pfizer patent

Malaysia Allows Generics for Gilead’s Hepatitis C Drug for Which India Issued Patent

India had first rejected a patent for this breakthrough drug which sells at US $1000 per pill. Last year, India overruled its own decision and granted Gilead a patent for it.

India had first rejected a patent for this breakthrough drug which sells at $1000 per pill but later overruled its own decision and granted Gilead a patent for it.

Credit: Reuters

The Malaysian government has approved a government-use compulsory license which would allow the import of generic versions of Gilead’s patented hepatitis C drug, Sovaldi. The decision was made in August but has become public this week. On September 14, Malaysia’s The Star reported that the Malaysian cabinet had approved for this license. The move will make generic and cheaper versions of the same drug, which has been sold globally at $1000 per pill. The low-cost versions will now be available in Malaysian public hospitals and will benefit around 4,00,000 people in Malaysia. Sofosbuvir, which goes by the brand name Sovaldi, is on the World Health Organization’s list of essential medicines.

In 2015, India’s patent office had rejected Gilead’s application for a patent on the same drug, which meant India would be able to make and sell generic versions domestically and globally. However, in 2016, India’s patent office reversed its own decision. This happened after Gilead appealed to the Delhi high court, which directed India’s patent office to reconsider its refusal of patent. India said it rejected Gilead’s patent application because the drug represented only minor changes to a previous formulation and that minor changes in the molecule did not improve the drug’s efficacy. After Gilead appealed it, the same patent office granted Gilead a patent, saying it had now found its compounds to be novel and inventive. Last month, India also issued a patent for Pfizer’s pneumococcal vaccine. This vaccine had it’s patent revoked by the European Patent Office in 2014.

The hepatitis C virus destroys the liver and is estimated to have infected 150 million people globally, according to the World Health Organization. In Malaysia, hepatitis C affects 2.5% of the population, which is about 500000 people. In India, it has affected an estimated 12 million people.

The Malaysian government’s decision was apparently taken on August 4, 2017, but was made public only this week. Towards the end of August, Gilead reportedly offered Malaysia a voluntary license for this drug along with Thailand, Ukraine and Belarus, but the government appears to have rejected that offer in favour of a compulsory license.

Health watchers in Malaysia see Gilead’s sudden attempt to offer a compromise in the form of a voluntary license, a result of the Malaysian government’s resolve to push ahead with a compulsory one. “The decision to include these countries, however, no doubt is a response to increasing pressure from within these countries to either issue a compulsory license or a government use license, invalidate the Sofosbuvir patents, or block data exclusivity for the drug,” says Fifa Rahman, former manager for access and affordability for hepatitis C drugs at the Malaysian AIDS Council.

Other health advocacy groups have also expressed similar views. On this, the Consumers Association of Penang said in a statement, “The government’s move to issue a government use license is one reason why the company has after so many years agreed to include Malaysia in the scheme.” They encouraged the government to stick to its decision to issue a government-use license, and not take up Gilead’s offer for a voluntary license, as this would inhibit Malaysia’s freedom to develop, import, distribute and price generics.

Different countries and different approaches for the same drug

While it seems Malaysia has not risen to the company’s bait for a voluntary license, which Gilead offered to Malaysia, Thailand, Ukraine and Belarus in August, India has taken this option.

In India as well, Gilead issued voluntary licenses for their hepatitis C drug to 11 generic manufacturers in 2014, which would benefit 101 developing countries. One among these companies was Natco Pharma Ltd. Natco had opposed Gilead’s patent at India’s patent office but withdrew its opposition after Gilead gave the company a voluntary license to begin manufacturing generic versions of its drug. The other companies in India with licenses are Cipla, Ranbaxy, Cadila, Mylan Laboratories, SeQuent Scientific, Strides Arcolab and Hetero Drugs. Gilead has also reportedly given licenses to two manufactures in Egypt and one in Pakistan.

Gilead’s hepatitis C breakthrough drug Sovaldi, has been a point of friction in many countries with governments and patient groups trying to convince the company to make its drug more affordable. While India rejected and then granted a patent to Gilead, countries like Egypt, Argentina and Ukraine have rejected it. Malaysia is the first country to issue a compulsory license to Gilead’s patented drug. This compulsory license is also Malaysia’s second one – Malaysia had previously issued them for anti-retrovirals, to treat HIV which is estimated to have helped close to 90% of those on HIV treatment since 2006. India has so far issued only one compulsory license – for Bayer’s cancer drug Nexavar in 2012.

India’s initial rejection was based on section 3(d) of the Patents Act. This section seeks to prevent ‘evergreening’ of patents, by which companies seek to continually extend their monopoly over their patents by applying for its renewal close to its expiration. Section 3(d) denies patents for drugs which are only modified versions of previously known substances and which are not truly inventive. Writing about the change in India’s stand, lawyer Shamnad Basheer wrote that the granting of a patent seemed to have placed the burden of proof on the opponents to Gilead’s patent, whereas according to section 3(d), it is on the patent applicant.

In Malaysia, the government seems to have relied on Section 84 of their Patents Act. The Malaysian health ministry had recently tabled a cabinet paper on the rights of the government under this section.

Malaysian patients will benefit the most

About 5,00,000 people are estimated to be suffering from hepatitis C infection in Malaysia. The Malaysia AIDS Council (MAC) commended the Malaysian government for issuing this license as it would allow the import of “the highly effective but exorbitantly priced medicines at the lowest possible costs from generic drug companies.” Their statement says that this decision will “significantly reduce the financial burden of the government to provide cure to the thousands of Malaysians living with hepatitis C.” They also cited section 84 of the Malaysian Patents Act, which protects the government’s right to have taken this decision. This clause is also compliant with the World Trade Organization’s TRIPS agreement (Agreement on Trade Related Aspects of Intellectual Property), says MAC.

The government of Malaysia is currently conducting clinical trials on hepatitis C drugs, with the aim of bringing the price down to approximately $240 per patient for treatment. The Malaysian government had been offered the price of $12,000 for Gilead’s drug whereas generics are available at $200-1000. In 2013, Gilead listed the price of Sovaldi in the at $1000 a bill, or $84,000 for a 12-week course.

This liver-destroying disease is caused by the highly infectious hepatitis C virus. The virus results in liver failure or cancer, and is likely to be detected only in its advanced stages. There is also a high risk of HCV and HIV co-infection as the virus is passed through blood and semen. Treatment for hepatitis C has changed drastically over the years and now can be cured with oral anti-virals like Gilead’s Sovaldi.

With Pneumococcal Vaccine Patent, Pfizer Wins on Many Counts

Not only was Pfizer given a subsidy to ‘develop’ a drug that already existed, the profits they will make from the inefficient vaccine is much beyond what was originally stipulated.

A company logo is seen through branches at a Pfizer office in Dublin, Ireland November 24, 2015. Credit: Reuters/Cathal McNaughton

New Delhi: Pfizer has been granted an Indian patent for its Prevenar 13 – a pneumococcal vaccine. The vaccine costs more than Rs 3,000 per dose and the three doses required to immunise a child cost more than Rs 10,000. The decision of the patent office bars other Indian companies from making a cheaper version of the vaccine. Although the vaccine is exorbitantly expensive, it has poor efficacy. Yet one is not surprised by the news of the patent, given the background story, nationally and internationally, of this vaccine. According to the petition by Prashant Bhushan in the Delhi high court, this vaccine has the distinction of being recommended even before it was manufactured, let alone tested, by the National Technical Advisory Group on Immunization, which is meant to evaluate and recommend vaccines for introduction in the country.

Vaccine with little efficacy

Pneumococcal bacteria are only one of a very large number of organisms that cause pneumonia. There are many other bacteria, mycoplasma and viruses that can also cause pneumonia. The pneumococcal bacteria itself has around 100 strains. The vaccine is against only 13 of those pneumococcal bacterial strains. It is clear that this vaccine impacts only a tiny fraction of the causes of pneumonia. Bacterial pneumonia is an eminently treatable condition, responsive to antibiotics with few long-term sequlae.

Before this vaccine against 13 strains was brought to the market, most pneumococcal pneumonia was caused by seven strains of the bacteria, which strains were responsive to inexpensive antibiotic like penicillin. A vaccine against the seven common strains was introduced in the US in 2000. It resulted in the near disappearance of these seven strains but other strains replaced the ones eliminated. The new strains caused more problems like pus collection in the chest and many were resistant to the first line penicillins. In short, the use of the vaccine was making the problem worse. This was followed by the development of a ten-strain vaccine and when that caused further strain shifts, the 13 valent vaccine was brought out. Other countries clearly had the opportunity to learn from these mistakes and grab the option not to introduce a vaccine that aggravates the problem. But such is the clout of the vaccine manufacturers and their international promoters like the WHO and GAVI, that the vaccine is being recommended in the poorest of countries that can ill afford to make such costly mistakes.

The vaccine has very poor efficacy. According to a WHO bulletin, the vaccine reduces the incidence of pneumonia by 3.6 cases per 1,000 children vaccinated. Preventing these four cases (a generous approximation) of pneumonia by vaccinating 1,000 babies with a vaccine at Rs 10,000 per child will cost a mind boggling Rs 100 lakh, whereas treating four cases of pneumonia with syrup Septran, as advised by the WHO, will cost Rs 40. Even if the vaccine is procured at a tenth of the market price, the vaccine will still cost Rs 10 lakh to reduce four cases of chest infection.

Adverse effects

The vaccine has other problems besides poor efficacy. A study published in the prestigious New England Journal of Medicine shows that the vaccination nearly doubled the incidence of asthma. For every two cases of pneumonia prevented, one child developed asthma. Pneumonia is a one-off transient disease. Asthma, on the other hand, has long0term implications. One is left to wonder what the trade-off is. In spite of all this evidence, this vaccine is being introduced in India to be given to every child.

The need for introducing this exorbitantly expensive vaccine that perhaps aggravates rather than alleviates respiratory morbidity in children and the need, now, to grant it a patent in India, has left organisations like Medecins Sans Frontiers (MSF) wondering about the clout that the manufacturer wields. We had evidence of this clout ten years ago when it the company hijacked the GAVI Advanced Market Commitment (AMC) funds. Professor Donald W. Light of Stanford University described this in lurid detail.

A woman walks past a chemist shop in Mumbai, India, on April 28, 2017. Credit: Reuters/Files

AMC hijacked

Pharmaceutical companies in general are keen to make drugs for the rich countries that they can sell at great profit. They have little interest in making vaccines for diseases like malaria that affected poor countries because the countries that needed the vaccine cannot afford their profit margins. In 2005, the Center for Global Development and the Bill and Melinda Gates Foundation came up with an idea to incentivise drug manufacturers to manufacture vaccines for neglected diseases like malaria. Donors made an AMC to make up the loss of revenue to the company that makes a drug for a neglected disease. The MSF estimates that profits for a breakthrough drug is approximately $400 million. The AMC agreed to buy upto a few hundred million doses of the new vaccine at what they called the ‘buyout price’ that ensured that the manufacturer made the profits it would make if the vaccine had been made for rich countries’ market. In turn, the manufacturer would commit to making the drug for low-income countries at $1-2, with no profit. Donors would not pay till the manufacturer came up with the breakthrough vaccine. The company that arrived there first would walk away with all the profits.

After the monies were collected from international donors for setting up the AMC, inexplicably the money was given to Pfizer for the Prevenar 13, which vaccine the company had already developed to replace their blockbuster seven-serovalent pneumococcal vaccine made for the rich market. Also, the buyout price was raised from $5-6 to $10 and the tail price (the no-profits price) was raised to $3.50 from the agreed $1-2. So in fact, no new vaccine for a neglected disease was developed. The company made profits in excess of $600 million, where the normal profits are $400 million according to calculations of the MSF. At the international level, this AMC killed off any interest other manufacturers may have had to make a cheaper vaccine. They could not compete against the huge subsidy given to Pfizer.

The last straw

India does not qualify for GAVI funding as its GDP per capita is in excess of $1,500 a year. It has to pay the full negotiated price for the vaccine. Indian manufacturers therefore had an incentive to make a cheaper vaccine for the local market and for other countries like India that have graduated out of GAVI aid. The present grant of the patent to Pfizer for Prevenar 13 kills that incentive all the way up till 2026.

Of course if the patent were not there, it may have helped the development of a less expensive vaccine and addressed the cost issue, but it would not alter the facts about the poor efficacy or the problem of asthma caused by the vaccine.

Jacob Puliyel is an expert member of the National Technical Advisory Group on Immunisation, an apex body that advises the government on immunisations, and is the head of paediatrics at St Stephens Hospital in New Delhi.

Pfizer Gets Pneumonia Vaccine Patent, Months After Inclusion in India’s Universal Immunisation Plan

Pneumonia kills two lakh children in India every year, but the vaccine has so far been available only in the private market at a high price.

India’s patent office has just granted the US pharmaceutical corporation, Pfizer, a patent for their pneumonia vaccine. Credit: Reuters

“No child should die in the country from vaccine preventable diseases. This is the goal and commitment of our government,” Union health minister J.P. Nadda said as he announced the introduction of the pneumococcal conjugate vaccine (PCV) into India’s Universal Immunisation Programme (UIP).

This was three months ago – in May. Nadda was launching the PCV in Mandi district in Himachal Pradesh. He is a Rajya Sabha parliamentarian from the state.

Three months later, India’s patent office has just granted the US pharmaceutical corporation, Pfizer, a patent for their PCV. It will extend upto 2026. The order, on August 11, is for Pfizer’s vaccine that is marketed as Prevnar13 and protects against 13 types of pneumococcal bacteria. The patent was opposed by Medecins Sans Frontieres and Panacea Biotech Ltd.

PCV is the world’s best-selling vaccine and it has earned Pfizer nearly $35 billion in sales between 2009 and 2017. Until now, in India, PCV has only been sold in the private market, to those who can afford it. Here, it costs approximately Rs 11,000 per child for all three doses of the Prevnar13 vaccination.

Pneumococcal disease is the leading cause of vaccine preventable deaths globally in children under five. India alone accounts for 20% of all pneumonia deaths globally. In India, two lakh children die from pneumonia annually and it kills more children in India under the age of five, than any other infectious disease.

Despite being part of India’s “universal” immunisation programme, it is in fact only available to children in three states – Himachal Pradesh, Bihar and Uttar Pradesh. Madhya Pradesh and Rajasthan will be included next year. India’s immunisation programme began with providing protection against six diseases and now offers 12.

At the roll out in Mandi, Nadda talked about the high prices of this vaccine: “While these vaccines in the private sector were accessible to only those who could afford them, by making them available under the UIP, the government is ensuring equitable access to those who need them the most, the underprivileged and underserved.”

The PCV, sold globally with a duopoly between Pfizer and GlaxoSmithKline, began to be rolled out in India’s immunisation programme only this year, due to a “commodity assistance” from Gavi, the global vaccine alliance.

Gavi is making these Pfizer vaccines available to India only for three years, according to a health ministry official. Gavi has committed $500 million to India between 2016 and 2021. Gavi purchases the vaccine at approximately Rs 500 per child for a full vaccination. In May, Gavi’s CEO Seth Berkley said, “This is a huge milestone because it means that, for the first time, India’s most vulnerable children will be protected against one of India’s most deadly diseases.”

After Gavi pulls out in 2021, the Indian government will find itself dependent on these patented vaccines but will have to bear the full cost. “Any vaccine which we introduce, we cannot withdraw. We will have a public hue and cry. Clearly when the government takes a decision whether to introduce a vaccine or not, it definitely has made up its mind to continue to provide the vaccine,” says Dr Pradeep Haldar, deputy commissioner for immunisation at the health ministry.

Post 2021, the PCV may not be sold at Gavi’s subsidised rate of Rs 500 to the Indian government. In 2013-2014, for example, the US government was buying the same vaccine from Pfizer at approximately Rs 21,000 for a single child’s vaccination.

Inventive in India but not inventive in Europe

The same vaccine had their patent recently revoked in 2014 by the European Patent Office (EPO), which judged it to be “non-inventive”. It had been opposed by five applications, including by competitors Merck and Novartis. The Indian patent office has found the same vaccine to be both “novel” and having “inventive step”.

“The EPO is a far more patent-friendly body, as opposed to India which has been more reluctant. For the EPO to revoke a patent that they themselves have granted, is an important factor and should have been considered in India too,” says Leena Menghaney, South Asia Head for Doctors Without Borders’/Médecins Sans Frontières (MSF) Access Campaign.

“It’s unfair and unacceptable that almost a million children die each year from pneumonia, even though a life-saving vaccine is available. Children everywhere have a right to be protected from pneumonia, but many governments can’t afford the prices set by Pfizer,” said Dr Prince Mathew, Asia Regional Coordinator for MSF. “We urgently need additional manufacturers to rapidly introduce competition with the aim of lowering vaccine prices,” he said.

MSF believes that the granting of this patent may bring competition down as this will block other manufacturers in India from supplying the vaccine. This patent is being challenged currently by MSF in South Korea and it is also being challenged separately before the US Patent Trademark Appeal Board. The humanitarian agency feels this signals a weakening of India’s high standards of patentability.

The Wire has reached out to Pfizer and Gavi for comment, and will update this story if there is a reply.