PATENT LINKAGE IN TAIWAN
Walking on eggshells
Implementation of a patent linkage system has continued to be one of the non-negotiable trade policy areas between the US and Taiwan. Susan Wu and Daphne Fang of Top Team International Patent & Trademark
W
ith free trade agreements (FTAs) signed between Taiwan’s major trading partners, notably Korea
and the EU in 2011, Korea and the US in 2012, and one between Korea and China expected in 2015, the Taiwan government has made it a priority to enter into FTA agreements of its own. However,
given Taiwan’s peculiar
international standing (it is recognised by just 22 countries), the only FTAs signed so far have been with its fi ve diplomatic allies in central America: Panama, Guatemala, Nicaragua, El Salvador and Honduras. Since 2012, Taiwan has slowly been
ramping up its eff orts to join the Trans-Pacifi c Partnership (TPP) trade pact, which includes the US, one of Taiwan’s
linkage trading partners.
One of the conditions of joining the TPP—a patent
the intellectual property rights of US pharma companies—is a continuing matter between the US and Taiwan.
system designed to protect
A forced issue Patent
regulatory
linkage is the practice of
linking approval for the marketing,
pricing and reimbursement of a drug to the product’s patent status. Accordingly, if a patent covering a drug is in force, a national health authority must refuse or suspend marketing approval for generic versions unless there is consent or acquiescence by the patent owner. In addition, the patent owner must be informed about applications for the approval of generic drugs. Taiwan has no patent linkage system. Article
60 of the Taiwan Patent Law permits companies to conduct pre-clinical trials, clinical trials, and other activities related to the registration and marketing approval of a generic drug without suff ering a penalty of infringement. Meanwhile, although
required to sign a declaration for generic drug applications with the Taiwan Food and Drug Administration (FDA)—in essence, stating
50 World Intellectual Property Review Annual 2015 World Intellectual Property Review November/December 2014
that their generic drug does not infringe an innovator’s drug—there is no obligation by any party involved to notify the patent owner of the generic drug application. Accordingly, drug manufacturers in Taiwan may receive marketing approval for a generic drug without a patent owner’s permission and before the expiration of a patent. The onus is on the patent owner to infringement
file a patent lawsuit for
civil remedies, including injunctions and damages. Unfortunately, a generic pharma company’s licence can be issued even if a dispute is continuing, which may sometimes take a year to reach trial, not including the time for appeals. While alternative IP protection such as
generic pharma companies are
patent term extensions and data exclusivity are available in Taiwan, implementation of a patent linkage system has continued to be one of the non-negotiable trade policy areas between the US and Taiwan.
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