Test data protection is a sui generis intellectual property right that was first developed in the 1980s for pharmaceutical drugs, and has been extended recently to biologic drugs and vaccines.
When politicians and trade officials tell you they want to impose a restrictive 3-step test to narrow the copyright limitations and exceptions permitted under the Berne Convention, take a minute to review what the Berne exceptions cover, and ask yourself, why would anyone want to further limit these exceptions?
[The related rights in the Rome Convention, the rights in the WCT, WPPT and Beijing treaties, and the flexabilities in the WTO TRIPS Agreement require a separate discussion].
The Berne Convention revisions for limitations and exceptions to copyright 2012:1 KEI Research Note August 2012. Revised June 18, 2017. This research note reports on the evolution of each copyright exception found in the Berne Convention for the Protection of… Continue Reading →
Kista Cox on a provision in the TPP trade negotiation that would restore right to sue surgeons and other medical professionals for patent infringement. The US law (35 USC 287(c)) was changed after lawsuits were filed against surgeons performing certain procedures in eye surgery. USTR and USPTO have been asked to protect this exception in the TPP Intellectual Property Chapter, but have not done so.
Deputy USPTO Director Teresa Stanek Rea has issued a retraction of her statement regarding Administration support for 12 years of exclusive rights in test data for biologic drugs, and moderated somewhat her statement on the India compulsory license for Nexavar. USTR also issued a statement on the issue of biologic test data in response to Rea’s earlier comments.
On June 27, 2012, Teresa Stanek Rea, the Deputy Under Secretary of Commerce for Intellectual Property and the Deputy Director of the United States Patent and Trademark Office (USPTO), testified at a hearing on: “International IP Enforcement: Protecting Patents, Trade Secrets and Market Access”, before the US House of Representatives, Judicary Committee, Subcommittee on Intellectual Property, Competition, and the Continue Reading →
Earlier this month, the European Parliament and the European Commission released a new compromise text on orphan works.
The Compromise Text is available here:
http://register.consilium.europa.eu/pdf/en/12/st10/st10953.en12.pdf
KEI sees the text as a step backwards for access to knowledge. The proposed directive makes far too many compromises, is too limited in terms of the beneficiaries and uses of works, and creates complicated, burdensome and costly procedures and record keeping requirements.
