Drug makers may get six months extra patent life

[James Love <love@cptech.org>]

This was just sent to me.  Jamie

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Subject: Drug makers may get six months extra patent life
   Date: Sun, 19 Apr 1998 09:41:34 +0800

DRUG MAKERS MAY GET SIX MONTHS EXTRA PATENT LIFE

WASHINGTON, April 8 (Reuters) - Pharmaceutical companies will discover in
late May whether U.S. federal authorities will add six months to the patent
life of some top products in return for firms submitting data from drug
studies on children. The U.S. Food and Drug Administration (FDA) is due by
May 20 to publish a list of drugs that have not yet shown safety or
effectiveness in children.

If the makers of those drugs submit data and meet agency standards, they
will receive six months more patent life.

The FDA published a preliminary list of 345 drugs on March 25. The
medications on that list included: cardiovascular drugs, anti-seizure
medications, allergy and asthma drugs, cancer drugs - including
Bristol-Myers Squibb's Taxol (paclitaxel), skin drugs, major antibiotics,
antifungals, and most AIDS drugs - including all the protease inhibitors
and Glaxo Wellcome's AZT (zidovudine).

The list also covered antipsychotics and antidepressants such as Eli Lilly
& Co.'s, and top-selling anti-ulcer drugs such as Merck Astra Inc's
Prilosec (omeprazole) and Glaxo Wellcome's Zantac (ranitidine). Merck Astra
is a joint venture between Sweden's Astra Ab and Merck & Co Inc .

After years of ineffective cajoling of drug makers to gather data on
children, the FDA said last August that it would require pharmaceutical
companies to conduct new studies.

In November, when a FDA reform bill was signed into law, drug companies
were given the plum of extra patent life in return for producing data on
children.

Generic drug makers opposed the giveback. Washington-based Generic
Pharmaceutical Industry Association (GPIA) said giving drugs more patent
life would cost the U.S. government at least $126 million, and states and
insurers millions more due to lack of generic competition. GPIA is hoping
to convince the FDA to require drug companies to complete pediatric studies
as soon as possible - so they can't wait until the end of the patent term
to win six months more exclusivity. The longer drug makers wait, the longer
it will take to bring a generic to market.