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US should tighten rules for patenting changes to drugs

The ruling by India’s supreme court to reject a patent for Gleevec, a powerful cancer drug, is a victory for patients seeking more affordable treatment. India has a woeful history of ignoring patents, but in this case, the court was rightfully skeptical of so-called “evergreening,” the practice of tweaking existing drugs to prolong a firm’s hold on a patent. There’s good evidence this kind of widespread patenting is impeding, not promoting, the search for new, more innovative medications — and driving up costs for American consumers. It’s time to reexamine the US patent system, too.

Monday’s verdict will have little impact on Gleevec’s maker, Novartis, which says 95 percent of patients using Gleevec in India do so free of charge. Gleevec is patented in 40 other countries, yielding about $5 billion in profits annually.

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India, however, is the developing world’s low-cost pharmacy, with its generic-drug industry exporting $10 billion worth of medications annually. Copycat versions of antiretrovirals, for instance, have helped cut the cost of HIV treatment in poorer nations by roughly 99 percent over the past decade. Gleevec generally costs $70,000 annually, but the Indian generic version goes for $2,500. By allowing Indian firms to keep producing the lower-priced generic, the court granted a much-needed reprieve to cancer patients who can’t afford Gleevec.

India agreed to enforce patents in order to join the World Trade Organization but, conscious of its role as low-cost supplier, has traditionally set the bar higher for patent approval than most developed nations. It is, in part, a deliberate move to prevent evergreening by establishing that a fresh patent will only be approved if a drug maker can prove a modified version shows much improved efficacy over an existing compound. Novartis, the court said, did not.

The United States, on the other hand, has loosened its patent qualifications since the 1980s, and while the number of patents for genuinely new pharmaceutical products has dwindled, the total number approved has more than doubled. Nearly two-thirds of drug patents approved from 1989 to 2000 were for incrementally modified, or evergreened, medicines, according to the National Institutes of Health Care Management.

Indeed, groundbreaking science appears to be taking a back seat to extending already profitable franchises for many drug makers: A Boston University study found that the number of researchers and scientists employed by pharmaceutical firms has declined steadily since 1995, while marketing positions are up by 60 percent.

Drug makers maintain that the profits they reap from patents are plowed back into research and development; the cost of developing a new drug can reach $1 billion. The United States, for one, is right to insist upon stringent patent protection rules from countries that want to benefit from American biomedical discoveries. India should be no exception. Protecting intellectual property, however, doesn’t need to stand in the way of more checks on the evergreening of medicines.

It may also be true that the US health care system is wasting money on new forms of old drugs.

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American patients are often asked to subsidize the rest of the world by paying far higher prices for medicine than anywhere else in the world. Yet it may also be true that the US health care system is wasting money on new forms of old drugs. Recent studies suggest that eliminating secondary patents could free as many as one-third of new medicines for generic production, bringing down costs for American consumers by up to 85 percent.

Patents can often spur innovation, but granting second and third patents on the same drug may be standing in the way of future cures. For patients who need affordable treatment — inside and outside the US — the wait has been too long.

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