Novartis is pursuing legal action against the government in India following its decision to decline the patent for Glivec® / Gleevec®, our ground-breaking cancer treatment.

To be clear, our case in India is solely about safeguarding intellectual property. This is not about patient access. With our well-regarded record in social responsibility, we are surprised that some groups are confusing the issue. In India, 99% of patients who receive Glivec receive it free from Novartis.

We are contesting the rejection of the Glivec patent in India. Furthermore, we are challenging the establishment of additional hurdles to patentability in India that discourage both breakthrough and incremental innovation. Patents save lives by stimulating innovation. With effective patent laws, companies such as Novartis can continue to bring improvements and innovations to patients and societies.

We commend the progress India has made in advancing intellectual property rights, but more needs to be done to align this increasingly important industrial country with its international obligations. We call on the Indian Government to grant the patent for Glivec and ensure its laws reflect international standards of patentability.

The case is generating public interest and inquiry, in particular around the potential impact on access to medicines. We have heard these concerns and want to clarify our point of view.

Novartis is deeply concerned that patients have access to medicines
Novartis is concerned that all patients have access to the medicines they need, as demonstrated by our well-regarded record in social responsibility.

In 2006, our access-to-medicines program reached 33.6 million patients. Novartis spent USD 755 million last year alone. We engage in a number of innovative public-private partnerships with efforts spanning a number of disease areas, including our partnerships with WHO to combat leprosy, malaria and tuberculosis. Novartis also established an Institute for Tropical Diseases in Singapore dedicated entirely to drug discovery for neglected diseases.

The Glivec International Patient Assistance Program (GIPAP) is one of the most far-reaching patient assistance programs ever implemented on a global scale. In India, 99% of patients who receive Glivec receive it free from Novartis.

Sustainable access to medicines in developing countries is complex and requires much more than the availability of generic drugs. Generics alone do not solve the issue. For example, in India the cost of a one year treatment with generic imatinib is USD 2,100, or 4.5 times the average annual income. Even our critics recognize that generic versions of Glivec are not the solution for the poor in India. Furthermore, generic makers in India have yet to come forward with an access program for generic imatinib.

Our case in India is solely about safeguarding intellectual property, not about patient access
Novartis is not challenging any provisions of the Indian patent law that were put in place to promote access. We are challenging parts of the Indian patent law that led to the rejection of the Glivec patent.

The international community has established agreements that allow for the export of essential medicines to poor countries without sufficient manufacturing capabilities. Our legal action will have no impact on these provisions.

In India, Novartis is faced with a globalization dilemma that characterizes many emerging economic powers today: two markets within one country.

India has a booming middle class on the one hand, and a vast number of extremely poor people on the other hand. We are aware of the many obstacles that poor patients face regarding access to medical care. For that reason, we are pursing a dual, patient-focused strategy: we take poor patients seriously by giving them free access to Glivec and we take well-off India seriously as a formidable power with all the rights and obligations that such a status brings with it. Respect for intellectual property will strengthen, not weaken, the Indian economy, helping India reach its aspiration of becoming a pharmaceutical powerhouse.

In India, Novartis currently provides Glivec at no charge to more than 6,600 diagnosed patients. Our actions show that Novartis is deeply concerned about ensuring patients have access to this life-saving cancer drug. Around the world, Novartis provides Glivec free of charge to more than 19 000 patients in 80 countries through GIPAP.

We are contesting the provision of Indian Patent Law that has led to the rejection of the Glivec patent in India. Our case does not challenge provisions that provide for access under international trade agreements, specifically the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the Doha Declaration. In fact, Novartis supports the TRIPS conditions that promote access for developing countries. We are challenging the establishment of additional hurdles to patentability in India that discourage both breakthrough and incremental innovation.

Protecting innovation is the best protection for patients, laying the foundation for the massive R&D investments made by the pharmaceuticals industry that are vital to medical progress. With effective patent laws, companies continue to bring improvements and innovations to patients and societies. For a research-based company such as Novartis, patents are not negotiable.

Many of the points which we have raised around India’s patent laws have been corroborated by the recent Mashelkar Committee report on patent issues in India. The high-level panel said that denying patent protection to new forms and uses of older drugs is not in line with the WTO’s TRIPS agreement.

Glivec is recognized as one of the medical breakthroughs of the 20th century
Glivec is a life-saving drug for cancer and has been widely recognized as true innovation. That Glivec failed the Indian test for patentability indicates the deficiencies in India’s patent system.

The journey of Glivec through the patent process in India illustrates the difficulties faced in a country in transition. The Indian patent law creates new hurdles for pharmaceutical innovation, unjustifiably and illegally narrowing what is patentable. The list of exclusions under challenge in our legal case includes new chemical compounds (defined as “derivatives of known compounds”), combinations, salts and esters of known compounds. These exclusions, among other therapeutic areas, could impact innovation in HIV/AIDS treatments by denying patents for combination therapies. They could also impact infectious diseases where new antibiotics resulted from introducing new salts and esters of the known compound penicillin.

That Glivec is a tremendous innovation is widely-recognized throughout the scientific community; it has received numerous awards for innovation. Glivec has been awarded a patent in 36 other countries, including China.

Our legal action shows that we are deeply concerned about establishing effective protection for pharmaceutical innovation in India
If the Indian patent law is allowed to remain unchallenged, India’s credibility and legitimate, long-term ambition to thrive as a pharmaceutical powerhouse will be in jeopardy.
India is a signatory to the WTO TRIPS agreement and as an increasingly important industrial country should adhere to international commitments. A catalyst for India’s economic growth has been its agreement to apply global trade rules, including intellectual property protections. Recognizing patents is a necessary precondition for India’s drug industry to pursue additional drug research and development and attract foreign investors.

Novartis believes that India, as an increasingly important industrial country, should adhere to its international obligations
We call on the Indian Government to grant the patent for Glivec and ensure its laws reflect international standards of patentability.

We commend the progress India has made in advancing intellectual rights, but more needs to be done to align this increasingly important industrial country with international standards.

For more information about our extensive corporate responsibility and patient assistance programs, please visit our website: http://www.novartis.com/corporate_citizenship/en/index.shtml

Yours sincerely,

Head of Global Public Affairs, Novartis AG

For more information on this issue from Novartis, please visit:
http://www.novartis.com/about-novartis/corporate-citizenship/india-glivec-patent-case/index.shtml

Novartis are challenging India over a leukemia drug (Gleevec) that they manufactured generically, as the Indian government did not deem it truly innovative as it was an ‘improvement’ of a previous drug produced before 1995, when India joined the WTO and became TRIPS compliant.