[Ip-health] Haddad: World Watches as Indian Hig h Court Allows Cipla to Market “Patented” Cancer Drug

[robert weissman]

Bill Haddad asked me to post the following write-up on the Indian court
decision on Erlotinib/Tarceva.

Robert Weissman

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World Watches as Indian High Court Allows Cipla to Market “Patented”
Cancer Drug
Bill Haddad
March 28, 2008

In a historic ruling, India’s Delhi High Court will permit Cipla, Ltd to
market a currently patented expensive anti-cancer drug potentially
opening the door to other challenges and disengaging India from the
World Trade Organization’s restrictions on use of generic drugs.

In an interim order, the High Court denied Hoffman La Roche’s action to
block Cipla’s right to manufacture and market “Tarceva” (Erlotinib), a
cancer drug currently required … and unaffordable … to more than 160,000
patients in India. In its interim decision the High Court said Erlotinib
should be made available based on the dramatic price differences between
the generic and brand price.

High Court Ruling “Tilts” In Favor of the People
The Economic Times of India noted “the Court said the balance has to be
tilted in favor of the people when the interest of the company
manufacturing the drug and that of those using it is compared.” Cipla
reduced the price of Tarceva by two-thirds.

Erlotinib is required for patients suffering from advanced or
metastatic, non small cell lung cancer.

Roche had been granted a patent by India’s Controller General of
Patents. Roche said it sued to block Cipla when it learned Cipla was
planning to launch the generic version. Cipla’s generic version,
Erlocip, is currently being sold in India.

The Court instructed Cipla to keep records of Erlocip’s sales as a basic
for compensating Roche if the company succeeds in its challenge. The
Court allowed Roche four weeks to file a counter-claim.

India’s Patent Law Key to Cost of Generics Worldwide
As the first test case of India’s new patent regime, the case is being
closely watched by pharmaceutical firms and consumer organizations
throughout the world. If Cipla succeeds in its patent challenge, it
opens the door to similar challenges … and lower prices … throughout the
world.

If India’s patent laws are upheld, two-thirds of the world’s population
will be systematically denied access to affordable medicine. The change
in the long standing Indian patent law was mandated as the price for
India’s admission to WTO. Under the changed law, any drug entering the
market after January 1, 2005 will enjoy a minimum of twenty years of
monopoly. Many affordable AIDS medicines will be included in that ban.

Until it joined the WTO, India was legally able to manufacture generic
clones of brand products when it could do so without infringing the
patent. Under the old patent law, India became the principle supplier of
affordable medicines for the Third World.

Cipla Dramatically Reduces Cost of AIDS Medicines
Under that law, Dr. Yusuf Hamied, Cipla’s Managing Director, combined
the three most successful ARVs for AIDS into one tablet taken twice a
day eliminating the complicated brand regime of a dozen tablets/capsules
taken at various times of the day and selling for $15,000 a year. Cipla
reduced the initial price to a dollar-a-day.

The Cipla triple, cloned by other generic companies, became WHO’s
recommendation for first line AIDS treatment. The “triple” now sells for
under $100 a year. Almost a million patients now use the triple (out of
1.5 million in treatment in Africa). Last year Cipla created the first
pediatric triple which sells at $50 a year.

President Bush in his 2003 State of the Union cited Cipla’s success as
the rationale for a fifteen billion dollar AIDS contribution.

The Doha Agreement and the initial WTO arrangement mandated that poor
nations could manufacture essential medicines required in times of a
medical crisis. Political roadblocks have prevented almost all poor
nations from exercising that right … a right many exchanged for their
participation in WTO.

Under a still-to-be explained action and based on an obscure United
Nations definition, with one exception, all nations with populations
over seventy-five million were excluded from a provision that allowed
existing national pharmaceutical laws to remain in place until 2016.
That provision forced India and China, the principal Third World
suppliers of affordable medicines, to change their patent laws. In India
the new law eliminated post-1995 generic medicines from reaching the
world’s poor nations.

Cancer Victims Hail Court’s Interim Judgement
Chairman Y K Sapru of Indian Cancer Patients Aid Association said “The
judiciary has given preference to the right of a human being to live
over all other rights enshrined under the Constitution of India.”

William (Bill) Haddad, wfhaddad@aol.com