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by Narayan Ramachandran for Live Mint
For complete article, click here: http://www.livemint.com/Opinion/zqnV2T5dz0XaGITEmSHfqI/Patently-unfair.html

The story of the Supreme Court turning down Novartis’s patent petition for a new and improved Glivec is well known. Less known is that the decision, made on the basis of Section 3(d) of the Indian patent law, is really a technical ruling rejecting the new and improved idea. A patient sympathizer would say the improved notion was merely an attempt by the company to evergreen the drug by extending the patent regime and keeping out generics for longer. A patent sympathizer would say the improved version was truly a more efficacious drug; how is a company to innovate if it cannot protect its innovation? Precisely how a court of law was able to adjudicate on such a technical matter (reasonable experts may well differ) is not clear, but the ruling is binding.
 

The fight is really about the future. It is about how different the future of the pharmaceutical industry will be from its past. It is about the pricing of drugs. It is about how governments will go about balancing patent and patient in a world in which the gap between rich and poor is wide (both within a country and internationally). Could we have a different price for inner city Washington DC, Kenya and India from that in the developed markets? Should the full impact of that differential be borne by the pharmaceutical company or also by the chain of stakeholders—rich consumers, insurance companies and governments? 

Western Drugmakers Expected To Practice Caution After Patent Defeat In India.

Reuters (4/3, Hirschler, Kulkarni) reports on Western drugmakers' reaction to a landmark patent defeat in India. Amit Backliwal, who heads South Asian operations for IMS Health, remarked, "India is too big to ignore. Companies will definitely get cautious, and it definitely means a change in their business model, but I don't think they will pull out." Raghunath Mashelkar, former director general of the Council for Scientific and Industrial Research and an architect of India's IP policies, added, "Drugmakers will have to work out strategies for the lower sections, to give affordable access to medicines and make money by large volumes and smaller margins. And then they will look at the middle and the upper sections and make money through smaller volumes but higher margins."

US Business Reacts To Ruling.Reuters (4/3, Palmer) reports that the US Trade Representative's office is considering its response to the ruling, while the US-India Business Council and other business groups have criticized it.

 

DIA Daily. This daily enewsletter features summaries of breaking news and information about the pharmaceutical, biotechnology, and medical device fields from thousands of global news sources. This easy-to-read enewsletter is delivered to your inbox every business morning.

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The man behind Glivec hails verdict

Business Standard

Even though Novartis and other multinational corporations (MNCs) are upset with the Indian Supreme Court's decision to reject Novartis' patent claim on Glivec, the key man behind the popular cancer drug has welcomed the verdict, saying it would benefit ...

 

 

'Destroying patent model is no solution'

The Hindu

A day after losing in the Supreme Court its seven-year battle over patent protection for anti-cancer drug, Glivec, Novartis India's Vice Chairman and Managing Director, Ranjit Shahani, said that destroying the patent model is not the solution to make medicines ...

 

Social media 'likes' Glivec verdict

Hindu Business Line

“No way will drug companies move out of India because of Supreme Court ruling against Novartis. They need our (Indian) market and (they) will find ways to sell drug cheaper,” tweeted internationally-reputed filmmaker Shekhar Kapoor, reacting to the ...

 

Giving pharma its prescription

Hindustan Times

The Supreme Court's (SC's) verdict on Swiss multinational Novartis AG's blockbuster anti-cancer drug, Glivec, is almost a classic East versus West story and it seems never the twain shall meet over the contentious issues of drug pricing and patenting rules.

  

From Apple to Novartis: Why some patents deserve to die

Firstpost

Yesterday's Supreme Court judgment in the case of Novartis' anti-cancer drug Glivec has given rise to calls for stronger patent protection in India. The multinational lobby is yelling blue murder, and Novartis India's chief Ranjit Shahani has muttered darkly ...

  

India's Cancer-Drug Ruling Likely to Have Global Impact

Voice of America - ‎12 hours ago‎

A landmark ruling by India's high court this week struck down a bid by Swiss drugmaker Novartis to extend patent protection for its cancer drug, Glivec. The decision is seen as a blow to Western pharmaceutical companies seeking to protect their financial ...

  

Patent Ruling Shouldn't Force Novartis Out of India

Bloomberg

Novartis AG feels stung by the Indian Supreme Court's decision this week to deny patent protection to the company's Gleevec cancer treatment. Its spokesmen have gone so far as to threaten to withhold investments and even products from the country.

  

US trade office reviewing Supreme Court drug ruling

Reuters India

By Doug Palmer. WASHINGTON | Wed Apr 3, 2013 5:19am IST. WASHINGTON (Reuters) - The United States said on Tuesday it was considering its response to the Supreme Court ruling that U.S. drug manufacturers warn is the latest sign of a "deteriorating" ...

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India's Supreme Court Allows Continued Low-Cost Generics.

The New York Times (4/2, A1, Harris, Thomas, Subscription Publication) reports in a front-page story, "Production of the generic drugs in India, the world's biggest provider of cheap medicines, was ensured on Monday in a ruling by the Indian Supreme Court," meaning the populations of developing countries "will continue to have access to low-cost copycat versions of drugs for" HIV and cancer. The court ruled that a previous patent for Novartis' Gleevec prevented the company from taking out a new patent on the drug. According to the Times, "the debate over global drug pricing is one of the most contentious issues between developed countries and the developing world." Because the US allows companies to repatent a drug by altering its formula or changing its dosage, the country "pays the highest drug prices in the world." Now, "the United States government has become increasingly insistent in recent years that other countries adopt far more stringent patent protection rules, with the result that poorer patients often lose access to cheap generic copies of medicines when their governments undertake trade agreements with the United States."

        The Washington Post (4/1, Lakshmi) reports, "Many international drug companies have said that the Novartis trial was crucial to addressing the rapidly growing perception around the world that India's patent protection system for drugs is weak." Recently, "other Western pharmaceutical companies have been facing similar patent-related setbacks in India." While health activists and Indian drug companies argue "most Indians cannot afford expensive patented drugs," the ruling also "is a huge boost for India's $26 billion generic drug industry."

        The New York Times (4/1, Gottipati) reports in its "India Ink" blog, "The case represents a high-stakes showdown between defenders of intellectual property rights, who say generic versions stifle innovation by drug makers, and Indian drug companies and international aid groups, who warned that a ruling in favor of Novartis could have dried up the global supply of inexpensive medicines to treat AIDS, cancer and other diseases."

        The AP (4/2, George) reports, "Novartis called the ruling a 'setback for patients,' and said patent protection is crucial to fostering investment in research to develop new and better drugs. Ranjit Shahani, the vice chairman and managing director of Novartis India, said the ruling 'will hinder medical progress for diseases without effective treatment options.'"

        Another AP (4/1) story reports, "Major drugmakers such as Pfizer and Bayer AG on Monday declined to say what they might do regarding the ruling and other recent decisions by poor countries to let local drugmakers sell cheap generic versions for medicines that have monopolies under patents in Western countries. ... One thing is clear, though: Emerging markets are not the gold mine that optimistic pharmaceutical executives have been making them out to be."

        The Los Angeles Times (4/1, Alpert) reports, "Despite its objections to the ruling, Novartis said it was unlikely to challenge the court decision." Meanwhile, Tahir Amin, co-founder of the Initiative for Medicines, Access and Knowledge, "said the next battleground for generic drugs will be a Pacific free trade agreement under negotiation among a long list of countries, including the U.S., Canada, Mexico, Vietnam and Malaysia."

       
Also reporting this story are the Wall Street Journal (4/2, Subscription Publication), Bloomberg News (4/1, Von Schaper, Patnaik), Reuters (4/2), another Reuters (4/2), The Hill (4/2, Viebeck) "Healthwatch" blog, Time (4/1), NPR (4/1) "The Two Way" blog, Forbes (4/1), and BBC News (4/2).

DIA Daily. This daily enewsletter features summaries of breaking news and information about the pharmaceutical, biotechnology, and medical device fields from thousands of global news sources. This easy-to-read enewsletter is delivered to your inbox every business morning.

Subscribe to the DIA Daily.View archives.
iPhone and iPad Apps available! Download "BulletinHC."DIA Daily is a digest of the most important news selected from thousands of sources by the editors of BulletinHealthcare. The presence of content or advertising does not endorse, nor imply endorsement of, any products or services by the Drug Information Association. Neither BulletinHealthcare nor the Drug Information Association is liable for the use of or reliance on any information contained in this briefing.

If you would like more information about, or have a question pertaining to, DIA Membership and its benefits, please email membership@diahome.org.Click here to check your membership status.

Drug Information Association | 800 Enterprise Road, Suite 200 | Horsham, PA 19044 Copyright © 2012 by BulletinHealthcare| 11190 Sunrise Valley Drive, Suite 130 | Reston, VA 20191

Book Now to Enjoy Insightful Sessions in May Dear Colleagues, Due to unavoidable circumstances we will be postponing the 6th Regulatory Conference in India. The conference will now be held on Thursday 23rd and Friday 24th May at the Courtyard Marriott in Ahmedabad, Gujarat. It is DIA’s constant endeavor to bring to you world class programs with renowned speakers. We hope you can join us at the conference in May. Seats are still available for the event. Please take a look at the conference program to find the sessions that interest you and register today. Best regards, DIA India Read More Download Program Register

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Indian Supreme Court Denies New Patent For Cancer Treatment.

The AP (4/1, George) reports, "India's Supreme Court on Monday rejected drug maker Novartis AG's attempt to patent a new version of" cancer treatment Glivec (imatinib mesylate), "in a landmark decision that healthcare activists say ensures poor patients around the world will get continued access to cheap versions of lifesaving medicines." The case "has global implications since India's $26 billion generic drug industry supplies much of the cheap medicine used in the developing world." India's patent office didn't issue a fresh patent for the medicine "because it was not a new medicine but an amended version of its earlier product," citing "a legal provision in India's 2005 patent law aimed at preventing companies from getting fresh patents for making only minor changes," which is called "evergreening."

        The New York Times (4/1, Harris, Subscription Publication) reports, "The court's ruling confirmed that India's criteria for the granting of such patents remain far higher than those in the United States, where patents are so easy to win that one was given in 1999 for a peanut butter-and-jelly sandwich." The Times adds, "In recent decades, the United States has become increasingly insistent that countries wishing to do business there adopt far more stringent patent protection rules, with the result that poorer patients often lose access to cheap generic copies of medicines when their governments undertake trade agreements with the United States."

        Bloomberg News (4/1, Von Schaper, Patnaik) reports the decision was "watched by non-profit groups seeking to expand access to medicines and drugmakers concerned about India's position on intellectual property." This "may add to concern among Western pharmaceutical companies that India is allowing domestic generic-drug makers to profit from products that deserve patent protection." India also "angered pharmaceutical companies by allowing generic-drug makers to produce copies of patent-protected medicines to ensure they're available in the country at affordable prices."
 

        The BBC News (4/1) reports a month of Glivec costs about $2,600, compared to $175 for the same amount of its generic equivalent in India. Reuters (4/1, Mohanty, Kulkarni) also covers this story.

DIA Daily. This daily enewsletter features summaries of breaking news and information about the pharmaceutical, biotechnology, and medical device fields from thousands of global news sources. This easy-to-read enewsletter is delivered to your inbox every business morning.

Subscribe to the DIA Daily.
View archives.
iPhone and iPad Apps available! Download "BulletinHC."DIA Daily is a digest of the most important news selected from thousands of sources by the editors of BulletinHealthcare. The presence of content or advertising does not endorse, nor imply endorsement of, any products or services by the Drug Information Association. Neither BulletinHealthcare nor the Drug Information Association is liable for the use of or reliance on any information contained in this briefing.

If you would like more information about, or have a question pertaining to, DIA Membership and its benefits, please email membership@diahome.org.Click here to check your membership status.

Drug Information Association | 800 Enterprise Road, Suite 200 | Horsham, PA 19044
Copyright © 2012 by BulletinHealthcare| 11190 Sunrise Valley Drive, Suite 130 | Reston, VA 20191

Book Now to Enjoy Insightful Sessions in May Dear Colleagues, Due to unavoidable circumstances we will be postponing the 6th Regulatory Conference in India. The conference will now be held on Thursday 23rd and Friday 24th May at the Courtyard Marriott in Ahmedabad, Gujarat. It is DIA’s constant endeavor to bring to you world class programs with renowned speakers. We hope you can join us at the conference in May. Seats are still available for the event. Please take a look at the conference program to find the sessions that interest you and register today. Best regards, DIA India Read More Download Program Register

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