[Ip-health] Indian patent office delivers major blow to affordable pneumonia vaccine hopes

leena menghaney leenamenghaney at gmail.com
Tue Aug 22 02:48:44 PDT 2017

Indian patent office delivers major blow to affordable pneumonia vaccine

Access Campaign, 22 August 2017

Geneva/New York/New Delhi, 22 August 2017 – Hopes for improved access to an
affordable pneumococcal conjugate vaccine (PCV) that safeguards both
children and adults from pneumonia was dealt a major blow after the Indian
patent office granted a patent to the US pharmaceutical corporation Pfizer
for its PCV13 product, marketed as Prevnar13.

“It’s unfair and unacceptable that almost a million children die each year
from pneumonia, even though a life-saving vaccine is available. Children
everywhere have a right to be protected from pneumonia, but many
governments can’t afford the prices set by Pfizer,” said Dr Prince Mathew,
Asia Regional Coordinator for MSF. “We urgently need additional
manufacturers to rapidly introduce competition with the aim of lowering
vaccine prices.”

The granting of this patent would block other manufacturers in India from
supplying this vaccine - which protects against 13 types of pneumococcal
bacteria (PCV-13) - to those who need it most.

According to Leena Menghaney, South Asia Head for MSF’s Access Campaign,
“The method Pfizer is trying to patent is too obvious to deserve a patent
under Indian law, and is just a way to guarantee an extended market
monopoly for the corporation for many years to come.”

In 2016, MSF challenged Pfizer’s unmerited patent claims in India, after
the same patent was revoked by the European Patent Office (EPO). The patent
is also being legally challenged in South Korea and before the US Patent
Trademark Appeal Board.

MSF relies heavily on affordable generic medicines to do its medical work
around the world: two-thirds of its medicines used to treat people with
HIV, tuberculosis, and malaria are generic medicines made in India. Indian
vaccine manufacturers have already announced that they can supply PCV for a
much lower price. However, Pfizer’s patent allows it to continue
controlling the PCV market in India until 2026, and blocks developing
country vaccine manufacturers from supplying a competing version of
Pfizer’s PCV. Manufacturers will have to find new routes to develop a
non-infringing PCV vaccine which may delay the availability of competing
products in the pipeline from Indian producers.

Dr. Anas Shorman, a paediatrician working for MSF in Jordan, added, “In our
work, we see many children with life-threatening respiratory infections;
many deaths could be prevented if more kids were vaccinated with PCV. More
than 50 countries have spoken out against high vaccine prices, and children
in countries like Indonesia, Jordan and Tunisia simply can’t wait any
longer to get access to the life-saving pneumonia vaccine.”

The Indian patent office’s decision also has broader implications, as it
indicates a weakening of India’s strict patentability standards, which
results in granting monopolies for minor and trivial improvements of
existing medical products, as allowed in some other countries. Such
ever-greening practices will hamper India’s role as ‘pharmacy of the
developing world,’ supplying governments and procurers like MSF with
affordable medicines and vaccines.


*PCV and Patents*

The patent granted to Pfizer involves the method of conjugating
(assembling) together serotypes of streptococcus pneumonia into a single
carrier and is essential for PCV developers. The patent is a mere addition
of serotypes to the already established 7 valent vaccine and does not meet
the inventive step requirement; it ought to have been rejected. In 2014,
the revocation of Pfizer’s patent by the European Patent Office in 2014
judging it to be non-inventive was based on the consideration of a total of
five oppositions, including those filed by Merck and Novartis. The
revocation was on upheld on appeal.

Pharmaceutical corporations have been building so-called patent thickets
restricting development and competition in the area of PCV. One study
identified 106 PCV applications potentially relevant to the manufacturing
of pneumococcal vaccines. GSK, first to manufacture PCV10 (Synflorix), and
Pfizer (previously Wyeth), first to manufacture PCV13 (Prevnar13), have
filed the most number of patents in India, China and Brazil, in an attempt
to create impediments in the development of less expensive alternative
pneumococcal conjugate vaccines by developing country vaccine manufacturers

The patent office decision, Pfizer’s patent application and patent
oppositions filed by MSF can be found here:

*Pneumonia and PCV*

Pneumonia is a leading killer of children, accounting for more than a
quarter of deaths of children less than five years of age. The vaccine does
more than protect those who are vaccinated from life-threatening
infections. Studies show that the vaccine lowers antimicrobial resistance
(AMR) by bringing down infection in the community and reducing antibiotic
use in children. One study estimates that introduction of Hib conjugate and
PCV13 to 75 developing world countries could reduce antibiotic use for
these diseases by 47% and avert 11.4 million days of antibiotic use in
children younger than <5 years old each year.

Pfizer and GlaxoSmithKline (GSK) control a duopoly market for the
pneumococcal conjugate vaccine (PCV), the world’s best-selling vaccine that
has brought in nearly US 40 billion dollars in sales between 2009 and
quarter two of 2017 for these two pharmaceutical corporations. Pfizer’s
PCV13 earnings from 2009 to Q2 2017 is USD 35.2 billion and GSK’s PCV10
earnings in the same period is USD 4.5 billion.

Meanwhile, many developing countries, where millions of children risk
getting pneumonia, simply can’t afford the vaccine. More than 50 countries,
including Indonesia, Jordan, and Tunisia, have spoken out against
exorbitant vaccine prices, while MSF has been campaigning for years for
lower PCV prices that are affordable for all governments.

At the lowest global prices, which aren’t accessible to most countries, it
is now 68 times more expensive to vaccinate a child than in 2001, according
to a 2015 MSF report, The Right Shot: Bringing down Barriers to Affordable
and Adapted Vaccines. The pneumonia vaccine accounts for almost half the
price of the entire vaccination package for a child in the poorest

*Context in India*

India has the world’s highest burden of pneumonia, accounting for nearly
20% of global pneumonia deaths in children under the age of five. In India,
PCV had until recently been available solely in the private market with
out-of-pocket price tags beyond the reach of not only vulnerable children
and impoverished parents but also the Health Ministry.  At present, only
two pneumococcal conjugate vaccines are registered by CDSCO and imported
into India: Pfizer’s Prevnar13 (PCV13) and GSK’s Synflorix (PCV10) which
are very expensively priced at approximately INR 3,800/dose (approximately
USD 59 per dose, with three doses needed for full vaccination) and INR
1,800/dose (approximately USD 28 per dose, with three doses needed for full
vaccination) respectively in the private market. No pneumococcal vaccine
has been registered from an Indian manufacturer and made available to
provide competition to Pfizer and GSK who currently dominate the market
internationally and India.

The pneumonia vaccine is now being introduced into India’s Universal
Immunization Program (UIP) with support from Gavi, the Vaccine Alliance.
Yet, at more than USD 9 per child, or USD 3 per dose for each of the three
doses needed for full vaccination, the price still remains too high,
forcing the government to do limited roll-outs of the PCV vaccine in just
three states: Himachal Pradesh, Bihar, and Uttar Pradesh. A lower priced
PCV vaccine is critically important to increase vaccine coverage across the
entire country in the coming years.

Leena Menghaney
Mobile: 9811365412

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