[Ip-health] Boston Global Editorial on Novartis decision - US should [also] tighten rules for patenting changes to drugs

Baker, Brook b.baker at neu.edu
Tue Apr 9 12:00:42 PDT 2013


US should tighten rules for patenting changes to drugs
  APRIL 08, 2013

THE RULING by India¹s 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 ³evergreening,² the
practice of tweaking existing drugs to prolong a firm¹s hold on a patent.
There¹s 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. It¹s time to reexamine the US patent
system, too.
Monday¹s verdict will have little impact on Gleevec¹s 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.
India, however, is the developing world¹s 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 can¹t 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.

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

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, doesn¹t need to stand in the way of more
checks on the evergreening of medicines.
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.

Professor Brook K. Baker

Health GAP (Global Access Project)
Northeastern U. School of Law
Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115 USA
Honorary Research Fellow, University of KwaZulu Natal, Durban, S. Africa
(w) 617-373-3217
(cell) 617-259-0760
(fax) 617-373-5056
b.baker at neu.edu


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