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EGA Press Release

Thursday, 10 November 2005

A CALL TO REVIEW THE PATENT SYSTEM

Greg Perry, Director General of the European Generic medicines Association (EGA) called today for a sweeping review of the current system of patents to eliminate abuses and to ensure a more ethical use of the world’s technological heritage.

Speaking today at the World Science Forum, organised in Budapest under the title “Knowledge, Ethics and Responsibility”, Perry reiterated his view that pharmaceuticals — both innovative and generic — play a vital role in healthcare policy throughout the world. While recognising that patents can play an important role in encouraging pharmaceutical innovation, he went on to point out that justified public concern is building against the accumulation of multiple patents and other forms of IP protection for pharmaceutical products which, when coupled with less than rigorous application of patent criteria for medicines, has generated lower rates of innovation and unjustified blocks to generic competition.

Over the past 15 years IP protection has increased dramatically for pharmaceuticals in the EU, making it the most protected pharmaceutical market in the world. In the meantime, the EU has become less innovative than other regions. In the USA and EU only one quarter to one third of “new” medicines are actually innovative, as indicated by a lack of important therapeutic advance. Meanwhile, any given originator pharmaceutical enjoys the protection of up to 40 different patents on various aspects and properties of the product.

Fortunately for patients and society in general, many of these patents have been or will be successfully challenged and invalidated by the courts as generic companies typically win 70% of all legal cases involving patents. “But why waste resources in this way?”, Perry asks. Excessive patents and patents that are frivolous, badly founded and easily granted only serve to delay the entry of new technology into the public domain for further developmental research. In the case of pharmaceuticals, they encourage wasteful investment into minor modifications and “me-too” products with little or no added value to society. These “blocking patents” seriously delay the delivery of low-cost medicinal treatment to patients and healthcare systems who can ill afford the high prices of originator products.

“All of this”, Perry said, “raises ethical questions about today’s use of scientific knowledge and creates a responsibility for society to take a long hard look at how and why patents are granted.”

To remedy the current situation Perry is calling for:

  1. a global re-assessment of the use of IP laws relating to medicines, particularly when granting patent extensions, secondary patents and data exclusivity;
  2. stronger enforcement of the criteria for granting patents, particularly the inventive step;
  3. greater incentives to develop genuine innovative medicines and to discourage the generation and protection of “me-too” products;
  4. the allocation of public funding to research into priority medicines; and
  5. ensuring quick access to the post-patent market for generic equivalents.

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