Access to medicines

 Affordable Medicines and Treatment Campaign

 “[L]ife in good health and free from disease is the foremost human right and is a constitutional fundamental. The humbler the Indian human, the higher the State’s duty to protect the person.”

—Mr. Justice V.R. Krishna Iyer, Former Judge, Supreme Court of India

 “My idea of a better ordered world is one in which medical discoveries would be free of patents and there would be no profiteering from life or death.”  

Mrs. Indira Gandhi, Prime Minister of India, World Health Assembly, 1981

 Can private actors be allowed to determine whether or not a person ought to live or die? For this, is precisely what patents, which allow the patent holder to exclude other competitors for a certain period and set monopolistic prices, do. By setting exorbitant prices on medicines, the patent holder basically tells a patient, “If you want to get well, be prepared to pay me the price I demand.” This was brought vividly to the fore in the late 1990s in Africa in the context of access to medicines to treat HIV.

Against a backdrop of the glaring inequity in access to lifesaving anti-HIV medicines and the impending change to the Indian patent lawwith respect to medicines, described below,the Lawyers Collective HIV/AIDS Unit, along with other Indian civil society actors, launched the Affordable Medicines and Treatment Campaign.

When HIV was first detected in the 1980s, there was no medicine available to treat HIV itself, no medicine that would halt or reverse HIV progression.  HIV progression rendered people living with HIV susceptible to opportunistic infections. These opportunistic infections could be treated. But, further HIV progression and the accompanying decline of the immune system, would render the medicines to treat opportunistic infections ineffective. HIV progression, absent any treatment, then meant inevitable certain death on account of opportunistic infections and other conditions. In the mid-1990s, it was discovered that certain antiretrovirals (ARVs), when taken in combination, could be used to treat HIV, to halt HIV progression and even reverse it. This transformed HIV from a death sentence to a manageable chronic condition.

But, this transformation came with a price tag attached. Pharmaceutical companies in the West, who manufactured these medicines, priced the medicines at over USD 10,000 per patient per year. This meant that the transformation could be realised primarily by persons living with HIV in the developed world, who were able to buy the medicines themselves or through insurance cover or government-sponsored social security schemes. For millions of persons living with HIV in the developing countries, HIV continued to remain a death sentence. Thousands of people lost their lives, despite treatment being available. This was brought home to the Lawyers Collective HIV/AIDS Unit when some of its clients died due to HIV-related complications without access to antiretrovirals. In a moving speech—the Jonathan Mann Memorial Lecture—delivered at the International AIDS Conference in Durban in 2000, Justice Edwin Cameron, a judge living with HIV, described himself as the “living embodiment of the inequity of drug availability and access in Africa” and said, “I am here because I can afford to pay for life itself.”

In 2001, Indian pharmaceutical companies were able to offer a fixed dosed combination of ARVs at a price of USD 350 and lower per patient per year as against a price of USD 10,000 per patient per year charged by multinational pharmaceutical companies.  The absence of product patent protection for medicines in India was what enabled Indian pharmaceutical companies to make generic versions of these medicines and fixed dose combinations thereof.  The availability of ARVs at low prices made it possible to upscale access to treatment for persons living with HIV in the developing world.

How were Indian companies able to offer the same medicines at such low prices—at a fraction of the cost charged by multinational pharmaceutical companies from the West? This was possible primarily due to the fact that India did not recognise product patent protection for medicines. Until 1972, India provided product and process patent protection for medicines. The consequent import dependence and exorbitant prices of medicines—amongst the highest in the world—led India to change its law. In the 1970s, India changed its patent law to exclude product patent protection for medicines in the Patents Act, 1970.  It did, however, continue to provide protection for process patents on medicines. The absence of product patents allowed generic competition, which led to low prices of medicines. Indian generic companies became, and remain today, the largest supplier of low-cost generic medicines throughout the developing world. With the conclusion of the Marrakesh Agreement establishing the World Trade Organization (WTO), of which India was a founding member, however, all this was set to change.

The Marrakesh Agreement included the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement). The TRIPS Agreement was pushed for by the developed countries at the behest of vested private interests of pharmaceutical companies. Developing countries, under the threat of sanctions, were constrained to consent to the inclusion of intellectual property in the trade agreement. Under the TRIPS Agreement, it would be mandatory for WTO-member countries to provide product and process patent protection for inventions in all fields of technology, including medicines. Yet, the TRIPS Agreement reflected a compromise between developed and developing countries. For instance, developing countries fought to ensure that it contained certain flexibilities that allow them to take measures to protect public health.

As a developing country which, in 1995, did not provide product patent protection for medicines and agrochemicals, India had until 2005 to change its patent law. Nonetheless, a change in India’s patent law to provide product patent protection for medicines was imminent.

Against this backdrop, Lawyers Collective HIV/AIDS Unit organised a national consultation with civil society actors in August 2001 in Mumbai. Subsequently, the Affordable Medicines and Treatment Campaign was launched on World AIDS Day that year—on 1 December 2001. The objective of the Campaign is to demand and create an environment that will ensure sustained accessibility and affordability of all medicines and treatment for every individual in India, including access to affordable medicines for people living with HIV.  The Campaign envisions a democratic and participatory involvement of civil society and key stakeholders in all the initiatives taken to ensure access to affordable medicines and treatment.

Post 2001, through the campaign, Lawyers Collective HIV/AIDS Unit started working on intellectual property issues affecting access to medicines.  It engaged in litigation to challenge the grant of exclusive marketing rights—a monopoly right that could be granted to pharmaceutical companies in the interregnum transition period allowing them to prevent others from marketing the medicine for which it had applied for a patent in India post-1995. This litigation marked the beginning of a case, now known as the Novartis case, which would influence subsequent legislative developments and which is also likely to set the way public health safeguards in India’s patent law will be interpreted.

Simultaneously, the Lawyers Collective HIV/AIDS Unit engaged in advocacy to challenge the lack of transparency and consultation with civil society stakeholders by the Government on the impending amendment. It underscored the likely adverse impact of the product patent regime on prices of medicines and also the importance of ensuring that the patent law contained public health safeguards.

Given that the impact of the impending change in India’s patent law would affect patients in other developing countries too, Lawyers Collective HIV/AIDS Unit also started engaging with treatment activists and civil society actors from the Global South. In March 2005, it organised the first Global South Dialogue on HIV/AIDS and Access to Medicines at Mumbai. The opening of this conference coincided with the tabling of the Patents Amendment Bill, 2005 in Parliament—a bill to make India’s law TRIPS-compliant by reintroducing product patents for medicines in India.

Extensive advocacy—both national and international—by civil society actors ultimately resulted in the retention and inclusion of key public health safeguards in the Patents Act, 1970, when Parliament finally amended by patent law in 2005 to make India’s patent law TRIPS-compliant. One such public health safeguard in the patent law is the establishment of stricter patentability criteria. In a bid to prevent evergreening—a practice of pharmaceutical companies to obtain multiple follow-on patents on the same medicine in a bid to extend their monopolistic period—Indian Parliament excluded patenting of new forms of already known substances unless there was a significant enhancement in efficacy [section 3(d), Patents Act, 1970]. Other public health safeguards include retention of pre-grant opposition proceedings, inclusion of post-grant opposition proceedings and amendment of provisions relating to compulsory licensing.

Presently, India is the primary source of generic medicines for patients in the developing world.  How the product patent regime on medicines affects this remains to be seen.

New threats continue to emerge. Developed countries are now attempting to push through their unfinished agenda at WTO through regional and bilateral trade and economic partnership agreements. These agreements generally push for greater levels of intellectual property protection and enforcement, which are beyond countries’ present obligations under the TRIPS Agreement and which are not compatible with the needs of developing countries.  There are also efforts to restrict the use of flexibilities available to countries under the TRIPS Agreement. Of particular concern to India are the multi-pronged efforts to dilute public health safeguards in the Indian patent law.

After the introduction of the product patent regime for medicines in India, Lawyers Collective HIV/AIDS Unit has been engaged in litigation to use the public health safeguards and also oppose attempts to introduce TRIPS-plus provisions in the Indian law. As a component of this, it provides free legal and technical aid to patients’ groups to file patent oppositions against key life-saving medicines. It also provides free legal aid to patients’ groups in other cases, where issues pertaining to intellectual property are likely to have an impact on availability of and accessibility to medicines.

The Lawyers Collective HIV/AIDS Unit also engages in research and advocacy on various issues pertaining to intellectual property rights and other issues that affect pricing, availability of and accessibility to medicines to counter any legislative or regulatory moves that would adversely affect access to medicines.

EU-India FTA Global Week of Action: Updates

India: Sign-on Letter to European Commission handed over

10 February 2012, New Delhi: As part of the Global Week of Action on the EU-India FTA, activists in India today intervened at a public lecture by Mr Van Rompuy, the European Council President, and handed over the sign-on letter to the European Commission signed by several international and national civil society organisations and individuals. The letter highlights the deleterious impact of EU-India FTA on access to medicines and calls upon the European Commission to demonstrate that its commitments to human rights are not mere protestations. The public lecture on ‘The European Union in a Changing World’ was jointly organised by India International Centre and the Delegation of the European Union to India. During the Q and A session, Anandi Yuvaraj, from the International Community of Women living with HIV/AIDS – Asia Pacific (ICW Asia-Pacific), made an intervention and handed over the letter to the European Council President. You can read a detailed description of the intervention and Anandi’s statement here.

Updates from other countries

Several letters were also sent to the Government of India and the European Commission as part of the Global Week of Action. Some of these letters are available below.

Argentina

Chile

Guatemala

  • Letter dated 8 February 2012 from AMUGEN to Indian ambassador
  • Letter dated 8 February 2012 from ITPC-LATCA to Indian ambassador

GLOBAL WEEK OF ACTION: EU-INDIA FTA

6-10 February 2012

In 2001, India’s generics brought prices down from $15000 per person per year to $350 for first line AIDS medicines.

80% of people living with HIV in developing countries are on Indian generic ARVs

Over 90% of pediatric AIDS medicines are supplied by Indian generics.

BUT ALL THIS COULD CHANGE IF INDIA DOES NOT SAY NO TO IP IN THE EU-INDIA FTA

This January, another round of negotiations on intellectual property was held between Indian and EU negotiators as part of the EU-India Free Trade Agreement (FTA) talks. News reports in India quote the EU Ambassador as stating that discussions on Pharmaceuticals have progressed significantly.

On the 10th of February 2012, at the EU-India Summit to be held in Delhi, the EU & India will agree on and finalize the political framework for the FTA. Groups in India are worried – how have the IP negotiations progressed?

Are the EC and India progressing towards an agreement with includes provisions that will seriously hamper India’s ability to manufacture safe, effective and affordable generic medicines and export these to other developing countries?

WHY THE CALL FOR ACTION?

6th – 10th FEBRUARY 2012!!

Since 2007, people living with HIV in India and across the world have been resisting the pressure of the EC on India to sign an FTA with provisions on intellectual property that will endanger access to generic medicines from India. We must once more show the EC and the Indian government that our lives cannot be traded away!

This is a Call for a week of Action across the globe from 6th – 10th February 2012 on the EU-INDIA FTA.

The week of action is a run up to the EU-India Summit that will be held in Delhi on 10th February 2012.

OUR DEMANDS

REMOVE:

  • Investment Rules, as they enable foreign companies to take the Indian government to private courts over domestic health policies like measures to reduce prices of medicines.
  • Border Measures, as they will deny medicines to patients in other developing countries with custom officials seizing generic medicines in transit.
  • Injunctions, as they undermine the independence of the Indian judiciary to protect right to health of patients over the profits of drug companies.
  • Other Intellectual Property Enforcement Measures, as they put third parties like treatment providers at risk of police actions and court cases.

DON’T BRING BACK:

  • Data Exclusivity, as it delays the registration of generic medicines and will not permit the placing of affordable versions of pediatric doses and combinations of “off-patent” medicines on the market. IT’S NOT REQUIRED UNDER THE TRIPS AGREEMENT!
  • Patent Term Extension, as it will extend patent life beyond 20 years.

The EC states that these two provisions are off the table. It must keep its word!

PLEASE JOIN US -YOUR COMRADES- IN INDIA!

In the coming days, groups from around the world and in India will demonstrate against the EU-India FTA. We ask you to join us in sending a clear message to the European Commission: our lives cannot be traded away.

1. Organise your own rally: You can organize rallies or demonstrations in front of European Commission offices in your countries to voice your opposition to their aggressive negotiations on intellectual property in FTAs. Don’t forget that the EU is also negotiating FTAs with many other developing countries and making the same demands.

2. Raise awareness/media action: Even though you might not be able to support our rally financially or physically you can help us by spreading the word about our concerns. Write an editorial in your local paper. Hold a press conference. Issue a press release or press statement.

3. Write to the Indian Government: You can also write to the Indian Government asking it to stay strong and not give in to the demands of the European Commission. India, as the pharmacy of the developing world, has an obligation to its citizens as well as patients across the world. Please try and meet the Indian ambassadors in your countries and convey to them how important it is that India reject ALL the demands of the EU. Millions of lives depend on this.

4. Write to your own government: Public health programmes around the world depend on generic medicines from India. Ask your government to tell the EU and the Indian government to keep IP out of the FTA negotiations.

5. Share your actions: PLEASE send us photos, articles, videos of all your actions immediately and FOLLOW the actions of other groups here: http://www.facebook.com/pages/Stop-the-EU-India-Free-Trade-Agreement/144687138908841 and here http://donttradeourlivesaway.wordpress.com/

6. Donate: In order to organize these protests, we rely on funding. Any financial support is welcome. No amount is too small – or too big! If you know organizations, which are interested in funding, if you want donate to our protest, please contact us.

We plan to meet the aggressiveness of the European Commission with our peaceful protests. There is too much at stake. Join us NOW!

In Solidarity

Delhi Network of Positive People & Lawyers Collective HIV/AIDS Unit

++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

SUPPORT US IN OUR ACTION AGAINST THE EU-INDIA FTA

4 February 2012, New Delhi.

India and the European Union (EU) are gearing up for the EU-India summit scheduled to be held in New Delhi on 9–10 February 2012. The two sides are expected to make some major announcements about the framework of the free trade agreement (FTA) they are presently negotiating and which they hope to conclude by the end of 2012.

Civil society groups in India and across the world are concerned about how the FTA between EU and India would affect access to medicines. Concerned about the developments, civil society groups in India have called for a Global Week of Action 2012.

You can support us by (1) sending a letter to the Prime Minister of India AND (2) by signing onto a global sign-on letter to the European Commission.

1. Write to the Government of India

Your voices must be heard by the Government of India. In the past, your letters have made a difference. A template letter to the Prime Minister of India, which you may use, can be downloaded HERE.

For those of you who are in India, you can directly send the letter via fax or email to the Prime Minister’s Office.

2. Sign-on to the letter to the European Commission

You can also support us by signing on to the letter to the European Commission, which can be viewed HERE.

To sign on, email us at ramya.sheshadri@lawyerscollective.org and aidslaw@lawyerscollective.org

Deadline: 8 February 2012

Novartis AG v. Union of India and Others, SLP (Civil) Nos. 20539–20549 of 2009

In this case, which is presently before the Supreme Court of India, Novartis AG (Novartis) challenges the order of the Intellectual Property Appellate Board (IPAB) rejecting its patent application for Gleevec (beta crystalline form of imatinib mesylate), an anti-cancer drug used to treat chronic myeloid leukemia.

The outcome of this case will affect not only the patenting of this particular anti-cancer drug, but will also determine the position in India on patenting of new forms of already known substances. Novartis has challenged the IPAB’s interpretation of section 3(d) of India’s patent law and its application to Novartis’ patent application for the beta-crystalline form of an already known substance, imatinib mesylate.

Section 3(d) of the Indian Patents Act, 1970 is the public health safeguard in the Indian patent law that, amongst others, disallows patenting of new forms of known substances, unless the new form exhibits a significant enhancement in efficacy. It is one of the safeguards introduced by Parliament of India in 2005 to prevent evergreening. Evergreening is the practice of pharmaceutical companies to obtain patents on frivolous or minor changes to known drugs and thereby establish or extend their monopoly over a drug.

Background Note

In 1997, Novartis AG, a pharmaceutical company based in Switzerland, filed a patent application in the Chennai (Madras) Patent Controller’s office for the beta-crystalline of imatinib mesylate, brand name Gleevec (Glivec) claiming that it invented the beta-crystalline form of imatinib mesylate, a salt of the free base, imatinib.

Novartis’ patent application was kept in the mail-box and not examined until 2005 as the TRIPS Agreement permitted developing countries such as India that did not provide product patent protection to pharmaceuticals and agrochemicals to introduce such product patent protection from 1 January 2005.

In the meantime, Novartis obtained Exclusive Marketing Rights (EMR) for marketing Gleevec in India. On the basis of this, it obtained orders from the Madras High Court preventing some of the Indian generic manufacturers from manufacturing and selling generic versions of the medicine. At that time, Novartis was selling Gleevec in India at USD 2666 per patient per month. Generic companies were selling their generic versions in India at USD 177 to 266 per patient per month.

In 2005, India amended its patent law to comply with its obligations under the TRIPS Agreement to provide process and product patent protection in all fields of technology, including pharmaceuticals and agrochemicals. Cognisant of patenting practices, Parliament introduced a significant and important provision to prevent evergreening— section 3(d).

After the 2005 amendment to the patent law, Cancer Patients Aid Association (CPAA) and several generic companies filed pre-grant oppositions against Novartis’ patent application for imatinib mesylate, claiming, among other things, that Novartis’ alleged “invention” lacked novelty, was obvious to a person skilled in the art, and that it was merely a “new form” of a “known substance” that did not enhance the substance’s efficacy, and was thus not patentable under section 3(d). These arguments were based on the fact that Novartis had already been granted a patent in 1993 in the United States and other jurisdictions for the active molecule, imatinib, and that the present application only concerned a specific crystalline form of the salt form of that compound.

CPAA and the generic companies contended that the 1993 patent effectively disclosed both the free base, imatinib, and the acid-addition salt, imatinib mesylate. Further, CPAA and generic companies argued that different crystalline forms of imatinib mesylate did not differ in properties with respect to efficacy, and thus the various forms of imatinib mesylate must be considered the “same substance” under section 3(d).

[Downloads: Novartis’ Patent SpecificationCPAA’s pre-grant oppositionNovartis’ reply statement and CPAA’s rejoinder.]

Novartis’ patent application rejected by Patent Controller [January 2006]

In January 2006, the Patent Controller in Chennai, in a series of landmark orders, refused to grant Novartis a patent, agreeing, amongst others, with the contentions of the CPAA and generic companies that the subject of the application lacked novelty, was obvious, and was not patentable under section 3(d).

[Downloads: Order of the Patent Controller in the oppositions filed by CPAACipla LtdHetero Drugs LtdNatco Pharma Ltd and Ranbaxy Laboratories Ltd]

The patent rejection meant that generic companies could manufacture and market their generic versions of the drug, both in India and abroad, and make available the generic imatinib mesylate priced at less than one-tenth of Novartis’ price.

In June 2006, Novartis AG and its Indian subsidiary, Novartis India, filed a series of writ petitions against the Government of India, CPAA, and four Indian generic manufacturers (Natco, Cipla, Hetero, and Ranbaxy), before the Madras High Court. These writ petitions challenged the decision of the Patent Controller to refuse to grant Novartis a patent for the beta-crystalline form of its anticancer drug, imatinib mesylate, as well as the validity of section 3(d) that provided one of several grounds for rejecting its patent application.

[Downloads: Writ Petition Nos. 24759 of 2006 and 24760 of 2006 were filed by Novartis AG and Novartis India respectively challenging the validity of section 3(d). Writ Petition No. 24754 of 2006 was filed by Novartis AG against CPAA and Union of India, challenging the decision of the Patent Controller on merits in CPAA’s pre-grant opposition. Writ Petition Nos. 24755 of 2006 to 24758 of 2006 were filed by Novartis AG challenging the decisions of the Patent Controller in the other pre-grant oppositions.]

Over a period of time, the writ petitions challenging the decision of the Patent Controller were converted into statutory appeals. In April 2007, the Government of India notified the IPAB as the body to hear appeals relating to patents. Consequently, Novartis’ appeals were transferred to the IPAB, a specialist tribunal on matters relating to intellectual property.

Constitutional validity of section 3(d) upheld by Madras High Court [August 2007]

Meanwhile, in August 2007, the Madras High Court issued its judgment rejecting Novartis’ writ petitions challenging the validity of section 3(d). The Madras High Court refused to examine whether section 3(d) was in compliance with the TRIPS Agreement.

Novartis’ primary contention in its challenge to the constitutional validity of section 3(d) was that the use of the term “efficacy” in section 3(d) is vague and ambiguous, and therefore violates the equality provision (Article 14) of the Constitution of India.

During the arguments, while conceding that the meaning of the term “efficacy” is known, Novartis contended that because there was no clarity as to what constituted “enhancement of efficacy” and “significant enhancement of efficacy” as required by section 3(d), the law was vague and lent itself to arbitrary decisions by the Patent Controller. The Government of India, CPAA and generic companies argued that section 3(d) is not in violation of the equality provision of the Constitution of India as the concept of efficacy is well-known to persons in the pharmaceutical industry and it is impossible to lay down a “one size fits all” standard to determine what constitutes a significant enhancement of efficacy. Dismissing the petition, the Madras High Court held that section 3(d) was not vague or arbitrary and therefore did not violate the Indian Constitution. It held that the term “efficacy” was known in the pharmaceutical field to mean “therapeutic efficacy”.

While dismissing Novartis’ writ petitions, the Madras High Court held: “We have borne in mind the object which the Amending Act wanted to achieve namely, to prevent evergreening; to provide easy access to the citizens of this country to life saving drugs and to discharge their Constitutional obligation of providing good health care to it’s citizens.”

Neither Novartis AG nor Novartis India challenged the judgment of the Madras High Court upholding the constitutional validity of section 3(d).

Appeal on merits rejected on the ground of section 3(d) alone [June 2009]

The next round of litigation then commenced before the IPAB

After a series of litigation in which Novartis contested the constitution of the IPAB, Novartis’ appeals challenging the Patent Controller’s orders were finally heard by a specially constituted Bench of the IPAB, comprising Justice Negi (Chairperson) and Dr PC Chakraborty (Technical Member) in November and December 2008.

In its order issued in June 2009, the IPAB overturned the Patent Controller’s findings on novelty and inventive step and held that the beta-crystalline form of imatinib mesylate was new and involved an inventive step.

However, the IPAB held that Novartis’ alleged invention did not satisfy the test of section 3(d) in as much as Novartis did not provide data to show that the beta-crystalline form of imatinib mesylate exhibited significantly enhanced therapeutic efficacy over imatinib mesylate, the known substance.

Primarily on the basis of this finding, the IPAB rejected Novartis’ appeal and refused to grant it a patent for the beta-crystalline form of imatinib mesylate.

Proceedings before the Supreme Court

Challenging the IPAB’s order, Novartis approached the Supreme Court directly by filing a special leave petition challenging the IPAB’s interpretation and application of section 3(d) to its patent application. Subsequently, Natco Pharma and CPAA filed cross-petitionschallenging the IPAB’s findings on other issues including novelty and inventive step.

Hearing Updates

Due to the keen interest, both domestically and internationally on this case, Lawyers Collective HIV/AIDS Unit, representing CPAA in these matters, will provide daily updates on the progress of the case. The reports will be factual updates and will not contain any comments as it is impermissible under the Indian law relating to contempt of court.