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February 29, 2008

Comments

Dear Patentdocs Team,

There is an error in your post.
The 2 years minimum time limit for application of a Compulsory license is for licenses which seek to sell products in India.
Natco seeks to sell the product in Nepal.
Hence, u/s 92 A of the Patent Act, the 2 years blocking window is NOT applicable.

Regards,
SKR

I hope this will not
start a new episode of challenging
Patent by way of compulsory licensing
provision.

I think time for compulsory
license is 3 years

Dear SKR:

Thanks for the comment. From the Times of India:

Indian firm Natco Pharmaceuticals made the plea for the country's first so-called "compulsory licence" to the patent office as it bids to make generic copies of Pfizer's Sutent and Roche's Tarceva cancer drugs. "This is the first case in India.

A compulsory licence will allow companies like ours to manufacture and export drugs to least developing countries," said M Adinarayana, secretary of Natco Pharma.

Maybe they are just being proactive.

Thanks for the post.

Dear Mr. Noonan,

Let us not get Indian news media in the fray... I can only say that their understanding of IP law/ basics.

The fact still remains:
a) The CL application was NOT for India, but for export to a LDC- Nepal;
b) I still think that the time limit for application of CL is 3 years [S. 84 (1)]and not 2 years.
The 2 years comes in picture if the Controller has already granted a CL to a generic and the generic itself does not use the license [works the invention] within 2 years from the date of grant of the CL [S. 85(1)].
SKR.

Dear Sandeep:

Thanks for the clarification. We agree that Natco wants to sell its generic drug in Nepal, and think that the post says that clearly. We have changed the compulsory license time from 2 years to three; between the Times of India, Patent Docs and yourself, I think it clear who is more informed about Indian patent law, and thank you for your correction.

What do you think about the trend (political, financial, etc.) of generic drugs and foreign company patent rights in India? We'd appreciate your insights.

Best regards.

Dear Kevin,

a) I apologize for not seeing the changes already made [2 years to 3 years etc.]
b) I do not claim to know the fine nuances of Indian law, though I am an Indian patent attorney, simply because the law itself is nascent/ developing.

WHAT FOLLOWS ARE MY PERSONAL VIEWS. PLEASE NOTE THAT I AM EMPLOYED WITH A MAJOR GENERIC COMPANY, BASED OUT OF INDIA; HENCE MY VIEWS ARE NECESSARILY BIASED AS I LOOK AT PATENTS IN INDIA FROM THE GENERIC INDUSTRY'S VIEWS [by training/ professional focus].

A) I personally agree that the patent litigation trend in India is not very healthy. Especially, the trend of opposing patent applications by generic companies on very filmsy grounds is bad.
B) The Innovator side has its issues. They try to mix too many issues such as whether Indian law is even TRIPs compliant in their case/ litagations at the Indian courts. To them I say that no country's law is completely TRIPs compliant. Every country protects its interests BEFORE it honours international commitments.

That being said, all players in the Indian context have to play within the system as it stands today.

If our Law has very narror definition of patentability [salts/ polymorphs/ esters etc not being patentable], so be it. Play and live within this frame work.

Personally, patent rights in India [with out restricting my views to ownership of the same] are healthy and well protected. You can read my blogs where I have posted cases on patent owners winning cases. See here:

http://genericpharmaceuticals.blogspot.com/2008/02/india-patentee-gets-injunction-against.html

Innovator companies are getting patents granted. See here:
http://genericpharmaceuticals.blogspot.com/2008/01/india-pfizer-gets-product-patent-for.html

The present trend of litigation will taper in few years, simply because the system [all players included] is testing every thing.
See here:
http://genericpharmaceuticals.blogspot.com/2008/02/india-compulsory-license-hearings-start.html

AND here:
http://genericpharmaceuticals.blogspot.com/2008/02/india-learnings-from-tvs-bajaj-patent.html

Kevin,
Indian patent law is an open topic.
Should you feel like talking on it, do touch base with me, via my email.
I would love to talk and debate our law.

Sincerely,
Sandeep.


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