Pharmacueutical industry faces fresh pressure on intellectual property

Expect new pressures on the pharmaceutical industry when it comes to protecting the patents on their product portfolio.

In some territories such as China the situation is far from clear from the legal point of view. But even if a pharmaceutical company feels it has a strong case, the real question is whether the corporation has the moral strength to pursue a court battle.

As we saw in the collapse of a prominent legal battle in S Africa over the use of generic drugs against HIV, the industry as a whole shows little appetite for big, highly publicised legal cases.

The more urgently needed a drug is to help save lives in the poorest nations, the greater the probability that the patent owner will be under pressure to allow other manufacturers to make and sell more or less at cost, or to cut their own market price.

Future blockbuster drugs are therefore more likely to be those which are targetted at developed markets, for lifestyle or chronic conditions.

In the meantime the cost of developing a new drug is approaching $1bn, and the time needed for the whole process of discovery through to marketing can be as long as 15 years, further eroding the 25 year protection interval for exploitation of a discovery.

Olive oil antiinflammatory effect

Interesting report in New Scientist recently showing that 50mls per day of olive oil in the diet is equivalent to a dose of ibrupfofen.  We are increasingly recognising the impact of diet on disease processes.  Expect to see new ranges of neutraceuticals:  products with nutrition as well as therapeutic effects.  Many of these will be artificial creations such as bananas which contain a vaccine.

Threat from generics in an online world

A few months ago there were two prices for Cipro online: the price in New York $5 a tablet, and in Delhi 35c a tablet.

One was made officially, the other was an "illegal" generic.

In the old days before the web such a thing would hardly have mattered so long as generics stayed in emerging economies where sales of the high priced alternative would have been almost zero.

But in the net world, with Fedex and other carriers able to carry packets in a day, and customs / regulators overwhelmed, more or less any medicine can turn up in any country from any source.

Expect countries like India and China to tighten up their intellectual property regulations, while other emerging nations quickly fill the gap as safe havens for unauthorised generic manufacturing.

Why pipelines are so empty

Around 75% of all pharmaceutical research spending is by the very few largest companies, while around 66% of all new innovation is being carried out by many hundreds of smaller independent biotech startups and similar organisations. In many pharma companies most of their work is still driven by extending the functionality and patent protection of existing therapies.

Meanwhile it now costs over $800 million to bring a new drug to market, and can take 15 years. The entire model is becoming unsustainable. Expect significant reforms and changes in pharma structure over the next decade.

Inventing disease or true unmet need - accusations against pharmacuetical industry

The future of the pharmaceutical industry will be dominated by innovation, much of it biotech driven.  But success depends on linking new product innovation to genuine unmet need.  The accusation is that some pharma companies have been inventing new treatment areas and diseases to maximise revenue from drugs that would otherwise have low sales.

 

However, at the end of the day the only real judge of unmet need is the person who is suffering.  As a physician myself I know how blind doctors can be to the true toll of illness on those who come to them.  An obvious example is the relief of pain in hospice medicine (my own specialty in the days when I was a practising doctor).  The entire hospice movement has been created in part to solve a nightmare for cancer patients – untreated pain and other major symptoms, despite the fact that many highly effective therapies are available.  Doctors are often ignorant, or afraid to ask the questions and patients often hold back from revealing the truth.  The reasons for these things are complex, but this is just one example where surveys of unmet need show huge differences between what doctors think is happening, what patients tell their doctors about and what patients actually experience.

Future of the Pharmaceutical Industry

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