265 / 610
263
approval for pharmaceuticals.
62
There is no indication of how long the patent term will
be extended due to such delays.
63
The impact of longer patent terms even further increases the costs of medicines by
delaying generics from market entry. Moreover, by postponing the time when the in-
novations will be made available to public, longer patent protection also delays inno-
vation of new drugs which could build on them. However, the same could have been
said about introducing twenty-year patent protection term in TRIPS, which was for
example for India a substantial prolonging of her existing patent protection period. It
needs to be noted that the patent extension in TRIPS-plus provisions only makes sure
that the patentees will be economically rewarded for their inventions for the twenty
years that were originally arranged.
V. Data Exclusivity of Biologics
One of the biggest compromises of the US in the TPP negotiations was on the issue
of biologics. TPP is the first FTA in history to issue the problem of biologics, perhaps
because it is a novel type of treatment. Biologics are medicines derived from living
organisms using a biotechnology process.
64
They are used to treat cancer, diabetes and
other life-threatening conditions and they are the fastest growing segment of phar-
maceutical industry in the world.
65
Unfortunately, they are also extremely expensive;
biologics are one of the main drivers of rising healthcare costs in the US.
66
In 2012, 11
of 12 biologics cancer drugs approved by the US Food and Drug Administration cost
more than 100 000 USD per year.
67
The generics for biologics are called “biosimilars.”
The development of biologics is enormously costly and lengthy. Therefore, the bio-
similars producers need data from the biologics in order to reproduce the medicines—
repeating the tests would be too difficult and unethical because the question of safety
and efficacy of the drug has already been answered.
68
62
Gowling & Lafleur & Henderson “The TPP—new rights for pharmaceutical patent holders in Canada”
Lexology
(13 November 2015) online
<http://www.lexology.com/library/detail.aspx?g=12abcee5-2954-4634-9022-104dce6178d0>.
63
Ibid.
64
“Ambiguity Leads to Fallacy: Biologics Exclusivity in the Trans-Pacific Partnership”
Wikileaks
(9 October
2015) online
<https://wikileaks.org/tpp-ip3/biologics/Ambiguity%20Leads%20to%20Fallacy%20(Biologics).pdf [Biologics]; “Why biologics were such a big deal in the Trans Pacific Partnership”
The
Conversation
online
<http://theconversation.com/why-biologics-were-such-a-big-deal-in-the-trans-pa-cific-partnership-48595> [The Conversation].
65
ibid
66
“Trans-Pacific Partnership Agreement: Harmful provisions for access to medicines”
Public Citizen
on-
line
<https://www.citizen.org/documents/specific%20provisions%20final%20draft%20w.o.pdf> [TPP:
Harmful Provisions].
67
Ibid.
68
Ibid.