A victory for patients & generic drugmakers vs Novartis in landmark patent case

The Indian Supreme Court’s ruling that only genuinely new inventions should be granted patents means that medicines can still be affordable.

The front office of Novartis in Mumbai, India, Monday, after India's Supreme Court rejected drug maker's attempt to patent a new version of a cancer drug Glivec. 

PATIENTS around the world who look to India for low-cost medicines to treat their ailments heaved a sigh of relief last week when the Indian Supreme Court turned down a claim for a patent for a cancer drug.

This means that drug companies in India can continue to produce generic versions of the same drug, Glivec or Gleevec, at a much lower price, thus making it affordable to thousands more cancer patients.

Glivec, produced by the Swiss-based company Norvartis, can cost a patient up to US$70,000 (RM217,000) for a year of treatment, whereas the generic versions of the same medicine made by Indian companies cost around US$2,500 (RM7,750). The drug is used to treat some forms of leukaemia as well as a rare type of stomach cancer.

The Supreme Court decision also seems to open the road for patents not to be granted for more medicines, since it confirmed that only drugs that are genuinely a new invention can be granted patents.

When a patent is granted to a company for a drug, other companies are not permitted to produce generic versions of the medicine for a period of 20 years or so.

The monopoly given to the patent holder enables it to charge high prices since there is a lack of competition.

Many or even most patients are unable to buy the medicines, giving rise to frustration and despair especially when their lives are at stake.

Some companies whose patents are about to expire apply for a new patent for the same drug after changing the composition slightly or changing the form of the drug.

The “new” drug is often not a new invention, but only a minor modification that is made with the aim of having the patent renewed for another period. This practice is popularly termed “evergreening” of the patent.

An extension of the patent term means that the company continues to enjoy the monopoly and high prices, which continue to be out of reach to many patients.

Although governments are obliged to have laws allowing for patents to be given for inventions under the World Trade Organisation’s TRIPS agreement, each country is allowed to set its own definition and standards for what is an invention.

The Supreme Court decision confirms that the Indian patent authorities exercised their powers lawfully and properly when they rejected the patent application for Gleevec on the ground that the medicine was not a new invention.

Novartis had challenged the interpretation given by the Indian Patent Office to Section 3 (d) of the Indian Patents Act that seeks to prevent the grant of patents for non-inventive new forms of known medicines.

The Novartis application had claimed a patent for a new salt form (imatinib mesylate), a medicine for the treatment of chronic myeloid leukaemia, sold under the brand name Gleevec (or Glivec in other countries).

The Indian patent office had rejected the patent application on the ground that the claimed new form was anticipated in an earlier US patent of 1996 for the compound imatinib and that the new form did not enhance the therapeutic efficacy of the drug. The decision was upheld by the Indian Patents Appellate Board.

The legal challenge from Novartis had caused anxiety among patients groups, governments of developing countries and some international organisations in view of the possible negative implications for access to affordable medicines if the Norvatis petition succeeded.

Most developing countries rely on Indian generic drug companies for the supply of low-priced medicines for many diseases.
A weakening of the interpretation or use of Section 3 (d) would have enabled multinational drug companies to extend their patent monopolies based on “evergreening” or “trivial” incremental improvements which could delay the supply of generic medicines for the treatment of HIV/AIDS, cancer and other diseases.

The decision by the Indian Supreme Court is thus of major significance not only for India but for patients and health authorities in the developing countries.

In interpreting Section 3 (d), the Supreme Court observed that this section was introduced in the 2005 amendment to the Patents Act to ensure that while India allowed product patents on medicines in accordance with its WTO obligations, it did not compromise public health through “evergreening” of pharmaceutical patents.

The court hence took into account the concerns about the impact of the TRIPS agreement on public health and on the development of an indigenous pharmaceutical industry.

Moreover, it considered the implications of the Novartis case for the availability of essential medicines at affordable prices globally.

The court decision reproduced two letters from Dr Jim Yong Kim, the former director of the Department of HIV/AIDS at the World Health Organisation (current president of the World Bank) and from UNAIDS to the Indian health minister expressing their concerns relating to the continuous availability of affordable Indian generic drugs in other developing countries.

Thus, the Supreme Court decision has implications beyond India. It upholds the high standards by which drug patent applications can be processed. While genuinely new inventions are granted patents, drugs that are not really new need not.

The implication is that Indian generic companies can be expected to produce many more medicines in future, and continue their reputation as the “pharmacy of the developing countries”.

It is also heartening that the court decision reaffirms the priority for concerns for the patients’ right to receive treatment at more affordable prices.

The court decision is also likely to spark interest among other developing countries about the Indian patent law and the policies guiding it. Developing countries can learn from the Indian approach of balancing patents and public health.

Global Trends
By MARTIN KHOR
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Boao Forum for Asia opens in China

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The opening ceremony of the 2013 Boao Forum for Asia will begin Sunday morning. The forum is being held in Boao, a coastal town in southern China’s Hainan province. Chinese President Xi Jinping will deliver a key-note speech at the opening ceremony. Full Story>>



For more on the Boao forum, we are joined in the studio by Joseph Pelzman, Professor of Economics and Law at George Washington University, and Professor Fu Jun from the School of Government at Peking University.

Q1, The theme of the 2013 Boao Forum for Asia is "Asia Seeking Development for All: Restructuring, Responsibility and Cooperation". What message can we take from that? What influence will this forum exert on Asian economies and world economies?

Q2, The Secretary General of the Boao Forum, Zhou Wenzhong, said this year’s forum will focus on "restructuring" in a more sustainable and innovative way. In regards to "restructuring", what topics are expected to be discussed?

Q3, What major concerns will this year’s forum address?

Q4, Chinese President Xi Jinping will deliver a keynote speech at the opening ceremony of the forum. In your opinion, what will be the big message he will deliver to the Asia-Pacific region?

Q5, The Asian economic integration has accelerated in recent years, thanks to Asian economies being highly interdependent in trade and investment. At the 2013 Boao Forum for Asia, more than 50 panel discussions will be held to offer suggestions on regional development. How important is cooperation for Asian economies?

Q6, In addition to economic issues, this year’s agenda also includes topics concerning people’s livelihood, such as property, education, health, and food safety. What can we expect regarding such issues?

Q7, What’s the distinguishing feature of this year’s forum, compared with previous ones?

Q8, The international economic backdrop to this year’s forum remains negative--particularly in developed countries suffering from the economic downturn. In light of this, what outcome can we expect from this year’s forum?

Q9, Highlights of this year’s forum include a newly set up of Africa panel, a Latin America panel. What’s the significance of these new panels?

Q10, The Boao Forum for Asia was launched in 2001 as a platform for high-level leaders from government, business and academic circles to discuss pressing global and regional issues. After more than a decade, how important is the forum now becoming on the global arena?



During the three-day forum, April 6- 8 leaders from government, business and academic circles will be able to choose from 50 panel discussions. What will they talk about? What can be expected?

Boao Forum for Asia is all about dialogue. The talks will take the form of sub-forums, round-table discussions, and closed door meetings.

In some cases, guests will even be able to have private talks with big names like Bill Gates.

President Xi Jinping is expected to have a one-hour talk with 30 entrepreneurs from around the world.
Organizers say topics of discussions this year illustrate the forum’s global vision.

Yao Wang, head of Research Inst., Boao Forum for Asia, said, "For the first time, we will set up sub-forums for Africa, Latin America and Europe. Such a design shows the Boao Forum for Asia is getting more and more international."

In addition to macroeconomic issues like the debt crisis and monetary policy, topics concerning people’s daily lives -- such as education, health, tourism, and the Internet -- will also be addressed.

Most of panel discussions will last anywhere from 45 minutes to one hour and a half. During the busiest time slot, guests will be able to choose from five seperate talks.

The International Monetary Fund said on Thursday that its Managing Director Christina Lagarde will visit China in April to attend the upcoming annual Boao Forum for Asia.

Lagarde will be traveling to China's Hainan Province on April 6- 8 to attend the Boao Forum, IMF spokesman Gerry Rice told reporters at a regular news briefing.

He added that Lagarde will meet with government officials of China and other Asian countries during her stay.

This year's Boao Forum for Asia, one of Asia's biggest annual economic meetings, will be held under the theme of "Asia Seeking Development for All: Restructuring, Responsibility and Cooperation ". More than 10 state and government leaders from Asia and other regions will be invited to the three-day forum, which will begin on April 6 in Boao, a coastal town in south China's Hainan Province.  

In  2012, more than 2,000 government, business and academic leaders from around the world attended the meeting.

Started on Sunday, the three-day forum is being held in Boao, a scenic town on the eastern coast of Hainan.

It introduces a wide range of topics, including eurozone debt crises, employment and growth, the reform of the international monetary system as well as the strategic breakthrough of Asian manufacturing.

The Boao Forum for Asia is a non-governmental and non-profit international organization founded in 2001.

It has been committed to promoting regional economic integration and bringing Asian countries closer to their development goals.

China, Brunei to foster ties

Both countries pledge to step up bilateral cooperation 

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China and Brunei agreed on Friday to nurture their relations at a higher level as "strategic" and "Cooperative", vowing to step up bilateral cooperation in areas like energy and infrastructure.



The agreement was reached while Chinese President Xi Jinping held talks with the visiting Brunei's Sultan Hassanal Bolkiah in Beijing.

Xi praised China-Brunei relations that featured mutual respect and equality as a regional model for small and big nations to harmoniously coexist and harvest mutual benefits and common prosperity.

"Strategic and cooperative China-Brunei relations will boost bilateral cooperation and play a leading role to promote regional peace and development," Xi said.

He stressed the two nations should pay sufficient attention to each other's key concerns and honor their independence, sovereignty, territorial integrity as well as the development paths chosen to fit their domestic situation.

"China encourages its companies to actively involve themselves into Brunei's infrastructure and agriculture development and looks for further progress on bilateral cooperation in the oil and gas, petrochemical and renewable energy sectors," Xi told Hassanal.

The Chinese president also highlighted the country's foreign policy with neighboring countries, calling on the members of the Association of Southeast Asian Nations (ASEAN) to jointly safeguard the peace and stability of the South China Sea and resolve disputes via direct friendly dialogue and consultation between the involved sovereign states.

China will work actively with Brunei, who chairs the ASEAN in 2013, to eliminate any possibilities that might undermine friendly cooperation with ASEAN and reinforce peace and stability in the region, Xi noted.

China will continue to back ASEAN's leading role on East Asia affairs, he added.

Echoing Xi's views, Hassanal acknowledged China's development as a major contributor to boost regional development and prosperity.

Brunei believes the ASEAN-China ties will continue to grow and involved parties should seek for peaceful resolutions to disputes concerning the South China Sea via dialogue and consultation based on the the Declaration on the Conduct of Parties, Hassanal said.

He also pledged an active role that Brunei will play to nurture ties between the ASEAN and China.

Hassanal is the first foreign head of state Xi has received after he was elected Chinese president in March. The two leaders will attend the opening ceremony of the annual Boao Forum for Asia on Sunday in southern China's Hainan Province.- Xinhua

Singapore kiasu (怕输) in a rising China

The republic is concerned about China’s rising economy resulting in an expanding maritime force at a time when the US military might is weakening.

FOR a few days last week, Singapore’s prime minister left behind his troubles at home to face a tricky foreign policy matter that his father once excelled in.

Lee Hsien Loong paid his second visit to the United States in six years that was evidently aimed at deepening Singapore’s strategic ties with Washington at a time of rising tensions in Asia.

In a meeting with President Barack Obama at the White House, Hsien Loong appealed to the economically-weakened United States to stay committed in Asia despite plans for big defence cuts.

Of late, Asia has been plagued by territorial claims and counter-claims involving China and at least a dozen countries, sometimes resulting in frictions and warning shots being fired.

While Hsien Loong was in America, former Singapore prime minister Goh Chok Tong arrived in China for a seven-day visit, where he met the new Chinese leader Xi Jinping.

The Singaporean leader’s US visit took place as many foreign leaders were sending congratulations to Xi on his assumption of office.

It comes in the wake of a decision by the American president and Congress to cut the Pentagon’s budget by US$487bil (RM1.498 trillion) over the next decade. The cut took effect on March 1.

Singapore has become more concerned about China’s rising economy resulting in an expanding maritime force at a time when the US military might is weakening.

His attempt to maintain a balance in the republic’s ties with China and United States had long been the forte of founding leader Lee Kuan Yew. It had kept Singapore in good stead with both.

Despite this, Singapore has been placing greater trust on the protection of the United States.

Although Singaporeans are predominantly Chinese and have built up strong economic and other ties with Beijing, the city has strong military and strategy relations with Washington.

Singapore is more worried about China’s soft encroaching use of its power in the area than any prospect of it starting a war in Asia.

For example, Beijing has begun using a new passport which shows a map showing several disputed territories as part of the nation of China.

This has instilled regional worries, leading several countries involved to strengthen ties with the United States.

In a new book released in February, Kuan Yew – now a passive 89-year-old Member of Parliament – voices worries about China’s rise in power.

“Many small and medium countries in Asia are concerned (and are) uneasy that China may want to resume the imperial status it had in earlier centuries,” Kuan Yew says.“They have misgivings such as being treated as vassal states.”

“China tells us that countries big or small are equal, that it is not a hegemon,” Kuan Yew writes.

“But when we do something they do not like, they say you have made 1.3 billion people unhappy. So please know your place.”

It prompted Singapore to move closer militarily to the United States years ago by offering passing facilities for its air force and navy, including aircraft carriers.

Hsien Loong’s visit probably has another purpose. Singapore is reportedly on the verge of making a decision to buy America’s F-35 fighter jets to upgrade its air force.

Singapore’s defence minister Ng Eng Hen said last week that the air force “has identified the F-35 as a suitable aircraft to further modernise our fighter fleet”.

“Our F-5s are nearing the end of their operational life and our F-16s are at their mid-way mark,” he said in parliament. “We are now in the final stages of evaluating the F-35.”

The order could be for 12 F-35Bs (estimated cost: US$2.8bil (RM8.6bil)), which can take off and land vertically, a useful feature given Singapore’s limited air space.

However, it is not known if there are further plans to buy more in future. Reuters quoted industry and US sources as saying Singapore may buy up to 75 F-35Bs eventually.

Singapore was the world’s fifth-largest importer of conventional weapons in 2008-12, at 4% of the global total, the Stockholm Inter­national Peace Research Institute says. It trailed behind India, China, Pakistan and South Korea.

The visiting Hsien Loong was assured by US Defence Secretary Chuck Hagel that the United States remained “committed to­­wards the Asia-Pacific region”.

Of growing US focus is China’s first aircraft carrier, the Liaoning, which is projecting the country’s new maritime power.

Although Hsien Loong became prime minister eight years ago, this is his first real test of his diplomatic skill in a major foreign policy without Cabinet guidance from his father.

This visit – and the consequences – will determine if he could succeed in steering Singapore through the intensifying rivalry of China and the United States.

In his after-dinner speech in Washington, Hsien Loong said Singapore got along well with both.

One reason he implied was China needed to look at his city-state to try to understand how it could balance its own economic and social goals while growing.

The Chinese needs Singapore as a political model for them to learn from, without political reforms, Hsien Loong told the Americans.

What of China’s intention? Kuan Yew says he is certain China’s leaders want to displace United States as the leading power in the Asia-Pacific.But in speeches published, he says he is less worried about the current generation of leaders than he does about the next.

  Insight: DOWN SOUTH By SEAH CHIANG NEE

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First lady in the limelight

China's Peng Liyuan joins the ranks of the world's most fashionable first ladies.

Xi Jinping and Peng Liyuan arrive in Moscow. Photograph: Ivan Sekretarev/AP

He is the most powerful person in China and head of the world's second largest economy, but when Xi Jinping arrives for the Brics summit in South Africa on Tuesday, chances are that all eyes in his home country will be on the woman at his side.

Peng Liyuan, China's new first lady, was the talk of Chinese social media at the weekend during a trip to Russia when she emerged as a trendy contrast to her predecessors.

Pictures of Peng stepping off a plane with Xi in Moscow on Friday – the first stop on his first trip abroad since assuming China's presidency on 14 March – went viral online with praise for her attire: black high heels and stockings, an understated leather bag and a light blue scarf emerging from beneath a dark trenchcoat, collar turned up against the wind.

The 50-year-old People's Liberation Army singer is often compared to Carla Bruni-Sarkozy, Michelle Obama, Raisa Gorbachev and even Kate Middleton: a charismatic performer, trendsetter and dash of colour in an otherwise monochrome regime.

"I kind of knew she would play some role in public life, but not in this way," said Wang Zhengxu, an associate professor of contemporary Chinese studies at the University of Nottingham. "Somehow she just hijacked the limelight from Xi Jinping on Chinese cyberspace. That's quite a dramatic development in my view."

After bloggers identified Peng's bag, coat and scarf as products from the Guangzhou-based outlet Exception, the company's website crashed on Friday from an overload of traffic. On Sunday the site was still loading only intermittently.

Exception was founded by a Guangzhou-based couple in 1996 who now run about 100 outlets across the country. "[Its CEO] once said Exception is best suited for this type of woman: a bit artistic, someone who appreciates quality but also stands apart, someone who understands international trends but wants to express her eastern flare," the LadyMax fashion website reported. "Is this not Peng Liyuan's style?"

The Beijing-based entrepreneur Wang Lifen said Peng's life story was a classic inspirational tale.

"Born into poverty, she used her innate singing ability to leave her home town, worked diligently to complete a master's degree at China Conservatory of Music, and used her gradually growing fame and visionary intelligence to start dating a low-level cadre," she wrote. "This is why so many people admire her."

The recently retired president Hu Jintao's wife, Liu Yongqing, and Jiang Zemin's wife, Wang Yeping, were both known to keep low profiles. Looking for their names on Chinese search engines brings up only fragmentary biographical information such as birth dates and alma maters.

When Xi assumed the Communist party's top post in November, analysts predicted that Peng would remain as low-key as her predecessors: after all, the soprano had chosen to eschew large-scale performances in recent years to avoid drawing attention from her husband's political career.

Yet Peng's arrival in Moscow was covered extensively by China Central Television and received a full-page spread in the Beijing News. The couple arrived in Tanzania on Sunday, and on Monday Peng was pictured in a bright red scarf casually draped over a tailored black jacket and white dress.

Some commentators have expressed hopes that she will take a more active role in forthcoming visits to South Africa and the Republic of Congo. Peng was appointed as the World Health Organisation's goodwill ambassador for tuberculosis and Aids in 2011.

Peng joined the People's Liberation Army as a civilian at 18 and had already reached the heights of folksinging fame when she first met Xi in the south-eastern province of Fujian in 1986. She is best known for her 24 years as a soloist at the annual spring festival gala, perhaps the most-watched television event in the world, belting folk songs in her brassy, nasal soprano.

In one widely shared video clip, Peng, dressed in military garb, sings about "bravely advancing for victory" amid a chorus line of bayonet-wielding soldiers. The stage show is juxtaposed with stock footage of battle-ready Chinese tanks, jets and warships.

Internet censors have given largely free reign to positive discussion of Peng but have kept a grip on the conversation. Terms such as "Auntie Peng" and "first lady Xi" have been blocked on Sina Weibo. Wang Zhengxu said censors probably wanted to maintain Peng's image as a symbol of public diplomacy rather than brash commercialism.

By Jonathan Kaiman Guardian News & Media

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