Bayer’s writ petition states that Cipla’s generic version of Sorafanib, purported to be sold under the brand name “Soranib” would amount to a “spurious drug” under Section 17B of The Drugs and Cosmetics Act, 1940. This section provides as below:
“17B Spurious drugs – For the purposes of this Chapter, a drug shall be deemed to be spurious, –
(a) if it is manufactured under a name which belongs to another drug; or
(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or
(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or
(d) if it has been substituted wholly or in part by another drug or substance; or
(e) if it purports to be the product of a manufacturer of whom it is not truly a product.”
If Bayer’s contention is accepted, then every generic drug would ipso facto amount to a “spurious drug”, by virtue of the mere fact that they are substitutes of originator drugs! Such an interpretation is highly “ludicrous” and completely antithetical to the very purpose and spirit of the Drugs Act.
No doubt, the drug which Cipla intends to sell under the brand name “Soranib” would amount to a “substitute” for Bayer’s drug, sold under the brand name, “Nexavar”. However, the fact that the brand names are so distinct is enough to ensure that there is no confusion in the mind of a consumer purchasing these drugs.
Therefore under section 17B, Cipla’s drug, Soranib is likely to be “plainly and conspicuously marked” so as to reveal its true character and its lack of identity with the petitioners drug, “Nexavar”. It cannot therefore be labeled as a “spurious” drug, by any stretch of imagination.
Shamnad,
We were at the GW IP seminars at Delhi and were ‘fortunate’ to meet and hear the lawyer on one of the briefs – Mr. P. Anand.
A) The fact that the lawyer was discussing the case when the orders were ex-parte, is not appropriate to me;
B) On top of it, Mr. Anand was trying to argue that the decision was right and not one which was based on fallacious logic;
C) I am waiting for the March hearings since both the Cipla and Hetero orders were Ex-parte.
I know the above does not really take the discussion forward, but I wanted to put in public domain, the attitude and possibilities of discussing your clients’ open cases in public.
Regards,
Frequently Anon.