Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

Enforcing pharmaceutical and biotech patent rights in China

Nature Biotechnology volume 26, pages 1235–1240 (2008)Cite this article

Companies with a significant intellectual property stake in China should put in place an effective protection and enforcement strategy against local and overseas competitors.

With a population of 1.3 billion and a rapidly expanding economy, China has become a manufacturing powerhouse and one of the largest consumer product markets in the world. Its current drug market of $15 billion is estimated to grow by eightfold between now and 2020 and is poised to become the world's largest pharmaceutical market by 2050 (refs. 1,2), drawing enormous attention from foreign drug companies interested in selling their products in China. Many Western manufacturers are also increasingly looking to China for a place to conduct drug discovery research, clinical trials and drug production. Thus, the notion of China as “factory to the world” has come to mean a lot more than just making toys, clothing and consumer electronics. For example, China already is the largest supplier of bulk drug materials in the world3. About three-quarters of the pharmaceutical ingredients consumed in the United States are made in China4.

This is a preview of subscription content, access via your institution

Relevant articles

Open Access articles citing this article.

Access options

Rent or buy this article

Prices vary by article type

from$1.95

to$39.95

Learn more

Prices may be subject to local taxes which are calculated during checkout

References

  1. Yidong, G. Science 309, 735 (2005).

    Article  CAS  Google Scholar 

  2. Yuanjia, H. et al. J. Med. Mark. 7, 295–300 (2007).

    Article  Google Scholar 

  3. Jia H. Chinese manufacturers vie for piece of outsourcing pie. Nat. Biotechnol. 25, 1337 (2007).

    Article  CAS  Google Scholar 

  4. Chem. Eng. News, May 19, 2008, citing Darrell Abernethy of US Pharmacopeia (USP).

  5. World Intellectual Property Organization (WIPO). The Paris Convention, Madrid Agreement for the International Registration of Marks, the Berne Convention, the Patent Cooperation Treaty (PCT), WIPO Copyright Treaty, WIPO Performance and Phonograms Treaty and the World Trade Organization.

  6. Art. 25 of Patent Law of the People's Republic of China (2000).

  7. Guo, J. & Xin, H. Science 314, 1232–1235 (2006).

    Article  CAS  Google Scholar 

  8. According to statistics from the Supreme People's Court of China.

  9. Art. 11 of Patent Law of the People's Republic of China (2000).

  10. Art. 63(2)–(4), supra.

  11. Rule 48 of Interpretations of the Supreme People's Court Concerning Several Issues on Application of Law to Trials of Civil Disputes over Patent Infringement (Discussion Draft, 10/27–29/2003).

  12. Section 35 USC 271(e)(1). See Merck KGaA vs. Integra Life Sciences, 545 US 193 (2005); 496 F.3d 1334 (Fed. Cir. 2007) and Proveris Scientific Corp v. InnovaSystems, Inc., No. 2007-1428 (Fed. Cir., 2008).

  13. EU Directives 2001/82/EC Articles 13(1)–13(7) and 2001/83/EC and Articles 10(1)–10(5).

  14. Art. 63 of Patent Law of the People's Republic of China (2000).

  15. Art. 63(1), supra.

  16. Art. 56, supra. See also, Rule 78, Implementing Regulations of the Patent Law of the People's Republic of China (2001).

  17. Rule 78 of Implementing Regulations of the Patent Law of the People's Republic of China (2001).

  18. Rule 81, supra.

  19. For example, Art. 58 of Patent Law of the People's Republic of China (2000).

  20. Rule 82 of Implementing Regulations of the Patent Law of the People's Republic of China (2001).

  21. Art. 62 of Patent Law of the People's Republic of China (2000).

  22. Art. 57, supra.

  23. Rule 63 of Interpretations of the Supreme People's Court Concerning Several Issues on Application of Law to Trials of Civil Disputes over Patent Infringement (Discussion Draft, 10/27–29/2003).

  24. Tonghua Antaike Biological Engineering Co., Ltd. v. Lily France S.A.A., 2006, People's Republic of China Beijing Municipal No. 1 Intermediate People's Court, Judgment No. 7493.

  25. Hengrui v. Aventis Pharma S.A., 2006, Shanghai Higher People's Court, People's Republic of China, Final Judgment No. 112.

  26. Art. 61 of Patent Law of the People's Republic of China (2000).

  27. Art. 60, supra.

  28. Rule 21 of Several Provisions of the Supreme People's Court on Issues Relating to Application of Law to Adjudication of Cases of Patent Disputes (2001).

  29. Art. 45 of Patent Law of the People's Republic of China (2000).

  30. Art. 46, supra.

  31. Id.

  32. Rule 64 of Implementing Regulations of the Patent Law of the People's Republic of China (2001).

  33. Art. 22 of Patent Law of the People's Republic of China (2000).

  34. Id.

  35. Id.

  36. Art. 26, supra.

  37. Art. 33, supra.

  38. Rule 25 of Implementing Regulations of the Patent Law of the People's Republic of China (2001).

  39. Art. 47 of Patent Law of the People's Republic of China (2000).

  40. The SFDA was as a restructured agency from its predecessor, China State Drug Administration, which was established in 1998 from the merger of the Ministry of Health's Department of Drug Administration with the State Pharmaceutical Administration of China.

  41. Approved by the State Council and promulgated by the State Medicine Administration in December, 1992, and became effective as of Jan. 1, 1993.

  42. Art. 1 of Regulations on Administrative Protection for Pharmaceuticals (1993).

  43. Art. 3, supra.

  44. Art. 5, supra.

  45. Art. 11, supra.

  46. Art. 13, supra.

  47. Art. 19, supra.

  48. Art. 15, supra.

  49. Art. 66, Provisions for Drug Registration (SFDA Order No. 28, 2007).

  50. Art. 71 and Art. 69, supra.

  51. Art. 20, supra.

  52. Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98–417, 1984 Stat. 1538 (codified as amended in scattered sections of 21 & 35 USC). Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use.

  53. Legislative activities in the US regarding biosimilars include “Pathway for Biosimilars Act” (H.R. 5629); “Biologics Price Competition and Innovation Act of 2007” (S. 1695); “Patient Protection and Innovative Biologic Medicines Act of 2007” (H.R. 1956); and “Access to Life-Saving Medicine Act” (H.R. 1038).

  54. Art. 18 of Provisions for Drug Registration (SFDA Order No. 28, 2007).

  55. Art. 12, supra.

  56. According to SIPO, the third major reform to China's Patent Law is expected to go into effect in early 2009. http://www.sipo.gov.cn/sipo2008/yw/2008/200807/t20080731_413639.html

Download references

Author information

Author notes

  1. Michelle M. Deng is at Genzyme Corp., 500 Kendall Street, Cambridge, Massachusetts 02142, USA. michelle.deng@genzyme.com

Authors and Affiliations

  1. Y. Philip Zhang is at Cooley Godward Kronish LLP, 800 Boylston Street, 46th Floor, Boston, Massachusetts 02199, USA pzhang@cooley.com,

    Y Philip Zhang & Michelle M Deng

Authors
  1. Y Philip Zhang
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Michelle M Deng
    View author publications

    You can also search for this author in PubMed Google Scholar

Additional information

The content of this article is not to be attributed to the authors' current, past or future clients or employers, nor should it be viewed or regarded as legal advice to anyone.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Zhang, Y., Deng, M. Enforcing pharmaceutical and biotech patent rights in China. Nat Biotechnol 26, 1235–1240 (2008). https://doi.org/10.1038/nbt1108-1235

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1038/nbt1108-1235

This article is cited by

Search

Advanced search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing