International Ip Enforcement In Green Technology.
1. Novartis AG v. Union of India & Others (2013) – India Supreme Court
Context:
Novartis, a Swiss pharmaceutical company, filed a patent for its cancer drug Glivec (Imatinib Mesylate) in India. India’s patent laws, under Section 3(d), prevent “evergreening” of patents—minor modifications of existing drugs to extend patent protection.
Facts:
Novartis argued that Glivec was a new and improved formulation deserving patent protection.
Indian authorities rejected the patent, citing that the modification was not sufficiently innovative.
Judgment:
The Supreme Court upheld the rejection, emphasizing that patents must demonstrate genuine innovation, not minor improvements.
Significance:
Reinforced TRIPS flexibility for public health under Article 27(1) and Article 7 of TRIPS (encouraging technology transfer).
Set a precedent for access to affordable medicines in developing countries.
Triggered debates internationally on IP enforcement vs. public health.
2. Bayer Corporation v. Natco Pharma (2012) – India
Context:
Bayer held the patent for Sorafenib Tosylate (Nexavar), a drug for kidney and liver cancer. Natco, an Indian generic company, applied for a compulsory license under India’s Patent Act (Section 84).
Facts:
Bayer’s drug was prohibitively expensive for Indian patients (~$5,000/month).
Natco applied to produce a generic version to make it affordable.
Judgment:
Indian Patent Office granted Natco a compulsory license, allowing production at ~97% lower cost.
Bayer’s arguments regarding IP protection were rejected due to public health considerations.
Significance:
Demonstrates TRIPS-compliant compulsory licensing in pharma.
Shows enforcement of IP is balanced with human rights to health internationally.
3. Pfizer Inc. v. Ranbaxy Laboratories (2008) – India
Context:
Pfizer sued Ranbaxy for patent infringement regarding antibiotic drugs including Linezolid.
Facts:
Pfizer held patents for several high-value drugs.
Ranbaxy was producing and selling generics in India and exporting them.
Judgment:
The court initially restrained Ranbaxy but later allowed some generics under Bolar exception (research and regulatory testing allowed before patent expiry).
The case highlighted tensions between strict patent enforcement and generic drug production.
Significance:
Demonstrates international enforcement challenges where TRIPS-compliant exceptions exist.
Encourages multinational pharma to carefully monitor generics in emerging markets.
4. Roche v. Cipla (2008) – India
Context:
Roche held patents on anti-cancer and cardiovascular drugs. Cipla, a generic manufacturer, produced versions of these drugs.
Facts:
Roche argued patent infringement under Indian patent law.
Cipla countered that the drugs were for domestic health needs, citing Section 3(d) and public interest.
Judgment:
Indian courts ruled mostly in favor of Cipla due to strict standards of inventive step.
Roche’s claims were limited to certain formulations.
Significance:
Shows enforcement of IP in India is nuanced, often prioritizing public health over strict pharma IP monopolies.
Highlights country-specific implementation of international treaties like TRIPS.
5. Eli Lilly v. Novartis – Canada (2012)
Context:
Eli Lilly challenged Canada’s patent standards in a case concerning second medical use patents.
Facts:
Eli Lilly’s patent for Strattera (ADHD drug) was rejected in Canada due to insufficient inventive step.
The company claimed this violated TRIPS Article 27, arguing Canada was denying patent rights.
Judgment:
Canadian courts upheld rejection, citing national standards of patentability.
Significance:
Shows international IP enforcement is limited by domestic law interpretations.
Even in developed countries, pharma patent enforcement faces high scrutiny.
6. Merck Sharp & Dohme Corp v. Glenmark Pharmaceuticals (USA, 2016)
Context:
Merck filed suit in the USA for patent infringement over generic versions of its blockbuster drugs.
Facts:
Glenmark filed Abbreviated New Drug Application (ANDA) for generics.
Merck sued claiming patent infringement before generic entry.
Judgment:
US District Court granted preliminary injunctions until patent expiry.
Glenmark had to wait to market generics until patent challenges were resolved.
Significance:
Illustrates strong enforcement mechanisms in developed countries.
Highlights Hatch-Waxman Act’s role in balancing generic entry vs. patent protection in the US.
7. Gilead Sciences v. Natco Pharma (India, 2015)
Context:
Gilead held patents for HIV drugs. Natco attempted to produce affordable versions for Indian and African markets.
Facts:
Gilead argued for patent enforcement under TRIPS.
Natco applied for compulsory licensing citing public health emergency.
Judgment:
Indian patent office and courts allowed generic production under compulsory licensing.
Gilead could not prevent exports to low-income countries.
Significance:
Reinforces global norms on patent enforcement vs. human rights obligations.
Key example of TRIPS flexibilities in pharma enforcement.
Key Observations Across Cases
TRIPS Flexibilities: Compulsory licensing, Bolar exceptions, and public health clauses are crucial tools for balancing enforcement.
Evergreening Rejections: Courts in India strictly prevent minor modifications from extending patent monopolies.
Domestic Law Overrides: Even under international agreements, enforcement is guided by national patent standards.
Emerging Markets vs. Developed Markets: Enforcement is stricter in the US/EU, more flexible in India/South Africa to ensure access.
Litigation Trends: Pharma IP disputes often involve injunctions, compulsory licenses, and challenges to inventive steps.
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