Pfizer says to appeal over India drug patent refusal

US drug giant Pfizer said Friday it will appeal against an Indian ruling overturning a patent for a cancer drug, saying the decision raises questions about intellectual property protection in India.


Indian generics heavyweight Cipla opposed the granting of the domestic patent for Prizer’s Sutent, which is used to combat liver and kidney cancer.

The patent office’s decision went to the heart of India’s patent act, which says a patent cannot be granted for a drug unless changes make it significantly more effective and innovative.

“The patentee (Pfizer) has miserably failed to demonstrate any improved activity” warranting a patent, the patent office said in its decision.

“The invention that is claimed in the patent does not involve any inventive step… and hence (is) not patentable,” Nilanjana Mukherjee, senior patent officer, said.

A spokesman for Cipla, which revolutionized AIDS treatment by supplying cut-price drugs to the world’s poor and which has been campaigning to be able offer other low-cost generic medicines, had no immediate comment.

But Pfizer managing director Jazz Tobaccowalla said the company believes the ruling “undermines intellectual property rights in India”.

“We will vigorously defend our basic Sutent patent,” the Pfizer executive said in a statement, adding the company would appeal against the ruling to India’s Intellectual Property Appellate Board.

The patent decision marked another win by Cipla against a global pharmaceutical company.

In September, a court threw out a patent infringement case launched against Cipla by Swiss drug maker F. Hoffmann-La Roche over the Mumbai firm’s version of a lung-cancer drug, ruling it had a different molecular makeup.

The cases have been watched worldwide as they involve interpretation of stricter drug patent protection rules introduced by India in 2005 to comply with World Trade Organization regulations.

India has some of the toughest criteria for drug companies to obtain patents, said D.G. Shah, secretary general of the Indian Pharmaceutical Alliance, an industry body.

“These rulings show (foreign) companies need to take into account that India will not permit tweaking of formulations for getting a patent. If they had those expectations, they were unrealistic,” Shah told AFP.

Medical charities have expressed concern compliance with WTO rules could reduce the country’s role as a supplier of low-cost medicines. India is the world’s leading exporter and manufacturer of non-branded medicines.

But Western firms — looking to countries such as India for sales growth — have voiced criticism of brand protection in India.

Earlier this year, an Indian ruling allowed a local firm to produce a vastly cheaper copy of German pharmaceutical giant Bayer’s patented drug Nexavar for liver and kidney cancer.

India’s patents chief ruled the price Bayer charged was “exorbitant” and told the firm to give a “compulsory license” — permitted under WTO rules for public health reasons — to Indian firm Natco Pharma to make a less costly version.

Experts say that ruling could pave the way for a rush of other “compulsory license” applications in India and other poor nations, allowing access to patented life-saving drugs at a fraction of the cost.

Read more:

Indian patent rules infuriate Big Pharma

A CLASH over India’s drug market was inevitable. Foreign drugmakers, facing paltry growth in the West, are eyeing India hungrily. Rising incomes and rates of chronic disease may push sales from $12 billion in 2010 to $74 billion in 2020, according to PwC, a consultancy. But tapping this growth means having patents that protect intellectual property. India is home to a thriving generics industry, whose copycat drugs make up about 90% of the market. India’s drug-patent laws are just seven years old. Its government is keen to encourage generics and keep prices down.

Now India’s patent rules are being put to the test. Novartis, a Swiss giant, is challenging India for denying a patent for Glivec, its blockbuster cancer drug. The fight is due to reach India’s Supreme Court on September 11th. Bayer, a German drugmaker, has a different problem: in March India’s patent controller ordered it to license a drug to a local manufacturer. Its appeal had its first hearing on September 3rd. The cases will help decide how quickly India’s 1.2 billion people get new drugs, and at what price.

India’s drug industry has a unique history. For more than 30 years, the country did not recognise pharmaceutical patents. Domestic firms became masters at copying medicine and making it cheaply. After joining the World Trade Organisation (WTO) in 1995, India had to change its patent policy. But its new system, in place since 2005, includes special protections for both patients and generic manufacturers.

For example, the law bars patents of minor changes to existing drugs, a practice known as “evergreening”. Drug reformulations are often used to extend patents elsewhere; they get no protection in India. The country also has broad criteria for “compulsory licensing”. A WTO agreement allows countries, in some instances, to force a firm to license a patented drug to a generic company. India’s rules give officials broad powers to do this.

Now both provisions are under attack. In 2006 India denied Novartis a patent for Glivec, calling it an unpatentable modification of an existing substance, imatinib. Novartis insists this is nonsense. Only by making it in salt form, imatinib mesylate, did Novartis have a proper drug: the body absorbed the medicine 30% more easily.

Paul Herrling, the chair of Novartis’s Institute for Tropical Diseases, says the case is a test of what is patentable in India. “We are being accused of evergreening,” he says. “Having that concept applied to Glivec, which was one of the major breakthroughs in cancer therapies, is completely ridiculous.” Michelle Childs of Médecins Sans Frontières, a non-profit, retorts that drug firms such as Novartis should not win patents for minor improvements. This would keep generics off the market, driving up prices.

Bayer’s case is equally heated. In 2008 it won an Indian patent for Nexavar, a kidney-cancer drug. But in March India’s patent controller issued the country’s first compulsory licence. He wrote that Bayer had not made Nexavar “reasonably affordable” (Bayer offered it for a whopping $5,000 a month), that the company failed to provide enough of the drug and, in a protectionist nod, reckoned that importing Nexavar further hurt Bayer’s case. The controller ordered an Indian company, Natco, to sell Nexavar for one-thirtieth of Bayer’s price. Bayer will receive a 6% royalty. Meanwhile Bayer is fending off another competitor, Cipla, which has sold generic Nexavar in India for years.

As these cases drag on, India’s government is considering other ways to get cheaper medicine. It plans to offer free generics in public hospitals, which would drive up sales of very cheap copies. It may also set price controls for patented drugs. However, generic companies are not immune to regulatory pressure. Ministers plan to expand price controls for a broader swathe of generics.

Cost versus innovation



“We realise the industry will take a hit,” explains D.G. Shah of the Indian Pharmaceutical Alliance, which represents big generic companies. “We’re trying to find a solution so that the government’s concerns on access and affordability are addressed without threatening the long-term growth of the pharmaceutical industry.” Nice work, if they can get it.


Court rules for Cipla against Roche in patent case

MUMBAI: A court has ruled in favour of local drugmaker Cipla in a patent infringement case filed by Switzerland’s Roche Holding AG over Cipla’s cancer drug Erlocip, a senior executive of the Indian company said.

The Delhi High Court made the ruling a week before India’s Supreme Court is due to begin hearing a patent plea by another Swiss drugmaker, Novartis AG, over its cancer drug Glivec. That case is expected to set a precedent for the Indian drug market, where major western companies are fighting to protect their intellectual property.

“The court judgement says we have not infringed any patent,” S. Radhakrishnan, a director on Cipla’s board, told Reuters late on Friday after the Delhi High Court’s ruling.

Roche accuses Cipla of infringing its patent on cancer drug Tarceva, which Cipla sells under the brand name Erlocip.

Roche could not immediately be reached for comment. The company has the option to challenge the judgement in India’s Supreme Court.

The ruling comes nearly four years after the court rejected Roche’s attempt to stop Cipla from selling Erlocip in India.

The court, however, said that Roche’s patent over Tarceva is valid in India, media reports said.


HIV/AIDS bell tolls


The delay in reforming a critical Bill in parliament may render AIDS drugs in Uganda illegal

We no longer fear AIDS. Eddagala gyelili e Mulago (drugs are available at Mulago Hospital),” says Ssenkindu Moses, 32,  who tells me he has had three sexual partners in the last one month and did not use condoms with any of them.

Many Ugandans take AIDS treatment for granted. This ‘ARV complacency’ has been partly blamed for the recent spike in new HIV infections. Uganda’s HIV prevalence rates have risen from 6.7% in 2005 to the current 7.3%.

Because most antiretroviral treatment (ART) in Uganda has been funded by the American taxpayer, with PEPFAR paying for as much 85% of all AIDS treatment costs in Uganda, you would regard financial sustainability as the challenge to continued access to treatment in Uganda. But you would be mistaken.

According to Dennis Kibira, Medicines Advisor at HEPS, a local NGO, 90% of AIDS drugs in Uganda are generic drugs.

A generic drug is an identical copy of a branded one that is usually developed and manufactured by innovator pharmaceutical giants such as Pfizer and Norvatis.

Pharmaceutical giants invest millions of dollars in developing and marketing new drugs, costs which generic drug manufacturers don’t incur and hence branded drugs are many times the cost of generics.

“Unless the Ugandan parliament revises and re-introduces the Industrial Properties Bill (2009), the permission to manufacture cheap generic ARV drugs will cease in 2016 with thousands affected since Quality Chemicals manufactures generic Aids drug,’’ said Moses Mulumba, Executive Director of CEHURD, a health rights advocacy NGO.

India which supplies most of Uganda’s AIDS drugs, has developed a thriving generics industry, leading to it being dubbed “the pharmacy of the developed world” for the low cost of its generic drugs, especially antiretrovirals, some of which cost as little as a tenth of the brand price.

For developing countries such as India, the ban on manufacture of generic Aids drugs came into force in 2005 under the TRIPS agreement of the WTO whereas a similar ban on poorer developing countries such as Uganda will take effect in 2016 unless the Ugandan parliament revises the industrial properties bill (2009) which would, inter alia provide for extension of this deadline.

According to the WHO, ‘Developing countries are failing to make full use of flexibilities built into the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to overcome patent barriers and, in turn, allow them to acquire the medicines they need for high priority diseases, in particular, HIV/Aids.

With the expiry of the TRIPS grace period, the alternative in Uganda would be to buy these drugs much more expensively from the original western manufacturers.

At the moment, passing the Industrial Properties Bill (2009) in Uganda, after amending it to take full advantage of the ‘flexibilities’ in the TRIPS agreement would, inter alia, extend the grace period for manufacturing generic Aids drugs remains the best hope for the thousands on Aids treatment in Uganda.

In November last year, a consortium of NGOs led by CEHURD took out a half page newspaper appeal to Kahinda Otafiire, the Justice minister to seek his support in revising the bill before it is passed by parliament.

“The bill left our desk. We did our part. It is now before parliament, specifically before the legal affairs committee” sources within the Ministry of Justice said.

However, the Bill which was brought before the committee in 2009 has not been enacted since and the Bill lapsed with the 8th parliament. The Industrial Properties Bill (2009) has now been inherited by the current parliament. The Ministry of Justice, however, indicated that a Bill should not spend more than 45 days before a committee of parliament.

“As stakeholders, we are waiting for the public hearing on this bill. However, since April this year when the Expert Report on this bill was released by Ministry of Trade, there have been no engagements on this Bill by the 9th Parliament,” says Mariam Akiror of HEPS-Uganda.

“Laws take time to enact as you have to follow so many procedures including the draft being presented before cabinet and even formulating policy and objectives and parliament has many priorities,” says a Uganda Law Reform commission official. However, ‘big pharma’ interests are always a part of the story.

Mariam Akiror of HEPS Uganda insists that the Bill as it is would  do more harm than good and even suggests that the status quo is preferable as ‘big pharma’ would be hard-pressed to enforce their patents in the current legal regime. In the current Bill, government would need the consent of a patent holder before making a generic drug yet the TRIPS flexibilities permit poor countries to make a copy without permission on account of a public health emergency.

Charles Birungi of UNDP(Uganda) insists that the current Bill is about “enforcement of certain types of intellectual property rights” which are private rights enjoyed mainly by western pharmaceutical giants. Revising the Bill would be a boost for Ugandan pharmaceutical industries such as Quality chemicals as it would legalize their production of generics.

“There are few priorities before parliament which should take precedence over our very lives as Ugandans. If I was an MP, this bill would be the most important item on the agenda because it affects millions of Ugandans. Look at how many Ugandans are getting infected every day and how many will need these drugs?” asks a dejected Gertrude Namusisi, 42, who is living positively with HIV/AIDS.

Henry Zakumumpa works with Makerere University and is 2011 Media Fellow of the Center for Health, Human Rights and Development (CEHURD).

Medicines Patent Pool Side Event at the International AIDS Conference on Ways to Increase Access to Medicines

This blog is a summary of a July 25 satellite event at the XIX International AIDS Conference titled “The Future of Affordable Antiretroviral Treatment: Trends in Patents and Price.” The event was hosted by the Medicines Patent Pool (MPP). Powerpoint slides are online at

Pedro Esgueira from the International Dispensary Association (IDA) foundation presented “Intellectual property-related challenges in the procurement of antiretrovirals: the perspective of a procurement agency.” His agency provides essential medicines to 160 million people, and regularly faces obstacles to antiretroviral delivery due to intellectual property rights. These include:

Seizures by customs officials, including those in the Netherlands, Estonia, and the Ukraine. As a result, IDA has had to reroute some of their medicines through less efficient transit hubs.

Limited sources of needed medicines. IPRs can block new entrants to the markets, even when there are bilateral voluntary licenses for generic production.

Lack of clarity regarding patent status and/or licensing status. For example, only one generic firm in Azerbaijan had a license to supply TDF+FTC, and it was unsure what the terms of the license permitted it to do.

High prices due to monopoly or restricted competition. This often puts patients on hold and makes second or third line drugs out of reach.

General delays and transactions costs. If there is a delay, IDA may be forced to go to the branded supplier, and the price can be significantly higher.

Political pressures that keep recipient countries from using TRIPS flexibilities, which forces IDA to purchase more expensive branded products. For example, El Salvador chose not to issue a compulsory license for political reasons.

Esgueira said that what has helped IDA deal with these obstacles is the use of TRIPS flexibilities; the MPP database and its voluntary license with Gilead; and WHO prequalification of medicines. His recommendation for overcoming the obstacles faced by IDA are:

Greater transparency of patent status and license terms in freely accessible public databases

Patent owner responsibility to disclose relevant information

More workshops on IP and the use of TRIPS flexibilities

Continued debate on redesigning the current research and development / IPR regime
More licensing to the MPP.

Gracia Violeta Ross Quiroga presented “Intellectual property-related challenges: a Latin American perspective.” Most countries in Latin America are categorized as middle income, so they are not a priority in global policymaking. There have been some countries that have done a great job in providing access to treatment, but the successes of some mask failures of others.

Concerns for treatment access in Latin America include:
High income inequality

Increased need for second and third line treatment due to first line treatment failure
High level of patenting of ARVs in the region

The patent situation is the worst in bigger countries with relatively high incomes that are considered to be potential markets for the branded firms. People living with HIV/AIDS often still lack the resources to buy medicines in countries where macroeconomic indicators rise.

ARVs are even patented in countries viewed as small markets (like Bolivia)
Many countries have already signed FTAs with TRIPS-Plus provision
Patents in India will also block access to antiretrovirals in Latin America that have Global Fund support

The Medicines Patent Pool is one mechanism (among others) that can help Latin America achieve universal access. However, it is a mechanism for bilateral licenses with pharmaceutical companies, and many company licensing policies do not include Latin American nations. It is important to address the terms of the licenses so that we can maximize the number of people who benefit.

Treatment advocates need to continue to work on intellectual property issues, as well as funding. Greater training on IPR and access to medicines is needed for people at the grassroots level.

Lihle Dlamini from the Treatment Action Campaign (TAC) presented “Mechanisms to address IP related challenges: the Experience of South Africa.”

TAC was born in December 1998 out of the need to supply antiretrovirals to people with HIV. At the time, a first line regime cost R75000 per patient per year (based on the average 1998 exchange rate, this is USD 13,656). Prices elsewhere had fallen, but South Africa couldn’t access the lower priced drugs due to patent issues. Early campaigns included mobilizing against a lawsuit by big pharma against a South African law that legalized parallel imports; the illegal importation of generic fluconazole from Thailand; and a 2003 competition law challenge against the prices of AZT and nevirapine.

TAC currently has a “Fix the Patent Law” campaign launched in 2007 to pressure the South African government to utilize all trips flexibilities. South Africa currently grants the highest number of pharmaceutical patents in comparison to other developing countries . These are often granted without proper examination. Researchers say that 80% of the patents issued in South Africa would not be granted if applications were examined. Therefore, the campaign is advocating for 1) stricter standards of patentability; 2) requiring proper patent examinations; and 3) establishing opposition procedures.

In 2012, TAC met with the Medicines Patent Pool to discuss disputes over the terms of the voluntary licenses reached with Gilead. Also discussed were concerns that the Pool was undermining efforts to achieve more fundamental changes to the global intellectual property regime through the greater use of TRIPS flexibilities.

Denis Broun from UNITAID discussed the issues that the organization considers when determining whether new generic firms can really enter the market and begin delivering medicines. The major problems faced by firms are access to raw materials (APIs); access to tech and know-how; the legal right to manufacture and get stuff on markets; and the ability to meet standards and to register their products.

Access to APIs. There are few firms that manufacture APIs, and generic firms can face patents or contract license issues. Companies with the exclusive APIs may end up using it to gain a competitive edge or to influence the market. For instance, nine years ago Abbotts’ price hike for ritonavir led to Kaletra dominating the market for ritonavir-boosted protease inhibitors.

Access to technology. The technology needed to manufacture medicines is protected by patents as well as by tacit knowledge. Licenses for the technology can come with a whole set of constraints related to its use. In some cases, you have situations where you could obtain a compulsory license, but lack the technology to bring the drug to the market.
Legal right to manufacture. Patents are still obstacles, and the patent landscape is changing. Many countries implemented TRIPS before they were required to do so, and it is among these countries that you find the most restrictive patent laws. Most new medicines now are patented in developing countries, and there are more patents per drug than there used to be. Patents are an even bigger problem for combination precuts, because the combination tends to be protected in more countries than the individual components. Other types of IP barriers to manufacture include data exclusivity and linkage.
Ability to meet standards and register. It is important that countries have fair and competent regulatory authorities. Many do not.

These types of obstacles are exacerbated by the trade agreements that are under negotiation. TRIPS flexibilities are important, and it is bad to undermine them.
Mariângela Simão from UNAIDS presented “Strategies for overcoming patent-related challenges in the generic industry: Different mechanisms to address intellectual property challenges.” She noted that treatment coverage has risen but we still have a long way to go, and that prices are still too high – especially for second line drugs. In some countries 25-30% of patients are already on second line. The vast majority of people with HIV/AIDS live in middle income countries, and the proportion is growing. However, many industry (and other) access policies are based on access for low income countries. A new approach is needed to ensure increased coverage for everyone, including those in upper-middle income countries.

There should also be no double standards regarding drugs prescribed in one region versus another. People in all regions benefit from drugs that are simpler to use and less toxic. Heat-stable drugs are good for patients no matter where they live.
UN agencies should continue to support countries on the use of TRIPS flexibilities and should continue to advise countries to avoid TRIPS-Plus measures in trade agreements.
Strategies for reducing costs of treatment include voluntary license mechanisms like the MPP, compulsory licenses, patent oppositions, and taking steps to avoid granting patents that shouldn’t be patented in the first place.

Chan Park of the Medicines Patent Pool presented “Addressing innovation and access though voluntary licensing: the MPP.” He noted that the patenting of antiretrovirals has increased in developing countries, and that newer drugs are more widely patented. This is true for first and second (and third) line drugs. There are also more follow-on patents. When you consider both the original and follow on patents on important medicines, patent expiry can be 10-15 years away.

The situation is more complicated when you get into fixed dose combinations (FDCs), where a patent on one component can block the whole product. The Patent Pool has found patent barriers on nine of eleven WHO-recommended FDCs, and all seven FDCs under development face patent barriers.

Mechanisms that can overcome patent barriers include taking full advantage of TRIPS flexibilities, as well as using voluntary licenses for generic production.
There are concerns that voluntary licenses are secret because only the basic features are disclosed. There are a wide range restrictions in the licenses that can negatively impact access. Licenses are often given to a few hand-picked manufacturers. There are no voluntary licenses on a number of products, and there are licenses with very restrictive terms on others.

The MPP currently has licenses with two patent holders and is in negotiations with four others. The core principles for MPP licenses are:

public health, pro-access perspective

reach as many people living with HIV as possible

terms and conditions should be consistent with TRIPS flexibilities

improve industry norms for voluntary licensing

manage licenses with a public health focus

work with partners to promote the development of needed formulations

The MPP aims to accelerate the availability of generic versions of new medicines, enable the development of FDCs, and enable the development of new formulations (i.e. – pediatric, heat-stable, etc.) It does sub-licensing work to ensure that the generic companies actually get drugs on the ground. It also provides a patent status database that includes data collected for 24 HIV compounds in 76 low and middle income countries.
Park listed the main achievements of the MPP:

Unprecedented publication of full text of licenses

Patent transparency on what HIV medicines are patented in which countries

Licenses from two patent holders and four more currently under negotiations

Higher standard on the number of countries covered by licenses (but there is still room for improvement)

Recognition of the importance of licensing medicines as early as possible (in pipeline)

Showing that voluntary licenses are TRIPS compliant

He listed the following as what still needs to be done:

obtain licenses from more patent holders

expand the number of countries benefiting from licenses

enable development of more FDCs and new formulations

enhance diversification of the manufacture of antiretrovirals