This is the last post in this series of six on biotech. The earlier posts can be found here (introductory), here (ethics), here (case law), here (strategies for protecting biotech inventions) and here (financing). This post will briefly the issues of ‘drug prices’ and ‘access to medicines’ which received the most comments on previous posts. In addition, certain topics tackled in earlier posts will be discussed in the wider context of giving advice to companies and changing the patent system.
Your comments on what to do about the price of medicines
|Benjamin worked hard to keep|
R&D costs low
Many of the readers’ comments defended high drug prices as reflecting the cost of R&D and criticised countries which did not respect patent rights. This Kat believes that we need to recognise that we are in a period of transition. Organisations that buy drugs are putting pressure on pharmaceutical companies to reduce prices. For the first time this is also happening in the US. Presently the high price of the drug ‘Sovaldi’ is causing controversy. After some consideration the National Institute for Health and Care Excellence (NICE) has agreed that the UK will buy it. France has negotiated a lower price. India has refused a patent application for Sovaldi based on the ‘enhanced efficacy’ requirement for drugs related to known drugs. This Kat believes that new payments models will evolve in response to the present difficulties and that in time the costs of R&D will come down as new research ecosystems come into being.
This Kat also believes that India is an important country in which to try and get things right. It is seen as a leader nation amongst the G77 group of developing nations and so its actions will have influence. There are no easy answers for providing affordable medicines to the developing world. However, this Kat suspects that things will change as we transition to a multipolar world and new forms of international collaboration will come about providing new solutions.
Patents as responsive tools to support innovation
|Few can handle complex strategy|
Recognising the complexity of decision-making in patent strategy
|Why would you file a weak patent case?|
The reality is that many small biotech companies simply don’t have the resources to develop and follow complex patent strategies, especially if they do not have an employee whose sole task is to be responsible for the IP. The Kat has seen that when a ‘weak’ case is filed to a ‘modest’ invention for strategic purposes, the complex reasoning might not be understood by the rest of the company, causing confusion and even criticism. That alone can be enough to make the filing counterproductive.
Should we change the patent system to help biotech?
This Kat firmly believes that early stage biotech research needs as much support as possible. He has worked with many people who are trying to commercialise such technology and they find the patent system to be too complex, too expensive and filled with too much uncertainty. However there are always ‘unintended consequences’ to changes in the patent system and this Kat believes such changes should not be driven by negative ‘reactions’ to things. In the US the reaction to ‘patent trolls’ contributed to the American Invents Act (AIA) and other proposed legislation. The AIA brought in new post-grant proceedings which have proved very effective in invalidating patents, and we still do not know how the consequences of this on all users of the patent system. Myriad’s aggressive patent strategy may have caused a negative reaction at the US Supreme Court leading to the controversial Myriad decision, which has led to an even more controversial USPTO Guidance completely changing the patentability of natural produces in the US (see Katpost here). This Kat is not afraid of thinking about how the patent system could be changed to better serve biotech research (see PatLit post here). However seeing the difficulties US companies are presently having in coping with a changing patent system makes one realise the need for caution.