James Love's blog

Xtandi 2016 March-In Request

Today Knowledge Ecology International and the Union for Affordable Cancer Treatment (UACT) petitioned the Department of Health and Human Services, the Department of Defense, and the National Institutes of Health, asking that they exercise federal "march-in" rights to end the monopoly on an expensive prostate cancer drug, enzalutamide, marketed as Xtandi by Astellas, a Japanese pharmaceutical company.

Xtandi was invented at UCLA on federal grants from the NIH and DoD.

51 members of Congress have asked the NIH to use March-In rights to rein in high drug prices

This was the release from Representative Doggett's office:

FOR IMMEDIATE RELEASE
January 11, 2016

Contact:
Leslie Tisdale, (202) 225-4865
Over 50 Members of Congress to Obama Administration:
Help End Drug Price Gouging Now

FDA approves 45 new drugs. 47 percent qualify for 50 percent Orphan Drug tax credit

In calendar year 2015, FDA’s Center for Drug Evaluation and Research (CDER) approved 45 novel drugs, approved as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs). This is a large number of approvals.

KEI's December 19, 2015 submission to the US ITC regarding the TPP

Attached here is a KEI submission to the US ITC for the January hearing of the

UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, DC
Investigation No. TPA-105-001
Trans-Pacific Partnership Agreement: Likely Impact on the U.S. Economy and on Specific Industry Sectors

Our earlier, related testimony on trade agreements was here: http://keionline.org/node/2370

The UK's rebates on drug sales, and introducing the budget constraint into pricing models

Under the UK's Pharmaceutical Price Regulation Scheme (PPRS), drug companies will make rebates of about £550 million in 2016, according to this story.

KEI intervention on definition of broadcasting

WIPO SCCR 31 is having a text based discussion of the language for a proposed broadcasting treaty. The meeting is open to NGOs, instant transcripts are streamed over the Internet, and the proceedings are webcast. I was allowed to make to technical interventions this afternoon on the definitions. This is a slightly edited version of my second intervention, on the question of whether or not to have separate definitions for broadcasting and cable casting.

KEI’s Initial Comments on the MPP/BMS license to patents and know-how for daclatasvir (DCV)

KEI’s Initial Comments on the MPP/BMS license to patents and know-how for daclatasvir (DCV)

November 23, 2015

FYI: Contact: Andrew Goldman (andrew.goldman@keionline.org) or Zack Struver (zack.struver@keionline.org)

Knowledge Ecology International (KEI) notes the successful conclusion of negotiations between Bristol-Myers Squibb (BMS) and the Medicines Patent Pool (MPP) for a royalty-free license and technology transfer agreement on daclatasvir (DCV), an important new medicine for the treatment of the hepatitis C virus (HCV), and offers comments on the agreement.

My testimony this morning at the US ITC hearing on "Economic Impact of Trade Agreements"

Attached is a PDF file with my testimony this morning for the United States International Trade Commission (USITC) hearing on
"Economic Impact of Trade Agreements Implemented Under Trade Authorities Procedure”, 2016 Report. Inv. No.: 332­555 November 17, 2015

Manon Ress also provided testimony at this hearing, for the Union for Affordable Cancer Treatment (UACT). A copy of her testimony is available here.

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.

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:

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:
. . .

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