In October 2007 I was delighted to be invited to speak at an International Alliance of Patent Organisation conference held at the World Health Organisation (WHO) in Geneva concerning public health, innovation and intellectual property. Whilst I decided to present the intellectual property effects of a WHO-declared pandemic, the reality of such a crisis was certainly not something within mine or anyone else’s contemplation at the time.
In a crisis, access to appropriate pharmaceuticals is clearly of paramount importance. At present there are six UK centres attempting to find an antiviral treatment for COVID-19. There are many more seeking other drug interventions to stop the rampage of the virus.
Access to patented pharmaceutical subject matter is denied by the ownership of a patent which is granted on a country-by-country basis to the inventor, or more often the inventor’s employer. The UK government has always had the right to bypass the system by commandeering UK pharmaceutical patents to its own use, but it possesses no such right with respect to foreign patents, ie those filed in other countries of the world.
Global patent filing is the hallmark of any successful pharmaceutical company. Not to undertake an extensive global patent filing strategy is a form of commercial suicide. It permits unauthorised third-party pharmaceutical manufacture of the drug invention in those countries in which the inventor has not protected his drug by patents, and thereby creates the risk of loss of sales in those countries. More dangerously, it permits parallel importation of the invented drug into the inventor’s patent protected territories at a price which undercuts its own monopoly-imposed pricing level.
So if the cure to COVID-19 is found, trialled, licensed and manufactured outside the UK, the government must be able to ensure its availability to the UK population despite a world protected with pharmaceutical patents. If the invention is discovered outside the UK, foreign patent rights prevent the UK government accessing the drug. For example, the UK government cannot call upon the export of a drug manufactured in India into the UK if the drug owner holds the patent for the drug for India. That patent owner can decide at their whim whether manufacture, export and sale take place.
At an international level the UK government might have had the right to obtain an automatic right to the drug for distribution within the UK, even though it had been manufactured in a patent protected country, by obtaining ‘a licence of right’ to the drug patent. This is a licence to the export of the pharmaceutical into the UK under Article 31bis of The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
The UK, alongside other member states of the EU, has unfortunately opted out of the benefit of Article 31bis of TRIPS. Article 31bis had permitted the UK government the right to import the active ingredient of a patented pharmaceutical into the UK from a country of manufacture, even if the imported drug was protected by patent in that other country of manufacture. Importation could have taken place without the consent of the foreign patent owner provided, of course, that the UK remunerated the patentee.
In fact, the vital necessity of overcoming foreign patent rights is amply demonstrated by, at the beginning of the COVID-19 pandemic, the initial export ban on pharmaceuticals. That ban was contemplated by countries such as Germany, France and the Czech Republic. At the time those bans were focused upon medical equipment supplies rather than patented drugs, per se.
Opting back into Article 31bis of TRIPs might take too much time given the urgency that the crisis demands. Political pressure increased recently. A letter requesting that the UK and other WHO countries that had opted out could now opt back in was sent by interested parties a few weeks ago.
By contrast, earlier this month the European Union launched a fighting fund to the vale of 7.5 billion Euros for the purpose of developing a vaccine, coupled with the promise that the money will go to the partners under the terms of a new Global Alliance for Vaccines and Immunisations (GAVI). The organisers comprise both EU and non-EU countries such as Norway and Saudi Arabia. The UK is one such contributor. Interestingly, the EU said that contributors would not forgo their respective drug patent rights but would agree to supply the antiviral at affordable prices to members of GAVI and, indeed, worldwide. The GAVI proposal is therefore something of a Trojan horse when it comes to overcoming patent rights. It does not hold the same allure as an opt back into Article 31bis of TRIPS, under which the supply of foreign patented drugs into countries like the UK is mandated irrespective of patent protection.
Even assuming that GAVI operates effectively, of the 11 potential vaccines for which human clinical trials have now commenced, six are Chinese initiatives and a further three are American joint ventures. The UK and Germany are the only two of the 11 parties to GAVI. But, again, the German team is a joint venture with the United States. Neither the US nor China have, as yet, agreed to join the GAVI party. So if one of the six Chinese or two US teams get to the COVID-19 antiviral first, those countries may enforce their respective foreign patent rights preventing manufacture or importation into the UK or, indeed, the EU.
Thus, assuming it is a non-UK entity which get to the COVID-19 antiviral first, the UK remains unable to export the antiviral from outside the UK (from patent protected countries) into the UK. The two main pharmaceutical manufacturing countries of the world, India and China, are routinely employed by pharmaceutical companies worldwide for their mass volume drug manufacturing capability. Due to the foreign ownership of patents in those countries by one of the other 10 contestants, the UK might have to look to manufacturing such vaccines itself, here in the UK, by commandeering that foreign inventor’s UK patent for the purpose of manufacture and distribution of the vaccine in the UK. But it remains unclear whether the UK has that sort of vaccine manufacturing capability.
The other option is that it is the UK team which finds the vaccine first. Oxford University’s Jenner Institute is the only UK entity which has managed to get its proto-vaccine across the line into first human clinical trials; the winner’s enclosure of the pharmaceutical world.
Jenner has recently publicised its intention to partner with AstraZeneca in order to achieve both manufacture and global distribution of its vaccine. Together, they will no doubt ensure that all worldwide patents for the antiviral will remain under their control, irrespective of the country of manufacture.
The difficulties which accompany affording any particular entity a global monopoly to the COVID-19 vaccine is reflected in the price of vaccines to the world’s patients. Recent research reported by The Guardian has found that a course of Sofosbuvir for hepatitis C costs just $5 to manufacture but is priced at $18,610 to patients. Pirfenidone for pulmonary fibrosis has a cost price of $31 for a 28-day course of treatment but can be priced at as much as $9,606 for patients. Treatment by Remdesivir, which has just obtained a Federal Drug Administration for use in COVID-19, is predicted to be priced at up to $4,460.
Despite all those potential difficulties one glimmer of hope in an otherwise highly competitive field comes from a commitment from the UK team, the Oxford-University based Jenner Institute/AstraZeneca joint venture, to distribute their vaccine globally, on a non-profit basis during the pandemic, and therefore ensure it is accessible to low and middle income people. One can only hope the other research teams demonstrate the same sentiment.