Pfizer in News

New IPR regime may not push up drug prices here
Publication : July 20, 2004

The new product patent regime is not likely to have a significant impact on the Indian drug market in the near term.

According to some industry watchers, as per the US Orange book there are currently only six drug molecules - thalidomide, arsenic trioxide, valdecoxib, formoterol fumarate, tadalafil, rosuvastatin calcium - that may be affected by product patents.

These drugs were patented after 1995 and have generic versions in the Indian market. Even then, they will impact generic versions only if they apply for and they get patent protection in India.

There may also be other formulations which might be patented post ’05, but this will not dislodge any presentation of the basic molecule if it is patented prior to 1995.

Anti-patent activists in the country have claimed that a new law could result in thousands of medicines getting patented, and existing brands will be forced to withdraw from the market.

Some IPR experts, however, refute this claim saying that this view is alarmist. “I do not think that there will be a drastic reduction in the number of products,” says R Mashelkar, director general, Council of Scientific & Industrial Research.

“In the Indian medicines market, where over 40,000 products already exist, the impact will not be significant even if multiple copies of the six molecules were to be withdrawn,” says S Ramkrishna of Pfizer and chairman of the IPR committee, Bombay Chamber of Commerce.

There are about 70 brands of the six drug molecules, of which valdecoxib has the maximum number of brands.

Recently, groups such as the National Working Group on Patent Laws and the Research Foundation for Science, Technology & Ecology are pushing for the inclusion of certain recommendations in the Patents Third Amendment Bill.

The Bill was introduced in Parliament in December ’03 but lapsed due to the change in government and is now being re-introduced. One of the recommendations was that patents should be granted to only new chemical entities.

“The definition of ‘patentability’ states that product patent should be granted for new chemical entities, new chemical molecules and new chemical formulations,” says Mr Mashelkar, quoting from the Mashelkar Committee report, which was released last year.

“This may be a bit short sighted as far as India is concerned. Globally very few new molecules are introduced every year, and it may take many years before any Indian blockbuster invention takes place,” adds Mr Ramkrishna.

According to him, the earliest advantage for Indian scientists would be to invent around an existing molecule and obtain a patent for their improvement.

In a letter to the minister for commerce and industry, Kamal Nath, the Organisation of Pharmaceutical Producers of India, said that “patent protection will enable Indian inventors to globally leverage their creative assets.

Early and quick success in patenting inventions will come from those who can incrementally improve on existing knowledge.”

The working group on Patent Laws has also urged the government not to introduce post grant opposition procedure for patents and continue the present procedure which allows for pre grant opposition.

“Most countries follow a post grant principle as the pre grant opposition can be used to endlessly delay the grant of patent to an inventor,” says Mr Ramkrishna.

Under the post grant principle, the patent to an inventor is not delayed while retaining the public right to oppose and revoke wrong applications.