[Ip-health] Cipro Lawsuit

[Mike Palmedo]

1.	Press Release from Prescription Access Litigation Project
http://www.prescriptionaccesslitigation.org/html/news.html

2.	Reuters Story
http://biz.yahoo.com/rf/011025/n25244894_1.html

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1.	Unlawful Conspiracy Restricted Production of Cipro, 
Consumers Charge in Suit Filed Today Against Bayer Corporation
Bayer Paid Competitors $200mm to Keep Generic Cipro Off the Market; Suit
Asks Court to Intercede, Nullify Agreement and Open the Way For Generics
to Enter the Market

WASHINGTON D.C., Oct. 24, 2001 – The Prescription Access Litigation
(PAL) project announced today it has gone to court to dislodge an
agreement between Bayer, Barr Laboratories, and two other generic drug
companies that it says is blocking access to adequate supplies and
cheaper, generic versions of Cipro, now the leading antibiotic used to
treat Anthrax.  Decrying the inadequacy of the arrangement that the
federal government just negotiated with Bayer, consumer groups in eleven
states – representing over one million consumers -  have signed onto the
litigation. 

The lawsuit asks the court to put aside the agreement, opening the way
for generic forms of Cipro to enter the market. The plaintiffs charge
that Bayer Corporation, a unit of Bayer AG, has unlawfully paid three of
its competitors – Barr Laboratories, Rugby, and Hoechst-Marion Roussel –
a total of $200 million to date to abandon efforts to bring cheaper
generic versions of Cipro to the market, manipulating the price and
supply of a drug that has suddenly become a crucial weapon in the fight
against bio-terrorism.  Because of these payments, the generic companies
abandoned their argument that Bayer’s patent was invalid and
unenforceable.

“This is simply wrong on the face of it,” said PAL spokesman Stephen
Rosenfeld.  “On the one hand you have people throughout the country
worrying that public health officials may not have sufficient supplies
of Cipro available.  At the same time Bayer is paying Barr and two other
companies millions of dollars to not produce the drug.  We’re calling on
the court to set aside an agreement that has given Bayer an unlawful
monopoly on a drug that’s now critical to public health in this
country.  And we believe it is urgent that the court act expeditiously.”

Cipro is the best selling antibiotic in the world and has been for eight
consecutive years.  In 1999 Cipro was the eleventh most prescribed drug
in the United States based on new prescriptions and ranked twentieth in
total US sales.  Bayer's 1999 gross US sales of Cipro were approximately
$1.04 billion.  

Fourteen consumer and senior advocacy organizations are joining the
suit, including Citizen Action of New York, Congress of California
Seniors, Florida Alliance for Retired Americans, Health Care For All,
New York Statewide Senior Action Council, New Jersey Citizen Action,
Consumers for Affordable Health Care in Maine, among others (see full
group listing on following page.)  The effort is being led by PAL, a
coalition of over 60 organizations in 29 states which is also the
nation’s largest consumer health advocacy organization seeking
enforcement of laws to combat the high price of prescription drugs.  
PAL was formed earlier this year by Boston-based Community Catalyst
(www.communitycatalyst.org), a national consumer health advocacy
organization, and the National Health Law Program, which is based in
Washington, D.C.

With today’s filing, the consumer groups have joined an existing federal
lawsuit filed last year in the Eastern District of New York to have
Bayer’s agreement with the three generic companies declared illegal.  In
that case, U.S. District Court Judge Trager has ruled that the
plaintiffs' anti-trust claim is plausible and deserves to go to trial.  


Bayer has marketed Cipro in the US since receiving approval from the FDA
in October 1987.  According to Judge Trager’s ruling, Barr Laboratories
applied in 1991 to the FDA to bring ciprofloxacin to market, asserting
that Bayer’s patent on Cipro was invalid and unenforceable.  Bayer
retaliated and sued Barr for patent infringement.  In 1995 Barr received
tentative FDA approval to manufacture and market generic Cipro, pending
the resolution of the patent litigation.  Beginning in 1997, however,
Bayer paid Barr and the two other generic companies millions of dollars
in exchange for their agreement to not manufacture the generic drug.  To
date, that agreement has resulted in payments totaling $200 million. 

Concerned about the possibility of a wider-spread Anthrax attack, public
health officials have announced plans to stockpile Cipro.  Meanwhile, US
pharmacies report their supplies are running low.  Yesterday, following
negotiations with Bayer, US Secretary of Health and Human Services (HHS)
Tommy G. Thompson announced that the federal government will purchase
100 million tablets of Cipro from the brand-name manufacturer at a price
of 95 cents apiece.

Commenting on that arrangement, PAL’s Rosenfeld said “if Bayer had not
entered into its collusive agreement with Barr and the two other generic
companies, there would today be an ample supply of generic Cipro
available at a fraction of the price that the federal government has now
agreed to pay Bayer.”  

Participating Organizations

Fourteen consumer groups have signed onto PAL’s Cipro litigation:
Citizen Action of New York, Citizens for Consumer Justice, Colorado
Progressive Coalition, Congress of California Seniors, Florida Alliance
for Retired Americans, Health Care For All, Inc., Maine Consumers for
Affordable Health Care, Massachusetts PIRG, Mississippi Human Services
Coalition, New Jersey Citizen Action, New York StateWide Senior Action
Council, Oregon Health Action Campaign, Pennsylvania Alliance for
Retired Americans, UHCAN-OHIO

They are represented by: Lieff, Cabraser, Heimann & Bernstein, LLP of
San Francisco (www.lchb.com); New York-based Milberg Weiss Bershad Hynes
& Lerach LLP (www.milberg.com); Carey & Danis, LLC of St. Louis
(www.careydanis.com). 


CONTACTS: 
Laurie Covens, Communication Dir.
Community Catalyst
(617)275-2805
covens@communitycat.org

Kim Shellenberger, PAL Director 
Community Catalyst
617-275-2815 or 617-275-2805
covens@communitycat.org
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2. Group joins suit against Bayer over Cipro payments

WASHINGTON, Oct 25 (Reuters) - A U.S. coalition of consumer groups said
on Thursday they were joining an existing suit against Bayer AG over
deals keeping cheaper generic versions of its antibiotic Cipro, now in
great demand to treat Anthrax, from the market.

The Prescription Access Litigation Project said it was joining a lawsuit
filed last year in U.S. District Court in New York that seeks to have
Bayer's deals with three drug companies declared illegal.

``We're calling on the court to set aside an agreement that has given
Bayer an unlawful monopoly on a drug that's now critical to public
health in this country,'' project spokesman Stephen Rosenfeld said in a
statement.

The suit charges that Bayer has paid $200 million to date to Barr
Laboratories Inc.(NYSE:BRL - news) , and Rugby Group and Hoechst Marion
Roussel, both now part of Aventis SA , to prevent challenges to its
Cipro patent.

Bayer is separately being probed by the U.S. Federal Trade Commission
along with other major drug makers for payments that delay the
introduction of generic products.

Cipro has become a household word since the anthrax scare began this
month in the United States. Three people have died of the most serious
inhalation form of the disease.

Bayer and the U.S. government on Wednesday reached a deal for the supply
of 300 million tablets of Cipro, the initial 100 million at a new
discounted price of 95 cents per tablet, compared with the $1.77 a
tablet previously paid by the federal government.