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.
Remote Working
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.
International Considerations
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.
Fast-tracking Applications
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:
- Track one: Prioritised examination under track one is available for a fee for 12,000 applications a year, and allows a final disposition within about 12 months. The cases currently have a pendency of 1.7 months from the grant of a track one petition request to a first office action, compared to a ~16-month pendency for regular applications. Track one cases are limited to a maximum of four independent claims and 30 total claims—and are available for new applications only upon filing, which can include continuations, continuations-in-part, and divisionals, as well as pending applications when a request is filed with a request for continued examination.
- Petition to make special: Upon petition at filing, an application (including a continuation/divisional application) may be advanced out of turn under certain conditions, such as the applicant’s age (over 65) or health, or that the invention will materially enhance the quality of the environment, contribute to energy resources, or contribute to countering terrorism—or possibly for other reasons of importance. Cases with such petitions currently have a pendency of ~2.4 months from the grant of a petition request to a first office action. The USPTO does not have a definitive rule or any specific guidance as to whether COVID-19-related applications qualify for a petition, but they have said that they will consider petitions on a case-by-case basis.
- Patent prosecution highway (PPH): Under PPH, when an applicant receives a ruling of allowability from one country’s patent office or positive PCT work product, the applicant may request fast-track examination of corresponding claims pending in other participating countries’ patent offices. PPH cases currently have a pendency of ~166 days from the grant of a petition request to a first office action. A continuation/divisional application may be eligible for PPH, but substantive examination cannot have begun on the application availing itself of PPH.
- Quick path information disclosure statement (QPIDS): If an information disclosure statement (IDS) is filed after payment of the issue fee and the examiner determines that nothing in the IDS necessitates reopening prosecution, the QPIDS programme eliminates the requirement for processing a request for continued examination in order for the IDS to be considered by the examiner.
- After final consideration pilot 2.0 (AFCP): Upon request after final rejection, an examiner may conduct additional search and consider responses, as well as conduct an interview, without the applicant having to file a request for continued examination—provided that at least one independent claim is amended and not broadened.
- Full first action interview pilot programme (FAIPP): Upon request prior to the first office action on the merits, an applicant (including in a continuation/divisional) is entitled to an examiner interview and a condensed pre-interview communication, citing proposed rejections or objections. The first action allowance rate of applications participating in the FAIPP is 29%, as opposed to 14% for regular non-continuing applications.
Licensing
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.
