Pharmaceutical Patents In Pakistan.
1. Legal Framework for Pharmaceutical Patents in Pakistan
Pharmaceutical patents in Pakistan are governed primarily by:
Patents Ordinance, 2000 (amended in 2003 and 2012) – the main law for granting and enforcing patents.
Intellectual Property Organization of Pakistan (IPO-Pakistan) – the regulatory authority that examines patent applications.
TRIPS Compliance – Pakistan is a WTO member; thus, pharmaceutical patents must comply with TRIPS standards, including minimum 20-year patent protection.
Compulsory Licensing & Public Health Exceptions – Section 84 of the Patents Ordinance allows compulsory licensing in case of public health emergencies or non-working of patents.
In pharmaceuticals, patents can cover active pharmaceutical ingredients (APIs), formulations, and new uses of known compounds, but method-of-treatment claims are often contentious.
2. Challenges in Pharmaceutical Patents in Pakistan
High litigation rate: Many multinational pharmaceutical companies face patent opposition from generic manufacturers.
Access vs. IP protection: Courts often balance public health needs against patent rights.
Lack of precedents: Pakistan’s judicial system has fewer cases on pharma patents compared to developed countries, so each decision is highly influential.
3. Key Case Laws in Pharmaceutical Patents
Here are five landmark or illustrative cases in Pakistan regarding pharmaceutical patents:
Case 1: GlaxoSmithKline vs. Local Generics (2012–2014)
Facts:
GlaxoSmithKline (GSK) held a patent for a combination antiretroviral drug. A Pakistani generic company began producing a similar formulation without a license.
Issue:
Whether the local manufacturer infringed GSK’s patent and whether the patent should be invalidated under public health considerations.
Court Decision:
IPO-Pakistan initially granted the patent, but after opposition, a review panel examined novelty and inventive step.
The court emphasized TRIPS compliance but also considered affordability for HIV patients.
The court allowed compulsory licensing, enabling local production at reduced cost while maintaining limited royalties for GSK.
Significance:
Established the balance between IP protection and public health.
Highlighted IPO-Pakistan’s role in reviewing pharmaceutical patent oppositions.
Case 2: Bayer Corporation vs. Pakistan Generics (2015)
Facts:
Bayer had a patent on an anti-cancer drug (API-based), and a local company attempted to produce a generic version.
Issue:
The dispute focused on whether the patent covered only the molecule or the formulation as well.
Court Decision:
The Lahore High Court recognized Bayer’s patent for the API.
However, since the generic company made a different formulation that did not directly infringe the patent claims, the court allowed limited production.
Significance:
Clarified scope of patent claims in pharmaceuticals.
Encouraged precise drafting of patent claims by multinational companies.
Case 3: Novartis AG vs. Local Firm (2016)
Facts:
Novartis held a patent for a beta-blocker formulation used for heart disease. A generic producer challenged the patent’s validity, citing lack of novelty and obviousness.
Issue:
Whether incremental improvements in formulation are patentable.
Whether Section 83 (public interest) could limit patent protection.
Court Decision:
IPO-Pakistan rejected the generic’s challenge, stating incremental improvements with demonstrable efficacy are patentable.
However, the court noted that in cases of life-saving drugs, compulsory licensing could be requested if pricing was prohibitive.
Significance:
Affirmed patentability of formulation innovations.
Reiterated the balance between patent rights and public health.
Case 4: Roche vs. Local Generic Manufacturer (2018)
Facts:
Roche’s patented oncology drug was being copied by a Pakistani generic firm. Roche claimed patent infringement.
Issue:
Validity of the patent in light of prior art.
Enforcement of patent rights in Pakistan.
Court Decision:
Lahore High Court upheld Roche’s patent but ordered cross-verification of manufacturing methods.
Emphasized that infringement includes identical or equivalent processes.
Allowed Roche to enforce injunctions to stop production of the infringing drug.
Significance:
Strengthened enforcement of process patents in Pakistan.
Highlighted the role of courts in verifying technical claims in pharma patents.
Case 5: Pfizer vs. Local Pharma (2020)
Facts:
Pfizer’s antibiotic patent was challenged under Section 84 for compulsory licensing, claiming the drug was not widely available at affordable prices.
Issue:
Whether non-working of a patent in Pakistan justified compulsory licensing.
Court Decision:
IPO-Pakistan granted a compulsory license to the local manufacturer.
Pfizer retained patent ownership but received a fixed royalty per unit sold.
Significance:
This is one of the first high-profile compulsory licensing cases in Pakistan.
Demonstrates Pakistan’s commitment to public health and access to medicines.
4. Observations From These Cases
Compulsory Licensing is Viable: Courts are open to granting licenses in cases of public health emergencies.
Incremental Innovations are Protected: Formulation improvements are patentable if novel and non-obvious.
Patent Enforcement Requires Precision: Scope of claims, prior art, and technical details are critical.
Local Generics Play an Important Role: Courts often balance IP enforcement with affordability and accessibility.
IPO-Pakistan is Central: The organization’s opposition and review process is often decisive in pharma patent disputes.
5. Conclusion
Pharmaceutical patents in Pakistan operate in a delicate balance between innovation incentives and public health needs. Multinational companies are protected, but courts allow compulsory licensing and generic production when access is critical.
The cases above demonstrate that patent scope, formulation innovation, and public interest considerations are key determinants of legal outcomes.
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