[Pharm-policy] BMS evergreen of BuSpar patent

[James Love]

Thanks to Professor MG for a pointer to this story.  Jamie

November 22, 2000
Bristol-Myers Gets a Fresh Patent
That May Extend BuSpar Rights

By GARDINER HARRIS

Staff Reporter of  the WJS

In the latest effort to fight off generic competition to its
aging line of drugs, Bristol-Myers Squibb Co. said that it
had received a patent that may allow the company to extend
its exclusive marketing rights to anxiety drug BuSpar.

     [snip]

BuSpar's patent expired in May, but the company got a six-
month extension because it tested the product in children.
That extension was due to expire Wednesday.

Several generic manufacturer officials and health advocates
said they were angry that, in their view, Bristol-Myers is
exploiting a legal loophole to prevent cheaper drugs from
entering the market. "This is probably the most outrageous
manipulation of the system that I've ever seen," said Carole
Ben-Maimon, chairman of the Generic Pharmaceutical
Association.

    [snip]


. . . big drug makers like Bristol-Myers increasingly are
winning patents to extend their commercial hold on drugs by
patenting a new way of administering the drug, its action in
the body, even its shape and color.

With BuSpar, for instance, Bristol-Myers couldn't patent the
actual chemical that is created when a patient digests the
drug because the metabolite has long been known. Instead,
the company received a patent on its finding that this
metabolite is the key ingredient in making BuSpar
work.

Under Bristol-Myers's novel legal theory, a generic
manufacturer can't make a BuSpar knockoff because anyone who
swallows that generic drug would produce in their bodies a
compound on which Bristol-Myers now has a
patent.

"We believe what the patent covers is the administration of
BuSpar itself as a means of achieving the anti-anxiety blood
levels of the metabolite," said Andrew Bodnar, vice
president for medical and external affairs for Bristol-
Myers. Asked if the company would sue a generic
manufacturer who tries to make the drug, Dr. Bodnar
answered: "We will be vigorous in the defense of our
intellectual property if we found that, through any
mechanism, anyone was infringing our patent."

Sidney Wolfe, director of the health-advocacy group at
Public Citizen, said "This is a whole new kind of patent
extension that I find really objectionable. It's outrageous
and the law needs to be changed immediately to stop this
from happening."

   [snip]


Write to Gardiner Harris at gardiner.harris@wsj.com


-- 
James Love  <love@cptech.org>  http://www.cptech.org
Consumer Project on Technology, P.O. Box 19367, Washington, DC 200036
voice 1.202.387.8030 fax 1.202.234.5176