The unpredictability inherent to biological systems poses singular obstacles for biotechnology patents regarding the satisfaction of the enablement and written description requirements.
This is a preview of subscription content, access via your institution
Access options
Access Nature and 54 other Nature Portfolio journals
Get Nature+, our best-value online-access subscription
$29.99 / 30 days
cancel any time
Subscribe to this journal
Receive 12 print issues and online access
$209.00 per year
only $17.42 per issue
Buy this article
- Purchase on Springer Link
- Instant access to full article PDF
Prices may be subject to local taxes which are calculated during checkout
References
Senior, M. Nat. Biotechnol. 41, 174–182 (2023).
Liao, C. et al. Health Sci. Rev. (Oxf.) 7, 100097 (2023).
De Maria Marchiano, R. et al. J. Pers. Med. 11, 216 (2021).
Williams, M. S. Annu. Rev. Genomics Hum. Genet. 20, 389–411 (2019).
Ledford, H. Nature 606, 443–444 (2022).
Singh, S. K. et al. Biologics 12, 159–170 (2018).
Seymore, S. B. UCLA Law Rev. 56, 127–168 (2008).
Zorzal, P. B. et al. Biotechnol. Res. Innov. 3, 91–102 (2019).
Latimer, M. T. Genome Biol. 6, 203 (2005).
Karshtedt, D., Lemley, M. A. & Seymore, S. B. Harv. J. Law Technol. 35, 1–72 (2021).
Seymore, S. B. Northwest. J. Tech. Intell. Prop. 6, 278–292 (2008).
Falati, S. Technol. Law Rev. 24, 249–297 (2023).
Sampson, M. Berkeley Technol. Law J. 15, 1233–1274 (2000).
In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
Tritel, M. J. Intellect. Prop. Law Pract. 4, 623–628 (2009).
Pac. Biosciences of Cal., Inc. v. Oxford Nanopore Techs., Inc., 996 F.3d 1342, 1352 (Fed. Cir. 2021).
Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010).
Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005).
Chiron Corp. v. Genentech, Inc., 363 F.3d 1247 (Fed. Cir. 2004).
In re Wright, 999 F.2d 1557 (Fed. Cir. 1993).
Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342 (Fed. Cir. 1998).
Amgen Inc. v. Sanofi, Aventisub LLC, 598 U.S._ (2023).
Ex parte Maizel, 27 USPQ2d 1662 (Bd. Pat. App. & Interf. 1992).
Maizel, A. L. et al. Proc. Natl. Acad. Sci. USA 80, 5047–5051 (1983).
In re Fisher, 427 F.2d 833, 839 (CCPA 1970).
PTO Guidelines on Examination of Patent Applications Under 35 U.S.C. 112, ¶1 “Written Description” Requirement, 66 FR 1099–1111 (2001).
Amgen Inc. v. Sanofi, Aventisub LLC, 141 S. Ct. 1163, 593 U.S. ___ (2021).
Fiers v. Revel, 984 F.2d 1164 (Fed. Cir. 1993).
Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1567 (Fed. Cir. 1997).
Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1206 (Fed. Cir. 1991).
Hormone Research Foundation Inc. v. Genentech Inc., 904 F.2d 1558, 1568 (Fed. Cir. 1990).
The Wyeth and Cordis Corporation v. Abbott Labs., 720 F.3d 1390 (Fed. Cir. 2013).
Centocor Ortho Biotech v. Abbott Labs., 636 F.3d 1341, 1352 (Fed. Cir. 2011).
Bosies v. Benedict, 27 F.3d 539, 542 (Fed. Cir. 1994).
Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362 (Fed. Cir. 1999).
Univ. of Rochester v. G.D. Searle Co., 358 F.3d 916 (Fed. Cir. 2004).
AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1299 (Fed. Cir. 2014).
Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991).
Lefstin, J. A. Berkeley Technol. Law J. 23, 1141–1226 (2008).
Rai, A. K. & Sherkow, J. S. Nat. Biotechnol. 34, 292–294 (2016).
Acknowledgements
The perspectives presented in this publication represent the personal opinions of the author and should not be construed as legal advice. The commentary does not reflect the views of Pergament & Cepeda LLP or its clients. Neither the author nor the firm endorses or promotes the ideas discussed herein, which are provided for academic purposes only. While diligent efforts have been made to ensure the accuracy of statements in this work, there is no guarantee against errors or omissions. The author and Pergament & Cepeda LLP disclaim any liability arising from the use of the contents herein. This article is not intended to provide legal counsel or representation for any party or situation. Readers should consult appropriate professionals for legal advice.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Competing interests
The author declares no competing interests.
Rights and permissions
About this article
Cite this article
Ranbhor, R.S. Overcoming unpredictability in biotech patents by tailored claiming aligned with genuine enablement. Nat Biotechnol 42, 695–697 (2024). https://doi.org/10.1038/s41587-024-02228-w
Published:
Issue Date:
DOI: https://doi.org/10.1038/s41587-024-02228-w