The problem of "ever-greening" in pharmaceuticals: Is it legal?

Syed Akbar
Hyderabad: After Bayer losing its patent rights on generic
drug Nexavar, the focus has now shifted to another important
anti-cancer drug, Gleevec, manufactured by Novartis AG.

The Supreme Court of India is likely to deliver its judgment on
Gleevec later this month. Novartis has been fighting a legal battle in
India for the last six years claiming patent rights over imatinib
mesylate, which is sold under brand name Gleevec in the USA and Glivec
in the rest of the world. It has been hailed as a wonder cancer drug
that has made as “manageable diseases” the deadly chronic myelogenous
leukemia, and some types of gastrointestinal cancers.

However, the cost of treatment through Gleevec is highly prohibitive
with patients in the USA spending on an average Rs 37.50 lakh a year.
The drug, marketed in India though at a subsidised price, is still
beyond the reach of many patients. Hyderabad-based pharmaceutical
company, Natco, which won the case against Bayer, has also been
manufacturing the generic version of Gleevec, and marketing it as
Veenat. Veenat is available at Rs 10,000 for a monthly dose.

The Supreme Court’s order will decide the price of the Gleevec in
India – if Novartis wins the case it gets the right over the new
price; and if it loses the battle, the cost of this anti-cancer drug
will come down drastically, bringing it within the reach of millions
of cancer patients.

“We have to look from both the sides – patients and research. If
patented drugs are violated, it will have an adverse impact on
research and there will be no new molecules. To strike a balance,
multinational companies should subsidise the products in developing
countries and make them affordable for the common man,” points out
cancer specialist Dr Mohana Vamsy.

The legal battle over Gleevec is on its patenting rights. While
Novartis argues that it is a new drug, the Indian government maintains
that the drug company has simply improved upon its earlier drug to
claim new patent rights. Many pharmaceutical companies, in a bid to
perpetuate their patent rights, follow what is called “evergreening”.
Once the patent rights of a drug come to an end, the pharma company
tries to extend it by remodeling the drug.

“There have been several instances of evergreening. It should not be
allowed in the larger interests of patients. Many pharma companies
want to perpetuate their patent rights by simple changes to the
existing drug. Several Arab countries have been allowing local patents
to help the patients. In a recent case, the supreme court in Egypt has
allowed a generic version of interferon Alpha 2A for hepatitis C, thus
bringing down the cost for local patients,” says senior researcher Dr
NM Khaja.