Strong patents are the foundation of any valuable patent portfolio. In my latest book, Billion Dollar Patents, I explore ways to draft patents and build strong patent that will not only provide products with a competitive edge but that will also be upheld should they be challenged in a post-grant proceeding.
Drafting strong patents is equally important in today’s pandemic climate. We have seen many companies and universities devote significant resources to COVID-19 research in hopes of developing a vaccine or cure for the disease.
With so many companies working to develop a cure, companies are rushing to patent their innovations. Despite this rush to the patent office, it is important to still follow best practices when filing applications. Below are five strategies when it comes to filing COVID-19 related inventions.
1. File quickly
The U.S. and other countries have a first-to-file patent system. Accordingly, it is important to file patent applications quickly before your competitor does. If you file an application even a day after a competitor does, you likely lose all rights to that invention.
Despite the rush to file, it is important to understand that the pandemic does not suspend patent laws. Accordingly, patent applications must still satisfy the various requirements of patent law, especially written description and enablement, in order to have a defendable priority date. This means that to actually benefit from the filing date of the application and predate competitors, that patent application will need to have sufficient information and data to support the claims.
Generally speaking, the more information and the more data you provide in an application, the better chances you will have to end up with strong claims. Problems may arise, however, when you do not have enough data because experiments are still in progress. In these situations, it is still important to file patent applications early using hypothetical examples. While hypothetical examples are viewed differently across jurisdictions, they may provide a viable alternative when experimental data is not available.
2. File Often
Not only is it important to file early, it is also important to file often. This is particularly true when experimental data is not immediately available as discussed above. It is important to remember that you are not limited to filing just one provisional patent application. You can file as many as you want during the course of the year and then merge them together to file one utility or non-provisional application. In these situations, you could file new provisional applications as soon as new data becomes available.
One caveat to be aware of is that the new data will only provide priority to the date on which it was filed. Unless it was supported by adequate disclosure, such as a hypothetical example, it will likely not benefit from any earlier provisional filing dates. This makes it even more important to file updated provisional applications as often as possible.
In addition to covering new data, the patent applications should cover work arounds and foreseeable new developments to the invention. Patents provide a value in create barriers to market entry and “excluding” others from your field. By filing applications to modifications, you can expand your footprint in the market.
3. Take advantage of USPTO’s accelerated program
The USPTO is currently offering an accelerated program for COVID-19 related technologies, called the COVID-19 Prioritized Examination Pilot Program (May 14, 2020). It is applicable to any product or process related to COVID-19 that requires FDA approval such as INDs, IDEs, NDAs, BLAs, PMAs, and EUAs.
To submit a patent application under this program, that patent application must be limited to 4 independent claims or 30 claims in total. Only small or micro entities can apply for this accelerated pathway and only 500 cases will be permitted in total. As part of the program, the USPTO hopes to reach final deposition with 1 year and possibly within 6 months.
By taking advantage of the USPTO’s accelerated program, companies can expedite the process by which they can obtain patent protection for their products.
4. Conduct quick FTO studies
As previously mentioned, the coronavirus pandemic does not suspend patent laws. Companies therefore still need to be aware of potentially blocking third party patents that may present hurdles to commercialization. Such patents can be identified with a freedom to operate (FTO) study. This is particularly true when companies are using pre-existing drugs, such as Gileads’ antiviral, Remdesivir.
Even when the process is rushed, conducting FTO studies during the course of development is important to identifying potential roadblocks to commercialization. This allows companies to proactively seek licenses or workarounds to their inventions.
5. Prepare for compulsory licensing situations
We are in uncharted territories. While only a handful of countries have ever issued a compulsory license, which would allow a country to circumvent a patent to manufacture and distribute a patent protected drug to its public, companies need to prepare for the possibility that this could happen. Earlier in March, Israel issued a compulsory license to AbbVie’s HIV treatment Kaletra® for use to treat COVID-19. It is likely that more countries will employ similar measures depending on what drug will prove effective to treat the disease.
To put themselves in the best possible situation, companies need to proactively think about how compulsory licensing could be used for their products and better prepare themselves for dealing with that possibility.
While the need to find a treatment or a cure for COVID-19 has created a rush to patent coronavirus technologies, companies in this space should be mindful of following existing patent laws as well as being aware of the new opportunities afforded to them.
BioPharma Law Blog posts updates and analyses on IP topics, FDA regulatory issues, emerging legal developments, and other news in the constantly evolving world of biotech, pharma, and medical devices.