Inter Partes review (IPR) can efficiently invalidate drug patents and potentially convey strategic advantages to follow-on drug makers. However, recent changes in the IPR system foretell a tectonic shift in the landscape. Here we summarize these major changes and discuss the implications for the biopharmaceutical community.
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Opposing a granted patent in the USA: post grant and review.
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Lost in the cacophony surrounding the debate about high drug prices is the fundamental principle that pharmaceutical innovation will not occur without the prospect of outsized returns enabled through market exclusivity. Biopharmaceutical patents are currently under siege, subject to challenge both in inter partes review ("IPR") proceedings and in Hatch-Waxman actions. These twin assaults threaten to eliminate the incentives necessary for biotechnological innovation--particularly for discoveries made upstream in the innovation pipeline--thus imperiling the development of new drug therapies.
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School of Law, National Chiao Tung University, Hsinchu, Taiwan; School of Law, Duke University, Durham, NC, USA.
Inter Partes review (IPR) can efficiently invalidate drug patents and potentially convey strategic advantages to follow-on drug makers. However, recent changes in the IPR system foretell a tectonic shift in the landscape. Here we summarize these major changes and discuss the implications for the biopharmaceutical community.
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Biologics and biosimilars are medicines made from living cells that treat common and serious diseases such as cancer, diabetes, rheumatoid arthritis, and other inflammatory diseases. They are highly targeted, efficacious, and represent an increasingly important part of physicians' armamentaria in the combat against these medical conditions. Yet they are extremely expensive, costing on average $10,000-$30,000 per year and exceed $500,000 for the most expensive biologics.
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