Test data protection for medical inventions
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.
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Members of Congress and Governors backing PhRMA/BIO, calling for 12 years data protection for biologic drugs in TPP
While the GOP and Democratic conventions highlight the differences between the parties, there are some bipartisan issues, and one of the biggest is taking care of corporate interests.
KEI Comments to Federal Register Notice on Mexico, Canada Joining TPPA
USTR will host two public hearings regarding the Trans-Pacific Partnership Agreement (TPPA). The first, to be held on Friday, 21 September 2012, will cover Mexico’s participation in the TPPA. The second hearing will be held on Monday, 24 September 2012, and will address Canada’s participation in the TPPA.
2011: Survey of drug prices for 14 drugs with US government rights in patents listed in the FDA Orange Book
Survey of drug prices for 14 drugs with US government rights in patents listed in the FDA Orange Book
Tedmund Wan
Knowledge Ecology International
November 11, 2011
Introduction
September 2011: Spotlight on India at the WTO Trade Policy Review
On 14 September 2011 and 16 September 2011, the World Trade Organization (WTO) undertook a trade policy review of India. All members of the WTO are subject to review under the Trade Policy Review Mechanism (TPRM). The TPRM takes place in the “Trade Policy Review Body which is actually the WTO General Council — comprising the WTO’s full membership — operating under special rules and procedures” (Source: WTO, Trade Policy Reviews: Brief Introduction). Continue Reading
Birch Bayh’s competing interests and evolving views
The 1980 Bayh-Dole Act is named after two former US Senators, Birch Bayh and Bob Dole. In 2002 both claimed the Bayh-Dole Act march-in provisions were not intended to address cases where prices for inventions are unreasonable, and Senator Bayh repeated this view during a 2004 march-in case involving Abbott patents on ritonavir.
Among the provisions of the Act that suggest otherwise are the following:
Federal Circuit decision again results in three-way split in reasoning in AMP v. USPTO; 2-1 ruling upholds DNA patents
On Thursday, 16 August 2012, the Court of Appeals for the Federal Circuit issued its opinion in the case Association for Molecular Pathology v. US Patent and Trademark Office, again rejecting the plaintiffs’ contentions that isolated DNA is not eligible for patent protection. This case surrounds the patent eligibility of isolated DNA, particularly the BRCA1 and BRCA2 genes known to be associated with an individual’s susceptibility to breast and ovarian cancer.
Geneva Fall/Winter 2012: What’s in store at the WHO, WIPO and WTO
As Geneva awakes from its summer slumber post-Jeûne genevois (6 September 2012), the following conferences and negotiations are expected to shape the knowledge governance landscape in the second semester of 2012 at WHO, WIPO and WTO.
World Health Organization
Here are upcoming meetings of the WHO in 2012 of relevance to public heath, innovation and access.
Text of 1971 Berne Convention Appendix on Special Provisions Regarding Developing Countries
Berne Exceptions not subject to 3-step test
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].
Article 2(4,7 and 8) – Protected Works: