Analysis: India’s Supreme Court Upholds Strict Patent Standards and Patients’ Right to Access to Affordable Medicines

Court dismisses unmeritorious court challenge by drug giant Novartis

By Professor Brook Baker, Health GAP

April 1, 2013.  In a stunning victory for poor patients throughout the developing world, the Indian Supreme Court today ruled against a Novartis challenge of a denial of a patent on its cancer medicine Glivec.  The Court upheld strict standards in the India Patents Act thereby limiting pharmaceutical monopolies and speeding access to more affordable generic medicines.  The Indian generic industry, the pharmacy of poor in the Global South that supplies over 80% of AIDS medicines for the 8 million people in low- and middle-income countries, will not have to delay introduction of medicines year after year as Big Pharma evergreens its patent monopolies by seeking new 20 year patents on minor variations to existing medicines.

Novartis, the Swiss pharmaceutical giant that challenged section 3(d) of the Indian Patents Act, had one goal in mind – to expand its pharmaceutical empire and price impunity in India and the countries that imports Indian generic medicines.  Novartis said that it was appealing an adverse decision on the patentability of Glivec as a matter of principle – and that principle was to maximize profits and to pave the way for a flood of easy-to-get patents on medicines.  Novartis tried every legal trick in the book.  It first challenged the constitutionality of India’s strict prohibitions against unwarranted patents and its compliance with the WTO TRIPS Agreement that establishes baseline global standards for intellectual property protections.  That case was thrown out by the Madras High Court in 2007.  For five additional years, Novartis pursued a second challenge in appeals at the Indian Patents Office and in the courts of India asking that the challenged provision be reinterpreted to allow successive patents on minor tweaks to existing medicines.

But the Supreme Court of India held firm, ruling that the Indian Patents Act was clear on its face and in its intentions.  Indian parliamentarians wanted to allow new patents only in special circumstances where a revised medicine offered significant enhancements to the treatment or prevention of human illness but not for routine changes such as those that extend shelf life, improve solubility, extend or shorten uptake in the body, or the like.  Taking cognizance of India’s duty to protect the health and wellbeing of its citizens and recognizing the pivotal role India plays in supplying other countries as well, the India Supreme Court found the Novartis challenge not only unmeritorious, but bordering on frivolous.[1]  Specifically, the Court held that Novartis’ application satisfied neither the requirements defining inventions (with respect to inventive step) nor the requirements of section 3(d) of the Act.

This ruling is important not just because it augers well for the continued enforcement of strict standards of patentability in India, but also because it shows that courts can and should stand up to attempts to extend transnational corporate power and monopolies on medicines.  It is a cottage industry for Big Pharma drug companies to sue developing countries to try to change legal rules that thwart their quest for profits.  There are several such cases still pending in India, including a Bayer case challenging the issuance of a compulsory license on a cancer medicine and a Pfizer case challenging the denial of one of its patent applications.  The Novartis ruling is also important because several countries have followed India’s lead and adopted comparable strict patenting standards as a key flexibility under international law.

Novartis, in response to the adverse ruling, has threatened to take its marbles and go home.  Paul Herrling, Novartis’ former head of research and development, is on record saying that Novartis may no longer bring its new medicines to the market in India.[2]  This is a hollow threat.  Big Pharma continues to file patents on all of its truly new medicines in India because Indian law allows such patents and there’s plenty of money to be made off of India’s growing middle class.  As proof, hundreds of patents on medicine have been granted in India since its patent law was revised to become compliant with international standards in 2005.  What Novartis and other companies can’t do, is file for new patents on revised version of older medicines, which comprise 90-plus percent of Pharma filings globally.

Although India, its generic industry, and patients around the world have won a key victory in the fight for affordable access to life-saving medicines, Big Pharma and its supporter in US and EU trade offices will not stop pressuring and threatening India and other countries to allow longer, stronger, and broader patent and data monopolies on medicines.  Indian policy makers, health advocates, and courts must continue to remain vigilant in trade negotiations and elsewhere to resist intellectual property proposals that encroach on fulfillment of the right to health. 

[1] The text of the Supreme Court’s decision is available at http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212.

[2] Paragraph 194:  “[T]he case of the appellant appears in rather poor light and the claim for patent for beta crystalline form of Imatinib Mesylate would only appear as an attempt to obtain patent for Imatinib Mesylate, which would otherwise not be permissible in this country.”

[3] Novartis warns India over drug patent, Financial Times (March 31, 2013), available at http://www.ft.com/intl/cms/s/0/c377e20a-99eb-11e2-83ca-00144feabdc0.html#axzz2PCguK9ie    the case of the appellant appears in rather poor light and the claim for patent for beta crystalline form of Imatinib Mesylate would only appear as an attempt to obtain patent for Imatinib Mesylate, which would otherwise not be permissible in this country.


Kenyan People Living with HIV/AIDS Get to Prime Minister Raila Odinga

Kenya.jpeg12 brave Kenyan AIDS activists, organized by Maureen Milanga as AIDS Law Project/Health GAP Fellow, and Jacque Wambui as a Health GAP / AVAC Fellow, birddogged Prime Minister Raila Odinga with help from HG Director of Global Campaigns, Paul Davis, at the final rally of the CORD Coaltion. The AIDS activists got the Prime Minister, the Vice President and the Minister of Medical Services each one-on-one for several minutes early during the rally and he committed to providing free Anti-Retroviral Treatment for all people living with HIV and 15% of the national budget toward health!

Activists then got front-and-center at the huge rally in Nyayo Stadium in front of 100,000 supporters and held up signs demanding free AIDS drugs for all. He took a look at them and quickly spoke in support of our demands. PLHIV in Kenya thank the Prime Minister for hearing them and agreeing to their demands.


AIDS Doesn't Take Spring Break and Neither Can Its Funding

Student AIDS Activists Expose Themselves, Hold Spring Break Party in Senator Reid’s Office

Nearly Naked Student AIDS activists took over Senate Majority leader Harry Reid’s office to protest funding cuts to global AIDS programs on Thursday, March 21, 2013. The students from schools including City College New York, Columbia, Harvard, Iowa State and Yale are members of the Student Global AIDS Campaign skipped the trip to Cancun in order to spend their Spring Break demanding full funding to fight AIDS, including the passage of a Robin Hood Tax, a tiny tax on big banks that could raise $350 billion each year.

Three female students wore bikinis and painted slogans on their bodies instead of holding signs. Six others joined them clad in beach attire, with slogans painted on their tank tops: “AIDS Cuts Kill”, and “Fund PEPFAR, Fund Global Fund, Robin Hood Tax to end AIDS.” The students completed their beach party with a rendition of the hit song “Call Me, Maybe”, entitled “Fund AIDS, Harry”. These protestors were nearly naked, following in the footsteps of naked AIDS protestors who took over Speaker Boehner's office in November. 

The stunned staff did appear to hum along to the catchy tune.

The beach party, which included a beach ball and frisbee, occurred days before the spring congressional recess begins.  “We came here today to remind Senator Reid of the importance of funding lifesaving global health and AIDS programs. As Senate Majority Leader, Mr. Reid has a responsibility to ensure that the United States meets it’s commitment to ensure the end to AIDS that has been outlined by former Secretary of State Hilary Clinton and President Obama,” said Lily Ostrer from Harvard University.

In May of 2011, the U.S. funded study, HPTN 052 proved that HIV treatment works as prevention, and that the world could see the end of the AIDS pandemic if a small number of people were put on treatment around the world. 

“We have a small window of time to get ahead of the pandemic.  If we invest enough money into treatment and prevention during this window, we will see the end of the AIDS pandemic in less than 30 years. The United States Senate and Congressional leaders need to remember this when deciding on budget priorities during both the current Continuing Resolution for FY13, and for the FY14 budget process,” said Iowa State Student, Deepak Premkumar. 

"The excuse that there's no money to end the AIDS pandemic is a lie," said Bryan Edwards of City College NY.  "If Congress passes a Robin Hood Tax we would have enough money to end AIDS, with lots left over to stop student debt, fight climate change, and provide jobs."

‘The students are campaigning in support of a Robin Hood Tax rate of .5% with a commitment to have that money used to save lives at home and abroad, provide jobs, strengthen education and fight global climate change.

There are currently 34 million people living with HIV/AIDS across the world, and only around 8 million of them are receiving treatment. The disease has already claimed over 30 million lives. The sequestration cuts recently passed signed a death sentence for 37,000 people living with AIDS in this year alone.

The Naked AIDS activists who took over Congressmember Boehner’s office in Novemeber are expected plead guilty to a misdemeanor and have been complying with their order to stay away from the Longworth Office building. As the weather warms up, and Congress continues budget cuts instead of increasing revenue with a Robin Hood Tax, expect more and more AIDS activists to shed their clothes.

Spring_Break.jpeg


Health GAP Applauds New Pediatric Drug Deal with Patent Pool, and Condemns GlaxoSmithKline’s Threats to Obstruct Access to Critical New HIV Medicine

Activists from Health GAP (Global Access Project) welcomed a new voluntary license agreement on pediatric formulations of the antiretroviral medicine abacavir (ABC). The group welcomed improvements of the license between the drug company ViiV (a venture between Pfizer, GlaxoSmithKline and Shiongoni) and the Medicines Patent Pool (MPP) compared with a deal previously negotiated between MPP and Gilead, which contained more onerous restrictions. The terms and conditions of the new agreement will extend unfettered generic competition to more than 99% of children with HIV in low- and middle-income countries--an improvement in geographic coverage over Gilead medicines for adults. The license also comes without harmful restrictions on the physical location of manufacturers, sourcing of active pharmaceutical ingredients (APIs), use of compulsory licenses, or data exclusivity. The agreement directly covers 118 countries with 98.7% of the developing world's children with HIV. In addition, explicit provisions in the agreement allow sale in additional countries where there are no policy blocks in place to extend generic coverage to 99.4% of the pediatric epidemic. Health GAP asserts that, unless similar provisions are agreed by ViiV’s shareholders in upcoming license agreements, these improvements will appear to be merely a calculated public relations move, given the shrinking pediatric HIV market.

MPP is still in negotiations with ViiV on dolutegravir (DTG)--an even more important medicine that is part of entirely new class of anti-AIDS drug called integrase inhibitors. In spite of the step forward on ABC, drug giant and 76.5% majority ViiV shareholder, GlaxoSmithKline currently limits ViiV’s adult voluntary licenses to only 69 least developed, low-income, and sub-Saharan African countries.

"The agreement on pediatric ABC is a significant step up over previous MPP licenses, but the children's antiretroviral market is small and fragmented. A license on the small children's ARV market with low commercial value cannot be used by ViiV or GSK as PR cover for restrictive licensing on critical newer drugs for adults like dolutegravir," said Health GAP's Senior Policy Analyst Brook Baker, a professor of law at Northeastern University. "Glaxo must back away from its current geographical limitations on adult ARV voluntary licenses, or they will expose the new ViiV license as a public relations gesture that is good for children but deadly for their parents."

Health GAP strongly cautioned against any deadly limitations on access to DTG. "Glaxo is threatening to profoundly restrict adult access to critically needed newer medications," said Health GAP's Nairobi-based Paul Davis. "This improved voluntary license on abacavir must be the floor for GSK, not the ceiling. We need integrase inhibitors here and everywhere in the developing world, and GSK must cease its efforts to gouge monopoly profits out of people with AIDS."

"The improvements in the pediatric ABC license over the Gilead license show that we can improve over the flaws of previous licenses ," said Asia Russell from Health GAP in Kampala. "We call on the Patent Pool, ViiV and GSK to replicate and expand the terms and conditions of the pediatric ABC license for adult and pediatric dolutegravir."


Keep the Clothes on Our Backs...

As you know, the sequester, those automatic across-the-board budget cuts that will kill 36,000 people living with AIDS this year who would have otherwise survived, have taken effect because Speaker Boehner and Congress decided to protect Wall Street and the wealthiest 1% instead of poor and people living with HIV/AIDS.  This will have a devastating direct effect on the global AIDS pandemic.

To stand up against these draconian cuts, members of Health GAP, Queerocracy, ACT UP NY and ACT UP Philly stripped naked in the House Speaker Boehner’s office in the Longworth Building in Washington D.C. on November 27th,  2012, in an act of civil disobedience. Our goal was to expose the “naked truth” about what sequestration cuts will mean to AIDS programs.  We must remember that this demonstration was not primarily about nudity, but was intended to be a smart tactic that would bring media attention to these deadly cuts. 

We have been told that all seven of us will be found guilty of a misdemeanor. We will have to continue to make trips to DC from NYC, Providence, Tampa and Philadelphia to attend court and potentially perform community service. Our fines will be several hundred dollars each.  

We are asking you to do 2 things:

1. Call Senator Mikulski, 202-224-4654 and demand that she restore cuts to programs that will end AIDS in the FY13 and 14 budget processes. Call him at (202) 224‐3542

2. Please donate here to help with the legal fees of the Naked seven.



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