Call for longer drug patent life

The pharmaceutical industry should fight a major battle to prolong patent protection and encourage real innovation and discovery, a leading pharmacologist told a Melbourne audience last week.

"If you invented a drug 50 years ago, in two or three years you were on the market. You had 17 years of patent protection," said Paul Vanhoutte, who is president of the International Union of Basic and Clinical Pharmacology (IUPHAR) and director of the BioPharmaceutical Development Centre at the University of Hong Kong.

It now takes 12 years or more before a drug is on the market, and you have seven years of patent protection, he said.

"Most of those 20 years are being lost in regulatory demands and we end up spending $1 billion. How can we recuperate our investment except by asking very high prices?" asked Vanhoutte.

If patent protection was extended, he said, the industry could charge less for drugs and "make the generics industry obsolete".

"This is the most important battle the pharmaceutical lobby should fight," said Vanhoutte.

Reducing the cost of drugs

Vanhoutte said he also believed that unless the industry finds "ways to make smaller groups of patients more attractive from a financial point of view" the costs of drugs would keep escalating.

"That's a matter of negotiation with the regulatory authorities and the scientific community," he said. "After the Vioxx disaster, there will be new demands in terms of safety and exposure of patients."

Pharmacogenomics will provide a means to identify sub-groups of patients for whom a particular drug could work in 100 per cent of cases, said Vanhoutte. "This may make the bill much smaller," he said.

Vanhoutte also suggested that the promise of gene or stem cell therapies was over-hyped. "I remain convinced that gene therapy is, and will remain -- if it comes to fruition -- something for the very rich," he said. "The beauty of chemistry is that it provides sufficient material to help a very large group of people. With gene therapy and stem cells we are far away from a solution and it will, I predict, remain for a very select group of people."

Vanhoutte's years in Hong Kong have convinced him that the West can benefit from traditional Chinese medicine, particularly because if they are proven to be efficacious these medicines are far less expensive than Western drugs.

"Governments in emerging countries, in the People's Republic of China in particular, are pushing traditional medicines for a very simple reason -- it's cheaper," he said. For example, it costs the government 25 per cent less for patients with coronary artery disease to take a traditional formula compared with an equivalent drug from the west. "That's why they push it," he said.

However, the basic problem with Chinese medicine is standardisation, said Vanhoutte. "Today if you take one carrot, one tomato, one apple and one pear and you make an extract of that, tomorrow -- depending where you buy your carrot, your tomato, your apple and your pear -- you will have a different mixture," he said.

Another basic problem is that Chinese traditional physicians treat their patients very individually, which makes it "difficult to design a study where you can do a double blind control" or even to make a placebo, he said. Creating capsules "probably totally undermines the spirit of these traditional medicines," he said.

Vanhoutte and his team at the University of Hong Kong are designing mortality studies and clinical trials to try and prove the value of Chinese medicine.

'Nature has no imagination'

Vanhoutte said that as more powerful drugs were created, there needed to be better ways of delivering them to sick organs.

"One of the major challenges with very potent intracellular agents is to get them only to where we want them," said Vanhoutte. "Nature has no imagination and all cells in our bodies use the same tricks."

Drugs targeting intracellular agents such as kinases, which are used by every cell in the body, could produce horrendous side-effects, he said. "The deeper you go into the cell, the more dangerous the exercise becomes."

The big challenge, therefore, is to create drugs that are targeted, for example using receptor pharmacology, and reduce the risks of side-effects.

Biotech's fate

Vanhoutte said that in the last 15 years he had seen the "emergence and implosion" of many biotechnology companies. "In biotech, a company has two possible fates," he said. "One is apoptosis [programmed cell death], and the other is phagocytosis [being engulfed and destroyed by a cell]."

However, even if this is true, Vanhoutte believes in the invention and the human mind and "would hope that 1 per cent will be able to survive and grow up to be real companies."

"If that is the case, then the whole adventure is worth it," he said.

From 1995 until 2004, Vanhoutte served as the vice president of research and development and director of Discovery Research at the Institut de Recherches Servier. He has also held a variety of tenured positions at the University of Antwerp, the Mayo Clinic, and Baylor College of Medicine.

While in Australia, Vanhoutte received a doctorate from RMIT, and was a guest of the Harmonisation of Traditional and Modern Medicine Conference and the Australian French Association for Science and Technology.

He was speaking in Melbourne at a BioMelbourne Network function held in conjunction with the Australia-French Association for Science and Technology (AFAS), and sponsored by drug firm Servier.