A/70/279
78. In 2013, the Supreme Court of the United States held that human DNA
(isolated genes) could not be patented and that merely isolating genes found in
nature does not make them patentable. The Court did, however, uphold the patents
of the concerned company, Myriad Genetics, on the complementary D NA version of
the genes, a synthetic creation not normally present in nature. 28
79. Patient organizations, health activists and generic companies have used pre and post-grant opposition systems to challenge patents applications as not satisfying
patentability criteria in some countries. In Brazil, the Brazilian Health Surveillance
Agency (ANVISA) has authority to require re-examination of patents on inventions
that have important health implications.
80. Compulsory licensing has been initiated in countries such as Brazil, Ecuador,
India, Indonesia, Malaysia and Thailand. Compulsory and government -use licenses
have been issued for HIV/AIDS-related medicines, and for cardiovascular, cancer
and hepatitis medicines. In addition, nearly 25 least developed countr ies have taken
advantage of their TRIPS transition period with respect to pharmaceutical products
to decline to enforce patents on medicines, thereby being able to import cheaper
generic antiretroviral medicines to treat HIV and AIDS.
81. The Human Genome Project mapping the genetic information of human
chromosomes, as a basis for future medical research, was proposed by the United
States and became a global collaboration, with sequencing carried out by
universities and research centres in several countries. The information generated by
the project was put into the public domain and made available to all researchers
without charge. 29
82. The Medicines Patent Pool, supported by UNITAID, has negotiated in -licenses
for 11 medicines from 6 patent holders and out-licenses to 10 generic manufacturers
who can thereby supply cheaper generic antiretroviral drugs to the vast majority of
people living with HIV and AIDS in low- and middle-income countries. This
“collective management” of patent rights is an approach that might be extended to
promote access to other medicines.
83. Databases have been created for the documentation and conservation of
traditional knowledge, in an attempt to combat biopiracy. Interesting models include
the 2004 National Commission against Biopiracy of Peru, which has prioritized
35 Peruvian biological resources of significant utility and potential value. The
Commission has sent information to relevant intellectual property offices in third
countries, contributing to decisions to reject, abandon or withdraw nine
controversial patents utilizing Peruvian genetic resources and associated traditional
knowledge. Notably, the Peruvian patent office took the lead in this exercise, as
patent examiners are best situated to compile dossiers that help o ther patent offices
to reach an informed decision. 14
84. Many States have introduced a requirement that applications for patents for
inventions based on genetic resources and/or associated traditional knowledge
should disclose information about their source or origin, as well as on whether or
__________________
28
29
20/26
See Supreme Court of the United States of America, Association for Molecular Pathology et al.
v. Myriad Genetics, Inc., et al., Decision of 13 June 2013, No. 12-398.
See Heidi L. Williams, “Intellectual property rights and innovation: evidence from the human
genome”, Journal of Political Economy, vol. 121, No. 1 (February 2013); available from
hdl.handle.net/1721.1/78858.
15-12543