[Ip-health] SCP28: KEI statement on Exceptions and limitations to patent rights

Thiru Balasubramaniam thiru at keionline.org
Mon Jul 9 08:37:00 PDT 2018


https://www.keionline.org/28336

SCP28: KEI statement on Exceptions and limitations to patent rights

Posted on July 9, 2018 by Thiru

On Monday, 9 July 2018, Knowledge Ecology International (KEI) made the
following statement on exceptions and limitations to patent rights.

KEI made the following proposal:

In terms of future work on this item on exceptions and limitations to
patent rights, we propose that the Committee request the WIPO Secretariat
to conduct a study on the implications of Article 27.3(a) of the TRIPS
Agreement on the patentability of gene and cell-based therapies including
those involving autologous T-cell immunotherapy (CAR T), CRISPR and other
technologies when treatment can be described as a service or a medical
procedure, rather than a product.

________________________________

9 July 2018

Statement of Knowledge Ecology International

Agenda item 5 – Exceptions and limitations to patent rights

KEI welcomes the publication of the Second Draft of WIPO’s Reference
Document (SCP28/3) on the Exception Regarding Acts for Obtaining Regulatory
Approval from Authorities. The document provides a detailed overview of the
policy objectives that engendered the creation of the regulatory review
exception and a comprehensive insight into its application in over 65
countries. Importantly, it also describes the challenges faced by countries
in its implementation.

The reference document cites a study produced for the European Commission
which estimated that the “extension of the regulatory review” exception to
“cover any medicines and marketing authorizations in any country would
benefit the European pharmaceutical industry by reducing legal costs, such
as freedom-to-operate (FTO) studies, validity opinions, patent oppositions
and costs of infringement proceedings. In particular, the study estimates,
inter alia, that cost savings from FTO studies could amount between
€23-€34.3 million per year.” The study also noted the “cost savings of not
having to run clinical trials in four additional countries would be €2.6
million to €4.4 million per case.”

In terms of future work on this item on exceptions and limitations to
patent rights, we propose that the Committee request the WIPO Secretariat
to conduct a study on the implications of Article 27.3(a) of the TRIPS
Agreement on the patentability of gene and cell-based therapies including
those involving autologous T-cell immunotherapy (CAR T), CRISPR and other
technologies when treatment can be described as a service or a medical
procedure, rather than a product.

We would note that Article 27.3(a) states:

“3. Members may also exclude from patentability: (a) diagnostic,
therapeutic and surgical methods for the treatment of humans or animals.”

Such a study could evaluate the relationship between autologous T-cell
immunotherapies such as tisagenlecleucel (TN Kymriah) or axicabtagene
ciloleucel (TN Yescarta), the first two chimeric antigen receptor T-Cell
(CAR T) treatments approved by the United States FDA, or voretigene
neparvovec (TN Luxturna), a novel in vivo gene therapy for the treatment of
congenital blindness (Leber’s congenital amaurosis), and a national
exception to patentability, under TRIPS Article 27.3(a).

The study should determine if certain cell and gene based treatments are in
fact, exempt from patentability when a country has an exception that
mirrors Article 27.3(a), and also discuss non-patent approaches to
providing incentives to invest in innovations for such treatments, such and
innovation inducement prize funds and market entry rewards (MERs), that
delink R&D costs from prices and monopolies on the medical technologies.


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


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