USDOJ 2017 UPDATE OF THE ANTITRUST GUIDELINES FOR THE LICENSING OF INTELLECTUAL PROPERTY STANDARD SETTING AND COMPETITION November 8, 2012 COMPETITION, INNOVATION AND INTELLECTUAL PROPERTY, April 26, 2012 CHAPTER 6 : COMPETITIVE ISSUES REGARDING PRACTICES THAT EXTEND THE MARKET POWER… Continue Reading
(More on compulsory licensing here.) This is a non-exhaustive set of provisions in US statutes that are used to for non-voluntary use of patented inventions. 28 USC 1498 – Patent and copyright cases 28 USC 1498(a). http://www.gpo.gov/fdsys/granule/USCODE-2011-title28/USCODE-2011-title28-partIV-chap91-sec1498/content-detail.html 42 USC Sec… Continue Reading
For more information on the 2021-2022 Xtandi request please visit: https://www.keionline.org/xtandi2021 (More on government funded inventions here.) On January 14, 2016, Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatment (UACT) submitted a request to the National Institutes… Continue Reading
On August 13, 2014, the Republic of South Africa (RSA) Competition Commission (CC) released the redacted versions of the reports provided to the CC by CPTech in 2003 in the TAC competition case involving GSK and Boehringer Ingelheim. A complete… Continue Reading
July 15, 2014
Knowledge Ecology International (KEI) asks the FTC to investigate Shire decision to abandon efforts to compete in US market for Fabry’s disease treatments. Letter to FTC provides evidence of possible conspiracy to segment markets, involving licensing of an NIH funded invention for use in Europe, in return for abandoning efforts to enter US market.
For More Information:
James Love, Knowledge Ecology International
Email: james.love@keionline.org
Tel +1.202.332.2670
Cell +1.202.361.3040
Informed sources have revealed that Mark Dybul, Executive Director of the Global Fund to Fight AIDS, Tuberculosis and Malaria, is the brains behind an initiative to create global framework for the tiered pricing or in the Global Fund’s own words, “Equitable Access to Essential Medicines and Vaccines: Developing a Framework for Success”, enforced by the rules of the World Trade Organization. KEI has obtained this internal concept note prepared by the Global Fund which we understand is a work in progress.
On January 16, the India Intellectual Property Appeals Board (IPAB) began a hearing on the merits of Bayer’s appeal of India’s first compulsory license.
The outcome of this trial, which focuses on the cancer drug Nexavar, is a matter of first impression for the IPAB, and is expected to set precedents on a wide range of issues, including the permissible grounds for granting compulsory licenses, the relationship between the India patent law and the TRIPS Agreement, and the setting of terms and conditions for the compulsory license, including the royalty rates.
The India Controller General Controller General of Patents, Designs & Trade Marks has just (March 12, 2012) issued an order granting a compulsory license to patents on the cancer drug sorafenib/Nexavar, in the matter of NATCO Vs. BAYER. A copy of the decision is attached below.
KEI has provided an affidavit in an India compulsory licensing dispute involving Natco and Bayer, for patents on the cancer drug sorafenib (sold by Bayer under the brand name Nexavar).
The Bayer price for sorafenib/Nexavar in India is $47 per 200 milligram tablet. At a daily dose of 4 tablets, this comes to $5,637 per month, or more than $68 thousand per year. In 2010, per capita income in India was $1,330.
John L. LaMattina, the former President of Pfizer Global Research and Development, has just published an article in Nature that looks at the impact of drug company mergers and increased industry concentration on R&D. Among his conclusions: the “impact on the R&D of the organizations involved has been devastating.”
http://www.nature.com/nrd/journal/v10/n8/full/nrd3514.html
COMMENT
NATURE REVIEWS | DRUG DISCOVERY VOLUME 10 | AUGUST 2011 | 559
The impact of mergers on pharmaceutical R&D