A furore has been created by a recent Supreme Court Ruling on a patent application by NOVARTIS in India which was rejected by the court.
Evidence in a widely cited study by the National National Institute of Health Care Management in USA on Changing Patterns Of Pharmaceutical Innovation is telling between 1989 and 2000 the US food and Drug Authority approved 1,035 new drug applications - of these -
65% contained ingredients that were already active in the market (ie .incrementally modified drugs)
11% were Identical
15% were considered "highly innovative drug".
Now what we have to note is that mischief like this results in a patent thicket around a single molecule to delay generic entry . Indi is the leading global drug supplier of bulk drugs ,formulations and generic Anti retrovirals (ARV),more than that domestic worry of affordability of drugs was a main factor . Further it was stated that "the efficacy is a pharmacological idea associated with the ability of a drug to produce a desired therauepetic effect independent of potency ie."healing of diesease" again changing the making something more soluble or changing its properties (ie.flow properties, thermodynamic stability ) would not qualify it as an improvement . and the learned Court further says "there is absolutely nothing on this score (ie increased healing ) apart from the adroit submissions of the counsel".
Now please read the following link if interested
Any for and against opinions are welcome - was this a fair ruling or not ?