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Are the new clinical trial transparency rules incompatible with the patentability requirements in Europe?

Nature Biotechnology volume 36, pages928–930(2018)Cite this article

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New transparency policies have created a tension between the regulatory obligation to post clinical trials early and the desire to obtain patent protection.

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References

  1. 1

    Price, W.N., II & Minssen, T. Nat. Biotechnol. 33, 685–686 (2015).

    CAS  Article  Google Scholar 

  2. 2

    Kallenbach, L. & Vallazza, M. epi® Information 4/17, 36–43 (2017).

  3. 3

    EPO's Technical Board of Appeal decision T 433/05 (2007).

  4. 4

    EPO's Technical Board of Appeal decisions T 1364/08 (2010), T 1255/11 (2017), and T 950/13 (2017).

  5. 5

    EPO's Technical Board of Appeal decision T 488/16 (2017).

  6. 6

    EPO's Technical Board of Appeal decision T 1045/13 (2017).

  7. 7

    EPO's Technical Board of Appeal decision T 609/02 (2004).

  8. 8

    EPO's Technical Board of Appeal decisions T 1616/09 (2014) and T 45/12 (2015).

  9. 9

    EPO's Technical Board of Appeal decision T 2506/12 (2016).

  10. 10

    EPO's Technical Board of Appeal decision T 158/96 (1998).

  11. 11

    EPO's Technical Board of Appeal decision T 715/03 (2006).

  12. 12

    EPO's Technical Board of Appeal decision T 385/07 (2007).

  13. 13

    EPO's Technical Board of Appeal decision T 239/16 (2017).

  14. 14

    EPO's Technical Board of Appeal decision T 725/11 (2017).

  15. 15

    ImpaxLabs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383 (Fed. Cir. 2006).

  16. 16

    Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010) (citing Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1366–67 (Fed. Cir. 2006)).

  17. 17

    The Standing Committee on Pharma and Biotechnology. AIPPI position paper re recommendations on the use of post-filing data in support of inventive step (2017).

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Acknowledgements

The discussion herein represents the personal views of the authors and not the views of the authors' company.

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Affiliations

  1. Lorenz Kallenbach is at Merck KGaA, Aubonne, Switzerland.

    Lorenz Kallenbach

  2. Marco K. Vallazza is at Merck KGaA, Darmstadt, Germany.

    Marco K Vallazza

Authors
  1. Lorenz Kallenbach
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  2. Marco K Vallazza
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Correspondence to Lorenz Kallenbach.

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The authors declare no competing financial interests.

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Kallenbach, L., Vallazza, M. Are the new clinical trial transparency rules incompatible with the patentability requirements in Europe?. Nat Biotechnol 36, 928–930 (2018). https://doi.org/10.1038/nbt.4265

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