Of possible interest

The US Secretary General High Level Panel on Access to Medicine. KEI submissions.

Request to NIH and Army to use government royalty free or march-in rights in the prostate cancer drug Xtandi.

Proposal for a WTO Agreement on the Supply of Public Goods.

Prices and patents on drugs, vaccines and diagnosis of hepatitis.

Innovation inducement prizes, possibly as an alternative to IPR monopolies to reward successful innovation.

Now is a good time to donate money to KEI

KEI Timelines, on a variety of topics.

Poll

Governments can ration access to cancer drugs, or break patent monopolies. Why is rationing so popular?:

Seminars on Drug Pricing: Part 5 Kevin Outterson, Antibiotic Delinkage

UPDATED:
Here is a link to the recording of the seminar. Please see Professor Outterson's slideshow for more detail and explanation.


Original

Tentative witness list for USITC hearing on Economic Impact of Trade Agreements

This is the tentative witness list for the November 17, 2015 United States International Trade Commission (USITC) hearing on "Economic Impact of Trade Agreements Implemented Under Trade Authorities Procedure, 2016 Report. Inv. No.: 332-555"

The August 4, 2015 USITC notice about the hearing is here.

Dr. Margaret Chan: TPP may "close access to affordable medicines"

World Health Organization (WHO) Director-General Dr. Margaret Chan addressed civil society and policy-oriented “think tanks” on November 12, 2015, and “challenge[d]” them to “help with issues that keep me awake at night.” Specifically, she mentioned the problems with pharmaceutical patents, high drug prices as a barrier to access, and the current system of incentives for new drug innovation. Dr. Chan also raised concerns about the the TPP, which she said may raise drug prices and harm access to generics.

US Chamber of Commerce lauds USPTO for securing a time-bound LDC waiver for pharmaceutical products

Nestled at the end Intellectual Property Watch's (IP-Watch) brilliant reportage of a US Chamber of Commerce event - "Has the Sun Set on Multilateral Rulemaking on IP?” - is a quote by Patrick Kilbride (Executive Director, U.S. Chamber of Commerce's Global IP Center) praising the efforts of the US Patent and Trademark Office (USPTO) in WTO negotiations on the LDC waiver for pharmaceutical products.

IP-Watch reported,

Joint NGO Statement on TRIPS Council Decision On Extension of the Transition Period Concerning Pharmaceutical Products

JOINT NGO STATEMENT
TRIPS Council Decision On Extension of the Transition Period Concerning Pharmaceutical Products

(PDF copy available here)

Today (6th November), the WTO-TRIPS Council adopted a decision granting Least Developed Countries (LDCs) an exemption from patents and test data protection for pharmaceutical products for a duration of 17 years.

TPP has provision banning requirements to transfer of or access to source code of software

Updated. The TPP E-Commerce chapter has a provision banning requirements to transfer or provide access to software source code. This applies to "mass market software."

Article 14.17: Source Code
1. No Party shall require the transfer of, or access to, source code of software owned by a person of another Party, as a condition for the import, distribution, sale or use of such software, or of products containing such software, in its territory.

Some parts of the TPP that deal with drug, medical device prices, reimbrusements

The whole TPP text.

CHAPTER 8, TECHNICAL BARRIERS TO TRADE.

ANNEX 8-C: PHARMACEUTICALS

7bis. Each Party shall make its determination on whether to grant marketing authorisation for a specific pharmaceutical product on the basis of:

TPP on registration of drugs, bans requirements to disclose or consider certain financial or pricing data.

This is from one of the 26 chapters that was never leaked before.

CHAPTER 8 TECHNICAL BARRIERS TO TRADE, ANNEX 8-C: PHARMACEUTICALS, Annex 8-E: Medical Devices (Page 25)

ANNEX 8-C: PHARMACEUTICALS

7bis. Each Party shall make its determination on whether to grant marketing authorisation for a specific pharmaceutical product on the basis of:

Western or Fairy Tales? Global Copyright Policies & Info Soc VII Seminary, Curitiba Brazil

Here is my presentation at the VII Seminary Internacional Sobre Sociedade Da Informacao E Propriedade intelectual organized by Professor Marcos Wachowicz, Universidade Do Parana and Professor Jose Augusto Fontoura Costa, Universidade De Sao Paulo. Participants --all experts in copyrights-- were from Spain, Portugal and Brazil and the discussions were lively and informative. Great copyright event in Curitiba, Brazil.

Despite assurances to contrary, intellectual property covered asset for TPP ISDS mechanism

The negotiators have finally released, for the first time, TPP text, which is on the web here.

Despite assurances from the contrary by Australia and USTR, intellectual property is a covered asset subject to Investor State Dispute Settlement (ISDS):

Article 9.1: Definitions

For the purposes of this Chapter:
. . .

Seminars on Drug Pricing: Part 4, Bhaven Sampat

UPDATED:
Here is a link to the recording of the seminar. Please see Bhaven's slideshow for more detail and explanation.


Original

Copyright norms in treaties & trade agreements - what possibly can go wrong?

My presentation at IX CODAIP, Curitiba, Brazil, on Copyright norms in treaties & trade agreements - what possibly can go wrong?.

WTO Decision on Least Developed Country (LDC) Drug Patent Waiver

For Immediate Release
3 November 2015
Contact: Zack Struver, +1 (202) 332-2670 or zack.struver@keionline.org

Geneva — The World Trade Organization is poised to announce this Friday its approval of a limited 17-year extension of a 2001 waiver of obligations in the TRIPS Agreement, set to expire at the end of this year, the terms of which exempt Least Developed Countries (LDCs) from requirements to grant patents or related intellectual property rights on pharmaceutical products.

European parallel trade in pharmaceuticals, 2013

As candidates consider parallel trade in pharmaceutical drugs, a practice blocked by Obama during his presidency, here is how common it is in Europe, where it is regulated and mainstream, as reported in the EFPIA publication, the Pharmaceutical Industry in Figures. Key data, 2015.

EU-drug-parallel-trade-efpia-data-2013.png

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