Sunday, May 5, 2013

Trial in India about patent of a new drug

On April 1, 2013 Supreme Court in India rejected the claim by Novartis about a new patent of anticancer drug.

The New York Times: Low-Cost Drugs in Poor Nations Get a Lift in Indian Court

Formerly, huge drug making companies such as Novartis tend to apply a new patent for a drug minimally changed from the original form to maintain their intellectual right after developing an innovative drug. Court in India denied their strategy.

This case is very suggestive.

To create a new drug is extremely difficult. First, researchers have to discover an effective chemical for human health. The opportunity of success is astronomically low. When a hopeful chemical is identified, they try to evaluate its effect on animal body. A lot of mice will be sacrificed. If this chemical has been proven to be safe and effective, clinical trials will be planned. As I have experienced to participate in clinical trials several times, they are quite complicated and tough. At last, an authority such as the Food and Drug Administration decides whether the drug should be approved or not. It is said that it costs millions of dollars and a few decades to establish a new drug.

Considering this circumstance, I understand that drug makers persist the patents. They must compensate the developmental cost. Unless they would lose the motivation to create a new drug.

On the other hand, it is true that the patent raises the market cost of a new drug. Some new drugs are so expensive that poor patients hardly use ones continuously. There are few people to gain the benefit of new drugs.

Indian or other drug industries develop more cheaper drugs mimicking the original ones whose patent has been exhausted. They are called Generics. Generic drugs are now available all over the world to be beneficial for the patients not so rich. Also in Japan, many patients use generics. The government recommends generics to reduce cost of medicine.

This case of trial is similar to the conflict between Apple and Samsung. Whether Samsung invaded the patent of Apple or not is controversial even now. Some of US Court acknowledged the infringement of Samsung. But The Korean Court stood by Samsung. This kind of trial cannot be completely free from national interest I guess. Even if the judges act extremely as neutral, they are bound by the national cultural thought.

Intellectual property is quite a difficult problem. In Japan, discussion is rising around TPP. We must be careful, and keep balanced thought between our own benefit and the whole happiness of us.

1 comment:

  1. In India, there are a lot of Generics companies, such as Ranbaxy Laboratories.

    Such kind of "patent" problems sometimes become much complicated and difficult, as there is a big difference in background cultures between every countries. In America, "copying other person's idea" is very bad thing, whereas in other countries it is not, for example. Now as internet system makes the world " more narrow", I think such kind of problem will happen more often.