Healthy Skepticism Library item: 478

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Publication type: media release

Press Release: Tangled Patent Linkages Reduce Stimulation for Pharmaceutical Innovation 6,730 patents for only 27 pharmaceutical inventions
European Generic Medicines Assocation 2004 Jun 1

Full text:

EGA highlighted the continued difficulties facing the European generics industry in making low-cost medicines available to patients and cash-strapped healthcare systems during its participation in the 7th Annual International Conference on Generic Pharmaceuticals in Prague on 28-30 June,

The increasing number of patents on minute and obscure aspects of pharmaceutical products is fast becoming the principle obstacle facing the industry. In the year 2000, for example, while the US Patent Office granted 6,730 pharmaceutical patents, the US Food and Drug Administration only registered 27 new chemical entities (NCE). This growing global trend is resulting in a tangled web of patents that creates a complex legal minefield protecting pharmaceutical inventions well-beyond a product’s basic patent.

Designed to delay the entry of market competition from lower-priced generic products, the practice also allows the originator industry to reap continued benefits from older products. This not only keeps the cost of medicines unnecessarily high, but more worryingly, it eliminates the stimulus needed by research companies to discover new cures for life-threatening illnesses.

Greg Perry, Director General of EGA said, “The growing trend of establishing numerous patents on superfluous aspects of pharmaceutical products for the sake of prolonging market exclusivity must not be allowed to become common practice in the EU. The current system of multiple patents is particularly worrying in the light of the newly adopted EU legislation on the enforcement of Intellectual Property protection which will allow automatic court injunctions against new generic products. The US experience of denying patients timely access to affordable medicines must not be repeated in Europe.”

Rory O’Riordan, President of EGA, said “The growing use of superfluous patents, frivolous lawsuits and damaging court injunctions against legitimate generic competition pose serious threats to the generic medicines industry and to the continued availability of affordable medicinal care for Europe’s patients. Increasing legal obstacles to the rapid availability of generic medicines is particularly disturbing as the overall use of generic medicines is still generally very low in Europe, compared to the 50-60% prescribing rate in the United States.
While many countries across greater Europe are taking measures to encourage the use of generic medicines, more must be done to simplify current patent structures to make equivalent generic products of newer medicines available to patients immediately upon the expiry of the basic patent.”