In 2006, Swiss pharmaceutical giant Novartis launched a legal battle challenging India’s adoption of strict standards used to regulate patents on medicines. They argued that Section 3(d) of the recently amended Patents Act was ‘unconstitutional and violated international standards’ and wanted a 20-year patent monopoly on their anti-cancer medicine, Glivec (Gleevec in the USA). Global campaigning organisations, backed by half a million people, voiced their opposition and Novartis lost the case. However Novartis is trying again to undermine India’s right to produce affordable medicines and next week, on February 28, there will be a hearing in the Indian Supreme Court. The company is now challenging the established interpretation of Section (d) which requires a minor variation to previously invented medicines not be granted unless it significantly enhances the efficiency of the medicine in treating human illness or disease.

Today, a few days before the hearing, Novartis’ shareholders are meeting in Basel at their Annual General Meeting (AGM). As the Indian Government gears up to fight this legal battle, campaigning groups around the world, including Oxfam, the Berne Declaration, Health GAP, and Act Up, will be holding demonstrations to coincide with the day of the AGM, with a clear message for Novartis to stop the attack on the Indian law and generic medicines. The groups point out that the price of Novartis’s Glivec is ten times the cost of generic equivalents. They also argue that Section 3(d) of the Indian Patent Act is a legitimate and invaluable flexibility that represents an important public health safeguard in Indian law meant to support access to essential medicines.

Rohit Malpani, Oxfam’s Policy Advisor, said: “Novartis seems determined to pursue its case against the Indian Government. If they win the case the consequences will be devastating, not only for patients in India but also the millions of people in poor countries across the globe whose lives depend on the affordable generic medicines India currently produces.”

Patrick Durisch, Health Programme Coordinator of the Berne Declaration, a Swiss advocacy NGO, said: “What is at stake goes far beyond the granting of a patent for this anticancer drug. Glivec’s successor drug Tasigna (nilotinib) has already been granted a patent in India. In fact, Novartis is acting as a corporate bully for all of Big Pharma to weaken the Indian Patents Act, so as to allow patenting on trivial changes to all sorts of existing medicines in the future.”

Brook Baker, a spokesperson from Act Up Basel and Health GAP said:  “How long should poor people be forced to wait for new medicines – 20 years, 30 years, 40 years?  To gain monopoly rights to sell to rich middle class consumers in India, Novartis is willing to sacrifice the health rights of a billion poorer Indians and a similar number of other poor patients worldwide.  We defend India’s rights to try to limit monopolization of trivial changes to existing medicines.”

Notes to editors:

Full list of organisations protesting: ACT UP-BASEL, ACT UP-PARIS, ASIA PACIFIC NETWORK OF POSITIVE PEOPLE (APN+),  BERNE DECLARATION, HEALTH GAP, INTERNATIONAL TREATMENT PREPAREDNESS COALITION (ITPC) & OXFAM INTERNATIONAL

What is the current Novartis case in India about?

Novartis patented the molecule imatinib in 1993. After the signing of the WTO TRIPS agreement by India in 1995, Novartis filed another patent application on the mesylate salt form of imatinib in 1998 at the Indian patent office. In 2005 India amended its patent law to comply with the WTO TRIPS agreement but also included Section 3(d) an important health safeguard that does not allow companies to get patents on new forms of old medicines. Novartis’ application was rejected by the Indian patent office on several grounds including that the application claimed a new form of an already existing medicine. The company then sued the Indian Government, cancer patients and several generic companies in order to get its patent monopoly on imatinib mesylate by getting Section 3(d) knocked out of the patent law.  Simultaneously, Novartis pursued a separate appeal of the denial of its patent application on Glivec arguing that it met the standards of India law.  When its administrative appeal failed, Novartis appealed again, this time to the Indian Supreme Court to try and change the interpretation of Section 3(d). In essence, Novartis wants section 3(d), which requires stringent evidence of proof of significantly enhanced therapeutic efficacy if a modification of an existing pharmaceutical entity is to receive new patent protection, to be reinterpreted to allow routine “ever-greening” of minor modifications to existing medicines resulting in additional 20-year patent monopolies.

Professor Brook K. Baker

Novartis has lined up very senior and very expensive lawyers including two former Solicitor Generals’ of India to argue the matter. The government was earlier represented by the Additional Solicitor General -Haren Rawal – in the case.

We will keep you updated once information regarding the dates of the final hearing  becomes clear.

Background: Novartis on its imatinib mesylate (Glivec) sales alone generated $4.7 billion (3.5 billion euros) in 2011, but is unwilling to give up its court case against the Indian government. Its aim is to get the legal framework for examining patent applications in India relaxed.

Why: Novartis is upset that India did not grant its patent claims on the salt form of the drug for which it had applied for in 1998, six years after it first applied for a Swiss patent on the imatinib compound in 1992.

This is a common ploy by pharmaceutical companies – applying for patents on new forms of an existing compound – to obtain patent monopolies in developing countries like India who have newly introduced a patent regime on medicines. If Novartis succeeds then Swiss, European and American multinational pharmaceutical companies will be able to get many more ever-greening patents in India, which ultimately will have a chilling effect on Indian generic production. Novartis India’s strategy is aimed at maximising  profits across the world – literally -by risking the lives of patients in developing countries who rely on Indian produced generic medicines.

Press Release issued by the groups protesting in USA.

In Basel many shareholders came out of the meeting to enquire about the issues treatment activists from Berne Declaration, Oxfam and ACT UP and Health Gap were raising.

The Berne Declaration also presented a statement on behalf of an international NGO coalition at the Novartis Annual General Assembly. See Statement by the Berne Declaration.

To know more about the action at Basel, click here.

AFP reported the Basel action, see here

MSF issued a press statement stating “Shareholders at this meeting need to know what the stakes are on this case and what the consequences will be.” Read more

The crucial Indian patent case concerning Novartis’ anticancer Glivec (imatinib mesylate) and its rejection due to Section 3(d), a controversial provision in India’s patent law, comes up for hearing next week, amid hope and concern for the parties involved.

The case is set to be heard on 28 February, before the Supreme Court, with NGOs and health activists claiming that a Novartis win would cut off Indian supplies not just within the country but also across much of the developing world.

The stakes are high for Novartis too and perhaps much of Big Pharma. Glivec is patented in about 40 countries including China and Taiwan. Asked how important a favourable ruling for Novartis would be in terms of its overall India outlook, and as an opportunity barometer, Ranjit Shahani, vice chairman and managing director of Novartis India told Scrip that the ruling is important for “all innovators, national and global”, having a presence or wanting to have a presence in India.

“This is about safeguarding incentives for better medicines so that patients’ needs will be met in future. As a manufacturer of generics, Novartis understands and recognises the contribution of generics once drug patents expire; our concern is with the non-recognition of intellectual property rights that ultimately help sustain and advance pharmaceutical R&D,” he said, adding that India is a formidable world power with international rights and obligations.

Mr Shahani said that patents provide an incentive to the pharmaceutical industry to invest in the development of new medicines to treat diseases that are currently untreatable or incurable, and provide options when patients develop resistance to older drugs. Novartis has, however, all along stressed that generic versions of Glivec would remain on the Indian market regardless of the outcome of the case before the Supreme Court, since Indian law allows generics launched before January 2005 [when India implemented a product patent regime] to stay on the market.

The company also said that generics alone will not solve the issue of access and that even its critics recognise that generic versions of Glivec are not the solution for the poor in India, with the real barriers to access in India being issues such as lack of diagnosis, infrastructure and distribution. Dr Paul Herrling, Head of Corporate Research at Novartis, dismisses the argument that a win at the Supreme Court for the company would result in patients losing access to Glivec. “More than 95% of all patients diagnosed with CML in India receive their medicine free of charge through the Glivec International Patient Assistance Program (GIPAP). Whether we win or lose that will be maintained” he told Scrip.

The drug is used to treat patients with chronic myeloid leukaemia (CML).While imatinib mesylate is sold by Novartis in India for Rs.1,20,000 ($2,400) per patient per month, Indian generic companies sell generic versions for Rs. 8,000 – 10,000 ($160 – 200) per patient per month.

“The poor cannot even afford the generic versions, which would be allowed to be sold even if the patent was granted, and so we have to find more innovative ways of getting the drug to those patients. Our fundamental position is that we always try to find ways of getting life-saving drugs to patients who cannot afford them. These include public-private partnerships, tiered pricing arrangements and shared contribution models in addition to donation programs.,” he added.

Activists and NGOs, though, will have none of that. They argue that Novartis is attempting to get the legal framework for examining patent applications in India relaxed. If Novartis wins this case, it will affect not only the examination of patent applications related to imatinib and its improved formulations, but also, critically, all other essential and life saving drugs, including those for AIDS and TB treatment, Leena Menghaney, India manager of the Médecins Sans Frontières (MSF) Access Campaign, said.

“By taking this to the highest court in India, it means that the manner in which section 3(d) – the clause against evergreening – is interpreted will be applied across the four patent offices in the country,” Ms Menghaney added. A Novartis win, NGOs claim, will put pressure on Indian patent offices to grant other patent applications on improvements of drugs which are currently off-patent in India.

India’s Intellectual Property Appellate Board had earlier rejected Novartis’ patent application for Glivec on the grounds that the product did not meet the criteria set under Section 3(d) of India’s Patent Act. This section broadly deals with incremental inventions that are not patentable unless they show improved efficacy or unless a known process results in a new product or employs at least one new reactant.

Predictability

Novartis, which had earlier claimed that the current case does not challenge Section 3(d), says that it needs a “predictable” interpretation of section 3(d). It, however believes that section 3(d), intended as a hurdle for evergreening, was “never” applicable to Glivec.

Novartis claims that the patent that was granted on the pure molecule should have no bearing on the application for the patent covering the salt as the original was never sold as a drug.

Mr Shahani explained that for any industry and for any law, interpretation must be predictable in that it is not left to “subjective” interpretation. “This gains importance for all technology innovators including the pharmaceutical industry. We are seeking clarity on whether we can rely on patents in India and whether we as a research-based organisation can continue to invest in the development of better medicines for India. The case is now before the Supreme Court and it is expected that the decision of the Court will be made by applying universally accepted principles of law without prejudice to any party,” he said.

NGOs claim it’s the generic industry that’s threatened by litigation, which affects predictability of generic production, instead. They claim that for Novartis and many other pharmaceutical companies patents are not synonymous with innovation and are also used very often to legally “fence in or block” generic competitors. They also claim that the interpretation of the definition of “efficacy” [under Section 3d] is central to this case and to the future of India’s role as pharmacy of the developing world.

Dr Herrling thinks the biggest losers, should the Supreme Court uphold the findings of the previous courts, will be India’s burgeoning innovator pharmaceutical companies and Indian patients who might find access to life-saving medicines more difficult. Novartis’ special leave petition before the Supreme Court of India challenging the decision of the Intellectual Property Appellate Board, which turned down its appeal for a patent on the beta-crystalline form of imatinib mesylate, and related petitions, was originally scheduled to be heard on 29 November 2011, but is now set to be heard on 28 February. Activist groups claim that the Attorney General of India, Goolam E Vahanvati, is expected to represent the government, with Novartis being represented by T R Andhyarujina and Gopal Subramaniam, senior counsels. Mr Subramaniam is a former Solicitor General of India.

The attorney general’s appointment comes after NGOs and health activists had been pressing for the appointment of the ‘senior-most’ legal advisor to the government of India to take on the line up of “very senior and very expensive lawyers” that Novartis had appointed to the case that involves complex patentability issue. A confirmation on the attorney general’s appointment could not immediately be got.

Source: IP Watch

By Liza Porteus Viana for Intellectual Property Watch

Precious little is known publicly about the details of the Trans-Pacific Partnership (TPP) agreement being negotiated by the United States and other Pacific-bordering nations, but some sources say the agreement could contain some of the strongest language on intellectual property rights that has come under attack in other agreements. The US trade office, meanwhile, says they are consulting stakeholders widely.

The TPP is gaining attention throughout the world not only because it holds the promise of opening up markets in participating countries and exporting stronger intellectual property protections enjoyed in the United States, but because some fear a greater backlash could ensue in the wake of outcry over the Stop Online Piracy Act (SOPA) and the Anti-Counterfeiting Trade Agreement (ACTA). SOPA critics were able to slow that legislation in the US Congress, arguing that it would permanently hurt the internet and force draconian enforcement laws on international partners, while protests are popping up all over Europe in opposition to ACTA provisions they say will curtail internet freedoms. For instance, Slovenia’s new government is actually considering putting a freeze on ACTA implementation there.

The European Commission has sought to counter the rising criticism of ACTA. “ACTA will not lead to limitation of civil liberties or harassment of consumers,” Cezary Lewanowicz, a European Commission spokesman, wrote on Twitter on 13 February. “#ACTA does not change EU law, does not prevent people from sharing content online, will not monitor the internet.”
Related: ACTA Doubts Rampant In Europe; Industry Call For “Reasoned Assessment”

“As protests against the Anti-Counterfeiting Trade Agreement (ACTA) sweep across Europe, two conclusions are possible: the era of closed-door IP policy is over; and the content industry’s insatiable quest for more power and control is no longer irresistible,” Ed Black, president of the Computer & Communications Industry Association, wrote recently on The Huffington Post. “Internet users realized during the debate over SOPA and its companion bill, PIPA, that because they were not at the table, they were on the menu. …TPP can and must be negotiated in a transparent process and become an agreement that supports innovation and Internet freedom. It would do a disservice to all if that agreement were SOPAfied.”

‘The Proof Will Be in the Pudding’ Participating TPP countries include: Australia, Brunei Darassalam, Chile, Malaysia, New Zealand, Peru, Singapore, and Vietnam. Japan, Canada and Mexico have also signalled interest, but groups such as the American Automotive Policy Council and International Intellectual Property Alliance say some of those countries need to do more in terms of enforcement to live up to TPP partner standards. IIPA’s statement on Mexico is here [pdf].

Negotiations are coming under fire for not being transparent and open enough; many civil society and other stakeholder groups argue that large corporations have had too heavy a hand in the talks. Knowledge Ecology International has prepared a list of groups and individuals involved in the talks on the US side here. IP trade advisors are from groups such as the Pharmaceutical Research and Manufacturers of America, Entertainment Software Association, Verizon, Johnson & Johnson and the Recording Industry Association of America.

“Although the general public is not permitted to see the texts, hundreds of ‘cleared advisers’ – often representing large corporate interests – are permitted to analyse the text and offer feedback … USTR also routinely provides detailed briefings to corporate lobbyists,” reads a letter sent to Vermont Sen. Patrick Leahy, the Democratic chairman of the Senate Judiciary Committee, sent by Knowledge Ecology International (KEI) on 26 January, appealing to lawmakers to make the process more transparent. KEI argues that little information is even known about “intersessional” rounds on IP negotiations in between major scheduled discussions. “This secrecy is an effort to further limit public participation.”

The fact that so many intersessional rounds are going on could be a sign the US isn’t getting as much as it wants in the negotiations, sources said.
Heading into the high-octane round of TPP discussions in Melbourne, Australia, early next month, the more contentious provisions will likely include those involving patents, copyrights and access to medicines.“The proof will be in the pudding of the copyright and patent negotiations where the issues are likely to be much more contentious and where the US has some more dominant industry interests backing those demands,” said Sean Flynn, associate director of the Program on Information Justice and Intellectual Property at the American University Washington College of Law.

Thus far, the only text of the TPP available to the public are leaked versions of the IP chapters proposed by the United States, New Zealand and Chile. There are many brackets in the text, sources said, which means other countries’ proposals are on the table for inclusion.

USTR Offers Some Insight
A spokeswoman for the US Trade Representative (USTR) told Intellectual Property Watch last week that there are no current plans to release the text, but pointed to white papers on key proposals involving access to medicines and environmental conservation on the USTR website, as well as information about progress and goals for the TPP, released last November.

The spokeswoman said negotiators have not signed any confidentiality agreement to not discuss TPP with the public, “but there is such a confidentiality agreement regarding texts and working papers themselves, to ensure the ability to draft, revise, and change texts freely among the partners according to evolving stakeholder input and individual partners’
equities, but all negotiating parties are free to discuss overall TPP and related issues as they please.”

The spokeswoman said the Obama administration discusses TPP with, and listens to, “a wide range of stakeholders with opposing inputs on various aspects of TPP, and then we fulfill our responsibility to synthesize a negotiating position that will best achieve TPP’s goals.” She noted that at the last US-hosted round in September, stakeholders were invited to be on site to interact with delegates, and more than 250 people from business, labour, academia and non-governmental organisations attended. Stakeholders also have presented at other meetings – and are invited to do so in Melbourne, as well. In addition, chief US negotiators have held mid-round briefings for stakeholders at US rounds and Congress is involved, as well.

“We believe our increased stakeholder input has resulted in better tabled texts and better negotiations throughout the process,” she added.There are two contrasting approaches to TPP, according to sources: the US approach, which includes what is being described as more maximalist norms, and a more development-oriented agenda reflected in leaked texts from Chile and New Zealand, which uses TRIPS as a floor and encourages further coordination among countries in IP enforcement.

“You have, on the one side, developing countries fearing the developmental impacts of the US proposal but on the other side, wealthier countries like New Zealand and Australia fearing for the impacts it could have on developments in their countries,” such as the impact of limitations and exceptions to patents language, pharmaceutical provisions, and regulatory concerns, Flynn said. “That’s creating a very interesting alliance with the non-US wealthy countries and the more developing countries who all seem to stand essentially in agreement in opposition to the US proposals to the IP chapter.”

What We Know
According to leaked drafts and documents released by USTR within the past year, this is what we know so far about the IP and related chapters; many of these are expected by observers to be hot topics in Melbourne…

The US wants:
-To work with TPP partners to create a “TPP access window” and establish a pathway for generics to enter TPP markets with pharmaceutical-specific IP protections requiring innovators to bring medicines to TPP markets within an agreed window of time. Critics call this “window dressing” for piling on monopoly privileges for large drug companies and would inappropriately extend patent protections for drugs, thereby undermining progress made by the Bush administration in 2007 to roll back such perceived monopolies. The US wants to allow for patent exceptions and incentives for generics; large numbers of medicines have had their patents expire in recent years.HIV/AIDS patients in Malaysia worry that US proposals could lead to price hikes in their medicines, while Peru’s trade minister has said the IP enforcement provisions in TPP go beyond the Peru free trade agreement when it comes to access to affordable medicines.

Related: US Copyright Industries Call for Action on Piracy; NGOs Call for Scrutiny
-To curb trade in counterfeit medicines
-Many brand-name pharmaceutical firms would like to see 12 years’ data exclusivity included in the TPP to protect their research on biologic drugs before generic firms can use brand companies’ data to produce their own cheaper versions. Brand names argue more times is needed to recoup costs incurred from researching, developing, and marketing these drugs. The 2010 US Affordable Care Act gives 12 years of exclusivity, but the Obama administration is trying to reduce that to seven years. To date, there is only a placeholder included in the text for specific provisions applying to biologics. “We think the industry demands are excessive, they’re strained, they’re odd in light of the current domestic context,” said Peter Maybarduk, Access to Medicines Program Director at Public Citizen.
-Trademark protection similar to what is included in the US-Korea FTA; elimination of the requirement that trademark licences must be recorded in order for the trademark owner or licensee to enforce their rights against infringers.
-Language to clarify that temporary copies are fully subject to reproduction rights
-All TPP parties to fully implement World Intellectual Property Organization “internet treaties” that provide global minimum standards for electronic commerce (WIPO Copyright Treaty and the WIPO Performances and Phonograms Treaty).
-Exclusive rights for sound recordings
-Copyright extensions to mirror US law
-TPP countries’ laws to provide for statutory damages regarding IP enforcement
-Law enforcement officials to have the power to seize infringing goods even if not specifically named in a warrant and without complaint by a right holder.
-Clearly defined guidelines on ISP liability in copyright infringement claims
-Availability of civil remedies – using TRIPS as a floor – for infringement, including: providing for injunctive relief, ex parte procedures, seizure and destruction of infringing copies, and requirement for those accused of copyright infringement to identify third parties in the production or distribution of pirated goods
-TPP parties to prosecute not only direct electronic commerce infringers, but also those who “purposefully take steps to promote infringement and ‘profit from developing and maintaining services that effectively induce it.’”

Some are concerned that the TPP would create a loophole for US copyright holders to take over all secondary markets for their works, as well as to control primary markets by requiring retailers to obtain a “licence to sell,” in addition to ownership of the copies. Similar importation provisions have been rejected in previous FTAs. eBay is one American company that has been asking USTR for this language to be stripped but so far, to no avail.

There is also worry that pressure will be placed on countries employing – or soon to employ – “notice and notice” takedown provisions in Chile and Canada, which provide some liability protections to internet service providers from alleged copyright infringement. This is in contrast to the US notice and takedown approach; Canada and Chile routinely make the USTR’s annual Section 301 watchlist.
“One of the key questions is whether the TPP more explicitly makes these kind of ‘notice and notice’ systems illegal, which is the current position of the US proposal,” Flynn said.

IP Policies Are ‘Based on Existing US Law’

An overarching concern is that the IP chapter may escalate the IP protections included in the US-South Korea FTA (KORUS) and ACTA and export overly protective provisions to TPP countries. This is particularly concerning given that the TPP region ranges from very underdeveloped countries, to wealthier countries such as Australia.

“The question is whether the maximalist provisions you find in ACTA and the Korea Free Trade Agreement … are appropriate for exporting to the widest possible range of countries,” Flynn said. “I would say everyone except the US opposes the idea on that broad level.”

The suggested Chilean text, considered more minimalist, includes language that seems more general than the US language, such as:
-“Parties shall be free to determine the appropriate method of implementing the provisions of this Chapter within their own legal system and practice.”
-“Nothing in this Chapter shall prevent a Party from adopting appropriate measures to prevent the abuse of intellectual property rights by right holders or the resort to practices that unreasonably restrain trade or adversely affect the international transfer of technology, provided that such measures are consistent with this Agreement. … [nothing] shall prevent a Party from adopting measures necessary to prevent anti-competitive practices that may result from the abuse of intellectual property rights.
and…
-TPP parties may “establish that provisions in standard form non-negotiated licenses for products do not prevent consumers from exercising the limitations and exceptions recognised in domestic intellectual property laws”

Despite some groups’ concerns that some US TPP proposals conflict with even US law, the USTR spokeswoman said that is not the case.
“The administration has made it a top priority to build high standards of IPR protection and enforcement in the TPP that will stand alongside those of prior US FTAs in the Asia Pacific region, that will foster regional integration, and that will support US economic growth and the creation and retention of American jobs,” she said. “Congress has set out US IP law, and our IP trade policy and negotiating positions are based on existing US law.”

The spokeswoman also noted that negotiators have made “encouraging progress” in the area of removing barriers to electronic commerce in the TPP region, including provisions addressing customs duties in the digital environment, authentication of electronic transactions, and consumer protection.“Additional proposals on information flows and treatment of digital products are under discussion,” she said.

Still, stakeholder groups are gearing up to make their case once again in Melbourne.“This is a new template that we can’t afford to have be made entirely under the radar,” said Maybarduk, “because it looks to change the rules in the knowledge economy of many countries and many people.”

Source : www.keionline.com

In NY, DC, and Boston, activists take over Novartis offices warning that pharma giant Novartis’ lawsuit in India could deny millions around the world to lifesaving medicines.

AIDS activists, students, and community groups “OCCUPIED” the offices of pharma giant Novartis today in three U.S. cities on the eve of the Swiss pharmaceutical company’s annual shareholders meeting in Switzerland.  The effort was part of a global day of action drawing attention to the company’s lawsuit against cancer patients and the government of India, aiming to reinterpret India’s patent standards to block access to life-saving generic
medicines.

 In 2006, Novartis sued the Indian government after its request for a patent on its blockbuster cancer drug Gleevec was denied. The Novartis version of the drug costs roughly ten times the cost of the high-quality generics on the market and the company is trying to stop production of those versions. Prior to 2005, India did not grant patents on medicines at all – a policy that fostered generic production of essential medicines then shipped to poor countries around the world. After a World Trade Organization agreement forced India to start granting patents in 2005, India created Section 3(d) of its patent law that requires pharmaceutical companies to demonstrate that changes to an existing substance actually shows increased efficacy for patients before a new patent is granted-preventing frivolous patents. Novartis was unable to show that its tweaks to the basic compound in Gleevec had resulted in improved efficacy in treating cancer.

“Without this protective provision in place, patents will be granted indiscriminately on trivial changes to existing medicines, thereby preventing generic production and allowing drug companies to charge high prices,” explained Brook Baker, policy analyst for Health GAP (Global Access Project).

India has historically proved vital in the global fight against AIDS-producing the vast majority of high quality, affordable drugs used in Africa and throughout the world.

“Novartis’s shortsighted corporate greed could have disastrous long-term consequences for nations reliant on generic medicines. India supplies 80% of AIDS medicines in the developing world as well as good quality generic equivalents for many other health needs.  Poor patients will continue to need access to new, improved, and affordable medicines instead of having them blocked by successive patent monopolies,” said Darshali Vyas, from
Harvard College and member of the Student Global AIDS Campaign.

Since Novartis initiated action against the Indian government, protests have been held around the world. On Wednesday, demonstrators in New York, Washington, and Boston stood in solidarity with actions in India, Switzerland, and other regions. “We’re here to try to ensure that India remains the pharmacy of the developing world,” said Katrina Ciraldo, Boston University medical student and member of Occupy Boston’s Health Justice group.

February 22, 2012, 2:10 P.M. ET

By LAURENCE NORMAN And BEN ROONEY

BRUSSELS—A new international treaty aimed at clamping down on pirated goods and counterfeiting that has generated protests across Europe will be referred to the European Union’s top court to determine whether it clashes with public freedoms.

In a surprise development Wednesday, the European Commission, the EU’s executive arm, said it would refer the Anti-Counterfeiting Trade Agreement to the European Court of Justice for legal guidance on whether it is fully compatible with freedom of expression and freedom of the Internet.

The European Commission and the European Council of member states have already approved ACTA, which has faced prompted demonstration in a number of European capitals, including Berlin and Paris. The European Parliament is set to debate it formally in June. A number of senior parliamentarians have raised concerns about the treaty, and last week, Justice Commissioner Vivane Reding had publicly backed calls by some parliamentarians calling for an ECJ review.

ACTA is an international legal framework for targeting counterfeit goods, generic medicines and copyright infringement on the Internet. Critics say it endangers freedom of speech and privacy. Wednesday’s decision means ratification of the treaty, which took years to negotiate, could be by more than a year. The U.S. is among states from outside the EU that have also signed the agreement.

“We are planning to ask Europe’s highest court to assess whether ACTA is incompatible—in any way—with the EU’s fundamental rights and freedoms, such as freedom of expression and information or data protection and the right to property in case of intellectual   property,” EU Trade Commissioner Karel de Gucht said Wednesday.

The move won backing in the European Parliament, where there is concern over its impact.

Hannes Swoboda, the leader of the Socialists and Democrats Group in the European Parliament, said the group’s main concerns related to copyright enforcement on the Internet and monitoring of activities online.

“Our group strongly supports the fight against counterfeiting goods. This is not only detrimental to industry and jobs but also to consumers. There is a need for greater international co-operation but we question whether ACTA would be the right tool to achieve this, particularly as several relevant countries such as China and India would not be included,” he said.

Mr. De Gucht said he continues to believe that the ACTA treaty strikes the right balance between ensuring protection of intellectual property and individual rights. And he said the standards set by ACTA are already applied in the EU so that “ACTA will change nothing about how we use the Internet and social websites today.”

A spokesman for Mr. De Gucht declined to comment on how long it is expected to be before the European Court of Justice responds to the Commission. A spokesperson for the ECJ wasn’t immediately available to comment.

There is a precedent for the EU’s move. In its fifty year history, the EU’s executive has asked for the ECJ to offer guidance on major issues more than a dozen times, including on the Uruguay round of world trade talks in the early 1990s

The delay for ACTA comes in the wake of similar controversy in the U.S. Attempts by U.S. legislators to introduce legislation designed to protect intellectual property online were withdrawn in the face of strong protest. The Stop Online Piracy Act provoked large scale opposition and in January plans to draft the bill were postponed.

Newly leaked documents of the European Commission reveal the disgraceful attempts to push for higher levels of commitments in trade in industrial goods and agricultural products, services and investment liberalisation, geographical indications and government procurement under the proposed India-EU free trade agreement.

Click here to read the analysis.

“The issue of drug seizures became a point of conflict between the EU and India. Recently, Netherlands had seized a drugs consignment from India. The EU is changing its customs laws in this regard. What do European pharma companies feel about this?

This is a sensitive subject, as this touches health and safety. The key element here is respect for intellectual property rights, and that is a battle between generics and the origin of drugs. I think we can solve both together. I know this issue has been discussed with India at a political level, but we are not aware of any changes in the laws. However, pharma companies have made it clear if the EU signs a trade deal with India, it has to be ensured that generic drugs from India to European markets respect the intellectual property rights of those who have invented and developed these.”

Access the full interview here

DAF-K has decided to renew the boycott call after prolonged deliberation, given the intransigent attitude shown by Novartis in obstructing access to a vital medicine for blood cancer. Imatinib mesylate is useful in the treatment of chronic myeloid leukemia (CML) a type of blood cancer. In addition to Novartis, several Indian companies – viz. NATCO, Cipla, Ranbaxy and Hetero — also produce and market this drug. Treatment with imatinib mesylate manufactured and marketed by Novartis costs Rs. 1,20,000 per patient per month, whereas Indian companies market the same drug at about Rs. 8,000 per patient per month.

Access the website here: http://novartisboycott.org/

Dr Gopal Dabade,
57, Tejaswinagar,
Dharwad 580 002
Tel 0836-2461722
Cell (0)9448862270