Monday, March 19, 2012

A pat to the Patently brave Patent Office

SreeNair | 10:36 AM | Be the first to comment!

           The Controller General of Patents, Designs & Trade Marks in India on March 12, 2012 has issued an order under Section 84 of the Indian Patent Act allowing Natco Pharma, a hydrabad based pharmaceutical company.to manufacture and sell a copycat version of Bayer's Nexaver ,In the first-ever case of compulsory licensing approval. Natco has been producing and selling this medicine for quiet some time now and has been engaged in a legal battle with Bayer.

The order was issued by India Patents Office as a 'Compulsory Licence' under the Indian Patent Act, which is in compliance with the TRIPS agreement of the World Trade Organisation and would effectively strip the German pharmaceutical company of its exclusive rights to the cancer drug.There is an estimated 1 lakh patients in India who needs to be administered with the medicine and the majority of them could not afford the cost.

Bayer ,the German pharmaceuticals and chemicals giant , maker of Aspirin which developed sorafenib/Nexavar with US biotechnology firm Onyx Pharmaceuticals has the monopoly for the drug used for renal and liver cancer.The Bayer sells it at Rs 2.84 lakh for a pack of 120 tablets while the Nateco pharma would offer the generic version at Rs 8,880 on a 120-capsule pack for a month's therapy. The life extender medicine could now be made available to patients at a price not exceeding Rs 8,880 for 120 tablets,over 30 times lower than that charged by its patent-holder.Thus it is a land mark verdict.

It is the second time ever, a country has issued a compulsory license for a cancer drug after Thailand , on affordability grounds. Thailand also issued Compulsory Licenses(CL) for HIV/AIDS and heart disease treatments.

"This could well be the first of many compulsory rulings here," said Gopakumar G Nair, head of patent law firm Gopakumar Nair Associates and former president of the Indian Drug Manufacturers' Association.

Under Section 84, a Compulsory Licence to manufacture a drug can be issued after three years of the grant of patent on the product, which is not available at an affordable price. Under the World Trade Organisation TRIPS Agreement, Compulsory Licences are lawful means to access affordable medicines by allowing others to manufacture and sell a patented product or process without the consent of the patent owner. This is the first time in the history of the Indian Patents Act, 1970, that the provision under Section 84 has been invoked.The provision of the Indian Patents Act allows for a Compulsory License to be awarded after three years of the grant of patent on drugs that are deemed to be too costly.

In July 2011, Natco the generic pharma company in India sought for a compulsory license in the Mumbai patent office to make Sorafenib Tosylate for which Bayer has a patent in the country since 2008 ,under the following three grounds of Section 84 of the Patent Act:


    (a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or
    (b) that the patented invention is not available to the public at a reasonably affordable price, or
    (c) that the patented invention is not worked in the territory of India.

All three grounds were upheld by the Controller general of patents in India.

"Global pharmaceutical manufacturers are likely to be worried as a result ... given that the wording in India's Patent Act that had been amended from 'reasonably priced' to 'reasonably affordable priced' has come into play now."adds Gopakumar G Nair.

The Controller general of patents ruled that the Bayer's Nexavar cancer drug costs around $5,500 a month in India, making it "not available to the public at a reasonably affordable price", where 40 percent of the citizens live below the poverty line.

The Controller general of patents, P H Kurian who is due to relinquish the office and return to Kerala service , based his decision on Bayer's admission that only 2% of kidney and liver cancer patients were able to access the drug, and its pricing (Rs 2.8 lakh for a month) did not constitute a "reasonably affordable" price.

WHO estimates that the patent companies are charging 20% to 100% on the manufacturing cost of life saving drugs.The companies put up the case by the logic that the R&D costs are to be met with in the short patent period.

Economist and intellectual property expert James Love said"The Bayer price of INR 3,411,898 per year (69 thousand USD) is more than 41 times the projected average per capita income for India in 2012, shattering any measure of affordability. Bayer tried to justify its high price by making claims of high R&D Costs, but refused to provide any details of its actual outlays on the research for sorafenib, a cancer drug that was partly subsidized by the US Orphan Drug tax credit, and jointly developed with Onyx Pharmaceuticals. Onyx told the SEC that the cost of R&D, pre-Orphan Drug tax credit, was $275 million through the 2005 FDA approval of sorafenib, including outlays on other compounds, indications that were not approved for marketing, and for expanded access trials in the United States that had limited value as scientific experiments. Bayer has made billions from sorafenib, and made little effort to sell the product in India, where its price is far beyond the means of all but a few persons"

The ruling sets certain restrictions also. NATCO cannot import the drug to satisfy the Indian market. It has to pay to Bayer a 6% royalty rate on net sales every quarter (maximum of the UNDP royalty recommendations). Natco has to make the drug itself and can't name it Nexavar, make it look the same or even state that it's the same as Nexavar although it can make its own version of the drug and sell it, and the license lasts the life of the patentie 2020.

"This (Bayer) case might become a trend-setter, wherein generic players can make copies of patented products," said Siddhant Khandekar, analyst at ICICI Direct.

"While global giants might not like this, generic companies will benefit along with common people," he said, adding that the cancer treatment market in India was worth up to 30 billion rupees.

No drugs have a unique world wide patent.The patent is distributed by the individual countries concerned.The majority of peoples in the African countries were denied access to the HIV drugs as the multinationals developing these drugs sold them at exorbitant rates.When Indian companies developed anti-HIV drugs and sold them at cheaper rates in these countries they had to face stiff resistances from these multinationals.But social health activists in the respective states stood by the Indian companies and thwarted their machinations.

Some years back when birds flue was ravaging the country, the central government has thought of making drugs available through compulsory licensing,but an order to the effect has only come up for the first time now.

Dr Tido von Schoen-Angerer, director of independent health care organization, MSF, said, "We have been following this case closely because newer drugs to treat HIV are patented in India, and as a result are priced out of reach. But this decision marks a precedent that offers hope. It shows that new drugs under patent can also be produced by generic makers at a fraction of the price, while royalties are paid to the patent holder. This compensates patent holders while at the same time ensuring that competition can bring down prices."

Generic manufacturer Cipla has already launched generic Nexavar (Sorafenib Tosylate) at around Rs 28,000 per 120-capsule pack, and is battling in a litigation with Bayer in the Delhi high court.The CIPLA faces infringement charges, and would have to seek a separate license

The order has set a precedent . A long-standing case for granting of an Indian patent for Swiss drug maker Novartis' cancer drug Glivec is to come up for hearing in the country's Supreme Court this month.

As in western countries if Universities,Drug manufactures ,R&D institutions should come together ,we can fail the brute dominance of the foreign multinationals in the drug sector.

*************

Sri.Kurian is an IAS officer of 1986 batch of Indian Administrative Services (IAS). Before taking over as Controller General of Patents, Designs and Trademarks on 22nd January 2009, he was a Secretary to Government of Kerala, (Industries-Investment Promotion). He holds a Master Degree in Chemistry and did research for three years in the Institute of Science, Bangalore which is one of prestigious Institutes of India.


Thursday, March 15, 2012

pulling out from ICU-a budgetary exercise

SreeNair | 6:12 AM | Be the first to comment!

The maiden  rail budget presented by Dinesh Trivedi,the Trinamool Minister cannot be depicted as pernicious for the aam aadmi.Mr Trivedi announced a hike  in passenger fares after 8 years since  the last exercise ,by two paise per km for suburban and ordinary second class, three paise per km for mail/express second class and five per paise per km for sleeper class. the increase will be 10 paise per km for AC chair car, AC-three tier and first class. AC-2 tier will cost more by 15 paise per km while AC-1 will be pricey by 30 paise per km.

The lowest fare of Rs. 2 for travel up to 10 km in a non-suburban train has been raised to Rs. 5.

Mr Trivedi said he has exercised restraint  keeping in mind the objective that it causes “minimal impact on the common man and to keep the tolerance limits in general.”

95% of the rail traffic proceeds from  general class passengers and the  balance 5 per cent is made up by those travelling in air conditioned coaches. The hike appears nominal in paise terms which may not put the lay man's budget to disarray- for those travel short distances.Long distance travellers will have to dole out more money. For example, the Delhi-Chennai sleeper class fare will go up from Rs. 488 to Rs. 600, a hike of 23 per cent, and Thiruvananthapuram to Delhi in AC two-tier will rise from Rs. 2,181 to Rs. 2,650, a hike of 21 per cent.

Emphasis has been put on safety  in Mr Trivedi’s budget and is a footstep towards  modernisation and sophistication-all of which require huge resources. Rolling stock in the next five years is expected to cost Rs. 1,70,751 crores.

A Railway Safety Authority will be set up as a statutory regulatory body. Tracks, bridges and signalling and telecommunication systems will find funded. A rail-road grade separation corporation will be  put in place to avoid butchery at unmanned rail crossings. The budget proposes to augment safety measures by  increasing the number of trains to be escorted by RPF/GRP personnel to 3,500 and desegregating the RPF helpline with the All-India Passenger Helpline.

The budget proposes to recruit at least one lakh persons in the next fiscal year, clearing the backlog of SC/ST/OBC vacancies and those in other categories, to ensure the safe running of trains and the safety and security of passengers.

Hygiene in trains and stations have been another important area where the minister has been seemingly vocal. The  Railways' green initiative would bring in  2,500 coaches with bio-toilets. 200 remote stations will be powered by solar energy. Solar lighting systems will be installed at 1,000 manned level crossing gates, and two bio-diesel plants will be commissioned at Raipur and Tondiarpet.

A pilot programme is in the pipeline to make  alternate arrangements for the wait-listed passengers.

84 model stations have been sanctioned across the country.

The extent of resources required by Railways is huge.The Kakodkar committee constituted to study safety requirements for the railways have put up recommendations for expending 1 lakh crores in 5 years .The Pitroda committee set up for modernisation of Railways have set forth a staggering amount of 5.6 crores. Money is the forerunner.Railways require 14 lakh crores for the next 10 years to full fill its promises.the Railways projected earnings to go up by about Rs 7,000 crores in next year, 25 per cent more than the expected earnings in 2011-12. The present hike would generate Rs 4000 lakhs , much needed funds at a time when Railways have failed to meet many of their earning targets.

Although the Indian railways are among the few in the world still making cash surpluses, its finances are never smooth. According to the Railways own estimates, their resources are insufficient to meet the estimated capital expenditure necessary for modernisation. Its capital outlay for the next financial year is estimated at Rs. 60,100 crores. "The funding relies heavily on borrowings."

The Indian Railways have proposed bringing down its operating ratios down to 84.9 per cent next financial year from 94.9 per cent.

"The fares have to take into account fuel hikes and roadways fares; we are still cheap compared to that. The railways was getting into an intensive care unit (ICU) and I have pulled it out."Divedi said .

"I had asked for a gross budgetary support of Rs 43,000 crore; I got only Rs 24,000 crore. How do I keep myself afloat? "The minister adds.

We have to wait and see how these imaginative ideas are put in practise.

The budget moots   a much-needed thrust to public-private partnerships in railways by planning to induct a member in the Board to specifically  pursue PPP projects.

Price of rail ticket and cargo rates would fluctuate and needs to  be revised with changing cost of diesel and electricity.

 The budget also envisages an independent  tariff regulatory authority , to detach the political game plan in manoeuvring  passenger fares and freight rates.

“I am contemplating a system of segregating fuel component in the cost associated with passenger services and call it FAC (fuel adjustment component),” Mr Trivedi told Lok Sabha. “The FAC will be dynamic in nature and will change in either direction with the change of fuel cost,” he added.

Railways spent about 25 per cent of their total expenditure on  buying fuel to run trains. India’s largest oil marketer IOC supplies 84 per cent of railways’ diesel demand.

Mr Trivedi said that he would be appointing a body of experts with representatives of customers, passengers and industry, among others to examine setting up of independent tariff regulatory body.

Minister claims that he has received more than 5000 representations seeking favoured considerations.But it is worth noting that unlike his predecessors no favouritism has been shown by the minister to a particular region ,by more or less keeping a balanced mindset when it came to allotting trains,investments.

Monday, March 12, 2012

The one and only one Rahul

SreeNair | 12:11 AM | Be the first to comment!

Rahul Dravid who fortified the frontiers of Indian Cricket for the last 16 years has finally called it a day.The cricket legend ,the most successful No. 3 willow announced his retirement from his international career on Thursday .

A gentleman to the core-a consummate gentility in the gentle mans game-a savant in all the editions of the game-one who vowed the game before self -the embodiment of patience ,perseverance and determination-a soft-spoken and passionate towards team mates - a man who wielded respect even in the opposition camps -the epithets are unending. The vacuum his absence creates is not facile to fill.

“His biggest assets,”Rahul's father reminded, “were concentration and commitment. Till today, his commitment has been the same. That’s why he has come so far.”

Times Of India wrote "In cricket, it is said a player is only as good as his last innings, and so much the pity that Dravid couldn't finish his career on a high, though the tour of Australia in no way diminishes his stature as one of the modern greats."

Rahul took success and failure with courage and equanimity.He saw glimpses of success in every failure.

"I didn't make this decision based on one series (in Australia). It's a combination of a lot of other things. I needed to be sure I was playing the game for the right reasons. "Dravid proclaims in his farewell speech.

He together with Sachin and Laxman collectively called as the triumvirate has scripted many a unparalleled triumphs to Indian cricket at home and at oversees. Dravid was the embodiment of romantic cricket in India and one of the insatiable and most prolific run getter on all verities of the turf-fast and bouncy pitches, slow and turning tracks and against spin as well.

"The world's most respected cricketer over the last 20 yrs," Vaughan wrote.

"Rahul Dravid-legend!! Plain & simple," said Pietersen. "India will miss The Wall."

Cricket is the test target on partnerships.The maverick has put on record 88 century partnerships.He amassed 8920 runs spanning through 219 innings along with Sachin Thendulkar.

Dravid quit one day cricket last year to concentrate more on his more-friendly test edition.

Truly he was a legend.

Dravid rose above his constraints with sheer toil and perfected the batting techniques and remained central to the espirit-de-corps in the team which alone has shored it from disasters.The man fondly christened as" the wall" has more than 10,000 runs each in both the classic formats of the game.

A natural choice and the toast of test cricket he finishes as the second-highest run-scorer in Test cricket- his first love , next only to his compatriot Sachin.

His one-day tally stood at 10,889 runs from 344 matches at an average of 39.16 with 12 centuries while he was chaffed with incompetence to the one day patterns.

He captained India to winning streaks in the West Indies and England to end the years of long droughts, and played decisive role in some of Indian cricket's most famous overseas victories.

Rahul Dravid made his debut century in a foreign soil-Johanasburg in South Africa with 148 runs.There after 35 more centuries flowed from his bat.In the recent English tour when the Indian players went in droves to the pavilion with drooped heads in quick succession ,Dravid stood in the middle unfazed with head raised majestically to make 3 centuries in 4 tests -a feet which is hard to forget.

Dravid's runs were indispensable in many Indian victories abroad.He made 1577 victory runs in his 5131 made at overseas. He was man of the match 11 times in foreign soil ,5 of them contributed in the winning spree.

The carrier graph of Dravid saw crusts and troughs.He scored at an average of 40 runs in the first 7 of the 10 test series. It contained 9 centuries and 24 half centuries.Of the 16 tests series played between 2002-2006 he made an average of 49 runs in 13 series.It includes 9 series in which the average was more than 75 runs.He made 14 centuries and 22 half centuries during the period.This was the period when India showed to the world that the Indians can win outside the peninsula.Dravids batting strength was critical in these tests.

In cricket getting runs is every thing.It is the only sign that you are there. 2006 to 2008 were the years when skids were put under his wheels. Clamours were raised for the blood of this monolith.Bile's and brickbats came in as pandemic from past big-shots in the game.When the smear campaign peaked ,In a rare show of resilience ,without bothering to detraction he lumped together 10 centuries and 10 half centuries in the year that followed to shut the mouths of the critiques.

"When you play international sport, you have to learn to deal with praise and criticism which are two sides of the same coin. For me, it was about doing my best at all times," Dravid said on Friday.

Dravid was the first batsman to score a century in all test-playing countries, the first batsman to score 10,000 runs at No. 3, the batsman to face the most deliveries in Test cricket. He batted 173 consecutive innings in international cricket (Tests and ODIs) without a duck between 2000 and 2004 .

"I believe Rahul should have retired after the England series and not wait for the Australian tour. In any case this is a right decision and I saw it coming," Ganguly told reporters at the Ferozeshah Kotla stadium on Friday. Asked to pick a favourite Dravid inning, Ganguly said, "180 at Calcutta against Australia tops my list. 148 at Headingly was also good but the situation in Calcutta was far more difficult."

As for Dravids father,his prodigies debut at Lord’s in 1996 was his proudest moment.He said “He might have played many great knocks but that was the most memorable moment. Though he missed a century by just five runs, his Lord’s debut was the best thing to have happened…”

The vacuum he leaves is up for somebody to fill and we have no dearth of talents of his pedigree.

**************

He brings a serenity to the crease that is so good for the nerves in the dressing-room. He also helps ease the tension away by the way he plays. He then proceeds to make the fastest of bowlers look easy to bat against. His economy of movement and the preciseness of his footwork gets him into position quickly, and so, the bowlers look quite clueless. The fastest of deliveries is played as if it's done every day and with minimum fuss.
Sunil Gavaskar


Saturday, March 10, 2012

Spare the Rhode-No to Corporal Punishments

SreeNair | 4:48 AM | Be the first to comment!

               The nation witnessed a wild  furore  over the suicide of Class VIII student Rouvanjit Rawla on February 12, 2010.Police arrested  Sunirmal Chakravarth the principalof Kolkata's famous school La Martiniere for Boys, teachers David Ryan and Partha Datta and produced them before the chief metropolitan magistrate's court on October 4.

The boy was caned four days back at school.

Before the ink writing the NCPCR guidlines dried up, a case of thrashing of a  fourth class student for speaking to her friends in Telugu at the English medium public school in Vishakh patnam was on the news.The girl was admitted at Kisuch George Hospital.

In the Kairon episode at the Government Senior Secondary School for Girls, the male school Principal was charged for Corporal Punishment and using abusive language towards girl students. The Punjab education department has decided that only woman Principals take charge of such schools where girl students study in classes up to 10+1 and 10+2.

In Taran Taran school the principal was suspended for awarding corporal punishment to girl students as the police found enough evidence to prove the principal guilty.

In an extreme case of corporal punishment, two teachers of a boarding school in Ranip - NK Ashram Shala - have been accused of branding and beating up a five-year-old student, Vishal, for bed-wetting and vomiting ."The brutal assault left welts on his buttocks" said Bapunagar police officials who are probing the case.

These are but some from the slew of nasty incidences of Corporal Punishments meted out to the young students of our famous temples of education.How many incidences must have gone unnoticed from the public domain?

The Education Commission (1964-66) professed, “the destiny of India is now being shaped in her classrooms”. The National Policy on Education 1986 reiterates:“The status of the teacher reflects the socio-cultural ethos of the society; it is said that no people can rise above the level of its teachers ”.

But how pathetic are the rules in our class rooms!

According to the survey conducted in 2009-10 academic year, only 9 out of 6,632 students in seven states, ie 98.86% of children reported experiencing one or the other kind of punishment. "As many as 81.2 per cent of children were subject to outward rejection by being told that they are not capable of learning" it said.

NCPCR( National Commission for Protection of Child Rights ) defines Corporal Punishment as physical punishment, mental harassment and discrimination of children causing both physical and mental harassment.

The various forms of Corporal Punishment includes beating, thrashing, spanking, slapping ,punching, kicking , cocking, biting, slighting or even whipping'.Even the "cruel practice" of giving electric shock finds a mention in the study on the practice of corporal punishment brought out by the(NCPCR).Getting beaten by a cane, being slapped on the cheeks, being hit on the back and ears and getting boxed are the other four major punishments, it said.

Such medieval methods may inflict a perennial physically impairment on children. Psychologists say that the emotional scars accompanied will be even deeper.Verbal abuse could be as damaging and humiliating for children, especially the younger ones, as physical punishment. When teaching becomes coercive, students will neither have the proper education nor any discipline.The end result is fear, hatred and anger.

Corporal Punishment often leads to antisocial behavior. The brutal disciplinary processes hinder the psychological growth of a person. Inflicting physical punishment on a child does not fit to his or her right to life guaranteed by article 21 of Indian Constitution. This was held by Delhi High Court in a public Interest Litigation which was filed by the Parents Forum for Meaningful Education (AIR 2001 Delhi 212).

The National Commission for Protection of Child Rights (NCPCR) has suggested a code of regulations on the conduct of teachers in schools. It suggests a total ban on corporal punishment.Till date only six Indian states have banned the cane in schools.NCPCR has given various guidelines regarding corporal Punishment in schools. Children are precious resources of the nation, and therefore they are entitled to get education in an environment of freedom and dignity.

The guidelines include measures for affirmative action in schools towards positive development and positive engagement with children.It also discusses creating an environment conducive to learning and for mechanisms and processes to give children a voice and engage in the process of creating a positive environment as well as for accountability and multi-sectoral responsibility.

Several State governments have also passed orders to stop the Corporal Punishment. But substantial changes are not discernible in the class rooms.The class rooms remain tobe the abode of rot-learning.Here the captor and the captive shrink into one.The teachers have to change.The mirror is not to be changed, but our visages need to be repolished.

India's Right to Education bill, which guarantees universal education and bans corporal punishment from schools, has been waiting to become a full-fledged law for more than a decade. The Supreme Court ordered a ban on corporal punishment in 2000. But it has been implemented in only 17 out the 28 states. According to the 2007 report, Delhi was one of four states in India where corporal punishment is most common.

Teaching is the noblest profession where one imparts knowledge to others. The teacher must consider his students as his own children, and treat them as lovingly and caringly as possible. He should transform himself in to a mender and motivator. A teacher should be there to guide a student to become responsible, educated and a well groomed citizen of a country. Children are like delicate flowers ,to be nurtured with great care to blossom and spread their fragrance.

Spare the rod and save the childhood is the new slogan.


The test of the morality of a society is what it does for its children. Dietrich Bonhoeffer- German Protestant theologian anti-Nazi activist (1906 - 1945)


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