Seeking a cure for legal headaches

Apr 18th 2005
From The Economist Global Agenda

The world’s leading drugmakers face a growing threat from generic-drug manufacturers, a faltering pipeline of future blockbuster medications and a poor public image. Several court cases are highlighting their battles to stay healthy in the long term

FOR an industry that purports to make its customers well, “Big Pharma” has its fair share of ills. Last week, Eli Lilly saw off a legal assault by generic drugmakers on one of its blockbuster medicines, giving heart to other patent-holders that face similar attack. But an adverse decision for the big drug firms in a case to be heard before America’s Supreme Court on Wednesday April 20th could add time and expense to the development of blockbuster drugs—just as the supply of potential new medicines rebounds. And soon, personal-injury lawsuits related to Vioxx, a failed blockbuster sold by Merck of America, will come to court, showing the potentially huge costs of getting things wrong.

Big drug companies are struggling with a central plank of their business model: patent protection for branded drugs. A judge ruled last week that Eli Lilly’s patent on Zyprexa, a treatment for schizophrenia, remained valid despite attempts by three generic-drug companies—America’s Ivax, Israel’s Teva Pharmaceuticals and India’s Dr Reddy’s Laboratories—to persuade him otherwise. The “composition of matter” case turned on the fundamental molecular build of the drug. The judge decided that olanzapine, the active ingredient in Zyprexa, was suitably dissimilar to another compound developed by Lilly that is now out of patent protection.

The result is a huge relief for Lilly. Zyprexa provided it with $4.4 billion in sales last year, a third of its total. And Lilly knows suffering at the hands of generic drugmakers. In 2000, when its patent on Prozac was cut short by three years after a court ruling in favour of non-brand predators, its shares plunged by 30% in a day. But it may yet need a handful of its famed anti-depressant: an appeal in the Zyprexa case seems likely.

The ruling will cheer several other companies facing similar assault in America. Pfizer’s Lipitor, a cholesterol medicine, and Plavix, a blood thinner produced by Bristol-Myers Squibb and Sanofi-Aventis, will have their patents challenged later this year or early next.

In general, composition-of-matter lawsuits are considered harder to win than other avenues of attack employed by generic drugmakers to hack away at the thicket of patents that guard blockbuster medicines. That is because branded drugmakers deem patents covering molecular structure to be their most prized, and thus work harder to make them bomb-proof and fight harder when they are threatened. The outcome of the two cases later this year will shed more light on where the balance of power lies between Big Pharma and the generic upstarts.

The case coming before the Supreme Court this week will highlight another area of weakness for the big drug companies. New drug launches have slowed to a trickle in recent years. The number approved by America’s Food and Drug Administration (FDA) fell to a low of 18 in 2002 compared with an average of 59 in the previous three years, though the number rebounded to 34 in 2004. The costs of testing new drugs have spiralled in recent years, and if Integra LifeSciences prevails in its case against Merck, a German drug firm (no longer related to its American namesake), these could escalate.

The case concerns exemptions on patent protection for certain compounds. Drugmakers are allowed to use compounds patented by rivals if it hastens FDA approval for their own drugs. However, in a case first brought before the courts in 1996, Integra claims that Merck infringed its patent on peptides by using them more widely than merely to assist in securing approval for a new medicine.

Merck is supported by many of the big drug companies—despite being the alleged patent-infringer in this case; Lilly, Wyeth and Pfizer have filed supporting briefs to the Supreme Court. The drug giants fear that a victory for Integra would make drug development more complicated, perhaps adding several years and many millions of dollars before products could come to market.

Disreputable or misunderstood?

Big drug companies have also suffered several blows to their reputations in recent months. Quite apart from a general public perception that they are vastly profitable because they charge too much for their wares, they have been hurt by the forced withdrawal of high-profile drugs and a growing suspicion among consumers about their ethics.

In a court hearing last week, the American Merck argued for the dismissal of the first personal-injury lawsuit brought against Vioxx, a heart medicine. Merck withdrew the drug in 2004 after it was linked to increased risk of heart problems in some patients. The case, the first of many, will come to court in May, and Merck will have to pay out an estimated $15 billion if all the claims against it are successful. And last week Pfizer was forced to withdraw Bextra, a painkiller that contributed 2.4% of its revenues in 2004, after it was linked to a rare but fatal skin complaint.

Eliot Spitzer, New York’s attorney-general, launched a lawsuit last year against GlaxoSmithKline (GSK) for allegedly suppressing data linking anti-depressants to the risk of suicide in children. This prompted initiatives by some drug firms to disclose clinical-trial results. GSK is facing a class-action lawsuit in America from investors who allege it concealed problems with Paxil, an anti-depressant.

The failure of a single blockbuster can have serious consequences for a drug firm’s finances and reputation. An adverse court ruling can delay future blockbusters—and the threat from generic competitors is anyway never far away. At the moment, the world’s pharmaceutical giants seem to be holding their own in court. They will be glad that the hefty profits on offer in the business have enabled them to retain the very best legal counsel. But smart lawyers alone will not keep them on top.

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