Misconceptions blur debate on intellectual property rights and public health needs.

A patent maelstrom has broken out over Glivec, the drug that treats people suffering from chronic myeloid leukemia (CML), a life-threatening form of cancer.

Already granted a patent in over 40 countries, Glivec has now been enhanced by the beta crystal form of imatinib mesylate so patients can take it in pill form.  Now its manufacturer, Swiss pharmaceutical giant Novartis, has taken India to court over the constitutionality of section 3(d) of India's Patent Law that awards patent monopolies only for "truly innovative medicines," and not to mere modifications of existing ones.

In a landmark decision, the High Court in Chennai, India dismissed Novartis' writ petition and deferred to the World Trade Organization forum to resolve the TRIPS (trade-related intellectual property)compliance question.

Novartis and other pharmaceutical companies believe this ruling discourages investments in innovation needed to bring better medicines to patients. After all, effective patent systems ensure incentives are in place to stimulate long-term R&D efforts critical for medical progress.

As expected, international aid organizations Oxfam and Doctors Without Borders as well as other similarly minded groups immediately dubbed this as big business versus the little people and proclaimed the decision as a "major victory for patients' access to affordable medicines in developing countries."

A win for generic drugs and patient access to affordable medicine? Or a loss for medical progress? Novartis opponents contend that a ruling in favor of the company granting it more extensive patent protection for its products would have drastically restricted the production of affordable medicines in India – the "pharmacy of the developing world." And that this decision highlights developing countries’ legal right to use the WTO TRIPS safeguards to balance public health needs and intellectual property rights.

But according to Paul Herrling, Ph.D., Corporate Research head at Novartis, "Medical progress occurs through incremental innovation. If Indian patent law does not recognize these important advances, patients will be denied new and better medicines."

Section 3(d) also works against public health, because ongoing innovation frequently leads to medicines which are easier to take and encourages patient compliance – a critical issue when treating long-term diseases and children's illnesses. It can also result in a child-friendly or pediatric version of an existing medicine that now works for adults.

Can patients win if Novartis wins? To look objectively at this issue, certain facts must come to the fore.

·   99% of the patients in India who need Glivec receive it FREE from Novartis through the Glivec International Patient Assistance program (GIPAP). So fear of increased prices is unjustified.

·   Novartis fully supports flexibilities in the TRIPS agreement that allows government to make exceptions to patent rights and import pharmaceuticals produced under compulsory license in case of a national emergency or a lack of supply from the patent holder.

·   Last year, Novartis' access to medicines programs reached nearly 34 million disadvantaged patients with contributions worth nearly USD 755 million.

Generics vs. brand name products. Opponents fear that name brand pharmaceuticals could spell the demise of low-cost generic medicines. Yes, generics are unquestionably valuable as a solution in developing countries and once drug patents expire. But without recognizing intellectual property rights, the innovation and development that leads to long-term solutions for developing world diseases such as tuberculosis, malaria and dengue fever would stop.

Bottom line? Without new and original medicines that come from research and innovation, where would generics be?

TRIPS: Agreement on Trade-Related Aspects of Intellectual Property Rights The Novartis patent case in India has focused the spotlight on TRIPS. The TRIPS Agreement is Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization, signed in Marrakesh, Morocco on 15 April 1994. Here is an excerpt from the agreement that may shed light on the intellectual property rights debate: The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations. (From PART 1, Article 7, on Objectives)  1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.  Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced. (From PART 2, Section 5, Article 27, on Patentable Subject Matter) Source: World Trade Organization