This article originally appeared in Life Sciences Intellectual Property Review and is republished here with permission.
Public health officials have said that we can expect the coronavirus pandemic to last for months—and the underlying virus will likely be with us for the long term. Meanwhile, the response to the COVID-19 pandemic has included a flurry of innovation.
Many researchers have turned their efforts to providing innovative strategies to detect, mitigate, or cure COVID-19. Hundreds of journal articles are now being published concerning SARS-CoV-2, the virus that causes COVID-19, every week.
While little information is currently available on the exact extent of COVID-19-related patents, there is reportedly a corresponding uptick in such patent applications.
Although the coronavirus pandemic has led to numerous public health measures which have slowed many businesses and government services in the economy, the US Patent and Trademark Office (USPTO) has operated remote-work procedures for many of its examiners for years, so—at least for now—there’s no indication that the closure of the physical USPTO offices will adversely impact the rate of examination.
The office has waived any remaining requirements it had for original handwritten, ink signatures and has announced it will waive petition fees in certain situations, amid the coronavirus pandemic. However, the USPTO has not yet extended any deadlines.
Patent applicants are also implementing strategies to make sure docket deadlines are not missed and preparing contingency plans in the event that key company individuals are unable to make strategic IP decisions.
For example, applicants are considering early filings or accelerated examination, and implementing backup plans regarding docket management. Applicants are evaluating teleworking capabilities in the event that they are subject to shelter-at-home orders or similar measures—the effects of which will vary by state.
The COVID-19 pandemic is international. Accordingly, the patent procurement strategy for any COVID-19-related portfolio—be it therapeutic, prophylactic, or diagnostic—will undoubtedly involve filing applications with patent authorities around the world.
Certain countries and organisations have moved patent office deadlines. The European Patent Office has extended its deadlines to April 17, 2020, including deadlines for international applications under the Patent Cooperation Treaty (PCT), and may extend them further, upon evidence of a COVID-19-related disruption making deadline compliance impossible.
Other jurisdictions that have extended deadlines include Brazil, Canada, Colombia, France, Ireland, Italy, Malaysia, Peru, the Philippines, Spain, and Venezuela. The UK has not announced a blanket extension but will consider requests for extensions of time on a case-by-case basis—as will India.
Countries with statutorily set deadlines, such as the US and Germany, have been more constrained in what their patent offices can extend, but some, such as Austria, have extended at least the deadlines that are within the patent office’s discretion.
Other countries, such as Bolivia, Iraq, and Kuwait, have temporarily halted patent office activities entirely. This list, of course, is not exhaustive, and applicants should monitor how deadline extensions evolve during the pandemic in individual jurisdictions of interest.
International prosecution requires careful consideration and planning in order to satisfy the varying patent requirements and regulations within the different patent offices across the globe.
For example many jurisdictions, such as Europe and Japan, do not allow method of treatment claims, and some, such as Japan and China, do not allow generic diagnostic method claims. However, a similar scope of patent protection may be obtainable in many of these jurisdictions through use-type or Swiss-type claims.
Additionally, because there has been serious interest in using existing, established pharmaceuticals such as remdesivir, hydroxychloroquine, and azithromycin to treat COVID-19, a robust international strategy must consider whether a given jurisdiction allows second medical use claims.
For COVID-19-related technologies, speed is of the essence for both product development and distribution. Proper patent protection is often an instrumental part of the development process, and therefore applicants should consider whether any number of accelerated-examination pathways—many of which can cut examination time down by years—are appropriate for them.
Once an application is filed, companies can deploy or disclose previously confidential technical information without worrying about later losing the ability to protect it down the road. Thus, quick filing can help information be disseminated to the public quickly, too. Early publication of applications can also be requested (with a fee), but such publication still takes around 14 weeks.
At the same time, applicants should avoid filing an application too early out of panic. As always, care should be taken to ensure that an application is complete and that the disclosure will support patentability of the technology in a meaningful way.
At the same time, applicants should be aware that competitors may be quickly filing other applications—and that a flurry of publications from researchers online may provide unexpected prior art if an application is not filed first.
Some options for accelerated examination before the USPTO include the following:
For patents with a current broad scope, companies might consider carving out special, more favourable terms surrounding application of the patent to COVID-19.
Strong negative attention has been cast on a few entities attempting to enforce patents in a way that would have arguably slowed down a response to the pandemic, such as Labrador Diagnostic’s assertion of patents previously owned by Theranos against BioFire Diagnostics and its parent company, BioMérieux.
After a backlash, Labrador offered a royalty-free licence for entities doing COVID-19-related work.
The public may also be on the lookout for licence terms that seem exploitative. Patent owners should be cognisant of this when preparing or negotiating any licences involving COVID-19-related technologies.
Given the worldwide public health emergency, patent owners should also be mindful that some countries provide for compulsory licensing provisions in the interest of public health or during national emergencies.
Such licensing is permitted under the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and various nations have availed themselves of it for communicable-disease treatments, such as during the HIV/AIDS epidemic.
The US government has threatened the issuance of compulsory licensing in the past, such as in the wake of the 2001 anthrax attacks, in order to induce lowered prices for anti-anthrax drugs. After this threat, ciprofloxacin manufacturer Bayer lowered its price and no compulsory licence was instituted.
With the COVID-19 pandemic in full force, the need for biomedical innovation is apparent. Well-reasoned patenting and licensing strategies can help ensure that innovations crucial to the fight against COVID-19 make it successfully from the laboratory notebook to the medical front lines.