[Ip-health] IP-Watch: Patents-Access Relationship Not Clear-Cut, Speakers At WIPO Say; Biologics A Challenge For Generics

Andrew S. Goldman andrew.goldman at keionline.org
Thu Dec 3 06:48:37 PST 2015


Patents-Access Relationship Not Clear-Cut, Speakers At WIPO Say; Biologics
A Challenge For Generics


A seminar on patents and availability of medicines in developing countries
yesterday at the World Intellectual Property Organization considered
whether patents constitute a barrier to access. For the private sector,
patents are essential to the innovation system, for others they maintain
high prices and should be licensed for easier access. Beyond patents,
biologics seem to be taking over the pharmaceutical industry, and the
complexity of manufacturing biosimilars might well leave traditional
generic manufacturers by the wayside.

Separately, a side event at WIPO looked at IP management strategies in
private-public partnerships in agriculture and health technologies.

The 23rd session of the Standing Committee on the Law of Patents is being
held from 30 November- 4 December. A half-day seminar [pdf] was organised
today on the relationship between patent systems and the availability of
medicines in developing countries and least-developed countries.

Moderated by Zafar Mirza, coordinator, Public Health, Innovation and
Intellectual Property, at the World Health Organization, the seminar
gathered four experts to present their views.

Mirza said “the pipeline for innovation and new medicines was never so
rich, we are told, but still there are millions of people waiting to access
appropriate treatments.”

Biologics, New Challenge for Generic Manufacturers

Brian Tempest, editor of the Journal of Generic Medicines, underlined the
high prices of medicines. In the United States or in Japan, some medicines
are priced at over US$50,000 per year per patient. “It affects everybody in
this room,” he said.

Tempest underlined the new issue of biologics, bigger, very complex
molecules, which are very expensive. They are very difficult to make and
current manufacturing assets cannot do that, he said. In 2016, biologics
will constitute half of the top 20 medicines sold, and they are taking over
the pharmaceutical industry, he said.

According to the International Federation for Pharmaceutical Manufacturers
and Associations (IFPMA), “Biotherapeutics, also known as biotech drugs or
biologics, are therapies derived from living organisms. By harnessing these
living cells to make or modify protein products, therapies that treat
illness and improve health are able to be made.”

There is a global rise in cancer patients, and cancer drugs are getting
increasingly more expensive, Tempest said, adding, “There is a public
health crisis around the corner.”

Biosimilars, which can be developed after a biologic patent expires, are
very expensive to manufacture and the current generic industry would need
massive investment in equipment to get into biosimilars, he said.

Large pharmaceutical companies are realigning their R&D and most likely
future products will be coming from big molecules, he said. Those expensive
medicines will be available only to the wealthy of the world, he said, a
looming crisis.

Tempest said new names are emerging in this new market, such as South
Korean companies Celltrion, and Samsung, which is building large facilities
to supply larger molecules around the world.

Attracted by what has the potential to be a very lucrative market,
companies such as Fujifilm are also entering the market, he said.

Patents a Barrier but also Enablers, Speaker Says

Margaret Kyle, professor at MINES ParisTech, said several policy tools are
available to keep prices affordable in developing countries, such as price
control, and compulsory licences.

Although patents might constitute a barrier in terms of access, they may
also facilitate access under some conditions, she said. According to Kyle,
the highest regulatory costs to enter the market are born by the first
applicant, while subsequent entrants rely on the data submitted by the

Without protection, the first entrant, which bears the highest cost, may
not be willing to enter the market at all, she said.

Former MPP Director Calls for Essential Medicines MPP

Ellen ’t Hoen, lawyer and an independent consultant in medicines policy and
law, as well as former executive director of the Medicines Patent Pool
(MPP), said the patent system is a social policy tool meant to create
benefits for society but could have significant societal costs.

She underlined the importance of the flexibilities enshrined in patent law
[in the World Trade Organization Agreement on Trade-Related Aspects of
Intellectual Property Rights – TRIPS] and the wide use of those
flexibilities by governments in developing and least-developing countries.

Other mechanisms than patents create monopoly situations, she said, such as
regulatory data exclusivity which leads to the delay of generic entry and
is increasingly globalised through binding trade agreements.

‘t Hoen compared global pharmaceutical spending, which is is expected to
reach US$ 1.4 trillion by 2020, a 30 percent increase from 2015, to
spending on research and development (R&D), amounting to $137 billion in
2014. Policymakers need to take this information home: despite the size of
the market, some needs are not met, such as new antibiotics, Ebola
treatment, or paediatric medicines, she said.

The listing in the WHO list of essential medicines should have consequences
and should lead to the licensing of patents, she said, referring to the
entry into the list last spring of a number of new patented highly-priced
drugs, such as for hepatitis C and oncology drugs. She suggested studying
the concept of an essential medicines patent pool.

Short-Term Access No IP Problem, Novartis Says

Cory Salsberg, head of international IP policy at Basel-based Novartis,
said short-term access is often not about IP. He presented short-term
access as a complex problem with complex causes and complex solutions. Some
95 percent of WHO essential medicines are off-patent, he said. However,
one-third of the world’s population does not have reliable access to them,
and in parts of Africa and Asia, that is true for half the population.

IP is just one factor of access and one component of price, others include
lack of doctors, lack of infrastructure, and lack of education. IP is not a
barrier, he said, and if used appropriately, it can work, and has worked in
short-term and long-term access.

Most innovations in the past have come from the pharmaceutical industry and
it continues today, said Salsberg, adding that innovation “is at a peak.”
Some 76 percent of inventions in the pharmaceutical sector comes from
biotechnology or pharmaceutical companies, not from universities or
government-funded research, he said.

The patent system cannot be thrown out or weakened, he said, is innovation
is to be sustained. IP is the most convenient factor to focus on, he said,
but all other factors should be addressed, and capacity-building be
supported. He cited the company’s malaria initiative.

Side Event: IP Management In Health and Agriculture

Separately, a side event to the SCP was held yesterday on IP management
strategies of public-private development initiatives in agriculture and
health technologies. It was co-organised by Croplife and Innovation

On the panel, Sylvie Fonteilles-Drabek, executive vice president of the
Medicines for Malaria Venture (MMV), said MMV is a private-public
partnership set up to develop antimalarial drugs. MMV raises funds – with
the major donor being the Bill and Melinda Gates Foundation – and then
funds research and development through grants made to universities or even
pharmaceutical partners.

On IP ownership, Fonteilles-Drabek said pharmaceutical companies want to
own the IP, “which is fine with us,” adding that sometimes IP is co-owned.
Universities, on the contrary, mostly assign the rights to the MMV, she

MMV patents “almost systematically” molecules and methods of use to have
the freedom to operate, and attract potential partners, she said. Having an
IP asset is often a powerful argument for private partners. “Patents is a
language they understand,” she said. They might think that the molecule
could be used later for another indication.

Alhaji Tejan-Cole, director of legal affairs, African Agricultural
Technology Foundation (AATF), Kenya, said the foundation seeks to
facilitate and promote public-private partnerships for the access of
appropriate technologies by smallholder farmers in sub-Saharan Africa.

The foundation obtains “humanitarian use” licences, royalty-free or lower
cost, on diverse technologies, such as pest management, drought, and
climate change. It collaborates with several companies such as Monsanto,
and Arcadia Bio-sciences.

To a question about why should the foundation bother with patents when in
most sub-Saharan countries they are not registered, Tejan-Cole answered
that licensing allows access to the know-how, and test data.

Investors in AATF include the Bill and Melinda Gates Foundation, Syngenta
Foundation for Sustainable Agriculture, and the Rockefeller Foundation.

For Daniel Miller, associate director for PATH, the 1977 founded non-profit
organisation uses entrepreneur spirit, public health expertise and
commitment to health equity. PATH’s role, he said, is to catalyse
cross-sectoral collaborations, and seeks to drive innovation through a wide
range of tailored approaches. The Gates Foundation is a regular donor to

Access Threatened by Trade Agreements, NGO Says

Knowledge Ecology International (KEI), on 1 December, delivered a statement
to the SCP plenary on patents and health at the SCP. KEI representative
Thiru Balasubramaniam said bilateral and plurilateral agreements such as
the Trans-Pacific Partnership (TPP) are a cause of concern. “The TRIPS-plus
measures of the TPP are designed to make drugs, vaccines, diagnostic tests
and other medical technologies more expensive, often by broadening and
extending the monopoly protections conferred by intellectual property
rights,” he said.

Andrew S. Goldman
Counsel, Policy and Legal Affairs
Knowledge Ecology International
andrew.goldman at keionline.org // www.twitter.com/ASG_KEI
tel.: +1.202.332.2670

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