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    Patent exclusivity ensures growth of medicines
Feng Danlong
2004-05-31 06:38

Being in good health and away from disease are two of the greatest aspirations of the global population. And supporting strong patents for medicines throughout China and the world helps ensure the possibility.

Without strong patent protection, there simply would be no research-based pharmaceutical industry, which discovers and develops virtually all new medicines.

Innovation would stop and patients would be without new life-saving, cost-effective medicines.

If the research and development sector is the horse pulling the whole cart of the pharmaceutical industry, then intellectual property protection is the carrot rewarding the horse.

Patent protection is the essential element underlying the success of pharmaceutical industry.

Developing new medicines is generally hard work, and it's getting increasingly expensive and uncertain.

A new drug often costs more than US$800 million to develop and it is an uncertain process.

For every 5,000 to 10,000 compounds screened for development, just 250 proceed to pre-clinical testing and only five enter clinical testing. One will result in an application to file for regulatory approval.

And fewer than half the number of new drugs that enter the most expensive phase of clinical testing, so-called Phase 3, actually result in applications for regulatory approval.

In turn, the discovery of new medicines depends on intellectual property protection throughout the world.

Patents make a difference to medicine, economy, patients, and ultimately, development of the pharmaceutical industry.

Where inadequate therapies exist, patents provide the incentives to invest in the search for new medicines.

In places where weak patent protection exists, patients and their doctors are less likely to have access to many new medicines and the newest and most effective technologies.

Patents also make a difference to economy. Countries that adopt strong intellectual property protection attract more investment than those that do not.

As well, patents encourage innovation and offer hope to people who need new treatments.

New drugs come to patients because companies can invest in the years of research and the millions of dollars needed to identify effective treatments, test them thoroughly, and bring them through the regulatory approval process.

Patents are the rewards at the end of the expensive and time-consuming journey of discovery. Patents only give an inventor a limited period of exclusivity to make and sell an invention in exchange for agreeing to disclose data about the invention, which encourages the information sharing and continuing scientific progress.

Counterfeiting is a serious infringement of intellectual property right. As counterfeits put the health of patients at risk, they can also lead to a loss of confidence and trust in medicines.

Even if there is a counterfeit product on the market that has the same active ingredients, the product is still not safe because it is unregulated. That drug has no quality control; the company has no responsibility to any regulatory authority. The patient has no ability to self-regulate and determine whether the product is, in fact, what it says it is.

This is an extraordinary moment to consider patents in the pharmaceutical industry, for several reasons.

First, the industry needs to fund research that will turn information generated by human genome research into therapeutically valuable products.

In this highly competitive industry, the pharmaceutical firms are mobilizing to pursue opportunities posed by the multitude of new therapeutic targets identified via genome sequencing.

Second, an increasingly global market for products is placing greater importance on patent protection around the world.

The World Trade Organization (WTO) and many other international trade agreements are taking important steps towards global patent protection and enforcement.

Third, counterfeit medicines are an increasing threat to global health.

Once a drug is discovered and developed, it may be relatively easy to copy and counterfeit. Patents may be more important to the pharmaceutical industries than other areas.

Finally, as more people in the world are reaching record life expectancies, chronic diseases associated with aging are quickly replacing infectious diseases as the primary health problems.

If the pharmaceutical industry is allowed to pursue these illnesses in an environment that includes strong, uniform patent protection, I am confident we will also conquer these chronic, life-limiting illnesses.

China's entry into the WTO has compelled the country to start to bring intellectual property regulations in line with international standards.

At the recent national patent conference, Vice-Premier Wu Yi emphasized carrying out the strategy of intellectual property and improving the system of intellectual property protection.

We are pleased that over the last two decades China has made significant progress in improving intellectual property protection.

(China Daily 05/31/2004 page5)