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

Being Mortal in India

A peaceful, painless death is one of life's greatest blessings.

Atul Gawande's latest book is born out of experiences with those who, for most part, did not have this blessing. It discusses the way in which medical technology and social norms tend to mislead, dictate or overrule the options available to those who are terminally ill.

The book also brought back deeply disturbing memories of my father's last days at a hospital in Kerala. Much like a patient described in the book, he to was shuttling between hospitals and diagnostic labs, with an irreversible nervous system failure. Towards the end it was appalling to see somebody who stayed away from hospitals "drugged into oblivion and tubed in most natural orifices as well as a few artificial ones".

Gawande, with his focus on the prevailing healthcare system in USA, misses on some of the more disturbing aspects of what the urban elderly face in India. The fact that my father retired from the central government service prolonged his suffering in more ways than one. The first question they asked you at hospitals was - "He is fully insured under CGHS, isn't he?".

A comprehensive health insurance package seems to have prompted private hospital docs to prescribe drugs, diagnostics and procedures that were completely unnecessary. Towards the end, all the family members had to give a signed undertaking to get him out of the ICU, back into the pay-wards.

The priorities of the elderly, and the terminally ill in India may be the same as those in other countries -- to avoid suffering, strengthening relationships with family and friends, being mentally aware, not being a burden on others,

The challenge is trying to ensure that these priorities take precedence over those of the doctors, the healthcare service providers, pharma & diagnostic companies, as well as 'loving' family and friends.


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LINKS

Homepage - http://atulgawande.com/book/being-mortal/

Life-Saving Drugs - The Great Game

"Just as you cannot blame a dog for barking, companies cannot be blamed for seeking profits. The real villains here are governments and public servants who have betrayed public trust."

"Fire in the Blood" is one of the most thought-provoking documentaries I've seen in a long, long time.

It makes you question so many things that you always considered as self-evident truths: R&D costs big money; companies spend billions sifting through thousands of molecules to discover one that can be converted into a medicine or vaccine; Indian companies produce illegal, ineffective copies of patented drugs....and in 87 minutes you realize that all this while, you've been a naive, gullible idiot.

The award winning documentary is about the battle against the HIV-AIDS epidemic in Africa. It is about the role of small individuals and small third-world companies taking on the might of global pharma MNCs. Consider these timelines:

• The first anti-retro viral (ARV) drug, AZT came out in 1963. It was released 1985, with a patent cover up to 2005. Just as the patent was expiring, Glaxo claimed that the drug was effective only in combination with another drug, and had the patent cover extended patent till 2017. In effect, patent protection for the same drug was stretched and "ever-greened" to 54 years!
• 1996 - discovery of the triple ARV combo against HIV-AIDS. The drug cost $15,000 /patient/ year.
• 2000 - Yusuf Hamied of Cipla offered to sell a generic of the triple-combo ARV for $800/year/patient; He offered free know-how to manufacturers in Third World Countries and offered the drug offered free to infected mothers. In response the pharma MNCs launched a massive publicity campaign maligning drugs from developing countries in general, and Cipla in particular.
• In 2004, Cipla brought down the cost to $360/p/y and finally once country - Uganda - decided to take up the offer to save its people. By then over 10 million more people had died of AIDS.

 Fire in the Blood is also quite instructive about USA's amazing hypocrisy and double-standards when it comes to public access to life-saving drugs..