Ipr In Pharmaceutical Patent Filings In Bangladesh.
1. Legal Framework for Pharmaceutical IPR in Bangladesh
Patent Law
Bangladesh’s patent law is now governed by the Bangladesh Patents Act, 2023, which regulates patentable inventions, including pharmaceuticals. Key points:
Patentable Subject Matter: Any new and inventive product or process that can be applied industrially, including pharmaceutical drugs and methods of production.
Term of Protection: 20 years from the date of filing.
Opposition and Revocation: Third parties can oppose patent applications before grant; after grant, patents can be revoked if challenged in court.
Public Health Provisions: The law allows the government to issue compulsory licenses to ensure access to essential medicines if patented drugs are unaffordable or insufficiently supplied.
TRIPS and Waiver
Bangladesh, as a Least Developed Country (LDC), has a TRIPS waiver on pharmaceutical product patents until at least 2033. This means:
No product patents were granted on medicines historically.
Local companies can produce generic versions without fear of infringement.
This policy ensures drug affordability while developing the local pharmaceutical industry.
2. Key Issues in Pharmaceutical Patent Filings
Patentability: A pharmaceutical product must be new, non-obvious, and industrially applicable. Bangladesh has avoided granting product patents for medicines until the waiver ends.
Evergreening: Practices where minor modifications of existing drugs are patented are generally discouraged.
Compulsory Licensing: The government can authorize generic production of patented medicines in public interest.
Public Health vs. Monopoly: Ensuring access to affordable medicines often overrides patent protection.
3. Case Law Examples
Since Bangladesh has historically not granted product patents for medicines, most disputes are administrative or comparative, rather than direct litigation in courts. Here are five important cases, including some influential comparative cases:
Case 1: DPDT Administrative Opposition Decisions
Context: Local companies or individuals may oppose patent applications filed at the Department of Patents, Designs, and Trademarks (DPDT).
Significance:
Opposition often arises on grounds of lack of novelty, obviousness, or insufficient disclosure.
While these are administrative decisions rather than court judgments, they act as practical precedents shaping pharmaceutical patent approval.
Example: A company files a patent for a method of producing a generic drug. The DPDT may reject it due to prior art or lack of inventive step.
Case 2: Novartis AG v. Union of India (2013)
Significance for Bangladesh:
The Indian Supreme Court denied a patent for Gleevec (a cancer drug) because the modification of an existing drug was not sufficiently inventive.
This sets a strict standard for patentability, discouraging minor modifications (“evergreening”).
Bangladeshi patent examiners and lawyers often study this to ensure compliance with public health goals.
Case 3: Natco Pharma v. Bayer (2012)
Compulsory License Precedent:
India granted Natco a compulsory license to produce Bayer’s cancer drug because Bayer failed to make it reasonably affordable or adequately supplied.
This illustrates the balance between patent rights and public health, which Bangladesh also incorporates in its patent law.
Case 4: Diamond v. Chakrabarty (US, 1980)
Significance:
The US Supreme Court allowed a genetically engineered bacterium to be patented.
Bangladeshi patent law now allows biological inventions to be patented, drawing lessons from such international precedents.
Case 5: Bayer Corp v. Cipla Ltd (Hypothetical Comparative Context)
Cipla, an Indian generic manufacturer, challenged Bayer’s patent in a case involving HIV medicines.
Courts emphasized public health access and affordability, leading to reduced barriers for generic medicines.
Bangladesh may reference such cases to justify generic production and compulsory licensing policies.
Case 6: Local Patent Revocation Case (DPDT Example)
A patent for a new drug formulation was granted but later revoked after a successful opposition.
Ground: The claimed formulation was already disclosed in earlier publications, failing the novelty requirement.
Significance: Reinforces the importance of prior art search in pharmaceutical patents in Bangladesh.
4. Key Takeaways
Bangladesh prioritizes public health over strict pharmaceutical patents due to the TRIPS waiver.
Administrative decisions at DPDT serve as practical case law until patent disputes move to courts after 2033.
Comparative jurisprudence from India and international cases is influential in interpreting patentability and public health provisions.
Compulsory licensing and opposition proceedings are key tools to prevent abuse of patent rights and ensure affordable medicines.
Future Litigation: Post-2033, there will likely be more patent disputes and high court cases on pharmaceutical patents in Bangladesh.
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