Intellectual Property in Facial Plastic and Reconstructive Surgery: The Importance and Process of Obtaining Intellectual Property Rights

 

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Abstract

Understanding the purpose and process of obtaining intellectual property rights (IPR) is fundamental to health care innovation. Facial plastic and reconstructive surgeons are natural innovators; however, knowledge deficit in this space may hinder the ability to move ideas from the “bench to bedside.” Here we provide an overview of IPR, outlining the steps necessary to obtain intellectual property protection in an academic setting while highlighting recent U.S. Food and Drug Administration (FDA) approvals pertaining to facial plastic and reconstructive surgery.

Publication History

Accepted Manuscript online:
17 May 2023

Article published online:
23 June 2023

© 2023. Thieme. All rights reserved.

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333 Seventh Avenue, 18th Floor, New York, NY 10001, USA

• References

• 1 Smith SW, Sfekas A. How much do physician-entrepreneurs contribute to new medical devices?. Med Care 2013; 51 (05) 461-467
  CrossrefPubMedGoogle Scholar
• 2 Bogers M, Afuah A, Bastian B. Users as innovators: a review, critique, and future research directions. J Manage 2010; 36 (04) 857-875
  PubMedGoogle Scholar
• 3 Heus JJ, de Pauw ES, Mirjam L, Margherita M, Michael R H, Michal H. Importance of intellectual property generated by biomedical research at universities and academic hospitals. J Clin Transl Res 2017; 3 (02) 250-259
  PubMedGoogle Scholar
• 4 Patino RM. Moving research to patient applications through commercialization: understanding and evaluating the role of intellectual property. J Am Assoc Lab Anim Sci 2010; 49 (02) 147-154
  PubMedGoogle Scholar
• 5 Nakajima K, Mintz Y, Nickel F, Arezzo A. EAES Technology Committee. The EAES intellectual property awareness survey. Surg Endosc 2022; 36 (05) 3340-3346
  CrossrefPubMedGoogle Scholar
• 6 Johns Hopkins Technology Ventures. . The Johns Hopkins University Inventor's Guide. A Brief on Technology Transfer & Commercialization. 2022. Accessed June 2, 2023 at: https://ventures.jhu.edu/wp-content/uploads/2022/07/Inventors-Guide-2022.pdf
  PubMed
• 7 World Intellectual Property Organization. . What is Intellectual Property? Accessed March 12, 2023 at: https://www.wipo.int/about-ip/en/
  PubMed
• 8 Dymond E, Long A, McCarthy A, Drake MJ. Developing a new treatment device: how to get an idea to the marketplace. Neurourol Urodyn 2012; 31 (04) 429-436
  CrossrefPubMedGoogle Scholar
• 9 U.S. Patent and Trademark Office. . Types of Patents. Accessed May 2, 2023. https://www.uspto.gov/web/offices/ac/ido/oeip/taf/data/patdesc.htm
  PubMed
• 10 Fini R, Lacetera N, Shane S. Inside or outside the IP system? Business creation in academia. Res Policy 2010; 39 (08) 1060-1069
  CrossrefPubMedGoogle Scholar
• 11 Caviggioli F, De Marco A, Montobbio F, Ughetto E. The licensing and selling of inventions by US universities. Technol Forecast Soc Change 2020; 159: 120189
  CrossrefPubMedGoogle Scholar
• 12 Hockaday T. University Technology Transfer: What It Is and How to Do It. Baltimore, MD: Johns Hopkins University Press; 2020
  CrossrefGoogle Scholar
• 13 Marcus J. Think universities are making lots of money from inventions? Think again. 2020. Accessed January 17, 2020 at: https://hechingerreport.org/think-universities-are-making-lots-of-money-from-inventions-think-again/
  PubMedGoogle Scholar
• 14 Stanford Office of Technology Licensing. . Patent. Accessed May, 1 2023 at: https://otl.stanford.edu/patent
  PubMed
• 15 Rameau A, Hong RS, Djalilian H. et al. New medical device and therapeutic approvals in otolaryngology: state of the art review of 2019. OTO Open 2020; 4 (02) 2473974 ×20932506
  CrossrefPubMedGoogle Scholar
• 16 Brenner MJ, Shenson JA, Rose AS. et al. New medical device and therapeutic approvals in otolaryngology: state of the art review 2020. OTO Open 2021; 5 (04) 2473974 ×211057035
  CrossrefPubMedGoogle Scholar
• 17 Choi AM, Brenner MJ, Gorelik D. et al. New medical device and therapeutic approvals in otolaryngology: state of the art review of 2021. OTO Open 2022; 6 (03) 2473974 ×221126495
  PubMedGoogle Scholar
• 18 Sanan A, Most SP. A bioabsorbable lateral nasal wall stent for dynamic nasal valve collapse: a review. Facial Plast Surg Clin North Am 2019; 27 (03) 367-371
  CrossrefPubMedGoogle Scholar
• 19 Stolovitzky P, Senior B, Ow RA, Mehendale N, Bikhazi N, Sidle DM. Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial. Int Forum Allergy Rhinol 2019; 9 (08) 850-856
  CrossrefPubMedGoogle Scholar
• 20 Sidle DM, Stolovitzky P, Ow RA. et al. Twelve-month outcomes of a bioabsorbable implant for in-office treatment of dynamic nasal valve collapse. Laryngoscope 2020; 130 (05) 1132-1137
  CrossrefPubMedGoogle Scholar
• 21 Bacharach J, Lee WW, Harrison AR, Freddo TF. A review of acquired blepharoptosis: prevalence, diagnosis, and current treatment options. Eye (Lond) 2021; 35 (09) 2468-2481
  CrossrefPubMedGoogle Scholar
• 22 Haenisch B, Walstab J, Herberhold S. et al. Alpha-adrenoceptor agonistic activity of oxymetazoline and xylometazoline. Fundam Clin Pharmacol 2010; 24 (06) 729-739
  CrossrefPubMedGoogle Scholar
• 23 Slonim CB, Foster S, Jaros M. et al. Association of oxymetazoline hydrochloride, 0.1%, solution administration with visual field in acquired ptosis: a pooled analysis of 2 randomized clinical trials. JAMA Ophthalmol 2020; 138 (11) 1168-1175
  CrossrefPubMedGoogle Scholar
• 24 U.S. Food and Drug Administration. . UPNEEQ (oxymetazoline hydrochloride ophthalmic solution), 0.1% for topical ophthalmic use. Accessed March 20, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/0212520s000lbl.pdf
  PubMed
• 25 U.S. Food and Drug Administration. . Summary of Safety and Effectiveness Data (SSED): Hemoblast Bellows. 2023. Accessed June 2, 2023 at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170012B.pdf
  PubMed
• 26 U.S. Food and Drug Administration. . Premarket approval (PMA): Hemoblast Bellows. 2023. Accessed June 2, 2023 at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170012S023
  PubMed
• 27 U.S. Food and Drug Administration. . StarPore (Polymer, Ent Synthetic, Porous Polyethylene): 510(k) premarket Notification. 2023. Accessed June 2, 2023 at: https://www.accessdata.fda.gov/cdrh_docs/pdf20/K200532.pdf
  PubMed
• 28 Kirsner RS, Margolis DJ, Baldursson BT. et al. Fish skin grafts compared to human amnion/chorion membrane allografts: a double-blind, prospective, randomized clinical trial of acute wound healing. Wound Repair Regen 2020; 28 (01) 75-80
  CrossrefPubMedGoogle Scholar
• 29 Lullove EJ, Liden B, Winters C, McEneaney P, Raphael A, Lantis Ii JCA. A multicenter, blinded, randomized controlled clinical trial evaluating the effect of omega-3-rich fish skin in the treatment of chronic, nonresponsive diabetic foot ulcers. Wounds 2021; 33 (07) 169-177
  CrossrefPubMedGoogle Scholar
• 30 Kim TH, Park JH, Jeong HG, Wee SY. The utility of novel fish-skin derived acellular dermal matrix (Kerecis) as a wound dressing material. J Wound Manag Res 2021; 17 (01) 39-47
  CrossrefPubMedGoogle Scholar
• 31 U.S. Food and Drug Administration. . Meticuly Patient-Specific Titanium Mesh Implant: 510(k) premarket Notification. 2023. Accessed June 2, 2023 at: https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210099.pdf
  PubMed
• 32 U.S. Food and Drug Administration. . SofWave System: 510(k) premarket Notification. 2023. https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf
  PubMed
• 33 Fabi SG. Noninvasive skin tightening: focus on new ultrasound techniques. Clin Cosmet Investig Dermatol 2015; 8: 47-52
  CrossrefPubMedGoogle Scholar
• 34 Kauvar AN, Geronemus RG, Munavalli GS, Friedman PM, Wang JV, Kilmer SL. Synchronous Ultrasound Parallel Beam Technology Lifts Lax Submental and Neck Skin. Hoboken, NJ: Wiley; 2022. :S20–S20
  Google Scholar
• 35 Fernandes JR, Samayoa JC, Broelsch GF. et al. Micro-mechanical fractional skin rejuvenation. Plast Reconstr Surg 2013; 131 (02) 216-223
  CrossrefPubMedGoogle Scholar
• 36 Russe E, Purschke M, Farinelli WA. et al. Micro-fractional, directional skin tightening: a porcine model. Lasers Surg Med 2016; 48 (03) 264-269
  CrossrefPubMedGoogle Scholar
• 37 Pozner JN, Kilmer SL, Geronemus RG, Jack M, Burns JA, Kaminer MS. Cytrellis: a novel microcoring technology for scarless skin removal—summary of three prospective clinical trials. Plast Reconstr Surg Glob Open 2021; 9 (10) e3905
  CrossrefPubMedGoogle Scholar
• 38 US Food and Drug Administration. . AI.ME System: 510(k) premarket Notification. 2023. Accessed June 2, 2023 at: https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221011.pdf
  PubMed