[Ip-health] Boston Global Editorial on Novartis decision - US should [also] tighten rules for patenting changes to drugs
riaz.tayob at gmail.com
Thu Apr 11 02:37:45 PDT 2013
Better late than never as 40 million Americans join the ranks of the global
On 9 April 2013 22:00, Baker, Brook <b.baker at neu.edu> wrote:
> 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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