Two of the world's largest producers of biopharmaceuticals, Biogen and Serono, have been keeping their lawyers busy again with claims and counterclaims about the effectiveness of their respective interferon beta-1a products used by people with multiple sclerosis (MS; see p. 696). Both preparations are effective at the relapsing/remitting stage of the disease in reducing the severity or the frequency of relapses.

To an extent, though, Biogen and Serono now appear to be arguing about the number of angels that can fit on the head of a pin. The dispute concerns the result of a head-to-head trial indicating that patients on Serono's drug had fewer relapses over a six-month period than those on Biogen's. Biogen representatives have criticized the trial design, the data analysis, and its presentation. They have countered also with data that show their beta-interferon caused fewer immunogenic side effects. Biogen's lawyers have filed a criminal complaint asserting that Serono infringed an injunction preventing Serono from making “misleading claims” of superior efficacy. Serono then filed a civil complaint claiming that Biogen was trying to prevent dissemination of scientific data and manipulate the media. At stake for the companies is a slice of the US multiple sclerosis market. Biogen has two more years of market exclusivity in the United States under the Orphan Drugs Act—worth perhaps half a billion dollars a year to the company—and Serono can only gain access before that time if it can show that its drug has superior performance.

What both companies appear to have forgotten in their relish for a legal battle is that there are many people out there—in excess of 200,000 MS patients in the United States alone—for whom the stakes are significantly higher. No amount of vociferous and obnoxious legal jousting can obscure the reality that the Tweedledee and Tweedledum of beta-interferon are arguing over a rattle that, as a drug, is already broken. Both versions do no more than delay the onset of the more debilitating phase of the disease. They nudge the disease onto a more favorable, but still downward path. They do not stop it, or reverse it.

To be fair, both companies have potential MS treatments in the pipeline. Biogen, working with Elan, has an anti-autoimmune antibody in phase 2 trials. Serono has some small-molecule compounds under investigations through collaborations with British Biotech and Vertex. No doubt all these projects are receiving copious management attention. But that is not the impression that the legal wrangling gives.