Showing posts with label drug. Show all posts
Showing posts with label drug. Show all posts

Thursday, March 19, 2015

IPO - Like a Rock

In the early 1990's when I visited the Indian Patent Office (IPO) for the first time, it was as gloomy and depressing as any other dysfunctional sarkari office. Over the years, it certainly seems to have changed for the better.

Now, at a time when, "advanced industrialised countries are ratcheting up global standards for intellectual property protection with monotonous regularity, keeping in view the interests of the dominant corporate interests" (Biswajit Dhar, FE), our patent office has been standing its ground.

Section 3(d) of Patents Act ensures that rights cannot be obtained for minor innovations, and this is being implemented quite effectively -


  • 2006 - India’s patent office refused to give Novartis AG a patent for Glivec (Imatinib), an extremely effective drug for a rare cancer - CML
  • 2012 - India’s Intellectual Property Appellate Board revoked a Roche Holding AG patent for a hepatitis C drug (Pegasys) saying technology involved in the drug’s invention was “obvious” and could be replicated easily.
  • January 2015 - India’s patent office rejected a patent application from the U.S. biotech firm Gilead Sciences Inc. for a Hepatitis C treatment (Sovaldi) , saying it lacked novelty and didn’t show significant efficacy over previously known compounds.
  • March, 2015 - IPO withdrew patent protection for an emphysema drug (Spiriva) marketed by Germany’s Boehringer Ingelheim GmbH, in response to an objection filed by Cipla.


What (or who) is the driving force behind this transformation of the Indian Patent Office?  What mechanisms do they have in place to ensure that Big Pharma do not get away with Evergreening? And, most importantly, what can the patent office do to improve our own abysmal record in encouraging innovations, and building innovative, world-class products?

Perhaps organisations like the Lawyers Collective had a strong role to play here.

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LINKS

* Key Medicines -  Patent Status in India -- http://www.lawyerscollective.org/drugs-list

* http://in.reuters.com/article/2015/01/14/gilead-india-patent-idINKBN0KN20V20150114

* India Patent Office -- http://www.ipindia.nic.in/

* (19Mar15) - WSJ - India's fight against Big Pharma is a Just War -- http://blogs.wsj.com/indiarealtime/2015/03/19/inside-india-indias-fight-against-big-pharma-patents-is-a-just-war/

* Biswajit Dhar (2014): IPR policy must drive innovation -- http://www.macroscan.net/pdfs/ipr_policy.pdf

Saturday, January 18, 2014

Battle of Clones


Yesterday, Biocon India launched a 'new', cheaper breast cancer drug called CANMab

In India, breast cancer is the second-most common form of cancer after cervical cancer with 150,000 patients being diagnosed every year. The new drug, CANMAb, is priced about 25% lower than Roche's Herceptin.

For all practical purposes, this seems to be a copycat drug. Like Heceptin, CANMAb too disrupts HER2 protein production and is being marketed as a 'Biosimilar' to a monoclonal antibody called Transtuzumab.

So what does this mean in plain English?

An antibody is a "Y" shaped protein used by our body to identify and kill intruders like bacteria and viruses. Like matching pieces of a jigsaw puzzle, a part of the Y-shaped protein identifies and 'locks' on to a unique part of a foreign target (called antigen). An intruder thus marked can then be destroyed by the immune system. Monoclonal antibodies are produced by identical immune cells and are exact replica's (clones) of the parent cell.

Biosimilars are substances derived from a living organism by techniques that use recombinant-DNA or controlled gene expression methods.

So Biocon India has essentially found a better, commercially more competitive method of producing monoclonal antibodies (MAb's), to take bite of the Swiss MNCs lobal market share ($6.4b globally and $21m in India), for an existing anti-cancer drug.

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LINKS & REFERENCES

Heceptin from Roche - http://www.herceptin.com/

Biocon Press Release - http://www.biocon.com/docs/PR_Biocon_CANMAb_18Jan2014.pdf?subLink=news&Fileid=467

http://en.wikipedia.org/wiki/Antibodies
http://en.wikipedia.org/wiki/Monoclonal_antibodies