INDIA: LIFE-CYCLE INSIGHTS 

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IPD’s Indian subscription provides insight into this exciting and growing

market, featuring:

  • Easy-to-use Indian brand, biosimilar,

       and generic drug launch 

       tracking schedules

  • Indian litigation tracking and

       in-the-courtroom coverage with

       real-time email updates

  • Personalized consults with local Indian intellectual property analysts

  • Weekly updates including trending Indian drug topics, recent publications,

       and loss-of-exclusivity information

  • Complete drug information with locally reviewed Indian indications

  • Comprehensive Indian clinical development tracking in every major disease class

"Let's start with some of the biggest differences between the Indian patent and regulatory landscape as compared to the United States...

 

So, as an overview, if I have to highlight the largest, most striking differences between the U.S. and India, they would be, one, that India does not offer a patent linkage system like the U.S. does. The second would be, India does not offer patent term extensions in any manner. The third major difference is that our lawsuits go on for much longer. What that means is, interim injunctions, which are known as preliminary injunctions in other parts of the world, become crucial.


There are often cases where a patent expires while the litigation is still on, which means that the interim injunction often plays a more important role than a final injunction issued at the end of the litigation. And the last thing that I'll say is that information is not easily available. If you're not in court, there are a lot of things that you're likely not to know about. We don't have information available online or even offline. The point is, if you're not at the right place at the right time, you're going to not have the information that matters."

Our International Legal Analysts discuss the Indian patent and regulatory system, including:

  • Unique features of the Indian patent and regulatory system

    • Absence of a patent linkage system

    • Absence of patent term extensions

    • Lack of public information

  • Challenging a patent

    • Pre-grant opposition​s

    • Post-grant oppositions

    • Revocation petitions

    • Defense to patent infringement

    • Section 3 requirement​

  • Patent term extensions​

  • Presumption of validity

    • Challenging provisions​

  • Challenges in obtaining information

  • Length of proceedings​

    • Pre-grant oppositions

    • Post-grant oppositions

    • Infringement proceedings​

  • At-risk launches​

    • Example: Farxiga​

  • Patent office activity​

Listen to our podcast to learn more about the Indian patent and regulatory system