Covid 19 Update

Covid 19 Update

On Friday, May 29, 2020, the World Health Organization (WHO) officially launched the COVID-19 Technology Access Pool (CTAP), an initiative which is intended to improve access to treatments, vaccines and other medical technologies which are developed in response to the global COVID-19 pandemic. The program allegedly highlights the apparent tension between pharmaceutical developers and advocates for access to medicine. This tension is exacerbated by economic concerns caused by the global shutdown. 

Director-General Dr. Tedros Adhanom Ghebreyesus announced the organization is joining 37 other countries and “numerous partners” to launch CTAP. According to the Director, the initiative is intended to provide open access to information on the virus, including public disclosure of all clinical trial research and gene sequencing research. 

While this would appear to be a noble goal, no one should be surprised that this has raised a few “eyebrows” in the life sciences industry. In a perfect world, which we are not, issues like the COVID-19 crisis would be addressed by a coordinated, collaborative effort on behalf of our global citizenry. “All for one and one for all.” Its an easy argument to justify during a global pandemic – when the world is on fire everyone has a stake in putting the fire out. Why should this scenario be any different when we discuss finding and developing cures to the many diseases that Mother Nature has thrust upon us? The easy answer for me is that it should not! 

The parties supporting the WHO initiative suggest that “[v]accines, tests, diagnostics, treatments and other key tools in the coronavirus response must be made universally available as global public goods ……[to] help provide equitable access to life saving technologies around the world”. 

WHO wants to ensure better access to existing and new COVID-19 health products. WHO identified a five (5) point wish list: (1) public disclosure of gene sequences and data; (2) transparent clinical trial publications; (3) funding agreement clauses on availability and trial data publication; (4) promoting the licensing of related technologies to the UN’s Medicines Patent Pool (MPP); and (5) promoting open innovation models and technology transfer. 

Given the relatively small response so far (approximately 37 countries), one might conclude that this noble effort is doomed to fail – and I don’t say that lightly. The “eyebrows” I spoke of above see this as an attempt at a massive IP land grab without any meaningful upside for all the work that has already taken place and that which will take place. It is not unreasonable to assume that the owners of current technology and that which they will further create do not want to give away what they have created? WHO’s broadly defined missive encompasses patents, trade secrets, data, clinical studies, trademarks, copyrights, etc. How does such a collaboration between multiple countries, corporations, foundations, and academic institutions accommodate all competing needs of the various parties in a fair and equitable manner? 

As a longtime participant in the life sciences field I have seen, been part of, and heard of numerous collaborative partnerships that have successfully exploited each other’s strengths to create a lifesaving drug/treatment. But, in these scenarios the parties and their obligations to each other are well defined in terms of the science and, of course, the financials. This last piece, the financials, are what get the most attention from the “eyebrows” I mentioned above. The true value proposition is nonetheless based on the hard science – whether it works or not. 

Some critics argue that we are already partnering and creating new technologies, while others in favor of the WHO proposal argue that traditional market models do not deliver solutions at scale needed to cover the globe. Still others have argued for a wait and see approach to determine if the WHO platform “has a clear mandate that avoids confusion, duplication, and overlap” with other existing initiatives. WIPO’s Director argued for strong IP rights to address the lack of a Covid-19 vaccine. Some express concerns about voluntary or compulsory license “schemes” – the term “schemes is not a good choice of words given its alternative meanings. 

In my not so humble opinion, there is a major trust issue between the competing factions. For example, there have been questions raised about why WHO would take the lead on this issue in view of WIPO’s assessment that IP systems “are no barrier to access”. Finally, three very large players in the IP space, the US, UK and Switzerland have each opposed the WHO platform proposal. 

The WHO platform proposal is new, remains a work in progress, and has raised many questions that need to be addressed and resolved before this initiative could ever succeed. 

On a related note, the UK has called for a “freely available virus vaccine”. A vaccine summit hosted by the UK on June 4, 2020, raised almost 9 billion dollars to help create “a peoples vaccine … that would be freely available”. Much of the money raised will be used to vaccinate approximately 300 million children in many countries against diseases such as malaria, pneumonia and HPV. 

Hopefully, the WHO proposal can be reconciled with the existing IP infrastructure already in place or it may have limited long term impact. In the end, I believe that we should be willing to make some sacrifices to improve access for all that want or need to be treated regardless of individual circumstances. 

In this context, my first wish is that we find a vaccine/treatment to get rid of/treat Covid-19. My second wish is that my first wish happens ASAP! 

Stay Safe! 

Michael McGurk

Mike McGurk has more than 30 years of experience in virtually all aspects of patent law. Working with clients ranging from small start-ups to large Fortune 100 companies, he provides counsel in due diligence matters, global portfolio development and adversarial proceedings, including litigation, post-grant reviews, interferences and re-examinations. Mike works primarily with pharmaceutical, chemical, medical device and mechanical technology businesses. For at least the last fifteen (15) years, approximately 50-70% of Mike’s work has been focused in life sciences, including ANDA litigation support and pre-filing due diligence. Mike’s practice is informed by his background as a patent examiner in the chemical arts for the United States Patent and Trademark Office (USPTO), as a litigator for ten years, and as an expert in due diligence matters. He regularly provides strategic litigation counseling support to clients across the nation, and has handled numerous patent matters before the Patent Trial and Appeal Board of the USPTO. His extensive due diligence experience includes pre-litigation, acquisition, in-license, freedom-to-operate product and/or process clearance, design around, validity and patentability matters. Mike works with teams having the appropriate technical and legal abilities.