Open Source Innovation in the pharmaceuticals: Is that all for public health?

Dear Readers,

I hope you are reading this post in your good health and essentially operable outdoor conditions. In this unfortunate time, when the world is surviving in a quarantined state, the World Health Organisation (WHO) is rightly encouraging an initiative of open source innovation. It is the initiative among the countries to share resources to develop curative products for fighting COVID-19. But does it solve the problem?  Let us see!!!

“Well, the people, I would say. There is no patent. Could you patent the Sun?” replied Jonas Salk, developer of the first successful polio vaccine, when he was asked who owned the patent in 1955.

Open source innovation is already well-known in the software industry, but since the industry is mostly driven by copyright law, it is not often discussed in the patent world. In light of the COVID-19 pandemic, the pharmaceutical industry is now participating in open source innovation. Drug manufacturers, who invest a lot of capital, years of research, and other resources in the marketing of a drug, are always open for patent war. This is due to the potential of patents in the global drug market, as they have the ability to recoup the investment and earn huge profits. It is also one of the reasons why patent applications have increased exponentially in the pharmaceutical industry. Contrary to this ethos, public health is now encouraging the drug industry to share their resources in the patent pools and open source innovation.

Given the current scenario, many developed countries are funding their research agencies and striving to innovate a drug to curb the COVID-19 pandemic. Additionally, countries like USA, Germany, Israel, France, Chile and Canada (Bill C-13) have already begun planning to issue compulsory licenses for their relevant pharmaceutical patents. In other words, the governments are not thinking twice about granting compulsory licenses over any of their patented drugs or any part of their medical devices, diagnosis kits, etc. Even the leading drug manufacturers like AbbVie have voluntarily suspended their global patent rights to allow public use of their drug Aluvia, which may be used to treat COVID-19 patients. After long reluctance, the giant drug manufacturer Gilead Sciences Inc. is following suit and has asked the FDA to revoke the status of “orphan” to their drug Remdesivir.

However, the grant of a compulsory license within a state or a voluntary suspension of patent rights is not just enough to deal with the pandemic or any disease for this purpose. Compulsory license would barely serve the purpose of global protection and will not ensure access to essential health care to several sections of the world. Thus, the grant of compulsory license in the developed countries will not wash out this disease from the world, and not particularly from the Least Developed Countries (LDCs). To tackle such situations, the WHO director-general proposed various other means like an intellectual property pool and open source innovation. These initiatives would allow all countries, and not just developed countries, to benefit from the research. The partnership between the manufacturers in the patent pool and the open source innovation culture are necessarily a need of the hour.

For appreciating the above strategy, we need to understand the model of patent pool and the open source innovation. It is just like a normal pooling activity where all members contribute their resources to reach a common goal. Similarly, in the pharmaceutical industry, there is a Medical Patent Pool (MPP), which is already operating for innovating drugs to cure HIV, tuberculosis, and other deadly diseases. The pharmaceutical companies contribute their patents in the pool with an understanding that all the pool members can use these patents without the exchange of royalty and no infringement proceedings will be filed against such use.

Now, coming to the open source innovation, which operates at a much larger scale in comparison to that of a patent pool. This model promotes a partnership between the main actors of development like governments, academia, research organisations, manufacturers, etc. and it terminates the silos culture. The open source innovation works on the concept of open data, open science, and open collaboration between the aforesaid actors of the society. With all the available information on the research or the clinical trials, anyone can freely use it to conduct further research and develop the required drugs and in-turn supply the results back to the pool. Such projects play a significant role to effectively innovate a curable drug and provide access to the world.

Accordingly, critical information in the public domain becomes a strong weapon for generic producers. Particularly, the generic industry in developing countries makes use of this tool by manufacturing drugs at a reasonably affordable price. Another benefit is that burden of drug manufacturers is managed by collaboration with the generic producers to produce a huge quantity of drugs in a limited time.

That said, all these initiatives are highly advantageous for the high income countries, whereas access to public health for the developing countries ­– and LDC- remain unmet. Even after invoking compulsory licensing, patent pledges, patent pools and open source innovation, the developing countries will lack the proper infrastructure to develop therapeutic products. Thus, all these initiatives offering critical data in the public domain would be of little help. Astonishingly, the first two successful polio vaccines were never patented, yet the polio disease continues to prevail in many nations for decades.

ONE-MINUTE PLEASE!

1.    “Doha Style Compulsory License” refers to provisions for grant of a compulsory license to export drugs to the needy countries.

2.   Section 92-A of the Indian patent act is an example of “Doha Style Compulsory License”.

3.   Canada was the first (and only so far?) country to grant the compulsory license for export of the medicines.

4.   M/s Natco Pharma Ltd. was the first generic producer to apply for a Doha style compulsory license in India, 2008 for the Indian patent no. 209251. Unfortunately, the request was later withdrawn.

5.   Following the withdrawal, Pfizer delivered free patient assistance to two cancer hospitals in Nepal.  

Hence, surrendering the patent rights or encouraging open source innovation might not be a key to success over the rapidly spreading diseases. The patents, therefore, play a very limited role to ensure universal access to the medicines.

According to the reports of WHO, one-third of the world’s population lacks access to the medicine. LDCs in the Asian and African continents are facing major challenges to public health, like, affordability to the essential drugs, infrastructure to medical facilities, and a lack of skilled workforce to appropriately treat the patients. The inadequate manufacturing facilities are clear evidence of failure to meet the high demands of public health in the developing countries. 

Therefore, it is required that WHO shall separately adopt a model to promote united efforts to meet the demands of the developing countries and LDCs as well. The countries, including developed and potentially capable developing countries like China, India, Brazil, etc., with advanced manufacturing facilities should build additional capacity to manufacture new drugs, vaccines, medical equipment and diagnostics for export to other needy countries. From these manufacturing units, the global distribution should be made operational to allow quick access of these resources. It is then that the surrender of patent rights would have a real role to play. Thus, open source innovation or a patent pool should work together with the model for export to conquer the high demands of public health globally.

The above-proposed model spawns of Article 31bis of the TRIPS, based on the Doha Declaration, which required the member states to adopt a provision for granting the compulsory license for export of patented pharmaceutical products. The ‘Doha style compulsory license’ is granted for export of pharmaceutical products only to the countries lacking the capacity for local production. It is required that those countries should also issue a notification expressing their desire to seek import of such patented inventions from the manufacturing country. Accordingly, even assuming that the drug manufacturers from the developed countries were granted patent rights, the export provisions – like Section 92-A (1) of the Indian patent act­– would allow the poor countries to access the essential medicines.

Hence, it appears that the rich countries would be of utmost advantage with the initiatives like open source innovation, patent pledge or patent pools to curb the COVID-19 pandemic (or other diseases) and to effectively reach a result. But a global outreach on public health issues and a complete wipe out of the pandemic also requires a large-scale utilisation of ‘Doha style compulsory license’ or a similar model to be worked with open source innovation, as proposed above. Let’s hope WHO considers these kinds of initiatives as well, along with open source innovation and patent pool.

Note: Stay safe and indoors to collectively fight against COVID-19!!!

Happy Patenting!!!

About Krishnam Goyal 17 Articles
Krishnam is an LL.M. student at Munich Intellectual Property Law Center (MIPLC), Germany. He is an engineer, advocate and a patent agent in India. He holds around three years of working experience in the field of patent drafting and prosecution in the fields of ICT, electronics, computer-implemented inventions, mechanical engineering and green technology. The area of research that interests him is patenting of AI, SEPs, Green technology and climate change issues

36 Comments

  1. Very well articulated piece and very informative, Sir. Specially appreciative of the parts which highlighted the challenges that we face and the opportunities we have.

    Please find added information here:

    https://www.city.ac.uk/news/2020/february/why-patent-laws-matter-even-in-times-of-crisis

    https://heinonline.org/HOL/LandingPage?handle=hein.journals/mslr2011&div=25&id=&page=

    The Chinese action could also be replicated elsewhere. Furthermore, Article 31(b) is a powerful tool but lacks guidance and too vague for countries to implement.

    • Yes, you are right! Even after having all laws and technologies in place, we are still facing challenges on a global scale. Thus, it is required to have complete utilisation of these resources and opportunities.

      Indian patent law is already articulated with a comprehensive compulsory licensing regime (and don’t forget Section 66) and I believe it makes good utilisation of Article 31(b) TRIPS. However, large implementation of such provisions also affects the trade between countries. Thus, TRIPS though provides flexibility to countries but it has a limited implementation due to global politics.

  2. Insightful and Well articulated write-up for patent applications and I feel Krishnam will keep sharpening the analytical approach with such more thoughtful articles.

  3. A very good read. Also, a great initiative for creating such a forum. Congrats! Keep us updates with such more and more insigthful articles. All the best!

  4. The current pandemic is definitely driving a new, broader awareness of the role of patents in pharmaceutical field. Nevertheless, other affiliated measures should also be taken into consideration. A very thought-provoking blog! Look forward to reading more of your works!

    • Dear Lisha,

      You have rightly noted that broader awareness of patent law, collaborated with other measures, is necessary to deal with such situations like COVID. Thank you for your comments!

  5. The current pandemic is definitely driving a new, broader awareness of the role of patents in pharmaceutical field. Nevertheless other affiliated measures should also be taken into consideration.
    Very thought-provoking Blog! Look forward to reading more of your sharp observation and insightful views!

  6. Insightful, relevant to the current scenario, and wonderfully penned down! Kudos to the team. Waiting for more articles 🙂

  7. Insightful and relevant to the current scenario. Kudos to the team for sharing informative content with the readers 🙂

  8. Well articulated. Indeed, public health issues of this scale require global efforts to produce a safe and affordable solution to all.

  9. Thoughtful Writeup!
    However, I beg to differ w.r.t few points such as “drug manufacturer is always open for patent war” and the reason behind is “huge investment”.
    In my opinion, the drug manufacturer has already invested a huge chunk in R&D and would apply himself conscientiously before initiating a lawsuit. Unless, patent deals with high potential and lawsuit is the only option, originator is left with.
    Having said that, yes the COVID-19 has created a circumstances wherein the existing provision across the world would be of least help and platforms such as open source communications, patent pooling and transfer of data should be promoted for better and wider access.

  10. Thanks for your comments and I agree with you. By the quoted statement, I also meant the same that the drug manufactures invest a lot of money and they don’t wish to compromise their exclusive rights by compulsory licensing. Accordingly, to protect their interest, they involve in patent wars; not necessarily a patent litigation but many other ways of securing their interest.

3 Trackbacks / Pingbacks

  1. From the bolar provision to the issuance of the compulsory license and revocation in the public interest – Remdesivir drug of Gilead is a complete course on patent law – The IP Press
  2. From the bolar provision to the issuance of the compulsory license and revocation in the public interest – Remdesivir drug of Gilead is a complete course on patent law – The IP Press
  3. Public health lawfully outlaws the patent rights: a story of March-in rights! – The IP Press

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