Generic firms take on Bristol-Myers, Sanofi

Reddy's recent challenges have resulted in a string of failures.

Last month, the company lost in a patent challenge over Zyprexa, a treatment for schizophrenia.appeals court upheld Bayer's (up $0.09 to $34.30, Research) patent for antibiotic Ciprofloxacin.

Chandramouli does not own stock in the companies mentioned in her report and Merrill Lynch doesnot conduct banking with them.

. ruling for the generic companies," wrote Chandramouli, who rates Dr. Reddy's and Apotex in 2002.subsidiary won a challenge against the patent for Paxil, an antidepressant made by GlaxoSmithKline.

Apotex spokesman Elie Betito and http://www.everydayhealth.com/drugs/ondansetron a lawyerrepresenting the company declined to comment on the new case.

William West, a patent litigation attorney and partner with Howrey LLP, said the generic companies"win occasionally." But patent law tends to favor the patent holders, allowing them to file multiplepatents from a single drug while its patent is still in litigation, increasing the burden for thechallengers. Reddy's had challenged the patent with two other generic firms, Teva and ZenithGoldline, a unit of Ivax Corp (up $0.01 to $19.51, Research).

In 2002, a U.S. battle over Plavix, said Brian Henry, spokesman for Bristol-Myers. In her report,Chandramouli cited the 2004 loss of Teva Pharmaceutical Industries (up $0.15 to $34.08, Research),an Israeli maker of generic drugs, in a challenge to the same drug patent.

But Ram Rammohan, spokesman for Dr. Reddy's Laboratories Ltd. court shot down Dr. In 2002, aU.S. But Dr.

"In theory it's supposed to be balanced," said West. Reddy's would win in a separate district courtchallenge for the patent on Zofran, an anti-nausea drug produced by GlaxoSmithKline (up $0.32 to$49.72, Research). court rejected Dr. In 2004 a U.S. Following a lengthy series of court actions, thecase is getting closer to a jury trial. Reddy's patent challenge to Pfizer's (down $0.67 to $28.23,Research) Norvasc, a treatment for hypertension. court.

"With the Canadian patent for Plavix being recently upheld, we remain less confident on a positive

U.S. court with U.S. (up $0.05 to $16.32, Research), an Indian maker of generic drugs, has beeninvolved in at least 26 patent challenges.

NEW YORK (CNN/Money) -

Bristol-Myers Squibb and Sanofi-Aventis are preparing to defend their patent on blockbuster Plavix,an anti-stroke blood thinner, in a New York district court this week against two generic drugmakers: Dr. Reddy's and Apotex.

Who's going to win?

Generally, generics exploit legal loopholes in order to claim that a patent is invalid. "The standardsfor proving any patent invalid are higher than a normal civil case. The companies involved in thecase are required to submit all pre-trial hearing statements to the Southern District of New York byFriday, May 27.

Bristol-Myers (down $0.07 to $25.53, Research), the zofran lawsuit commercial U.S.-based salespartner for Sanofi, cannot afford to lose control of the patent for Plavix, which made $3.3 billion forBristol-Myers last year, especially since its patent on Pravachol, a $2.6 billion cardiovascular drug, isset to expire in 2006.

Bristol-Myers is not using Apotex's failed challenge in Canada as a testing ground for the U.S. "Inpractice, I think it's been skewed a little bit in favor of the patent holders."

Mark Banner, patent litigation attorney and partner with Banner Witcoff, said that drug patents aremore difficult to challenge that many other forms of patents.

"[Drug patents] are complicated, as opposed to a patent on a railroad car or a patent on a newbicycle accessory," said Banner. Reddy's as a "sell," in an April 15 report.

Chandramouli also expressed doubts that Dr. Reddy's the right to manufacture a generic form ofProzac is the company's only successful patent challenge since the company was founded in 1984,according to Chandramouli.

The Canadian Federal Court of Ottawa rejected a separate challenge of the Plavix patent, held byFrench drug-making giant Sanofi-Aventis (down $0.23 to $45.61, Research), by Apotex Inc., aCanadian generic manufacturer. The more complicated the technology, the more difficult it's goingto be for the challenger to prove it's invalid."

Dr. A district court judge in in Indianapolis ruled in favor of patent holder Eli Lilly and Co., whichmade $4.4 billion from Zyprexa in 2004. Reddy's has lost most of its court battles in recent years,eroding its chances of winning this Plavix challenge, according to Merrill Lynch analyst VisalakshiChandramouli.

A 2001 win giving Dr. "One can't make the comparison between the two."

Apotex Inc., a privately held firm, had better success last year, when its U.S. law," Henry said. Dr.Reddy's, said that judging his company's future success based on lost patent challenges is"speculative in nature."

"We are confident about the merits of our case and, as it is in all patent litigation cases, it is only

proper to await the court judgment," said Rammohan in an e-mail.

Sanofi-Synthelabo, a unit of Sanofi-Aventis, counter-sued Dr. "That case was decided in Canada withCanadian law and this case will be decided in a U.S. Reddy's challenge to AstraZeneca's (up $0.09 to$42.91, Research) patent on Prilosec, a medication for ulcers and heartburn. Chandramouli believesthis precedent will make it harder for the challengers to succeed in a U.S. Dr