Novartis Loses In Patent Court Ruling, India

Date: Apr-01-2013India's Supreme Court turned down Novartis' patent bid for an updated version of Glivec (imatinib mesylate), its blockbusting leukemia medication, saying that the updated compound "did not satisfy the test of novelty or inventiveness" required by the country's legislation.

The ruling means that generic drugmakers can continue manufacturing and selling copies of Glivec at low prices.

For the last seven years, Swiss pharmaceutical giant Novartis has been fighting a legal battle to gain patent protection for what the company calls an updated version of its top-selling leukemia drug. The company says that the new compound offers patients a significant improvement because it is absorbed more easily by the body.

However, the Indian judgment followed the country's laws which blocks drug companies from gaining new patents after making minor alterations to their medications - a practice known in the industry as "evergreening".

Dozens of advocates for cheaper medications described today's ruling as a big relief both for people in India and the rest of the developing world. They added that the Supreme Court decision has set a legal precedent.

Leena Menghaney, a lawyer for MSF (Medicins Sans Frontieres), said in an interview with AFP that this was a "Breakthrough, innovative medicines will still get patents in India but the judgment means drug companies cannot keep seeking patents for small changes to one drug."
Global drugmakers blame India for stifling innovation
Global pharmaceutical companies blame India's massive generics industry and its patent laws for undermining the incentives for research and development of new medications.

In an online communiqué today, Novartis wrote that today's decision by Indian Supreme Court regarding Glivec provides clarification on Indian patent law and undermines the drive for drug discovery, essential for the advancement of medical science for patients.

Novartis says that it was never granted an original patent for Glivec in India. It added that the Supreme Court in India denied an appeal challenging the rejection of a patent for Glivec, a life-saving medication for patients with leukemia. Glivec is patented in nearly 40 nations, including China, Taiwan and Russia.

Ranjit Shahani, Vice Chairman and Managing Director, Novartis India Limited, said:

"Novartis has never been granted an original patent for Glivec in India. We strongly believe that original innovation should be recognized in patents to encourage investment in medical innovation especially for unmet medical needs. We brought this case because we strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs. This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options.







Novartis will not invest in drug research in India. Not only Novartis, I don't think any global company is planning to research in India."

Novartis pointed out that 90% of patients currently taking Glivec in India will continue doing so at no cost through Novartis Oncology Access programs.

In 2012, Novartis reported a net profit of $9.6 billion on sales of $56.7 billion.

After the ruling, shares of Novartis India slid, while those of Cipla rose. Cipla is a large manufacturer of generic drugs.
Patents are for new drugs, not old ones, say advocates
Pratibha Singh, an attorney for Cipla, which sells a generic version of Glivec for less than one tenth of the branded drug price, explained to reporters outside the court that a patent can only be given to a new medication, not old ones which have been slightly altered.

Singh said:

"Patents will be given only for genuine inventions, and repetitive patents will not be given for minor tweaks to an existing drug."

Branded Glivec costs about $2,600 per month for leukemia patients needing treatment. Its generic version can be obtained in India for as little as $175 per month.

The Cancer Patients Aid Association, an Indian charity based in Mumbai, explained that this huge price difference makes life-saving treatment affordable for many poor people all over the world, not just in India. Spokesperson Y.K. Sapru said "For cancer sufferers, this ruling will mean the difference between life and death. Because the price at which it was available, and considering it's the only lifesaving drug for chronic myeloid cancer patients, this decision will make a huge difference."

It was not until 2005 that India started complying with WTO (World Trade Organization) drug patent rules. The country has been a major supplier of cheap, copycat drugs to treat chronic and/or terminal illnesses, such as AIDS, TB and cancer. For millions in the developing world who cannot afford the expensive brand name drugs, generic versions are lifesavers.
Today's decision affects all of the developing world
The Supreme Court's decision has implications worldwide, because India's $26 billion generic drug industry supplies much of the developing world with cheap medications. If multinational pharmaceutical companies were allowed to extend the lifespans of patents by making small changes to their medications, this market could be stunted.

As soon as a compound (drug) reaches the end of its patent life, generic manufacturers can legally make copies of it and sell it at a fraction of the price because they did not have to spend hundreds of millions of dollars on research and development.

A spokesperson for MSF disagreed with Novartis' prediction, saying that the ruling in India should encourage drugmakers to look for genuine innovations, instead of tweaking with older drugs in attempts for longer patent protection.

In 2010, the Indian courts rejected Swiss pharmaceutical giant Roche's attempt to patent a new form of a drug that had been around since the 1980s. It rejected a product patent it had previously granted for the drug valganciclovir, a medication given to organ transplant recipients, as well as patients infected with HIV.

Written by Christian Nordqvist

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