Taiwan needs to protect research data that looks into new uses for drugs that are no longer covered by patent in line with WTO regulations, biotech experts urged yesterday.
"Patent protection is pivotal, but data protection and exclusivity are also essential," Manuel Campolini, a spokesman for the European Federation of Pharmaceutical Industries and Associations, said at a Taiwan-Europe government-level intellectual property rights (IPR) seminar in Taipei yesterday.
"Taiwan is a highly developed country and it is extremely important that the system in terms of patent and data protection be modeled on the basis of the same system developed in [industrial] countries," Campolini said.
When drugs pass their patent period, their research data is no longer classified. Drug companies can then use the data to create their own version of the drug -- known as a generic -- which can be sold freely in competition with the original drug and other generics.
But if a company researches a new use of the expired drug, its data is protected under the WTO's "Trade Related Aspects of Intellectual Property Agreement."
As researchers exhaust the number of effective chemicals that can treat human ailments, finding new uses for old drugs is becoming increasingly critical. Money spent on research into new applications or variations of old drugs will be wasted if the research is not protected.
"The driving force towards new technology in the drug industry is reworking old drugs that have passed their patent period," said David Silver, director of Biotecheast.com, a Web site that promotes Taiwan's biotechnology and pharmaceutical industries.
Refusal to protect this kind of research could hurt public health, Campolini said, citing the example of a variant of the protein interferon that is now being used to treat the deadly hepatitis C virus.
"If biotechnology research is not protected, do you think investments in new uses of drugs will be made?" he said.
"No, never!" Campolini added.
A Taipei-based legal expert agreed.
"Taiwan is in a position to move in a club with the advanced countries," said John Eastwood, co-chairman of the Intellectual Property Committee of the European Chamber of Commerce Taipei.
"Does Taiwan really want to be a developing country that doesn't respect data protection? Even China offers six years of protection," Eastwood said.
Unfortunately the government has yet to offer a pledge on drug research data protection, Eastwood said. So far Taiwan has no legislation to protect this kind of research, he added.
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