Novartis AG (NVS)

Incremental Innovation

In challenging a provision of India’s new patent law, the primary objective for Novartis was to ensure protection for incremental innovation. Medical progress occurs through incremental innovation — innovation by steps — providing important value for patients in the form of enhanced efficacy or improved side-effect profiles.

One example is Sandostatin LAR, a Novartis medicine used to treat debilitating gastrointestinal tumors. Development of a long-acting formulation reduced the number of injections from more than a thousand per year to only 12, a huge benefit for patients. Development of Exelon Patch, the first and only transdermal treatment for Alzheimer’s disease, has been shown to increase compliance, reduce side effects and allow medication to be delivered through the skin continuously for 24 hours, helping to achieve optimal dosing.

These types of advances are currently not acknowledged by India’s patent law even though they meet WTO patentability standards and deliver significant value for patients. Novartis is concerned that hurdles to recognition of genuine innovation in the Indian patent law will hinder development of future medicines. We took on this case because we firmly believe it was the right thing to do for patients.

International nongovernmental organizations (NGOs), including Médecins sans Frontieres and Oxfam, drew attention to the case by claiming that, if Novartis prevailed, India would no longer be able to supply much of the developing world with inexpensive medicines, including treatments for HIV/AIDS.

The basis of those arguments is false and misleading. Safeguards established under international-trade accords allow governments in developing countries to make exceptions to patent rights and to import pharmaceuticals produced under compulsory license in cases of a national emergency. Access to HIV/AIDS medications is not, and has never been, threatened by our case. Independent of the legal outcome, currently available generic drugs launched before 2005 — including HIV/AIDS medicines and generic versions of Glivec — will continue to be available under a so-called grandfather clause in the Indian patent law.

We commend the progress India has made in recent years to advance intellectual-property rights. But more needs to be done to align this increasingly important industrial country with minimum international standards.

We are confident that dialogue about shortcomings in India’s patent law will continue and ultimately lead to establishment of effective protection for incremental in novation. Novartis will continue to participate in this essential debate both in India and as it expands globally.

“Despite the strident comments of some NGOs, I am convinced our efforts to gain clarity on India’s commitment to meet minimum international intellectual-property standards will benefit India and its people,” Dr. Vasella says. “For a research-based company like Novartis, patents are non-negotiable.”

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