March 8, 2006 at 09:39:55

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Genentech and Biogen Legal Troubles - When It Rains It Pours

By Evelyn Pringle (about the author)     Page 3 of 4 page(s)

opednews.com     Permalink

In any event, Genentech did not have much time to celebrate its good fortune before receiving another dose of bad news on February 21, 2006, when the US Supreme Court agreed to consider allowing a lawsuit by drug maker MedImmune Inc. to go forward that seeks to end royalties the company pays to Genentech on its drug Synagis, according to a report by the February 22, 2006 Washington Post..

MedImmune's lawsuit alleges that Genentech illegally obtained a patent on an antibody synthesis technology used in the production of Synagis, a drug that prevents certain respiratory infections in babies.

MedImmune claims Genentech and British biotechnology firm Celltech R&D Ltd. improperly schemed to obtain a patent on antibody technology, in violation of antitrust laws and MedImmune wants the patent invalidated, according to Mercury News on February 21, 2006.

Several companies use manufactured antibodies as the basis of new drugs. In return, the companies pay Genentech licensing fees under patents known as "Cabilly." That includes MedImmune, Mercury says, which uses antibody technology for Synagis which had sales that topped $1 billion worldwide last year.

Genentech obtained a Cabilly patent in 1989 that was set to expire in 2006. In 2001, it acquired a second patent through negotiations with Celltech, which had a similar patent. The second Cabilly patent is good through 2018.

MedImmune claims Genentech violated antitrust law, the Post says, "by colluding with a British biotechnology company in obtaining an extension on the antibody production patent, and MedImmune is seeking to have Genentech's patent declared invalid."

The Supreme Court will not hear the case until the fall term.

On March 2, 2006, yet another problem for Genentech became public knowledge when Reuters reported that Swiss drug maker Roche Holding AG, the majority owner of Genentech, said it would brief health-care regulators on rare cases of a brain condition seen in some patients taking its blockbuster cancer drug Avastin.

According to the New England Journal of Medicine, two women developed reversible posterior leukoencephalopathy syndrome, or RPLS, while on Avastin. Both patients later recovered from the condition, which according to Reuters, can lead to blindness and other complications.

Genentech spokeswoman Colleen Wilson told Reuters the company informed the FDA last year about one case of RPLS and learned of the other case from the journal.

She also said Genentech is investigating a third possible case and that the company would not know how frequently it occurred until it reviewed its safety database for further possible cases.

And last but not least, Biogen Idec has legal problems of its own. In January 2005, its drug Tysabri was the hottest new development for treating MS. The drug gained fast-track approval from the FDA after just one year of clinical trials, when typically two years are required and seemed so promising that Larry King did a show on the drug.

According to the FDA, at the time of its approval in November 2004, approximately 1,100 MS patients had received Tysabri for one year or more.

Four months later, on February 28, 2005, the joint makers of Tysabri, Biogen and the Elan Corp in Dubland, Ireland, told the FDA they were taking the drug off the market and suspending clinical trials because 3 patients were diagnosed with progressive multifocal leukoencephalopathy, or PML, a disorder that usually only affects people with weakened immune systems, such as AIDS patients, and 2 of the patient had died.

On July 1, 2005, News Inferno.com reported that Tysabri had now been linked to 5 cases of PML.

According to WebMD, "PML is a progressive disease of the brain and spinal cord that primarily affects people with weakened immune systems."

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