Indian drug companies warn of rocky IPR road ahead

[Guest guest]

Drug companies warn of rocky IPR road ahead

P.T. Jyothi Datta, Mumbai , April 9

DOMESTIC drug companies have sounded a note of caution on the hassles that could

surface in the details of the legal framework that is being laid out for the

product-patent regime, come January 2005.

The recent legal entanglements that have followed the country's first exclusive

marketing right (EMR) granted to Novartis is just an indication that

intellectual property rights (IPR) related issues are set for a rocky road

ahead, making it all the more necessary to have clarity in the rules that will

finally prevail.

The pharma industry will soon be governed globally by TRIPS or trade related

intellectual property rights, the detailed, multilateral agreement on IPR.

Given this reality, India should implement `TRIPS-minimum requirements and

maximum permitted flexibilities', according to the Indian Drug Manufacturers'

Association (IDMA).

Against the backdrop of recent patent-related wrangles, IDMA has stressed the

need for clarity in The Patent (Third Amendment Bill) that will govern the

industry when product patents are respected in the country.

In its presentation to the Government, IDMA has stated that patents granted to

" foreign patent holders " will result in Indian manufacturers being asked to give

up manufacture of the same drugs through injunctions received from Indian

courts.

" When this involves Indian manufacturers and over 50 essential molecules and

thousands of brands sold across India, it is bound to create shortages, price

rise disruption of the distribution trade, retrenchment of employees and

possible rush of spurious substitutes by unsocial elements. "

The reference is to the EMR granted to Novartis's blood cancer drug, Glivec,

which resulted in local manufacturers being restrained from producing knock-off

versions and selling them at a tenth of the cost.

Only earlier this week, Natco Pharma's case against Novartis's EMR for Glivec

was dismissed by the Delhi High Court, leaving Natco with the option of taking

the case to the apex court.

IDMA is a forum of 500-odd Indian pharma companies of all hues and from across

the country, including Dr Reddy's Laboratories, Orchid, Shasun, Sun Pharma,

Dabur, Cadila Pharma, Torrent and Cadila Healthcare.

During the period between 1995 and 2004, the Government has approved and Indian

manufacturers have produced new drugs, investing in facilities for the

same. " Since process patents are applicable till date, new drugs have been made

and the turnover of these is about Rs 5,000 crore, " IDMA said.

During the same period, about 7,000 patent applications were filed in India,

some which may relate to the drugs being made by local companies. If product

patents are granted on existing drugs, it could lead to a " chaotic situation " ,

the forum said.

IDMA has also underlined the need for " advance notification " or pre-grant

opportunity to anyone to oppose EMR or patent applications, in an effort to

avoid difficulties to consumers and " wasteful litigation " by companies.

Referring to the Bill's definition of " patentable invention " as being a " new

product " and involving an " innovation " , the IDMA presentation said that there is

no mention of " derivatives, polymers, etc., ... and their patentability is

debatable " .

In other words, if a patent application is for an existing drug where the

company has merely changed the dosage form - say, from tablet to crystalline

form - it should not be treated as a new drug.

The Hindu business Line, Internet Edition April 10, 2004

http://www.thehindubusinessline.com/2004/04/10/stories/200404100172010

0.htm