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On firm ground: IP protection of therapeutic nanoparticles

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The development of generic therapeutic nanoparticles faces a combination of scientific, patent and regulatory challenges.

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Figure 1: Market exclusivity: therapeutic nanoparticle versus conventional drug product.
Figure 2

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  8. US Food and Drug Administration. Draft guidance on doxorubicin hydrochloride http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM199635.pdf (February 2010).

  9. 21 CFR 314.94(a)(iii).

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Authors and Affiliations

  1. Paul Burgess, Scott Minick and Stephen Zale are at BIND Biosciences, Cambridge, Massachusetts, USA.,

    Paul Burgess, Scott Minick & Stephen Zale

  2. Peter Barton Hutt is at Covington & Burling, Washington, DC, USA.,

    Peter Barton Hutt

  3. Omid C. Farokhzad is at Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.,

    Omid C Farokhzad

  4. Robert Langer is at Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.,

    Robert Langer

Authors
  1. Paul Burgess
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  2. Peter Barton Hutt
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  3. Omid C Farokhzad
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  4. Robert Langer
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  5. Scott Minick
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  6. Stephen Zale
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Corresponding author

Correspondence to Paul Burgess.

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Competing interests

P.B.H., O.C.F. and R.L. have a financial interest in BIND Biosciences.

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Burgess, P., Hutt, P., Farokhzad, O. et al. On firm ground: IP protection of therapeutic nanoparticles. Nat Biotechnol 28, 1267–1270 (2010). https://doi.org/10.1038/nbt.1725

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