Vaccines and developing countries' access to medicines demands

 

Vaccines candidates for Covid 19 are at the forefront of the news. A proposal by India and South Africa for the World Trade Organization to suspend the implementation, application, and enforcement of relevant provisions under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) for the COVID-19 vaccine is now creating an IP dispute. India and South Africa have asked the WTO to waive certain TRIPS provisions to ensure access to Covid 19 medicines without IP restrictions. In October the WTO started discussing the issue. 

A number of developed countries have disputed the proposals and counter proposals have been made for licensing of patents to take place. The CTAP system has been proposed. The WHO has launched its Covid-19 Technology Access Pool (CTAP), inviting countries to share data, knowledge and intellectual property on vital, life-saving health products in the fight against the coronavirus. However India has pointed out in the WTO that no pharma companies have yet signed up to CTAP. 

More WTO discussions are due to follow.

An old Indonesian vaccines dispute shows the risks when countries do not cooperate.  The earlier issue arose from the 2005-7 H5N1 avian flu epidemic. A vaccine was created using samples from Indonesia by Australian research based pharmaceuticals maker CSL. However a dispute arose over access to the vaccine. The vaccine was developed using the Indonesian strain of the H5N1 virus, using samples submitted via the WHO. CSL argued the samples were obtained fairly for research, and there are no rights in the biomaterials themselves. CSL further had a contract to work on this and said they were not making a  commercial vaccine. However  Indonesia’s Ministry of Health, worried that ‘pharmaceutical industries of developed countries … produce and patent the products… and sell them back to the developing countries at unaffordable prices. As a result they withdrew from the WHO’s virus sample sharing programme.  

A recent article by Helen Gubby of Stamford University argues the entire biomedical sector should be taken out of the patent system. There is an alternative she argues. The Coalition on Epidemic Preparedness Innovations (CEPI) launched in 2017 at Davos uses public, government and philanthropic funding to create new vaccines through patent buyouts. In essence the R&D is funded, and the IP is acquired. There are also prizes  for access and the IP. CEPI is funding several COVID‐19 vaccine candidates. 

The international community needs to agree a clear structure to avoid lengthy arguments in 2021 over access Covid 19 vaccines. 

Indonesian Patent Law working requirements repealed

Indonesia’s Omnibus law on job creation adds several patent rules. The law mainly focuses on economic reforms to help foreign investment and job creation and has created some concerns over workers rights. 

However an amendment to the Patent Law working requirements has been added into it, following foreign IP owner lobbying over the last year. See here for previous details. Article 20 of the Patent Law contains the controversial working requirements. These require patent holders to manufacture a patented product or use the patented process in Indonesia within 3 years of grant or face compulsory license or cancellation of patents. This has now been revoked by the Omnibus Law.  

A new Article 20 has been added to the Patent Law. Instead of an obligation to make a product or to use the process in Indonesia, now a patent can be implemented in Indonesia in one of the following ways:  

a for product patents - making, importing, or licensing a patented product; 

b. for process patents - making, licensing, or importing products resulting from that patented process; 

c. for method patents - making, importing, or licensing products resulting from the patented method, system and use. 

The risk of compulsory licensing or revocation now only applies to failure to do one of the acts above.  

Previously a system had been used for patent owners to apply for delays to work their patents. This is expected to cease; since it was mainly expected to be used by those who license or import products (which was not working a patent previously). 

The final draft law has not been signed by the President yet. Once it is patent owners should review their patent implementation in Indonesia. Working a patent now has a wider definition, and there is a 3 year period to do that.  But patents that are not used or worked at all may still be vulnerable. 

A second Patent amendment has included in the Omnibus Law. It law also provides more clarification in relation to simple patents. An additional patentability requirement is added, namely the invention has a practical use. Secondly the examination process has been simplified. 

Patents are often seen as critical investment issues so the government hopes these amendments will ameliorate foreign investor relations. 

Foreign research in Indonesia

 

Indonesia is in a paradox over biopiracy. Conducting research in Indonesia and using the fruits of that research overseas tends to inflame nationalism. Repeated examples exist of how foreigners have stolen bio-resources and then commercialized them overseas with little local benefit conferred. The country is struggling to both encourage research but also restrict foreign access.  

In 2018 a University of Copenhagen's Centre for GeoGenetics paper explained how Indonesia's Bajau community (aka. the Sea Nomads) can free-dive exceptionally well due to enlarged spleens that store oxygenated blood during free-diving. Allegations arose that the researchers had failed to obtain government approvals, but still took DNA samples abroad without permits. Another allegation was that the single Indonesian researcher who participated had no subject matter expertise and was mainly used for travel arrangements. The University of Copenhagen's Centre for GeoGenetics asserts it had all the necessary government permits.  

A 2012 example was the discovery of Megalara garuda, (see picture) a giant venomous wasp, from Sulawesi. The dispute arose from a 2012 paper by a University of California, Davis professor and a German researcher. The dispute concerned the level of partnership with Indonesian researcher from LIPI, the National Science Institute, as well as lack of co-authoring of the paper and breach of an MOU between the institutions. UC Davis paid compensation to $25,000 to LIPI and returned one of the samples.  

This is in the context of a new set of rules on Indonesian research being introduced. Some are controversial, such as the ability to jail foreign researchers in breach of the rules (a sign of how sensitive the issue is). However the main issue is that the new National Science Law of 2019 has not yet been implemented with the subsidiary regulations still in draft. This means the permits and requirements in force are still those under the older laws which were those in force when all the earlier scandals arose. The government announced in October 2020 that a new National Board of Research and Innovation (BRIN) was being formed to take on the various old and new functions in the National Science Law of 2019. 

Many research partnerships are in place. However foreigners complain the paperwork is extremely challenging to deal with. Some claim they have had to pay unofficial payments too. Then there are challenges concerning research content. Foreign researchers do not know where the research and study borders are or which research will be beneficial to Indonesia.  The new National Science Law with its heavier politically driven rules and delayed implementation seems unlikely to make the system simpler. 

Government compulsory licensing in Indonesia

Indonesia has two different rules on compulsory licensing. One relates to third-party compulsory licensing which implements the TRIPS Doha Declaration rules. The second is government licensing. This enables the Indonesian government to implement a patent themselves due to public interest or security and defence reasons. 

Public interest government licensing is directed to 4 categories of public emergency - public health emergencies, agriculture and food resilience requirements, animal health emergencies or environmental or natural disasters.

The government can appoint third-parties to produce the patented product if needed. Such government implementation of a patent does not impair the patent holders exclusive rights. That means they can still implement the patent i.e. make a product themselves, and sue others for infringement. Patent holders are required to pay annual maintenance fees as normal. 

An application procedure is set out. The IP office will review the government application especially to check that what they request comes within the scope of the granted patent. The patent holder will be notified. The DGIP will then set a license fee to be paid.  This Regulation seems designed to support emergency Covid vaccine production if necessary. See the earlier concerns expressed here. 

The other form of government license relates to defense technologies. Security can include technology, encryption and surveillance related subject matter. The government can appoint third-parties to produce the patented technology if needed. The patent holder may not then exercise his own exclusive rights and implement the patent. But conversely, patent annuity fees are reduced to zero. An application procedure is set out. The IP office will review the government application especially to check that what they request comes within the scope of the granted patent. The patent holder will be notified. The DGIP will then set a license fee to be paid. 

The regulation also contains a set of rules relation to weapons technologies that conflict with Indonesia‘s defense and security. In essence it is prohibited to implement patents for these in the country without government approval.

Covid 19 research and IP in SE Asia

As research work on vaccines and treatments worldwide speeds up, SEA is taking part in various trials. See here for previous reports on concerns about access to Covid treatments. 

There are a dozen or so candidates to prevent or treat COVID-19 now in clinical trials. These include preventative vaccine candidates (like Oxford University’s ChAdOxInCoV19 or Pfizer’s BNT162), as well as various existing and new drugs for treating the disease (e.g. Gilead’s Remdesivir or Zhejiang Hisun’s Favipravir), as well as generics like Dexamethasone. 

Nearly 2,000 trials are ongoing worldwide now. Data in late July indicated nearly 30 in SE Asia, with Thailand leading with at 8 trials following by Singapore, Malaysia and Indonesia. Trials are hugely expensive and the majority fail at some point. The key to speed is the global coordination by WHO to avoid duplication of the same work. 

The majority of the work is re-purposing existing drugs.  The challenge with that is where there may be patent protection for these drugs.  A number of the older ones, including Tenofovir (another Gilead drug) have expired in many countries.  Another problem is second medical use patents, which are not consistently treated around the world or in SE Asia. Indonesia has also recently brought in new rules on compulsory licensing (report to follow) aimed to allow medical emergencies to override patents. 

There is no suggestion anyone will use IP to prevent access to Covid treatments. The race is on and it is useful to understand the IP background since the issue will need to be considered at some point. 

Covid vaccines and emerging markets

As the race for a Covid 19 vaccine speeds up, countries, especially developing countries, are starting to express concerns about how it will be created, patented, made and distributed. Indonesia recently asked the  International Coordination Group (ICG), a group of countries working on the COVID-19 pandemic response to seek fair distribution of the vaccine to every country in the world.

The concern appears to be the classic access to medicines one, albeit with a new pandemic driven urgency. Flexibility of intellectual property rules will be needed; that is, patents must not be used to prevent access to a vaccine.  The Covid 19 pandemic would almost certainly fits within the Doha Exception to the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement.

With so many companies in different countries working on procuring a vaccine the need for collaboration in development as well as production will be a test of the world's IP and other cooperation systems. Patent owners will need to decide if they will patent or not. Many will likely need to cooperate to accelerate the quality and efficacy testing process, and governments must fast track regulatory approvals. Then the process for making available and pricing must be considered. Will the TRIPS mechanism be used for governments to authorize themselves, or third parties, to make use of a patent without the permission of the patent owner through compulsory licensing?  Once that is worked out, how will manufacture and distribution potentially to billions of people occur? Even doing that alone will be difficult, before you consider the risk of hoarding and disputes.

Brazil, Indonesia and others are now seeing media discussions about these issues. In May the US rejected wording in a World Health Organization (WHO) resolution that backed the rights of poorer countries to ignore patents to gain access to Covid-19 vaccines and treatments. Trump’s America First policy worries many outside the US. So too does the continued assertion that China is somehow to blame. 

Public health experts and campaigners believe it is vital to pull together to end the pandemic. EU has taken a lead; leaders in Italy, France, Germany and Norway, together with the European Commission and Council, called recently for all innovative tools, therapeutics or vaccines to be shared equally and fairly.

Patent owners and the Indonesian working rules in light of delays to the law amendment

The big question for patent owners now is what happens while they wait for the amendments to the Patent law. See here for details.  The problem is that they have patents granted under the 2016 Patent Law which need to be worked or they are at risk of being lost. In theory patents under the old law are not subject to the working retirements. To avoid risk to granted patent under the 2016 law, a waiver must be sought. Meanwhile the President's assurances that the Omnibus Law (which will amend the Patent Law) would be passed quickly, may not be met due to the coronavirus outbreak. This means patent owners need to review their portfolios, identify at-risk patents and apply for waivers accordingly while they await the amendments. If not those patents could be at risk. 

Indonesia to revoke controversial patent working requirements

Indonesia plans a new commercial law to boost foreign investment called the Omnibus law on Job Creation. Backed by the President, the final draft bill consists of 79 laws, 15 chapters, and 174 articles as confirmed by the head of Parliament, Puan Maharani when she received the copy of the final draft bill yesterday.  

It contains one IP provision that Art 20 of Patent Law is revoked. This will bring an end to the endless debate about whether or not a patent can be revoked if it is not used in Indonesia.  See here for the previous details and debate. All the subsidiary legislation and procedures will also fall away. Tech companies will be pleased about the removal of this uncertainty.

Sanofi's TB patents dispute overflows to Indonesia

Indonesia may be getting caught up in a TB medicine dispute. Sanofi has filed numerous patents for medicines combining two APIs, rifapentine and isoniazid. Both APIs are out of patent protection globally. Sanofi patents include the combination of the drugs including as child formulations and film coated tablets. Some countries granted them, others objected. For example the patent for a film coated tablet and dispersible formulation was objected to in India as being a combination of two existing drugs so not patentable there.

Sanofi’s strategy appears to have been to file multiple forms, but to accept that some may not be patented, in order to get others accepted. In Indonesia, the child formulations and film coated tablets patent was withdrawn in order to get the combination of isoniazid and rifapentine drugs accepted.

Activists in India including Médecins Sans Frontières are particularly vociferous given TB is a serious problem there and there are concerns whether such countries can procure generic combinations of the two APIs if a patent is granted. Sanofi is coming under pressure to surrender all of its patents for these compounds and formulations.