MSF contended that the patent granted by the Delhi Patent Office in August was "erroneous" and it disregarded evidence that the product was not a technical advancement, but involved a "mere addition of serotypes" to its already established 7-valent vaccine.
‘Prevenar 13 is not a technical advancement, but involved a “mere addition of serotypes” to its already established 7-valent vaccine.’
MSF added that the decision indicated a weakening of India's strict patentability standards. India's amended Patents Act (2005) does not grant patents on a tweeked product unless it demonstrated greater efficacy.
Pfizer said, "Prevenar 13 provides the broadest serotype coverage of any pneumococcal conjugate vaccine available in the world today." Each dose of PCV 13 requires two and a half years to manufacture with 400 different raw materials, 580 manufacturing steps and 678 quality tests. In fact, adds an industry representative, patentability is not "subjective" and the patent office granted a patent only after evaluating technical details.
Prevenar 13 was included in the Government's immunisation programme in May. And it is being given at $3.05 per dose for the pilot phase, which covered 20 per cent of India's 26 million births, the representative added.
Prevenar 13 For Pneumonia
PCV13 safeguards against 13 types of pneumococcal bacteria. MSF's Leena Menghaney says that Indian vaccine companies were spending time and effort to develop similar vaccines through a patent non-infringing process, when the patent shouldn't have been granted in the first place. When the Government scales up its immunisation programme, there should be enough capacity to provide them, she added.
Responding to statements that Prevenar 13 faces patent challenges in Europe, South Korea and the US, Pfizer clarified that "Prevenar 13's patent remains valid in EU (European Union). The EU patent revocation order is under suspension and Pfizer's appeal is being considered.
In other countries where the patent was challenged such as Japan, the decision to grant Prevenar 13 a patent was upheld. In Korea, Pfizer is in the end stages of the appeal while having won at the trial court level. In fact, the US tribunal in charge too has rendered its decision last week, upholding the... patent."
Bringing Down Patenting Standards
A patent gives an innovator 20 years of unbridled market access to be help recoup research costs. But public health workers apprehend that such a monopoly could see medical products getting priced beyond the reach of ordinary people.
Responding to allegations on high price and being anti-competition, Pfizer said, "In the private market in India, Pfizer introduced Prevenar PCV7 covering seven serotypes, in 2006. In the past decade, a newer vaccine was developed to include 13 serotypes that together cover 78.4% of the serotypes of Pneumococcal Disease found in India, while keeping the price even in 2017 the same as it was for PCV7 in 2006 inspite of... inflation."
Domestic vaccine makers Panacea Biotec (also involved in challenging Prevenar) and Serum Institute are in the same segment. Serum Executive Director Dr Suresh Jadhav said their 10-valent vaccine was at least 18 months away. With MSF and Pfizer bracing for the long haul, this case will be closely watched as it is bound to impact on public health.