LONDON (Dow Jones)--French drugmaker Sanofi-Aventis SA (SNY) said Friday it lost a court case against two generic drugmakers that have been attempting to sell cheaper copies of Lovenox, its top-selling drug.
Although the patent protecting Lovenox doesn't expire until 2012, Amphastar Pharmaceuticals and Teva Pharmaceutical Industries Ltd. (TEVA) have been planning to launch generic copies of the drug in the U.S.[provided of course that they get FDA approval to do so].
The trial was to determine whether Sanofi-Aventis engaged in so-called inequitable conduct when it initially filed the Lovenox patent.
Sanofi-Aventis said in a statement it is currently evaluating its options for further legal recourse. A company spokesman declined to elaborate on Sanofi-Aventis' plans or the available legal options following the unfavorable court ruling.
Lovenox, a blood thinner, is the company's best-selling drug, with sales totaling EUR2.15 billion in 2005.
At 1123 GMT, Sanofi-Aventis shares were down 1.5%, at EUR66.8 in a higher Paris market.
Collins Stewart analyst Navid Malik said that while at the moment no generic drugmaker has regulatory approval to sell the blood thinner in the U.S., Lovenox's intellectual property has significantly diminished with the outcome of the trial.
Swiss private bank Vontobel said the risk of a generic version of Lovenox is real and makes an eventual takeover of Bristol-Myers Squibb Co. (BMY) by Sanofi-Aventis ever more likely.
Jerome Berton, an analyst with French brokerage Aurel Leven, expressed surprise about the outcome of the ruling but noted that in addition to legal barriers, there are further regulatory and manufacturing hurdles that can help protect Lovenox against generic competition.
Proving inequitable conduct - which may include the submission of incomplete documents when applying for a patent - could invalidate the entire patent.
Still, generic drugmakers may have to struggle to get Lovenox copycats approved by the U.S. Food and Drug Administration. The drug, which is derived from pig intestines, requires a complex manufacturing process that is difficult to duplicate.
Lovenox is also under threat by generic drugmaker Momenta Pharmaceuticals Inc (MNTA), which has teamed up with Sandoz, a unit of Swiss drugmaker Novartis AG (NVS).
As well as Lovenox, Sanofi-Aventis is defending its second-best selling product, Plavix, in a U.S. court. <<
One of Cambridge's highest-flying young biotechnology companies savored a win in patent court yesterday, but in a perverse twist watched its stock drop 20 percent as Wall Street digested the news.
Momenta Pharmaceuticals Inc., a 150-person firm, is trying to develop a generic version of the blood-thinning drug Lovenox, one of the world's top-selling drugs, with more than $2 billion in annual sales.
Yesterday, Lovenox's maker, French drug giant Sanofi-Aventis SA , said a California judge had thrown out its patent on the drug. The patent had been challenged by two other companies [TEVA and Amphastar] that want to launch generic versions.
An analyst for Deutsche Bank yesterday wrote that the decision "removes the first essential legal obstacle" for Momenta's drug to reach the market.
Although Momenta isn't the only firm trying to make generic Lovenox, many analysts believe its scientific expertise gives it an advantage over competing companies.[What matters, of course, is what the FDA believes on this point and there is not yet any evidence of that.] Momenta was founded in 2001 on technology created at MIT -- a unique way of analyzing the structure of complicated sugars such as Lovenox. Understanding the structure is crucial to developing a copycat version of a drug.
Other obstacles remain, however. The largest is the Food and Drug Administration, which must sign off on any new generic. The agency has not issued guidelines for approving a generic version of a drug as complex as Lovenox. Without guidelines, it is unclear whether such a drug could get approved. Momenta applied to sell generic Lovenox in August 2005 and still has not gotten a decision.
In an interview yesterday, Momenta chief executive Craig Wheeler said talks with the FDA were on track, and he expected to win approval this year.
Yesterday, either because of profit-taking or skepticism about the company's chances with the federal agency, shareholders sold the company's stock. Momenta shares dropped $4.03 or 20 percent, to close at $16.10. <<
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