PRIVATE PATENTS AND PUBLIC HEALTH
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“Biosimilars of trastuzumab,” first<br />
posted 19 September 2014, last<br />
updated 6 November 2015, http://<br />
www.gabionline.net/Biosimilars/<br />
General/Biosimilars-of-trastuzumab<br />
254 Naomi Kresge and Ketaki Gokhale,<br />
“Roche Herceptin Copy’s Price Still<br />
Out of Reach in India,” Bloomberg<br />
Business, 21 January 2014, http://www.<br />
bloomberg.com/news/<br />
articles/2014-01-20/roche-herceptincopy-s-price-still-out-of-reach-inindia<br />
255 See USFDA ‘Purple Book” for<br />
biologics here: US Food and Drug<br />
Administration, “Purple Book: Lists<br />
of Licensed Biological Products with<br />
Reference Product Exclusivity and<br />
Biosimilarity or Interchangeability<br />
Evaluations,” http://www.fda.gov/<br />
Drugs/DevelopmentApprovalProcess/<br />
HowDrugsareDevelopedand<br />
Approved/ApprovalApplications/<br />
TherapeuticBiologicApplications/<br />
Biosimilars/ucm411418.htm<br />
256 John Carroll, “Obama administration<br />
looks to chop back market exclusivity<br />
for biologics,” Fierce Biotech, 6 March<br />
2014, http://www.fiercebiotech.com/<br />
story/obama-administration-lookschop-back-market-exclusivitybiologics/2014-03-06<br />
257 The US objective in trade talks seems<br />
to be at variance with the Obama<br />
administration’s position that it<br />
wants the data exclusivity for<br />
biologics to be brought back to 5<br />
years. See: James Love, “Biden presses<br />
Colombia to block biosimilar drugs,”<br />
KEI blog, http://keionline.org/<br />
node/2085<br />
258 Generics and Biosimilars Initiative,<br />
“Colombia issues further draft<br />
guidelines for biologicals,” 12 June<br />
2015, http://gabionline.net/<br />
Guidelines/Colombia-issues-furtherdraft-guidelines-for-biologicals<br />
259 This has provoked questions from the<br />
US and the EU at the WTO<br />
Committee on Technical Barriers to<br />
Trade, a forum where regulation that<br />
creates unwarranted barriers to trade<br />
are discussed. See: James Love, “Biden<br />
presses Colombia to block biosimilar<br />
drugs,” KEI blog, http://keionline.org/<br />
node/2085<br />
260 Deena Beasley, “Analysis: Use of pill to<br />
prevent HIV may be limited in U.S.,”<br />
Reuters, 7 September 2012, http://www.<br />
reuters.com/article/2012/09/07/us-usahealth-aids-preventionidUSBRE88611M20120907<br />
261 Frederick M. Abbott, “Intellectual<br />
Property and Public Health: Meeting<br />
the Challenge of Sustainability,”<br />
Global Health Programme Working Paper<br />
No. 7/2011; FSU College of Law, Public Law<br />
Research Paper No. 566, 15 November<br />
2011, available online here: http://<br />
ssrn.com/abstract=1965458 or http://<br />
dx.doi.org/10.2139/ssrn.1965458 (last<br />
accessed 16 November 2015).<br />
262 Jerome H. Reichman with Catherine<br />
Hasenzahl, “Non-voluntary<br />
Licensing of Patented Inventions:<br />
Historical Perspective, Legal<br />
Framework under TRIPS, and an<br />
Overview of the Practice in Canada<br />
and the USA,” Issues paper number 5,<br />
UNCTAD-ICTSD Project on IPRs and<br />
Sustainable Development. Geneva,<br />
Switzerland: ICTSD, ISSN 1681-8954,<br />
June 2003, available online here:<br />
http://www.ictsd.org/<br />
downloads/2008/06/cs_reichman_<br />
hasenzahl.pdf<br />
263 For example, Thailand issued<br />
government use licences for<br />
medicines to treat HIV/AIDS and<br />
cancer between 2006 and 2008.<br />
Thanks to this policy, nearly 85,000<br />
additional people were able to access<br />
needed treatments, and considerable<br />
savings were made for the health<br />
NOTES <strong>AND</strong> REFERENCES<br />
174
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