Ipr In Biotech Patent Filings In Bangladesh
IPR in Biotech Patent Filings in Bangladesh
Biotechnology is one of the most innovation-intensive sectors, covering areas like genetically engineered vaccines, enzymes, diagnostics, and microbial products. In Bangladesh, biotech patent protection is governed primarily by the Bangladesh Patent and Design Act (2003, updated in 2023), which is aligned with TRIPS obligations under WTO law.
Patents in biotech protect inventions such as:
Genetically engineered microorganisms
Recombinant DNA technologies
Vaccines and therapeutic proteins
Novel diagnostic methods
The main requirements for patentability in Bangladesh are:
Novelty – The invention must not be disclosed anywhere in the world before filing.
Inventive Step – It must not be obvious to someone skilled in the relevant field.
Industrial Applicability – The invention must be useful in a practical context.
Disclosure – Biotech inventions must include detailed description, sometimes including deposited biological materials if necessary.
Litigation and enforcement in biotech patents are still evolving in Bangladesh, but several case studies and legal principles can illustrate how patent filings are treated.
Case Studies and Examples
1. Globe Biotech – mRNA COVID Vaccine “Bangavax”
Background: Globe Biotech Limited, Dhaka, developed an mRNA COVID-19 vaccine called Bangavax. The company filed patents internationally for the vaccine technology.
Key Points:
Represents a real-world Bangladeshi biotech invention receiving patent recognition abroad.
Demonstrates the importance of international filing strategy to protect biotech innovations globally.
Highlights that novelty, inventive step, and enablement are crucial in biotech patent applications.
Significance: Encourages Bangladeshi biotech firms to pursue patent protection both locally and internationally to secure licensing and commercialization opportunities.
2. Hypothetical Biotech Diagnostic Kit Dispute
Background: A Bangladeshi startup develops a genetically engineered enzyme for a rapid diagnostic kit. It files a patent in Bangladesh. A competitor challenges the patent claiming the enzyme sequence is already known.
Legal Principle: The Bangladesh Patent Office can conduct a post-grant opposition. If novelty is not sufficiently proven, the patent can be revoked.
Significance: This illustrates the importance of rigorous patent drafting, particularly biotech sequences and processes, to withstand legal challenges.
3. Novartis v. Patent Denial in India (Comparable Context)
Background: Novartis attempted to patent an improved version of its cancer drug Glivec in India but was denied under strict patentability rules.
Principle: Even if an invention is an incremental improvement, it must demonstrate significant therapeutic benefit to qualify for a patent.
Relevance to Bangladesh: Bangladesh applies similar TRIPS-compliant standards. Biotech companies must show that their inventions represent a genuine advancement to secure patent protection.
4. Diamond v. Chakrabarty (1980) – Global Biotechnology Precedent
Background: U.S. Supreme Court held that a genetically engineered microorganism could be patented.
Principle: Living organisms created through human ingenuity can be considered patentable “manufactures” if they satisfy novelty and utility requirements.
Relevance to Bangladesh: This principle informs how Bangladeshi patent examiners treat genetically modified organisms, recombinant DNA, or engineered microbes in patent filings.
5. Microorganism Deposit Requirement Case
Hypothetical Scenario: A Bangladeshi university isolates a probiotic strain for gut health and applies for a patent.
Key Issue: Without depositing the microorganism in a recognized collection, the patent could be rejected for insufficient disclosure.
Significance: Demonstrates the importance of following procedural requirements for biotech patents, especially biological materials, which must be reproducible.
6. Cross-Border Enforcement Scenario
Hypothetical Scenario: A Bangladeshi biotech firm patents a novel diagnostic device abroad (e.g., in the EU). Unauthorized imports enter Bangladesh.
Legal Approach:
File a local patent claiming priority from the foreign filing.
Enforce rights in Bangladesh through injunctions and damages once the patent is granted.
Significance: Shows that even if Bangladesh has limited biotech litigation history, effective IP strategy includes cross-border filings and local enforcement preparation.
7. Compulsory Licensing in Public Health
Hypothetical Scenario: A patented biotech drug is not accessible in Bangladesh. The government may issue a compulsory license to produce the drug locally.
Legal Basis: Bangladesh’s Patent Act allows compulsory licensing in cases of public interest or affordability.
Significance: Licensing agreements and patent enforcement in biotech must account for potential public health exceptions, which can influence commercial and legal strategy.
Key Lessons for Biotech Patent Filings in Bangladesh
Patent Strategy is Critical: Filing both locally and internationally ensures robust protection and potential licensing opportunities.
Enablement and Disclosure: Detailed methodology, sequence data, or microorganism deposits are mandatory to survive opposition.
Novelty and Inventive Step: Even incremental improvements must be shown to have real innovation.
Regulatory & Public Health Considerations: Patents may face compulsory licensing or revocation in the public interest.
Cross-Border Enforcement Planning: International filings combined with local filings enhance enforcement options.
Conclusion:
Biotech patent filings in Bangladesh are governed by TRIPS-compliant patent laws with increasing sophistication. While real litigation cases in Bangladesh are limited, international precedents and hypothetical scenarios provide a roadmap for biotech innovators. Effective filing, detailed disclosure, careful IP strategy, and awareness of public health exceptions are crucial for securing and enforcing biotech patents in Bangladesh.
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