Skip to main content

Advertisement

Log in

Drug patents and intellectual property rights

  • Review Article
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

Inquisitive scientists are untiring and relentless in the hard work they perform day in and day out. In this pursuit, a researcher has to exercise their intellectual expertise in its entirety. Eventually, all credit of the invention is vested with the inventor who has the right of control over their intellectual creation. Likewise, pharmaceutical companies spend extravagantly in successfully introducing a novel drug from hundreds and thousands of lead compounds. Hence, it is a prerogative for every company to protect its innovative products from unauthorized duplication. Certainly, "patents" are the sole custodians of these products of medical intelligence - the drugs! This review focuses on the various intricacies of the drug patent system all over the world with special emphasis on India, Europe, and the United States. A note on other intellectual properties such as copyrights, trademarks, and designs is also added.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. (2009) Patent activities and issues. In: Spilker. B. Guide to Drug Development – A Comprehensive Review and Assessment. Philadelphia: Lippincott Williams & Wilkins; 2009.

  2. (2006) Protecting the assets: patenting and intellectual property. In: Rang HP, Drug Discovery and Development – Technology in Transition. Philadelphia: Elsevier Limited

  3. World Intellectual Property Organisation. What is Intellectual Property? [Internet]. 2014 [cited 2014 Oct 9]. Available from: http://www.wipo.int/about-ip/en/index.html#ip

  4. Intellectual Property India. The Patents Act, 1970 [Internet]. 2013 [updated 2013 Jan 26; cited 2014 Oct 9]. Available from: http://ipindia.nic.in/ipr/patent/patent_Act_1970_28012013_book.pdf

  5. (2006) Patent issues in drug discovery. In: Rang HP, Drug Discovery and Development – Technology in Transition. Philadelphia: Elsevier Limited

  6. Spilker B (ed) (2009) Guide to Drug Development – A Comprehensive Review and Assessment. Lippincott Williams & Wilkins, Philadelphia, Table 109.1, Contents of a patent application; p. 1147

    Google Scholar 

  7. The United States Patent and Trademark Office. First inventor to file [Internet]. 2014 [updated 2014 Apr 2; cited 2014 Oct 9]. Available from: http://www.uspto.gov/aia_implementation/faqs_first_inventor.jsp

  8. (2010) Patenting and commercialization of discoveries. In: Lo B. Ethical Issues in Clinical Research: A Practical Guide. Philadelphia: Lippincott Williams & Wilkins

  9. (2009) Costs and pricing. In: Spilker. B. Guide to Drug Development – A Comprehensive Review and Assessment. Philadelphia: Lippincott Williams & Wilkins

  10. (2009) Biotechnology. In: Spilker. B. Guide to Drug Development – A Comprehensive Review and Assessment. Philadelphia: Lippincott Williams & Wilkins

  11. (2009) Mergers, Joint Ventures, and Alliances. In: Spilker. B. Guide to Drug Development – A Comprehensive Review and Assessment. Philadelphia: Lippincott Williams & Wilkins

  12. Spilker. B. Guide to Drug Development – A Comprehensive Review and Assessment. Philadelphia: Lippincott Williams & Wilkins; 2009. Figure 109.2, Series of major events in the patenting of a new compound; p. 1147.

  13. (2008) Law: Providing legal advice and protecting property. In: Freedman T. Career opportunities in Biotechnology and Drug Development. New York: Cold Spring Harbor Laboratory Press

  14. Abbreviated New Drug Application (ANDA): Generics [Internet]. 2014 [updated 2014 Sep 18; cited 2014 Oct 9]. Available from: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/

  15. European Medicines Agency: Data exclusivity, market protection and paediatric rewards [Internet]. 2013 [updated 2013 Apr 26; cited 2015 Jan 12]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2013/05/WC500143122.pdf

  16. U.S. Food and Drug Administration: Frequently Asked Questions on Patents and Exclusivity [Internet]. 2014 [updated 2014 July 18; cited 2015 Jan 12]. Available from: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079031.htm#

  17. (2008) Intellectual property: types, rights and caveats. In: Malhotra S, Shafiq N, Pandhi P. A Comprehensive Clinical Research Manual. New Delhi: Jaypee Brothers Medical Publishers (P) Ltd.

  18. (2007) Human genomic variation. In: Campbell MA, Heyer LJ. Discovering Genomics, Proteomics, & Bioinformatics. 2nd ed. India: Dorling Kindersley Pvt. Ltd.

  19. Novartis loses Glivec patent battle in India [Internet]. 2013 [updated 2013 Apr 1; cited 2014 Dec 20]. Available from: http://www.wsj.com/articles/SB1000142412788732329650457839567258

  20. European patent office – Glossary [Internet]. 2012 [updated 2012 Dec 20; cited 2014 Dec 20]. Available from: http://www.epo.org/service-support/glossary.html

  21. About IP5 co-operation - Five IP Offices [Internet]. 2014 [updated 2014 Dec 3; cited 2014 Dec 20]. Available from: http://www.fiveipoffices.org/about.html

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Gerard Marshall Raj.

Electronic supplementary material

Below is the link to the electronic supplementary material.

ESM 1

(DOCX 30.5 kb)

ESM 2

(DOCX 16.3 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Raj, G.M., Priyadarshini, R. & Mathaiyan, J. Drug patents and intellectual property rights. Eur J Clin Pharmacol 71, 403–409 (2015). https://doi.org/10.1007/s00228-015-1811-5

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00228-015-1811-5

Keywords

Navigation