Abstract
Additive manufacturing, specifically three-dimensional printing (3DP), has been in use in the manufacture of medical devices for some time, with the FDA recently issuing draft guidance for technical considerations in this regard. More recently however, attention has turned to the use of these techniques in modern medicinal manufacture, in particular, orally administrable dosage forms and drug-loaded implants. In addition to the technical challenges faced by inventors in this field, there are a number of legal issues which are likely to develop as 3D printing becomes more widespread, more specifically regarding not only the procurement and enforcement of intellectual property rights, but also potentially arising at the interface of 3D printed pharmaceuticals with competition and consumer protection laws. Intellectual property law can be complex and varies from country to country. This chapter provides an introduction to intellectual property and a discussion of the aspects and issues that are most likely to be relevant to those working in the field of 3D printing of pharmaceuticals.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
WO 2016/038356, claims 1–19.
WO 2016/038356, claims 20–24.
WO 2016/038356, claim 25.
WO 2016/038356, claims 26–27.
WO 2016/038356, claims 29–31.
WO 2016/038356, claim 32.
WO 2106/038356, claim 33.
Registered Designs Act 1949 (RDA 1949).
Copyright, Designs and Patents Act 1988 (CDPA 1988).
Community Design Regulation: COUNCIL REGULATION (EC) No 6/2002 of 12 December 2001 on Community designs.
Article 4, Paris Convention for the Protection of Industrial Property of March 20, 1883, as revised at Brussels on December 14, 1900, at Washington on June 2, 1911, at The Hague on November 6, 1925, at London on June 2, 1934, at Lisbon on October 31, 1958, and at Stockholm on July 14, 1967, and as amended on September 28, 1979.
Full list available here: http://www.wipo.int/pct/en/pct_contracting_states.html.
Section 2(1) PA77; Article 54(1) EPC.
Section 2(2) PA77; Article 54(2) EPC.
Merrell Dow v Norton [1996] RPC 76 HL.
Section 3(1) PA1977; Article 56 EPC.
Section 4(1) PA77; Article 57 EPC.
Section 4A(1) PA77; Article 53 EPC.
Procter & Gamble vs. OHIM, Joined Cases C-468/01 P to C-472/01 P.
Henkel C-218/01.
Section 3(2) UKTMA 1994.
Section 3(6) and Section 47(4) UKTMA 1994.
Section 39–43 UK Patents Act 1977.
Section 41 UKPA 1977.
Section 9 UKTMA 1994.
Section 5 (4) UKTMA 1994.
IRC v Muller & Co’s Margarine Ltd [1901] AC 217.
Generics (UK) Ltd (t/a Mylan) v Warner-Lambert Company LLC [2015] EWHC 2548 (Pat).
Nestec SA & Ors v Dualit Ltd & Ors [2013] EWHC 923 (Pat).
Schütz (UK) Ltd v Werit UK Ltd [2013] UKSC 16.
United Wire Ltd v Screen Repair Services (Scotland) Ltd ([2001] RPC 24).
Subject to ratification of the Unified Patent Court Agreement by the necessary parties and subject to the outcome of a pending Court challenge in Germany.
REGULATION (EU) No 1257/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 December 2012 implementing enhanced cooperation in the area of the creation of unitary patent protection.
Articles 25 to 29 of the UPC Agreement.
Section 60(6D) UK Patents Act 1977, as amended by the Legislative Reform (Patents) Order 2014.
Section 60(6F) UK Patents Act 1977, as amended by the Legislative Reform (Patents) Order 2014.
Section 60(6E) UK Patents Act 1977, as amended by the Legislative Reform (Patents) Order 2014.
COUNCIL REGULATION (EC) No 207/2009 of 26 February 2009 amended by Regulation (EU) 2015/2424 of the European Parliament and of the Council of 16 December 2015.
Section 10 UKTMA 1994.
Case C-412/05 Aventis Pharma v OHIM (26 April 2007).
Case T-95/07 Aventis Pharma v Nycomed GmbH (21 October 2008).
Flynn Pharma Ltd. Vs. DrugsRUs and Another, Court of Appeal [2017] EWCA Civ 226.
Article 7, Directive 2008/95/EC.
Joined Cases C-427/93, C-429/93 and C-436/93, Bristol-Myers-Squibb [1996] ECR I-3457, para 79.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2018 American Association of Pharmaceutical Scientists
About this chapter
Cite this chapter
Jewell, C., Stones, J. (2018). 3D Printing Techniques in the Pharmaceutical Sciences – Intellectual Property Issues. In: Basit, A., Gaisford, S. (eds) 3D Printing of Pharmaceuticals. AAPS Advances in the Pharmaceutical Sciences Series, vol 31. Springer, Cham. https://doi.org/10.1007/978-3-319-90755-0_10
Download citation
DOI: https://doi.org/10.1007/978-3-319-90755-0_10
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-90754-3
Online ISBN: 978-3-319-90755-0
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)