We must protect drug innovation

January 5, 2009
Thank you for shining light [in your Dec. 15 editorial] on the negative effects of unrestrained litigation by generic medicine marketers, aimed at breaking hard-won patents on branded prescription drugs. Anyone interested in pharmaceutical innovation needs to keep in mind several related points:

Without the enormous investments of time, money, intellect and energy by research-driven pharmaceutical companies, there would be no drugs to become generic. In fact, once patents expire, the pharmaceutical innovators make incredible gifts to the world of unpatented drugs that can be made and sold by anyone, anywhere. The generic companies do no research and contribute no new medicines to the world.

The tsunami of patent-breaking litigation unleashed by the Hatch-Waxman Act has created a disorderly market, in which innovative pharmaceutical companies cannot depend on the duration of patents to drive their business and research plans. Unpredictable loss of patent protection for several of its major drugs could sink an otherwise healthy company into bankruptcy.

As the editorial implies, there is urgent need for revision of the Hatch-Waxman Act, so that research-driven pharmaceutical companies can invest in drug development with some confidence that they may be able to recoup their investments and fund future research. Intellectual property must be protected through fair, stable, enforceable patent laws. Ceaseless litigation to protect patents costs money that would be better invested in R&D.

The pharmaceutical industry is under massive pressure to reduce the cost of prescription drugs. Powerful forces are driving down sales, having drugs withdrawn from the market, spreading questionable information about drug safety, hindering registration of drugs, limiting sales and marketing, restricting contact with physicians, requiring extensive post-marketing research, etc. The environment is so negative that Procter & Gamble recently announced it will cease all pharmaceutical R&D, despite its successful portfolio. Is this a sign of a future in which there is no business case to invest in developing medicines?

If the highest and only goal is cheap medicines, then there will be a "race to the bottom," in which we will see an even higher portion of our medicines made in India and China, countries with weak mechanisms for testing and quality control of medicines. Remember melamine in milk? Poisonous heparin? In the case of medicines, "cheap and safe" may be an oxymoron.

It is in the best interests of the American people for the United States to have a vigorous, creative, innovative, financially healthy pharmaceutical industry. Without government attention to its preservation, our pharmaceutical industry may go the way of Europe's-somewhere else.

Dr. Hunter Heath III
Hunter Heath Consultancy LLC

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