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BioDrugs

, Volume 31, Issue 3, pp 189–205 | Cite as

Biosimilars in the United States: Emerging Issues in Litigation

  • Alice Yuen-Ting WongEmail author
  • Martha M. Rumore
  • Albert Wai-Kit Chan
Review Article

Abstract

Many first-generation biologics will lose their patent protection by 2020. The biosimilars market is not only attractive but also competitive and tough. The United States (US) is the world’s largest pharmaceutical market and is critical to the success of most drugs. However, unclear regulatory requirements and confusing patent resolution procedures create hurdles to market entry of biosimilars. Trade secret exposure and scant exclusivity and adoption also limit the market access of biosimilars. Both biologics and biosimilar developers should closely follow the regulatory and litigation landscape to successfully navigate through the challenges. Focusing on the US landscape, this article provides a brief review of the regulatory framework for biosimilar products, market exclusivities, and patent issues under the Biologics Price Control and Innovation Act (BPCIA), analyzes emerging issues in the biosimilar litigation landscape, and provides recommendations for companies entering the biosimilars market.

Keywords

Patent Infringement Market Exclusivity Biosimilar Product Patent Litigation Patent Thicket 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Author Contributions

AYTW and MMR made substantial contribution to the conception of this study, and drafted and critically reviewed the manuscript. AWKC critically reviewed the manuscript for important intellectual content.

Compliance with Ethical Standards

Conflict of Interest

Alice Yuen-Ting Wong, Martha M. Rumore and Albert Wai-Kit Chan declare that they have no conflict of interest.

Funding

No sources of funding were used to assist in the preparation of this study.

Supplementary material

40259_2017_216_MOESM1_ESM.pdf (184 kb)
Supplementary material 1 (PDF 185 kb)

References

  1. 1.
    Food and Drug Administration. Licensed biological products with supporting documents. 2015. http://www.fda.gov/BiologicsBloodVaccines/ucm133705.htm. Accessed 22 Mar 2017.
  2. 2.
    Khanam R. Biosimilars are here. Now what? 2015. http://inmygroup.com/06/26/2016/biosimilars-are-here-now-what.html Accessed 22 Mar 2017.
  3. 3.
    Blackstone EA, Joseph PF. The economics of biosimilars. Am Health Drug Benef. 2013;6:469–78.Google Scholar
  4. 4.
    Parker GE, Witwer S, Bowker GM. Regulatory approval of biosimilars: a global Queryperspective. Regul Focus. 2014:1–11. Google Scholar
  5. 5.
    European Medicines Agency. Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. 2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003953.pdf. Accessed 22 March 2017.
  6. 6.
    World Health Organization. Guidelines on evaluation of similar biotherapeutic products (SBPs), Annex 2, Technical Report Series No. 977. 2009. http://www.who.int/biologicals/publications/trs/areas/biological_therapeutics/TRS_977_Annex_2.pdf?ua=1. Accessed 22 Mar 2017.
  7. 7.
    Krishnan A, Mody R, Malhotra H. Global regulatory landscape of biosimilars: emerging and established market perspectives. Biosimilars. 2015;5:19–32.Google Scholar
  8. 8.
    Blank T, Netzer T, Hildebrandt W, Vogt-Eisele A, Kaszkin-Bettag M. Safety and toxicity of biosimilars—EU versus US regulation. Generics Biosimilars Init J. 2013;2:144–50.CrossRefGoogle Scholar
  9. 9.
    Biologics Price Competition and Innovation Act of 2009. 2010. P.L. No. 111–148, §7001(b), 124 Stat. 119, 604.Google Scholar
  10. 10.
    21st Century Cures Act. 2016. P.L. No: 114–255. December 13, 2016.Google Scholar
  11. 11.
    FD&C Act §505, codified as 21 U.S.C. §355.Google Scholar
  12. 12.
    21 U.S.C. §355(a).Google Scholar
  13. 13.
    PHS Act §351, codified as 42 U.S.C. §262.Google Scholar
  14. 14.
    42 U.S.C. §262(a).Google Scholar
  15. 15.
    42 U.S.C. §262(i)(1).Google Scholar
  16. 16.
    Food and Drug Administration. Guidance for industry—biosimilars: questions and answers regarding implementation of the Biologics Price Competition and Innovation Act of 2009. 2015. http://www.fda.gov/downloads/Drugs/Guidances/UCM273001.pdf. Accessed 22 Mar 2017.
  17. 17.
    42 U.S.C. §262(i)(2).Google Scholar
  18. 18.
    Food and Drug Administration. Guidance for industry—Scientific considerations in demonstrating biosimilarity to a reference product. 2015. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Accessed 22 Mar 2017.
  19. 19.
    Panesar K. Biosimilars: Current approvals and pipeline agents. US Pharm. 2016; 41(10):26–29. https://www.uspharmacist.com/article/biosimilars-current-approvals-and-pipeline-agents. Accessed 22 Mar 2017.
  20. 20.
    Christl L. Comments by CDER Associate Director for Therapeutic Biologics, at the June 20, 2016, Alliance for Health Reform briefing, “The Emerging Biosimilars Market,” webcast at https://www.youtube.com/watch?v=XZvhLYZ_TZg. Accessed 22 Mar 2017.
  21. 21.
    42 U.S.C. §262(k)(4).Google Scholar
  22. 22.
    42 U.S.C. §262(i)(3).Google Scholar
  23. 23.
    35 U.S.C. §156.Google Scholar
  24. 24.
    PHS Act §351(k)(7)(A).Google Scholar
  25. 25.
    PHS Act §351(k)(7)(B).Google Scholar
  26. 26.
    PHS Act §351(k)(7)(C).Google Scholar
  27. 27.
    PHS Act §351(k)(6).Google Scholar
  28. 28.
    21 U.S.C. §355a.Google Scholar
  29. 29.
    PHS Act §351(m).Google Scholar
  30. 30.
    21 U.S.C. §360bb.Google Scholar
  31. 31.
    21 U.S.C. §360cc.Google Scholar
  32. 32.
    Food and Drug Administration, Purple Book: Lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations. 2016. http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm411418.htm Accessed 22 Mar 2017.
  33. 33.
    42 U.S.C. §262(k).Google Scholar
  34. 34.
  35. 35.
    Food and Drug Administration. Considerations in Demonstrating Interchangeability with a Reference Product. Guidance for Industry. 2017. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537135.pdf. Accessed 22 Mar 2017.
  36. 36.
    35 U.S.C. §271(e)(1)–(2).Google Scholar
  37. 37.
    PHS Act §351(l).Google Scholar
  38. 38.
    Hatch–Waxman Act. 1984. P.L. 98–417.Google Scholar
  39. 39.
    21 U.S.C. §355(b)(1)(G).Google Scholar
  40. 40.
    42 U.S.C. §262(l)(8).Google Scholar
  41. 41.
    Lucio SD, Stevenson JG, Hoffman JM. Biosimilars: a primer for the health system pharmacist. Am J Health Syst Pharm. 2013;70:2004–17.CrossRefPubMedPubMedCentralGoogle Scholar
  42. 42.
    Wiatr C. US Biosimilar pathway unlikely to be used. Biodrugs. 2011;1:63–7.CrossRefGoogle Scholar
  43. 43.
    Serafini AT, Kabler K, Yee G. Monoclonal antibody patents: Evolving law & strategies. 2012. https://www.fenwick.com/publications/pages/monoclonal-antibody-patents-evolving-law-and-strategies.aspx. Accessed 11 Jan 2017.
  44. 44.
    Wong HK, McMahon DJ. Preparing for uncertainties in biosimilars litigation. Financier Worldwide. 2011. http://www.financierworldwide.com. Accessed 22 Mar 2017.
  45. 45.
    Long G, Mulhern C. Recently released FDA guidance and biosimilar development: implications for the litigation environment. FDLI Update. In: FDLI’s 55th annual conference, March/April 2012. pp. 19–21.Google Scholar
  46. 46.
    Amgen Inc. v. Sandoz Inc., No. 14-cv-04741, 2015 WL 1264756 (N.D. Cal. March 19, 2015).Google Scholar
  47. 47.
    Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. July 21, 2015).Google Scholar
  48. 48.
    Blais EH, Lu A. Legal insights on the regulation of biosimilars. Pharm Purch Prod. 2015;68:70–1.Google Scholar
  49. 49.
    Amgen Inc. v. Sandoz Inc., No. 15-1039 (S. Ct. filed February 16, 2016).Google Scholar
  50. 50.
    Amicus Brief in Amgen Inc. v. Sandoz Inc., No. 15-1039 and No. 15-1195 (filed December 7, 2016)Google Scholar
  51. 51.
    Fischer A, Monroe-Yavneh N. Sandoz Seeks Cert on 180-Day Issue in Amgen v. Sandoz. 2016. Available from: http://www.jdsupra.com/legalnews/sandoz-seeks-cert-on-180-day-issue-in-57097/. Accessed 22 Mar 2017.
  52. 52.
    Bologicsblog. Supreme Court Grants Cert in Amgen v. Sandoz. 2017. https://www.biologicsblog.com/supreme-court-grants-cert-in-amgen-v-sandoz/. Accessed 9 Mar 2017.
  53. 53.
    Immunex Corp. v. Sandoz Inc., No. 2:16cv1118 (D. N. J. filed February 26, 2016).Google Scholar
  54. 54.
    Janssen Biotech Inc. v. Celltrion Healthcare Co. Ltd. No. 1:15-cv-10698 (D. Mass. March 6, 2015).Google Scholar
  55. 55.
    Janssen Biotech Inc. v. Celltrion Healthcare Co. Ltd. No. 17-1120 (Fed. Cir. October 24, 2016).Google Scholar
  56. 56.
    Amgen Inc. v. Apotex Inc. No. 15-cv-61631 (S.D. Fla. filed August 6, 2015).Google Scholar
  57. 57.
    Amgen Inc. v. Apotex Inc. No. 15-cv-61631, Order (S.D. Fla. December 9, 2015).Google Scholar
  58. 58.
    Amgen Inc. v. Apotex Inc. No. 16-1308 (Fed. Cir. July 5, 2016).Google Scholar
  59. 59.
    Amgen Inc. v. Apotex Inc. No. 17-1010 (Fed. Cir. filed October 3, 2016).Google Scholar
  60. 60.
    Amgen Inc. v. Apotex Inc. No. 16-1308 (Fed. Cir. July 5, 2016)., cert. denied, No. 16-332 (S. Ct. December 12, 2016).Google Scholar
  61. 61.
    Amgen Inc. v. Hospira Inc. No. 1:15-cv-00839 (D. Del. filed September18, 2015).Google Scholar
  62. 62.
    Amgen Inc. v. Sandoz Inc., No. 3:16cv2581 (N.D. Cal. filed May 12, 2016).Google Scholar
  63. 63.
    AbbVie Inc., v. Amgen Inc., No. 1:16-cv-666 (D. Del., filed November 1, 2016).Google Scholar
  64. 64.
    Rosenthal M. Biosimilar arena still littered with litigation. Pharm Pract News. 2015;42:6.Google Scholar
  65. 65.
    Citizen Petition from AbbVie, Inc. FDA-2015-P-2000-0001. June 2, 2015.Google Scholar
  66. 66.
    Federal Trade Commission v. Actavis Inc. 133 S. Ct. 2223 (2013).Google Scholar
  67. 67.
    Borkoski K. Details: FTC v. Actavis. SCOTUS Blog, 2013. http://www.scotusblog.com/2013/06/details-ftc-v-actavis/. Accessed 22 Mar 2017.
  68. 68.
    Robert Burt v. Genentech Inc. No. 2015-CI-05771 (Tx. October 30, 2015).Google Scholar
  69. 69.
    Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals Inc. et al. No. 1:11-cv-11681-NMG (D. Mass. October 28, 2011).Google Scholar
  70. 70.
    Liu ZQ. Biosimilar makers turn to IPRs before litigation under the BPCIA, May 15, 2015. http://www.biologicsblog.com/blog/biosimilar-makers-turn-to-iprs-before-litigation-under-bpcia/. Accessed 22 Mar 2017.
  71. 71.
    42 U.S.C. §262(l)(1).Google Scholar
  72. 72.
    Marquardt JL, Auten SR. Strategic considerations under the Biologics Price Competition and Innovation Act. Expert Opin Ther Pat. 2013;8:915–8.CrossRefGoogle Scholar
  73. 73.
    18 U.S.C. §1836.Google Scholar

Copyright information

© Springer International Publishing Switzerland 2017

Authors and Affiliations

  1. 1.Albert Wai-Kit Chan Intellectual Property LimitedHong KongChina
  2. 2.Touro College of PharmacyNew YorkUSA
  3. 3.Sorell, Lenna, & Schmidt, LLPNew YorkUSA
  4. 4.United States-China Intellectual Property InstituteNew YorkUSA
  5. 5.Law Offices of Albert Wai-Kit Chan, PLLCNew YorkUSA

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