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In the US, biologics are protected from competition of biosimilars by market ex-
clusivity for twelve years from the time they are granted marketing approval.69 Data
exclusivity prevents the regulator from accepting an application for marketing authori-
zation from a generic producer; this regulatory measure is independent on the patent
system.70 Data exclusivity system works as following: when a generic manufacturer
wants to register his generic version of a drug, he has to provide data showing that
the product is a bioequivalent to the original drug. The regulator already has all the
clinical data from the original producer. However, the data exclusivity system prevents
the regulator from “referring to existing clinical data to approve registration of generic
version.”71 This form of protection prevents competition even after a patent of the
original product expires.72 The only way the generic manufacturer can obtain the nec-
essary registration is to repeat all the necessary clinical trials.
The biologics producers, who are represented for example by the Biotechnology
Industry Organisation, pushed during the TPP negotiations for a twelve year73 data
exclusivity period. They argued that the term was a result of a lengthy debate and that
it is the best balance that both stimulates research and provides biosimilars in a timely
manner.74
However, evidence suggests that neither the existence of patentability of biolog-
ics nor the market encourage development of new drugs.75 The US proposition for
the prolonging of biologics protection was one of the most controversial and raised
protests from the observers, especially due to fears that it would lead to increase costs
of medicines and reduced access to them.76 On the other hand, evidence from Japan
and Canada showed that health expenditures did not increase after the introduction of
longer biologicals protection.77 Nevertheless, the fact that the countries did not spend
more on biologics does not mean that the treatment was available for everyone who
needed it – the reason for not increasing the expenditures might have been budgetary
restrictions, making the expensive treatment available only for few patients. The fact is
that the biologics are extremely expensive and their extensive protection delays access
to more affordable biosimilars. Due to this fact, even the US have been considering
69 The Conversation supra note 144.
70 Generics supra note 141.
71 “Trading Away Health” Doctors Without Boarders (August 2012) online -
> [Trading Away Health].
72 The Conversation supra note 144.
73 An early proposition of the US was even more restrictive: fourteen years; ibid.
74 Dan Stanton, “TPP: Five years data protection for biologics in US-Asia trade deal,” BioPharma (5
October 2015) online
data-protection-for-biologics-in-US-Asia-trade-deal>.
75 The Conversation supra note 144.
76 “New Report Suggests RDP Does Not Increase Healthcase Expenditures,” Biotech Now online <http://
crease-healthcare-expenditures>.
77 Ibid.