PHM-Exch> Delhi High Court Judgement

[Dr.B.Ekbal]

The recent Delhi High Court verdict on the patent case between Roche and
the Indian Company Cipla may have positive implication on the Novartis case
now being heard in the Supreme Court.  Along with the Compulsory Licensing
granted to the Indian Company Natco Pharma's cheap generic drug against
Bayer’s branded costly product Nexavar the present Delhi High ruling is
also historical. In the Nattco case it was for the first time that the
Patent Controller General granted compulsory licensing in India though
developing countries like Thailand had issued 7 compulsory licensing till
very recently.

The Delhi High Court case was the first patent case in India under the
patent regime implemented from 2005 onwards. Roche was marketing the drug
Tarceva for management of advanced or metastatic non small cell carcinoma
of lung in India from 2007 onwards. The drug costs Rs 4800 per capsule and
Rs.1, 44,000 for one month’s course of treatment. Tarceva is the brand name
of Erlotinib which acts by inhibiting the epidermal growth factor for which
Pfizer holds the original patent from US and European Union Patent Offices.
Roche is licensed by Pfizer to market the drug in India and subsequently
got the patent rights in India in 2007.

Meanwhile, Cipla announced that they are going to market the generic
version of Erlotinib priced Rs 1600 per capsule i.e. Rs 48,000 for a
month’s treatment. Roche then filed the case arguing that Cipla for
violating the rule 48 of the Indian Patent Act which gives exclusive right
to the patentee of a product to prevent any third party from non consensual
usage of the product.

Cipla opposed Roche’s case by invoking rule 3(d) of the Indian Patent Act
to argue that the Erlotinib is not a new drug at all and hence the patent
given to the drug is not valid. This drug is only an improvement of the
existing “prior art” as Quinazoline compound that inhibits growth factor.
It is a derivative of a known compound and hence not patentable under
section 3(d) of the Indian Patent Act. Cipla also pointed out that the
patented product is a derivative of Gefitnib of Astra Seneca for which
patent was refused in India on the ground that the compound was already in
public domain.

The Delhi high court accepted Cipla’s arguments and gave a verdict against
Roche. The Delhi High Court ruling in effect endorsed the validity of rule
3(d) and hence will have strong positive impact on the Novartis case on
Gleevec.

 Ekbal

-- 
Dr.B.Ekbal
Kuzhuvalil House, Arpookara East,
Kottayam-686 008, Kerala
Phone: 0481-2598305
Mobile: 94470 60912
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