IP litigation in this sector is highly specialized, demanding a deep understanding of science, law, and regulation. Key challenges in India include:

• Section 3(d) of the Indian Patent Act: Defending or challenging patents based on the stringent requirements for proving enhanced therapeutic efficacy for new forms of known substances.
• The Bolar Exemption (Section 107A): Managing disputes arising from the use of patented inventions for research and submission of information for regulatory approvals by generic and biosimilar manufacturers.
• Patent Linkage: Navigating the delinked system between the patent office and the drug regulatory authority, often requiring proactive litigation to prevent patent-infringing products from receiving marketing approval.
• Data Exclusivity: Addressing the protection of undisclosed clinical trial data submitted to regulatory authorities.
• Compulsory Licensing: Advising on issues related to the government’s ability to grant licenses to third parties to produce patented drugs under specific circumstances.
• Biologics & Biosimilars: Handling complex litigation involving large-molecule drugs, which requires sophisticated technical and scientific analysis.

Comprehensive IP Litigation Services for Pharma & Life Sciences Clients

This is a core focus of our practice. We handle:

• Infringement actions to enforce product, process, and formulation patents.
• Pre-launch litigation to secure injunctions against generic and biosimilar manufacturers.
• Patent invalidation and revocation proceedings before the High Courts.
• Litigation involving Standard Essential Patents (SEPs) in the context of medical devices.
• Disputes over Active Pharmaceutical Ingredients (APIs) and drug delivery systems.

Regulatory & Data Protection Litigation

We assist clients in disputes related to:

• Challenges to marketing approvals granted for infringing products.
• Litigation concerning the protection and use of proprietary clinical trial data.
• Disputes arising from drug pricing and control orders.

Trademark & Brand Litigation

Protecting brand identity in the pharmaceutical space is critical for patient safety and market share. We manage:

• Litigation against deceptively similar drug names to prevent medication errors.
• Anti-counterfeiting actions to combat the trade of spurious and substandard drugs.
• Passing off actions to protect the goodwill and reputation of established brands.

Trade Secret Litigation

We help protect invaluable proprietary information through litigation concerning:

• Misappropriation of confidential research data, chemical processes, and clinical trial protocols.
• Enforcement of non-disclosure and material transfer agreements.

Sector-Specific Experience

Our team has experience advising and representing a diverse range of clients in the life sciences ecosystem, including:

• Pharmaceuticals (Innovator & Generic)
• Biotechnology & Biologics
• Medical Devices & Diagnostics
• Agrochemicals & Crop Sciences
• Active Pharmaceutical Ingredients (APIs)
• Clinical Research Organizations (CROs)

Our Methodical Approach to IP Litigation

AMLEGALS provides expert litigation support services with a structured and strategic approach to every dispute.

1. Case Assessment & Strategy: We begin with a deep scientific and legal analysis of the patent claims, prior art, and regulatory landscape to build a robust case strategy.
2. Pre-Litigation Counsel: We explore strategic options including cease-and-desist notices and settlement negotiations to achieve favorable outcomes without protracted litigation where possible.
3. Litigation & Trial: Our advocates are experienced in representing clients at all stages of litigation, from filing plaints to managing complex discovery, expert testimony, and trial advocacy before High Courts and the Supreme Court of India.
4. Enforcement & Remedies: We are proficient in securing interim and permanent injunctions, search and seizure orders, and pursuing damages or accounts of profits to ensure our clients’ commercial interests are protected.

Frequently Asked Questions (FAQs)

• Q: What is the first step if a generic company is about to launch a product that infringes our patent? A: The immediate step is to file a “quia timet” action or a suit for patent infringement in the appropriate High Court, seeking an interim injunction to prevent the commercial launch of the infringing product pending the final outcome of the suit.

• Q: How does Section 3(d) of the Indian Patent Act impact our ability to patent improvements to existing drugs? A: Section 3(d) prevents the patenting of new forms of a known substance unless you can demonstrate a significant enhancement in therapeutic efficacy. This requires robust clinical data and careful legal argumentation to overcome.

• Q: Can we stop a competitor from using our clinical trial data to get their drug approved in India? A: While India does not have a formal data exclusivity regime, legal arguments can be made to protect confidential data from being relied upon by a drug regulator for approving a competitor’s product. This is a developing area of law requiring a strategic approach.

• Q: What is the “Bolar Exemption” and how does it affect our patent rights? A: The Bolar Exemption in India (Section 107A) allows competitors to use a patented invention for research and development to obtain regulatory approval. However, it does not permit them to manufacture, use, or sell the product commercially during the patent’s term.

The AMLEGALS Advantage: Pan-India Presence & Specialized Expertise