[Ip-health] WHA71: KEI intervention on the Preparation for the third High-level Meeting of the General Assembly on the Prevention and Control of Non-communicable Diseases, to be held in 2018

Michael H Davis m.davis at csuohio.edu
Mon May 21 10:04:35 PDT 2018


This statement is important. I am surprised to see mention of gene therapies as an arguable exception to patentability under 27(3). There seems nothing arguable about it. I published an article about this a few years ago and it was never criticized as wrong on this point. I think the reason it was published is exactly the fact that it is clearly stated in TRIPS. However the problem is whether these procedures are exempt (they are not) or whether countries are empowered to exclude them (they are) under Trips.

This does raise an additional legal issue which some here may find boring or over technical. The US goes around the world threatening to get exclusions minimized by saying they are prohibited by TRIPS' caution against illegitimate limits. That argument cannot succeed in areas such as this where the limit or exclusion is expressly authorized by TRIPS. I would love to argue such a point in a dispute proceeding. For free.

http://scholarlycommons.law.hofstra.edu/cgi/viewcontent.cgi?article=2849&context=hlr

Governments need to decide if new cell- and gene- based therapies, such as
autologous T-cell immunotherapy or gene therapies like Luxturna, are
medical procedures that are exempt from patent protection under Article
27(3)(a) of the TRIPS Agreement.

_________________________________________


Prof. Mickey Davis
216/687-2228(phone)
917/771-0235 (cell)

Mailing Address:
Cleveland State University
2121 Euclid Avenue, LB 234
Cleveland, OH 44115-2214

Campus Location:
Cleveland-Marshall College of Law
1801 Euclid Avenue
Law Building, LB 234

Admitted to practice before the United States Patent and Trademark Office, Reg. No. 45,863


-------- Original message --------
From: Thiru Balasubramaniam <thiru at keionline.org>
Date: 5/21/18 11:20 AM (GMT-05:00)
To: "ip-health at lists.keionline.org" <Ip-health at lists.keionline.org>
Subject: [Ip-health] WHA71: KEI intervention on the Preparation for the third High-level Meeting of the General Assembly on the Prevention and Control of Non-communicable Diseases, to be held in 2018

https://www.keionline.org/27898

WHA71: KEI intervention on the Preparation for the third High-level Meeting
of the General Assembly on the Prevention and Control of Non-communicable
Diseases, to be held in 2018

--

At the 71st World Health Assembly, KEI will deliver the following
intervention regarding the Preparation for the third High-level Meeting of
the General Assembly on the Prevention and Control of Non-communicable
Diseases, to be held in 2018.

11.7 Preparation for the third High-level Meeting of the General Assembly
on the Prevention and Control of Non-communicable Diseases, to be held in
2018

KEI is concerned that companies selling insulin, drugs and therapies for
cancer have been given a prominent role in limiting the discussion of
measures to address the high costs medicine in connection with the upcoming
High-level Meeting of the General Assembly on the Prevention and Control of
Non-communicable Diseases.

Globally, there is alarm over the soaring costs and high prices of new
drugs, vaccines, and diagnostics, as well as patented gene- and cell-based
therapies. However, these topics are barely addressed in the preparatory
documents. In the recent WHO meeting on partnerships and financing held in
Copenhagen, the meeting was co-sponsored by drug companies and a foundation
funded by insulin manufacturers. Drug companies were described as
“partners” in dealing with access issues, as if everyone is seated in the
same boat, with shared interests.

The WHO Framework of Engagement with Non-State Actors is a reminder of the
risks of collaborations with industry groups, and that seems to have been
largely ignored in the context of the NCD negotiations.

There are many obvious issues relating to the pricing of and access to
drugs and services used to treat non-communicable diseases, which should be
addressed.

Governments do not have workable models for determining when prices for
cancer, heart disease, diabetes and rare diseases are excessive, even
though this is a well known and significant problem that needs to be
addressed.

The issue of inadequate competition for biologic drugs well after patent
expiration needs to be fixed.


And finally, but critically, we need a path for implementing the delinkage
of R&D incentives from prices.

--
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org
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