Struggles at the Indian Drug Patents Office

I just read an interesting article on a topic that almost past me by, so thanks to PLOS for publishing the article.

The article can be summarised that there are two very important patent battles ongoing in the Indian courts. These two cases are not only important in India but will also have an impact on the developing world. Drugs manufactured in India account for around 80% of the drugs consumed in the developing world. This is largley because when India joined with WTO it put in place laws that stop the patenting of new forms of an existing drugs, this is designed to put a stop to pharma companies ever greening, in addition to this they also have a law that allows compulsory licensing where there is a public health case for doing so. The patent office can grant a license to another manufacture.

These cases are striking at the heart of these two laws, and if these are overturned it will impact on the supply of affordable drugs to the developing world, with potential effects on the lives of millions of people.

Firstly there is Novartis who is challenging the patient office for refusing a patent for a new salt of Imatinib if successful this could open the flood gate for new patents that keep generic drugs out of the market for much longer. The second case is Bayer who are challenging the granting of a temporary license for the production of Nxavar that has resulted in a product that is 90% cheaper, the license was awarded because the drugs were too expensive for most Indian consumers to afford.

These cases have the potneitla to impact on the global supply of low cost generics, so we watch this space.

For Assistance with Regulatory Planning and Execution of Clinical Trials Click Here

Damien Bové is the drug development and regulatory consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Fill Out the Short Form Below…

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”