After India, Australia too eyes tighter drug patent standards #Novartis judgement Impact


Rema Nagarajan, TNN | Apr 11, 2013, 05.31 AM IST

NEW DELHI: India is not alone in raising the bar for granting patents on pharmaceutical products. Australia, having reviewed pharma patents, has questioned the benefit of allowing patent extension beyond 20 years and is looking to tighten patent standards which have been found to be “less than rigorous” in the past. The draft report of Australia’s pharmaceutical patents review released recently also raised doubts about Australia necessarily getting more R&D investments from giving patent extensions.

While Novartis and the Big Pharma have threatened that they would not make R&D investment in India because of inadequate patent protection, the Australian review panel says: “It is difficult to see why a pharmaceutical firm would choose to conduct R&D in Australia, merely because the government decided to offer an extension of (patent) term here.” The panel report noted that it was fundamental issues such as relative costs of R&D and skill availability which influenced the location of R&D spending.

The report recommended that the current model of using the patents system to subsidise pharmaceutical R&D indirectly through patent extensions should be replaced with a direct subsidy. It observed that direct subsidy also had an additional benefit because it could be directed towards investment in pharmaceuticals which were not well addressed by the patent scheme, such as too little research for newer antibiotics, pharmaceuticals to address rare diseases, paediatric illnesses and endemic health issues in low income countries.

The patent review panel pointed out how the life of patent protection in Australia has been extended beyond even the 20 years mandated by the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property RightsTRIPS) because of a separate free trade agreement (FTA) that Australia signed with the US.

According to the review report, this FTA was signed “without careful regard to whether this was in our own economic interest” .

 

 

Novartis and Health – An analysis


 

Rajeev Dhavan on April 11, 2013 – 1

 

The Novartis judgment has started a huge war of words. The patent drug producers are livid. They declare: “Woe is us. This is the end of invention.”  The generic drug makers say: “Well done Supreme Court.  Now we can supply life saving drugs to India and the world at cheaper prices.”

First let us understand the judgment for what it is. The drug in question is Gleevec which is used by cancer patients. The foundation for it is Imatinib Mesylate (IM) free base which was an important discovery and undoubtedly a new invention attributed to Dr. Zimmerman. IM was converted into a salt in the crystalline form known as IM Alfa which was then improved into the IM Beta crystalline form. This Beta form was claimed to be an invention because it had better flow properties, thermo stability and lower hygroscopicity – in other words it was more stable and digestible.

Was the Beta form an invention? This was not just a technical question for the chemist. It had mighty implications in terms of ground realities in two significant ways. The life of the original Zimmerman patent would be extended by 20 years. If another “improvement” was accepted as a patentable invention, it would be extended for another 20 years. In patent law and practice, this phenomenon is known as “evergreening.” The second ground reality was that a patent is a “monopoly.” There are two kinds of patent monopolies: a process patent which protects how the patent is made; and a product patent which protects the product itself. A process patent is a low level protection. If a drug has a process patent, this means that anyone can make that drug by some other process. This was India’s solution in the original Patent Act, 1970. But a product patent is a master monopoly which, with “evergreening”, means that only that corporates or their licensees can make that product to the exclusion of all others.  This also means that the owner of the product can impose any price it wants. Ofcourse, countries can impose a compulsory license if there is scarcity, but that option comes with too many restrictions. This was the Euro-American solution devised by the TRIPS (Trade Related Intellectual Property Rights) treaty in the new WTO (World Trade Organization).

The Supreme Court took the view that Gleevec did not have novelty – in that IM was in the public domain of knowledge in a Cancer Research article and other publications. Nor could it be said that there was an inventive step because a person skilled in the task with what was known would be able to discover the IM in the crystalline form with the properties claimed for Gleevec. The narrow decision in the case concerns whether the product Gleevec could be given a product patent for the improvements. The answer was unequivocal. Novartis could not get a product patent but was entitled to a process patent to protect how it was made. Effectively, the ‘evergreening’ of Gleevec was stopped.

But, the court went further beyond the confines of the Euro-American patent law model which India accepted when it capitulated to accept TRIPS in the WTO negotiations. How TRIPS ordained patent monopolies as free trade is baffling. But, there was a loophole. TRIPS left it to the each country to “determine the appropriate method of implementing the provisions of this agreement within their own legal system and practice”. (Article 1). TRIPS also envisaged each country to innovate in a manner conducive to social and economic welfare and to balance of rights and obligations (Article 7) and “adopt measures to protect public health and promote social economic development”. (Article 8). A worried Indian Parliament decided that patents would have to meet one further test of patentability. In the area of medicine and chemicals, it was indicated that any change must be significantly efficacious. (Section 3(d) Indian Patent Act). The significance of the Novartis judgment lies in its interpretation of this section. It posed a more stringent test beyond novelty and inventiveness by requiring significant improvement in efficacy. It was not enough that the drug was more stable and easier to administer and absorb. A significant step requires a therapeutic efficacy which is curative. If this interpretation had not been forthcoming, every little change would have fortified an “evergreening”.

The argument that research will suffer is simply wrong. Scientists rely on the past research of others. There are actually few ‘eureka’ moments in technical research. But patent holding companies want to increase these ‘’eureka’ moments, exacting a heavy price for their products. Research shows that the wide spectrum research cost is recovered in less than five years. There is an invisible government subsidy because research costs are tax deductible. Innovation will continue. In fact, the competition for innovation will become more intense as “patent” companies do not seek evregreening monopolies for small changes but only significant curative ones. Meanwhile competitive sales between companies will make medicine more affordable.

India’s parliament has shown the way by adding the criteria of significant change of curative dimensions. The Supreme Court has interpreted this addition valiantly and creatively. The world was waiting for decision like this. With evergreening de-monopolized, Cipla and others can now provide life saving drugs to Indians and others all over the world at much lower prices.

 

Rajeev Dhavan is a Senior Advocate of the Supreme Court.

 

 

Asian countries act to get cheap drugs #rightohealth


SouthViews

No. 37, 22 October 2012
SOUTHVIEWS is a service of the South Centre to provide opinions and analysis of topical issues from a South perspective.
Visit the South Centre’s website: www.southcentre.org.

Staring with Malaysia in 2003, many Asian countries are now taking actions to promote cheaper medicines through compulsory licensing, with Indonesia being the latest case
………………………………………………………………

By Martin Khor

By Martin Khor
Recent government actions by Indonesia and India to issue compulsory licenses are extending the trend in Asia to increase access to cheaper medicines to treat serious ailments, especially HIV/AIDS, cancer and hepatitis B.

The supply of generic medicines, either through import or local production, has been the major method of reducing prices and making the drugs affordable to more people.

When the required medicines are patented, which usually results in high prices,   governments are allowed by the WTO rules to issue a compulsory license to enable themselves or private companies to import or produce generic versions, which usually cost much less.

In 2003, Malaysia became the first developing country to issue a compulsory license to a local firm to import drugs to treat HIV-AIDS from India.  The cheaper generic drugs enabled the government to treat many more patients within the same budget.

Following this, Indonesia in 2004 issued a Presidential decree enabling the production of a some HIV-AIDS drugs while Thailand in 2007 issued compulsory licenses for several HIV-AIDS and cancer drugs.

In March this year, India approved its first compulsory license enabling a local company to produce a generic version of an anti-cancer drug, which could reduce the price of treating kidney and liver cancer from US$5,200 a month (the price of the branded product) to $160 a month (the price of the generic product).

The latest measure was taken on 3 September by Indonesian President Dr. Susilo Bambang Yudhoyono who issued a decree which has the effect of a compulsory license.  It enables local manufacturers to make, import and sell generic versions of seven patented drugs used for treating HIV-AIDS and hepatitis B.

The decree said that in line with the urgent need to control HIV/AIDS and Hepatitis B in Indonesia, “it is necessary to continue and expand the access policies to provide access to antiviral and anti-retroviral medicines still protected by patent.”

This is the third time Indonesia has issued a set of compulsory licenses. The latest decree stated that the 2004 and 2007 decrees were no longer sufficient to implement the policies.

The compulsory license is aimed at significantly reducing the prices of these life-saving medicines and making them accessible to thousands more Indonesian patients.

“We will ensure the availability of good-quality, safe and effective generic versions of anti-retroviral and anti-viral drugs,” said HM Subuh, infectious disease control director at the Indonesian Health Ministry, as quoted in the Jakarta Post of 19 October.

According to the decree, the generic companies would have to pay a royalty of 0.5% of the net sales value of the generic drugs to the companies that own the patents, such as Merck, Glaxo SmithKline, Bristol Myers Squibb, Abbott and Gilead.

The first decree in 2004 enabled cheaper generic medicines that provided HIV-infected patients with first-line anti-retroviral therapy.  However, these have become ineffective or less effective because of increasing resistance or the lower safety of the drugs.

The latest decree enables the supply of generic anti-retroviral products for not only better first but also second-line anti-retroviral therapy.

“With the 2012 regulation, we obviously can improve access to quality but affordable drugs,” Maura Linda Sitanggang, the Health Ministry’s Director General for Pharmaceuticals and Medical Equipment, told The Jakarta Post. “We’re using this mechanism concerning public interest on the production of quality but affordable medicines to treat HIV and HBV.”

The seven medicines which are the subject of the compulsory license (known in this case as for “government use”) are efavirenz, abacavir, didanosin, lopinavir + ritonavir combination, tenofovir, tenofovir + emtricitabine, and tenofovir + emtricitabine + efavirenz.

All the drugs are used to treat HIV-AIDS.  The drug tenofovir (brand name Viread produced by patent holder Gilead) is also used to treat hepatitis B, which affects 13 million people in Indonesia.  It had been approved in the United States for treating HIV-AIDS in 2001 and for treating chronic Hepatitis B in 2008.

The combination drug tenofovir + emtrisitabin (brand name Truvada, produced by Abbot) is taken in a single dose once a day.  It has been used to treat HIV-AIDS and in July 2012 it also became the first drug approved by the US Food and Drug Administration for use as a preventive measure, to reduce the risk of HIV infection to people at high risk of infection including those who may engage in sex with HIV infected patients.

The Indonesian decree was the second compulsory license in Asia this year.

In India, the Patent Office in March approved the country’s first compulsory license to a local firm Natco Pharma to make a generic version of the cancer drug sorofenib tosylate (brand name Nexavar, produced by Bayer).

It was argued that at the high price of 2.8 lakh rupees (US$5,200) for a month’s dosage of Nexavar, only 200 patients were treated in India in a year.  Natco said that 8,000 people would need the drug, and it could supply a generic version at 8,800 rupees (US$160) for a month’s treatment.

The drug is used to treat advanced kidney and liver cancer.  According to the terms of the license, Natco would pay Bayer royalties of 6% of its net sales.

Bayer challenged the compulsory license and on 16 September the Intellectual Property Appellate Board rejected its petition, ruling that “If a stay is granted it will jeopardise the interests of the public who are in need of the drug.”

Other developing regions have also been making use of the compulsory license option in the WTO’s intellectual property treaty known as TRIPS.  They include Brazil and Ecuador in Latin America and Kenya, Zambia and Zimbabwe in Africa.

In 2001, the WTO’s Ministerial Conference in Doha adopted a TRIPS and Public Health Declaration that asserted that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health.

It affirmed that the Agreement should be interpreted in a manner supportive of the right to health and access to medicines for all.

The Declaration clarified:  “In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.”

Table: Active Substance Name, Name of Patent Holder, Patent Number, and Duration of Patents for Antiviral and Antiretroviral Medicines
 

NO. NAME OF ACTIVE SUBSTANCES NAME OF PATENT
HOLDERS
PATENT NUMBER DURATION OF
PATENT
1. Efavirenz Merck & Co., INC ID 0005812 Until the end of patent period,
August 7, 2013
2. Abacavir Glaxo Group
Limited
ID 0011367 Until the end of
patent period, May 14, 2018
3. Didanosin Bristol – Myers
Squibb Company
ID 0010163 Until the end of
patent period, August 6, 2018
4. Combination Lopinavir and
Ritonavir
Abbott
Laboratories
ID 0023461 Until the end of
patent period, August 23, 2018
5. Tenofovir Gilead Sciences,
Inc.
ID 0007658 Until the end of
patent period, July
23, 2018
6. Combination Tenofovir and
EmtrisitabinCombination Tenofovir, Emtrisitabin and Evafirenz
Gilead Sciences, Inc. ID P0029476 Until the end of
patent period, 3
November 2024

 

Open letter to the prime minister expressing concern over the EU-Trade negotiations


English: Manmohan Singh, current prime ministe...

Image via Wikipedia

To,

Dr. Manmohan Singh, Prime Minister of India

South Block, Raisina Hill, New Delhi-110 011
Tel: 91-11-23012312 Fax: 91-11-23016857/91-11-23019545; email: pmo@pmindia.nic.in

Dear Mr. Prime Minister,

All India Drug Action Network (AIDAN) members express grave concern with regard to the round of negotiations on intellectual property that continues to be held between Indian and European Union (EU) negotiators as part of the India-EU Free Trade Agreement (FTA) talks. News reports in India quote the EU Ambassador as stating that discussions on Pharmaceuticals have progressed significantly.

It is reliably learnt from media reports that on the 10th February 2012, at the India-EU Summit to be held in Delhi, the EU & India will agree on and finalize the political framework for the FTA.

We express grave concern that these negotiations between the EU and India are progressing towards an agreement which includes provisions that will seriously hamper India’s ability to manufacture safe, effective and affordable generic medicines and export these to other developing countries.

Background:-

Indian generic industry is rightly known as the “Pharmacy of the Developing Country” because:-
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.

For millions of people in the developing world, access to essential medicines is often a question of life and death. Most of them rely on the affordable generic medicines being produced by countries like India. Backed by the big multinational pharmaceutical companies, US, European Union and European Free Trade Association are pushing for aggressive trade policies to restrict the supply and production of the generic medicines. The attack is taking various forms but with a single handed objective: Pushing for TRIPS plus provisions through Free Trade Agreements and other international agreements. The impact of such actions could be devastating and result in loss of millions of lives in absence of affordable medicines.

BUT ALL THIS COULD CHANGE IF INDIA DOES NOT SAY NO TO INTELLECTUAL PROPERTY (IP) IN THE INDIA-EU FTA.

AIDAN demands:-

REMOVE:

§ Investment Rules, which enable foreign companies to take the Indian government to private courts over domestic health policies like measures to reduce prices of medicines.

§ Border Measures, which will deny medicines to patients in other developing countries with custom officials seizing generic medicines in transit.

§ Injunctions, which 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, which 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 EU states that these two provisions are off the table. It must keep its word!

We urge you to look into this important issue and save the Indian generic industry from the onslaught of the multinationals, which in turn will save millions of lives all over the world!

Yours truly

(Dr Mira Shiva) – 09810582028

(Mr Srinivasan S) – 08056292350

(Dr Anant Phadke) -09423531478

(Dr Gopal Dabade) – 09448862270

(Mr Naveen Thomas) – 09342858056

ALL INDIA DRUG ACTION NETWORK- http://aidanindia.wordpress.com/
Towards a people oriented, rational, drug policy!

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