Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

Trans-Pacific Partnership and Drug Patent Exclusivity


Trans-Pacific Partnership

The issue of patent exclusivity was one of the last hotly-debated issues as the TPP talks drew to a close.

Share this!

October 7, 2015 | by Sarah Massey

After five years of negotiations, the Trans-Pacific Partnership (TPP) talks have now come to a close. Though the US representatives argued in favour of a 12-year patent protection policy – the current term of a drug patent in the country – they faced opposition from the other nations involved in the talks.

With the support of patient-advocacy groups, representatives from New Zealand and Australia stressed the importance of capping biologics patents at 5 years. The issue of patent exclusivity was one of the last hotly-debated issues as the TPP talks drew to a close.

The partnering nations finally settled on a patent exclusivity period between 5 and 8 years – a positive outcome, according to commentators outside the industry. Nations involved in the TPP are said to now have, “an alternative of either providing 8 years of exclusivity to biologic drugs – or providing 5 years of so-called data exclusivity – plus up to three more years under a regulatory framework in the TPP,” said a report produced by the Wall Street Journal.

However, some industry insiders – including US Trade Representative Michael Froman – are less than thrilled with the compromise. According to a statement released by the Biotechnology Industry Association (BIO), “We are very disappointed in reports from Atlanta that suggest Trade Ministers have failed to include 12 years of data exclusivity for biologics in the Trans-Pacific Partnership (TPP) agreement.”

BIO’s sentiments were also shared by the Pharmaceutical Research and Manufacturers of America (PhRMA). Individuals who oppose short-term exclusivity for biologic patents, cite the need for an incentive for pharmaceutical companies to develop new drugs, and have intellectual property protection over their investment.

“While the TPP agreement will not impact the U.S. data protection period, we believe the failure of our Asian-Pacific partners to agree to a similar length of protection is remarkably short-sighted and has the potential to chill global investment and slow development of new breakthrough treatments for suffering patients,” said the statement released by BIO.

The TPP discussed trade regulations in a number of industries – including auto trade and agriculture – and involved 12 countries: Canada, Chile, Brunei, Singapore, New Zealand, Japan, Australia, Malaysia, Peru, Mexico, Vietnam, and the United States.




Accelerating Timelines from Candidate Selection to Proof-Of-Concept

Prescription & Over The Counter GMPs: Avoiding 483's and Making the Best Decisions

Keywords: Patent, Drug, Development 


    Share this with your colleagues!

    Drugs That Give Same Health Benefits as Exercise Could Be in the Pipeline

    October 5, 2015 - Excercise isn't always a viable treatment option, so developing drugs that mimic the effects may be a new way forward.

    Human Genomic Variation Database Launched for Clinical Use

    October 2, 2015 - A team of National Institutes of Health (NIH) supported scientists are developing the first database of human genomic variation, to aid in disease discovery research.

    Increased Calcium Uptake Ineffective at Preventing Fractures

    October 2, 2015 - Two studies published in The BMJ have warned that recommending calcium supplementation to prevent fractures, is ineffective at improving bone health in older individuals.

    Copyright © 2016-2017 Honeycomb Worldwide Inc.