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Q: EXTENDING DRUG PATENTS ( Answered 5 out of 5 stars,   2 Comments )
Question  
Subject: EXTENDING DRUG PATENTS
Category: Health > Medicine
Asked by: yesmam-ga
List Price: $5.00
Posted: 17 Jun 2003 15:10 PDT
Expires: 17 Jul 2003 15:10 PDT
Question ID: 218525
When a drug is reformulated as far as its delivery system, can the
patent be extended from that time and get a further extention making
it nearly impossible for generics to come in?
I take an injectable drug that for several years had to mixed with a
dilutan shortly before injection. Now, that drug comes in premixed
syringes. Since it costs nearly $1,000. a month, I am anxious to see a
generic within my lifetime.
I trust drug companies as much as pit bulls on steroids. :-(
Thanks,
YesMam
Answer  
Subject: Re: EXTENDING DRUG PATENTS
Answered By: justaskscott-ga on 17 Jun 2003 20:39 PDT
Rated:5 out of 5 stars
 
Hello yesmam-ga,

It appears that drug companies (at least in the United States) cannot
extend the patent for the drug itself, but can get a patent for the
drug delivery system.  In other words, a company cannot stop
manufacture of the drug after expiration of its patent on the drug,
but it can try to develop a better version of the drug -- easier to
take, longer-lasting, etc. -- prior to expiration of the patent, so
that it can remain the market leader (or dominator).

Moreover, some drugs are difficult to manufacture, which might give
the original company an advantage, especially if it also develops a
new delivery system.  In one case, a company patented an aspect of the
pre-expiration delivery system, and has sued to stop production of the
generic drug.

Here are three articles that discuss these issues.

"Advanced Drug Delivery Technology Infuses New Life into Product
Life-cycles", by Dr. Anand Baichwal and Deborah Neville [see
especially pp. 3-5]
World Markets Research Centre
http://www.wmrc.com/businessbriefing/pdf/pharmatech2002/technology/penwest.pdf

"Pharmaceuticals Fight Over $6 Billion Drug Begins", Matthew Herper
(12.06.01)
Forbes.com
http://www.forbes.com/2001/12/06/1206andrx.html

"FDA Stands Firm On Generics", Matthew Herper (11.26.01)
Forbes.com
http://www.forbes.com/2001/11/26/1126generics.html%20

I hope that this information is helpful.

- justaskscott-ga


Search terms used on Google:

patent generic "drug delivery"
patent generic formulation delivery
yesmam-ga rated this answer:5 out of 5 stars

Comments  
Subject: Re: EXTENDING DRUG PATENTS
From: fomoco-ga on 17 Jun 2003 16:30 PDT
 
Hi yesmam
I work in the drug distribution industry (not in pharma, but related)
and from what I know, what holds up generics is not only extensions
granted, but the court cases that lead up to extensions granted or
denied.

As far as granted extensions go, I believe that extensions can be
granted for drug delivery -- for example, I don't think there is a
generic for Claritin Redi Tabs or liquids, just for Claritin tablets
(the oral solid).

So I think the main issue with the meds you take are whether they are
profitable enough to the pharma company to defend vigorously or not.
If your disease state or medical issue is very common, chances are
they'll fight harder,like with Glucophage for diabetics or other
blockbusters like Prozac or Viagra.

The other positive possibility is that a newer, more glamorous
treatment will come along, and the older but still effective treatment
will go to generic more quickly because the money is in the new whiz
bang drug.
Best of luck to you
fomoco
Subject: Re: EXTENDING DRUG PATENTS
From: yesmam-ga on 17 Jun 2003 18:51 PDT
 
Thanks Fomoco. I have multiple sclerosis. We are about 300,000 in the
US. We will not get a cure as soon I think it is possible, because
there is more money in cholesterol fighting drugs, and heart disease
and diabetes drugs.
YesMam

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