[Commons-Law] US ruling lands Indian drug makers in a soup
Via: "Prashant Iyengar"
Hi,
Here's a chart comparing the prices of Brand Drugs vs. Generic Drugs
in the US with a row devoted to Neurontin - Pfizer's drug.
http://www.regencerx.com/prescriptions/physicianTools/generics/comparison/index.html
Just to get a sense of the amounts involved.
Prashant
http://www.thehindubusinessline.com/2007/09/26/stories/2007092652421700.htm
Pfizer will be eligible for full damages if it wins
BL Research Bureau
With the Washington Court of Appeals saying that a lower court had
erred in 2005 by saying that generic Neurontin would not infringe on
Pfizer Inc's patent for its blockbuster anti-convulsant.
Indian companies — both bulk drug makers and generics— might pay a
high price for their association with the drug.
Presently, nine companies including the three Indian drug makers have
FDA approvals for Gabapentin, the active pharmaceutical ingredient
(API) for the drug. Glenmark Pharma, Ranbaxy and Sun Pharma have
already launched the drug 'at-risk' while bulk drug makers like Hikal
and Shasun Chemicals are involved in manufacturing the active
pharmaceutical ingredient.
An 'at-risk launch' is a high risk-high gain strategy where pharma
companies launch a generic version of a drug which is under patent
challenge, before the expiry of that patent.
If it ends up losing the case, under US law, the generic maker can be
liable for triple the damages incurred by the patent holder.
However, this may not be a concern for Hikal and Shasun Chemicals, as
API suppliers.
Shasun Chemicals is a supplier to US based Alpharma Inc, it makes
generic prescription products and active pharmaceutical ingredients
for exclusive sale by Alpharma, which has an agreement with Teva on
gabapentin capsules and tablets. Hikal had entered into an agreement
with an unnamed US-based pharmaceutical company to supply gabapentin
and has begun selling the API to the US market from May 2005.
As a result of this development, Pfizer Inc will be eligible for full
damages if it wins in the patent trial. The patent(s) in question do
not expire until 2017.
Gabapentin is best known under the brand name Neurontin, which once
had sales of $2 billion annually for Pfizer.
In 2006, sales were at $496 million after cheaper generics entered the market.
As of now, the generic-drug companies can again contest that their
versions infringe the patent.
While Indian companies might be reviewing their courses of action, a
full trial is likely to be held on the allegations of patent
infringement.
(c) Copyright 2000 - 2007 The Hindu Business Line
Hi,
Here's a chart comparing the prices of Brand Drugs vs. Generic Drugs
in the US with a row devoted to Neurontin - Pfizer's drug.
http://www.regencerx.com/prescriptions/physicianTools/generics/comparison/index.html
Just to get a sense of the amounts involved.
Prashant
http://www.thehindubusinessline.com/2007/09/26/stories/2007092652421700.htm
Pfizer will be eligible for full damages if it wins
BL Research Bureau
With the Washington Court of Appeals saying that a lower court had
erred in 2005 by saying that generic Neurontin would not infringe on
Pfizer Inc's patent for its blockbuster anti-convulsant.
Indian companies — both bulk drug makers and generics— might pay a
high price for their association with the drug.
Presently, nine companies including the three Indian drug makers have
FDA approvals for Gabapentin, the active pharmaceutical ingredient
(API) for the drug. Glenmark Pharma, Ranbaxy and Sun Pharma have
already launched the drug 'at-risk' while bulk drug makers like Hikal
and Shasun Chemicals are involved in manufacturing the active
pharmaceutical ingredient.
An 'at-risk launch' is a high risk-high gain strategy where pharma
companies launch a generic version of a drug which is under patent
challenge, before the expiry of that patent.
If it ends up losing the case, under US law, the generic maker can be
liable for triple the damages incurred by the patent holder.
However, this may not be a concern for Hikal and Shasun Chemicals, as
API suppliers.
Shasun Chemicals is a supplier to US based Alpharma Inc, it makes
generic prescription products and active pharmaceutical ingredients
for exclusive sale by Alpharma, which has an agreement with Teva on
gabapentin capsules and tablets. Hikal had entered into an agreement
with an unnamed US-based pharmaceutical company to supply gabapentin
and has begun selling the API to the US market from May 2005.
As a result of this development, Pfizer Inc will be eligible for full
damages if it wins in the patent trial. The patent(s) in question do
not expire until 2017.
Gabapentin is best known under the brand name Neurontin, which once
had sales of $2 billion annually for Pfizer.
In 2006, sales were at $496 million after cheaper generics entered the market.
As of now, the generic-drug companies can again contest that their
versions infringe the patent.
While Indian companies might be reviewing their courses of action, a
full trial is likely to be held on the allegations of patent
infringement.
(c) Copyright 2000 - 2007 The Hindu Business Line
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