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Pharmaceutical patent challenges — time for reassessment?

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Abstract

For nearly 15 years after the passage of the Hatch–Waxman Act in 1984, generics drug companies took little advantage of its provisions, which provided financial incentives to them for challenging the patents of branded pharmaceutical products. However, during the past 3–5 years, generics manufacturers have dramatically increased the number of patent challenges. Although these challenges can certainly benefit consumers and payers, the number of challenges puts many innovator companies at risk, which they argue is detrimental to future R&D spending. If many of the challenges are successful, then the increase in challenges could in turn be detrimental to generics, and the system itself might therefore be due for a re-balance.

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Figure 1: Number of product challenges from 1990 to 2003 by selected companies.
Figure 2: Products receiving their first challenge from 2001 to 2004.
Figure 3: Current state of Paragraph IV patent challenges.
Figure 4: Average percentage R&D (and other) spending as a function of revenue in 2003 by selected companies.
Figure 5: Consumer and payer savings to successful Paragraph IV challenges.

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References

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Acknowledgements

The author would like to acknowledge F. Cohen and D. Snow for their contributions to this article.

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Authors and Affiliations

  1. the Principal of Gregory Glass Associates LLC, 902 George Pitt Drive, Downingtown, 19335, Pennsylvania, USA

    Gregory Glass

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  1. Gregory Glass
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Competing interests

G.G. is an editor of the Paragraph Four Report, and is a shareholder in Pfizer and Teva Pharmaceuticals.

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FURTHER INFORMATION

US FDA Orange Book table of contents

Electronic Orange Book

ParagraphFour.com

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Glass, G. Pharmaceutical patent challenges — time for reassessment?. Nat Rev Drug Discov 3, 1057–1062 (2004). https://doi.org/10.1038/nrd1581

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