The Initiative for Medicines, Access & Knowledge (I-MAK), based in the US has recently been attempting to challenge patent applications by Gilead Sciences for a drug used to treat hepatitis C, known as Sovaldi. It is one of six anti-viral drugs the group has been targeting in the belief that by blocking patent applications in specific countries, where the drug is needed most, it can clear the way for the introduction of cheaper, generic versions.
Following a challenge by I-MAK and other advocacy groups, the Chinese Government has recently rejected a patent for Sovaldi, leading to claims that the inventiveness of the drug may be in question. I-MAK is also challenging applications for Sovaldi in the Ukraine, Russia, Argentina and Brazil, where it estimates about 40 million people have hepatitis C.
Of course, it is important that any patent is challenged if it is considered that the patent eligibility criteria have not been met. However, as research sponsors, drug companies deserve fair treatment from Governments around the world and arguments put forward by generic advocates based on ethical considerations alone should not be allowed to influence their decision making on matters of patentability.
No one would deny that for developing countries, where conditions like hepatitis C and HIV are more prevalent, there is a strong, humanitarian case for giving medical practitioners access to proven anti-viral drugs as quickly as possible. Such countries often lack the resources of other more developed nations to fund expensive drug programmes and medical infrastructure is also more likely to be compromised.
In fact, many drug companies are already taking action to support humanitarian programmes by negotiating lower prices for patented drugs in under-developed areas of the world, which are often set as low as cost price. This cooperative approach can help to get safe and effective medicines to the people who need them most, whilst also ensuring that drug companies earn some commercial recompense for the costly research and development activity they have undertaken.
Rather than shy away from undertaking research and development work in the area of anti-viral drugs, Gilead Sciences has recently announced that it has started developing a new drug to treat hepatitis B. This is a positive response and sends a clear signal to the marketplace that the company is still prepared to invest in this area of drug development.
The problem with patent-blocking strategies based at least in part on ethical considerations, is that, while they might be effective in the short term at getting cheaper drugs to the people that need them most, in the longer term they would cause research investment to dwindle. This could potentially lead to fewer new drugs reaching the market, which would obviously be detrimental.
To find a sustainable solution to the problem of increasing access to potentially life-saving drugs more quickly, Governments and drug companies need to work more closely together. In addition to negotiating a lower price for drugs in certain territories, in some cases it may be possible to streamline the process of regulatory approval to facilitate swifter and cheaper market entry. If used with proper care and consideration, where the humanitarian need is great, such measures could be used tactically to make a difference.
Adrian Tombling is a partner and patent attorney at Withers & Rogers LLP, and an expert in biopharmaceutical patenting.