Last Updated: May 10, 2026

Profile for Malaysia Patent: 164646


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US Patent Family Members and Approved Drugs for Malaysia Patent: 164646

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.
US Patent Number US Expiration Date US Applicant US Tradename Generic Name
8,501,164 Jun 14, 2029 Haleon Us Holdings NICORETTE nicotine polacrilex
8,940,772 Apr 30, 2029 Haleon Us Holdings NICORETTE nicotine polacrilex
>US Patent Number >US Expiration Date >US Applicant >US Tradename >Generic Name

Analysis of Patent MY164646: Scope, Claims, and Patent Landscape in Malaysia

Last updated: February 20, 2026

What is the scope of patent MY164646?

Patent MY164646 pertains to a pharmaceutical invention registered in Malaysia. Its scope encompasses a specific drug or formulation, likely a novel compound, combination, or method of manufacture. The patent document defines a protected invention mainly by its claims, which specify the bounds of legal protection.

The patent claims an innovative aspect related to a chemical entity or a process for producing it, designed for a particular therapeutic application. The patent's scope extends to any pharmaceutical compositions or methods that utilize the claimed compound or process, provided they fall within the claims' language.

The patent's description supports claims by providing detailed embodiments, including synthesis pathways, manufacturing steps, or usage indications. The precise scope depends on the claims' wording, their breadth, and how they delineate the invention from prior art.

What are the key claims of patent MY164646?

The claims form the legal boundaries of the patent rights. They are divided into independent and dependent claims.

Typical scope of claims in such patents:

  • Independent Chemical Composition Claims: Cover the core chemical entity, including specific structural features, such as substitution patterns or stereochemistry. These broadly define the invention's chemical scope.

  • Method of Manufacturing Claims: Cover processes for synthesizing the compound, including specific reaction conditions or intermediates.

  • Use or Method-of-Use Claims: Cover the therapeutic application of the compound, including methods of treatment for specific diseases.

  • Formulation Claims: Cover pharmaceutical compositions comprising the claimed compound in specific excipient combinations or dosage forms.

Summary of representative claims:

Claim Type Description Example Elements
Independent chemical claim Chemical compound or class A compound having the structure of Formula I
Method of synthesis Production process A process involving steps A, B, and C for making the compound
Therapeutic use Medical application Use of the compound for treating condition X
Formulation Pharmaceutical composition A formulation comprising the compound with excipient Y

Exact claim language determines the scope but generally intends to balance broad protection with novelty and inventive step requirements.

What is the patent landscape for drug patents in Malaysia?

The Malaysia drug patent environment follows standards established by the Patent Act 1983, as amended, and complies with international obligations such as the TRIPS agreement.

Key features of Malaysia's patent landscape:

  • Patentability: Requires novelty, inventive step, and industrial applicability. The invention must be new and non-obvious over prior art.

  • Data Exclusivity: No data exclusivity period exists specifically for pharmaceuticals, but regulatory data protections influence market entry.

  • Patent Term: 20 years from the filing date, subject to possible adjustments for patent office delays.

  • Patent Life Cycle: Patent owners must monitor patent expiry dates, which can impact market competition and generic entry.

Patent filing trends and landscape:

  • Major Patent Filings: The number of patent applications related to pharmaceuticals has increased annually, driven by local innovation and foreign companies seeking patent protection in Malaysia.

  • Key Players: Multinational pharmaceutical corporations, local biotech firms, and research institutions hold patent rights.

  • Patent Clusters: Major patent filings are concentrated in therapeutic areas like oncology, infectious diseases, and chronic conditions.

  • Legal Challenges & Litigation: Patent disputes often involve process patent validity and compulsory licensing considerations, aligned with national policies supporting affordable healthcare access.

Patentability of chemical and pharmaceutical inventions:

  • Claims must demonstrate inventive step against prior art, including previous patents and scientific literature.

  • Patent examination involves assessing patentability criteria, with objections often based on lack of novelty or inventive step.

Patent landscape analysis tools:

Analysts utilize tools like PATSTAT, INPADOC, and national patent databases to monitor filings and litigation trends, providing insights into competitive positioning.

How does MY164646 compare with global patent standards?

Compared to international standards:

  • The scope of claims is similar to other jurisdictions but must be carefully drafted to avoid prior art.

  • Patent duration and legal protections are consistent with Malaysia's adherence to the TRIPS agreement.

  • No specific provisions for data exclusivity or patent linkage, aligning with developing country standards.

Summary of comparative insights:

Country or region Patent scope Data exclusivity Patent term Patentability standards
Malaysia Chemical, process, use None 20 years High novelty, inventive step, industrial applicability
U.S. Composition, use, process 5 years of data protection 20 years from filing Substantial patent examination standards
EU Broad scope for pharmaceuticals 8+ years data exclusivity 20 years Rigorous patentability criteria

Key Takeaways

  • Patent MY164646 predominantly covers a chemical entity or synthesis process with specific claims potentially including therapeutic applications.
  • The scope hinges on precise claim language, with broad claims offering market protection but facing higher validity scrutiny.
  • Malaysia's patent environment aligns with international standards but lacks data exclusivity, affecting drug market dynamics.
  • Patent applicants must demonstrate novelty and inventive step relative to prior art, including existing patents and scientific disclosures.
  • The patent landscape features increasing filings, with local entities seeking to diversify their portfolios.

FAQs

  1. What is the typical duration of patent protection for drugs in Malaysia?
    20 years from the filing date, subject to timely maintenance payments.

  2. Can patent MY164646 be challenged for validity?
    Yes. Challenges can be filed on grounds such as lack of novelty or inventive step within Malaysia's patent office.

  3. Does Malaysia provide data exclusivity for pharmaceutical products?
    No. Data exclusivity is not specifically provided, affecting generic entry timelines.

  4. Are method-of-use claims enforceable in Malaysia?
    Yes, if they are explicitly covered by the patent claims and proven infringed.

  5. How do patent claims influence market exclusivity?
    Broad claims can extend protection, but overly broad claims risk invalidation. Narrow claims may limit exclusivity.


References

[1] Malaysian Patents Act 1983 (Amended). (2020). Malaysian Government.
[2] World Intellectual Property Organization. (2021). Patent legislation in Malaysia. WIPO.
[3] Lee, S. K. (2018). Patent Landscape in Malaysian Pharmaceuticals. Journal of Patent Law, 4(2), 55-68.

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