Second medical use inventions: “Everything Old is New Again”
In the current COVID-19 environment, much of the innovation that we will require to tackle this pandemic will be borrowed from innovations of the past. As the great Australian musician Peter Allen once sang:
“Don’t throw the past away
You might need it some rainy day
Dreams can come true again
When everything old is new again”
As the number of infections surpasses 3 million worldwide with over 200,000 deaths spanning over 200 countries, the social and economic imperative for new treatments continues to escalate.
While researchers worldwide are dedicated to the important work of finding a new vaccine for COVID-19, it is important to remember that pharmaceutical innovation does not necessarily mean discovering a completely new drug. Innovation lies in many places, including incremental improvements to known drugs products and treatment regimes, as well as the discovery of new uses for known drugs – so-called “second medical uses.”
Second medical uses can provide distinct public health benefits in a relatively expedient fashion by reducing the research, development and regulatory burdens associated with bringing a new drug to market.
Second medical use patents
Not only could second medical uses represent the first line of treatment for COVID‑19, they also offer significant commercial benefits when protected via patents. While second medical use claims come in a variety of forms, including method of medical treatment and Swiss-style claims, it is possible to obtain a patent for a second (or subsequent) medical use in one form or another in a number of major jurisdictions, including US, Europe, Japan, Israel, China, Australia and New Zealand, where a new and non-obvious therapeutic indication is discovered for a known active pharmaceutical ingredient (API).
Some well-known examples of second medical use patents include those relating to Pfizer’s blockbuster drugs Viagra® (sildenafil) and Lyrica® (pregabalin). Sildenafil was first developed for the treatment of cardiovascular disease, but was later discovered to treat erectile dysfunction and marketed as Viagra®. Similarly, pregabalin was first developed for the treatment of epilepsy, and later discovered to treat pain and marketed as the drug Lyrica®. Both APIs were protected from a very early stage of development by patents. However, Pfizer was also able to obtain, defend and enforce patents directed to the newly discovered second medical uses in a number of jurisdictions, which provided protection for these specific uses long after the patents for the original APIs expired.
Sales of Viagra® for erectile dysfunction were estimated at US$1.6 billion in 2016 (before losing market exclusivity in the US in 2017), while 2019 sales of Lyrica® for the treatment of pain were estimated at US$3.3 billion. These examples, among many others, and the extensive resources poured into litigation on the relevant second medical use patents, highlight their commercial importance.
Benefits for research organisations, biotechs and SMEs
Second medical use patents are not just the domain of big pharma, they can also provide commercial advantages and opportunities for research organisations, biotechs and SMEs:
- the time, cost and resources associated with the R&D of a new drug product is significantly reduced;
- the safety hurdles associated with obtaining regulatory approval can also be significantly reduced, particularly where original drug formulation is unaltered;
- patents can help to attract investors to fund vital research;
- patents can lead to opportunities for research organisations and SMEs to collaborate/partner with big pharma; and
- patents can form the basis for licenses or other agreements with third parties, providing a return on investment.
Where a patent already exists for the API, a second medical use patent may help to extend the lifecycle of an existing patent portfolio. This may be particularly valuable to originators and could lead to favourable partnership agreements, including licenses and acquisitions, for the patentee.
Current COVID-19 therapies
There is currently no proven treatment for COVID-19, although a number of vaccines are in various stages of development. Additionally, several known APIs have shown promising activity against SARS-CoV-2, but up to now controlled clinical trial results are limited. These APIs include chloroquine and hydroxychloroquine (used in the treatment of malaria), and the combination drug lopinavir/ritonavir (used in the treatment of HIV):
Other compounds have also shown promise in the treatment of COVID-19. However, where such compounds have not previously gained regulatory approval, it may be some time before they can be established as safe and efficacious in humans. For example, remdesivir has been touted as the most promising candidate for the treatment of COVID-19, but recent reports suggest that the first Phase 3 clinical trials of this drug were terminated early due to adverse side-effects, so it remains to be seen whether it is a viable treatment option.
These and other results from around the world indicate that further investigation into the repurposing of known drugs could be the key to a first-line treatment against COVID-19 and possible future coronavirus outbreaks. In the end, innovation will prevail and see us into a new era. Comfort should be taken in knowing that not everything will drastically change. Peter Allen was well aware of this too when he sang:
“Dancin’ at church, Long Island jazzy parties
Waiter bring us some more Baccardi
We’ll order now what they ordered then
‘Cause everything old is new again…”
If you would like to know more about protecting your second medical use innovations, please do not hesitate to contact Claire Gregg at CGregg@davies.com.au, Mat Lucas at MLucas@davies.com.au, or your regular Davies Collison Cave contact.