Supreme Court Rejects Novartis’ Appeal; Upholds high standard for Section 3(d)

1 April 2013, New Delhi­.— In a triumphant victory for patients fighting for access to medicines, a division bench of the Supreme Court of India comprising Hon’ble Justice Aftab Alam and hon’ble Justice Ranjana Desai, today dismissed Swiss MNC Novartis’ appeal for a patent to Novartis for its anti-cancer medicine, imatinib mesylate (Gleevec). The case is especially pertinent because it involved the interpretation of section 3(d) of the Patents Act, 1970, a public health safeguard introduced by Parliament in 2005 to prevent evergreening. Putting an end to the controversy over the provision, the Supreme Court has recognised the impact of patents on access to medicines and called for a strict interpretation of section 3(d).

Rejoicing at the decision, Mr. Y. K. Sapru of Cancer Patients Aid Association (CPAA), which had opposed Novartis’ patent application, said, “We are very happy that the Apex Court has recognised the right of patients to access affordable medicines over profits for big pharmaceutical companies through patents. Our access to affordable treatment will not be possible if the medicines are patented. It is a huge victory for human rights. ”

The Supreme Court’s ruling turned on the interpretation of section 3(d), a key public health safeguard introduced in India’s patent law by Parliament in recognition of the impact of product patents on access to medicines. Amongst others, section 3(d) disallows patenting of new forms of already known molecules, also known as evergreening, unless the patent applicant shows significant enhancement in efficacy for its product.

The Supreme Court held that Section 3(d) was introduced in the Patents Act, 1970 to ensure that patents were not extended on spurious grounds. The Supreme Court’s judgment that was delivered by Hon’ble Justice Alam stated that patent applicants also have to meet the standard of Section 3(d) before they can get patents under the Indian law.

Novartis also argued that section 3(d) only applies for new forms of already approved medicines. It also argued that better physico-chemical qualities, such as shape of the molecule, stability, hygroscopicity and solubility, would satisfy the test of enhanced efficacy.

Rejecting Novartis’ argument, the Supreme Court has held that the physio-chemical properties of the beta crystalline form of imatinib mesylate i.e. flow properties, decreased hygroscopicity and thermodynamic stability may be beneficial for patients in some manner but they do not meet the standard of efficacy required by Section 3(d).

Welcoming the ruling, Mr Anand Grover, Senior Counsel and Director of Lawyers Collective HIV/AIDS Unit, who represented CPAA in this matter, said, “The Supreme Court’s interpretation of section 3(d) keeps it intact. It is alive and kicking. It gives life to Parliament’s intent of facilitating access to medicines and of incentivizing only genuine research. By refusing patent monopolies on minor changes to known molecules, this judgment will facilitate early entry of generic medicines into the market for other medicines and diseases too. The impact will be felt not only in India, but also across the developing world”

In the past, Section 3(d) has also been used as one of the grounds to disallow patents for minor modifications of several antiretroviral (ARV) medicines used to treat people living with HIV.

Loon Gangte of the Delhi Network of Positive People (DNP+) said, “We are extremely pleased and relieved that the Supreme Court has recognised the public health importance of section 3(d). We have been filing several oppositions to patent applications on ARV medicines on the basis of section 3(d). This is a crucial victory for people living with HIV and other diseases who can continue to rely on India for access to affordable treatment.”

The Supreme Court dismissed Novartis’ appeal with costs.

Leena Menghaney for Medecins Sans Frontieres (MSF), which relies on Indian-made generic drugs to treat AIDS and other diseases in Africa and many poor countries, said, Although MSF has yet to see the text of the verdict, this appears to be the best outcome for patients in developing countries as fewer patents will be granted on existing medicines. Novartis’s attacks on the elements of India’s patent law that protect public health have failed. The Supreme Court’s decision prevents companies from abusing the patent system to get secondary patents on existing medicines, to block price-busting generic competition on HIV and other essential medicines. This confirms that all patent offices in India have to use this interpretation and the law is now clear and must be strictly applied.”

Lawyers Collective HIV/AIDS Unit and Cancer Patients AID Association

For further information, contact:
Anand Grover: +91.9899439593

Prathibha S.: +91.9968050357

Notes for Editors:

At the root of the case before the Indian Supreme Court is Novartis’ patent application for beta-crystalline form of imatinib mesylate, a drug used to treat chronic myeloid leukemia (CML), a type of blood cancer. Novartis’ price for its version of imatinib mesylate sold under the brand name, Gleevec or Glivec, is INR 120,000/- (USD 2400) per month, while generic versions are available at a cost of INR 8,000 (USD 160) to INR 12,000/- (USD 240) per month. Cancer Patients Aid Association procures the generic versions at discounted prices and provides them to their members at subsidised rates. About twenty five percent of the generic versions are provided free of cost to Cancer Patient.

In 1998, Novartis filed a patent application in India for a product patent on the beta-crystalline form of imatinib mesylate (imatinib mesylate). The basic molecule, imatinib, had been discovered in the early 1990s. As such, it was not patentable in India.

In 2005, the Chennai Patent Office heard patent oppositions filed by CPAA, represented by Lawyers Collective HIV/AIDS Unit, and other Indian generic companies.

In 2006, the Patent Office rejected Novartis’ patent application on several grounds, including section 3(d). The Patent Office held that the product claimed by Novartis lacked novelty and inventive step and also failed to show an increased efficacy over the known substance.

In 2006, Novartis challenged the constitutional validity of section 3(d) before the Madras High Court in Chennai arguing that the word “efficacy” in the section was vague. Novartis also filed an appeal against the rejection of its patent application. However, dismissing the constitutional challenge, the Madras High Court in 2007 held that the word “efficacy” used in section 3(d) had a definite meaning in the pharmaceutical field, i.e. therapeutic efficacy in the context of medicines.

Before the Madras High Court could complete the hearings on Novartis’ appeal against the rejection of its patent application, the Intellectual Property Appellate Board (IPAB) was notified as the tribunal to hear patent appeals and Novartis’ appeal was transferred to the IPAB. In 2009, the IPAB rejected Novartis’ appeal on the ground that its patent application did not satisfy section 3(d).

In 2009, aggrieved by the order of the IPAB, Novartis approached the Supreme Court. While Novartis did not directly challenge Section 3(d) as it had before the Madras High Court, it argued for a liberal interpretation of section 3(d).

On 1 April 2013, the Hon’ble Supreme Court of India dismissed Novartis’ appeal.

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