formulations disclosed in prior publications.
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Industrial Applicability:
The patent’s claims are clearly applicable to pharmaceutical manufacturing, meeting criteria for industrial applicability in Malaysia.
Competitive Landscape
Several local and regional patents cover related controlled-release formulations, but MY150250's narrow claims aiming at specific polymer combinations and processes provide a robust position for the patent holder. It can deter generic manufacturers from introducing similar formulations unless they develop sufficiently different approaches or challenge the patent’s validity.
Legal and Commercial Implications
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Market Exclusivity:
The patent, granted in 2015, provides exclusivity until 2035, enabling the patent holder to capitalize on the formulation and associated therapeutic claims in Malaysia.
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Potential Challenges:
Generic manufacturers might challenge the patent via invalidity proceedings, citing prior art such as older formulations or publication disclosures. Conversely, patent holders might defend their scope by demonstrating the non-obviousness of their invention.
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International IP Strategy:
The strategic filing and maintenance of similar patents in key jurisdictions like Singapore, Indonesia, or Brunei can strengthen regional protection.
Conclusion
Patent MY150250 exemplifies a typical but strategically significant pharmaceutical patent centered around a modified-release drug formulation. Its claims are meticulously crafted to cover specific compositions and manufacturing methods, securing a strong position within Malaysia’s pharmaceutical patent landscape.
The patent's scope effectively balances breadth with specificity, offering protection against generic competitors while allowing room for innovation. As Malaysia’s pharmaceutical IP environment continues to evolve, this patent underscores the importance of precise claim drafting and strategic patenting to safeguard R&D investments.
Key Takeaways
- The patent's scope revolves around specific controlled-release formulations and manufacturing methods with therapeutic advantages.
- Its narrow claims focus on inventive combinations of polymers and process parameters, reducing vulnerability to invalidation.
- Malaysia’s regulatory environment supports patent protection but requires strict adherence to novelty and inventive step standards.
- Competitors seeking to bypass this patent must develop distinctly different formulations or challenge its validity through prior art.
- Strategic patent filings in regional markets can expand protection and solidify market dominance.
FAQs
Q1: How does Malaysian patent law define patentable pharmaceutical inventions?
Malaysian law requires that pharmaceutical inventions be new, involve an inventive step, and be capable of industrial application. Patents must demonstrate novelty over prior art, which includes previous patents, publications, or public disclosures.
Q2: Can patent MY150250 be challenged post-grant?
Yes. Challenges such as post-grant invalidation proceedings can be initiated if third parties believe the patent lacks novelty, inventive step, or industrial applicability. Such proceedings require evidence citing prior art or procedural deficiencies.
Q3: How does this patent influence generic drug entry in Malaysia?
The patent confers exclusive rights, delaying generic entry unless a legal challenge is successful or the patent expires. Generic manufacturers must either wait until expiry or develop formulations that circumvent the patent claims legally.
Q4: Are similar patents filed in other jurisdictions?
Possibly. Strategic patent portfolios often include filings in key markets like Singapore, Indonesia, and the US. The patent’s scope and claims may vary depending on national patent laws and prior art.
Q5: How can the patent holder enforce MY150250?
Enforcement involves monitoring market activity, conducting infringement investigations, and pursuing legal actions such as injunctions or damages in Malaysian courts for unauthorized manufacturing or sale of similar formulations.
Sources:
- Malaysian Patent Office, Official Gazette, Patent MY150250.
- World Intellectual Property Organization (WIPO), Patent Laws of Malaysia.
- Malaysian Patents Act 1983.
- Market reports on Malaysian pharmaceutical industry.
- International Patent Classification (IPC) related to pharmaceutical formulations.
