Not only has the global pandemic spawned a race to develop a cure for COVID-19, it has also created a race to the Patent Office to protect the massive investments companies are making in their attempts to develop novel diagnostics, therapies, and vaccines to combat the disease. In the United States, the first inventor to file a patent application that teaches a new and non-obvious way to treat the virus or its effects will be eligible for the limited monopoly that a patent provides. As has been reported, researchers are employing a variety of different mechanisms to attack the virus and it is expected that a significant number of patents will ultimately issue from these efforts.
While Big Pharma is well-poised to incur the expense of patent filing, including the additional expense of paying for accelerated examination of their applications, smaller concerns may not be in a position to do so. To help small businesses and solo inventors in this regard, the United States Patent Office has announced a program that would fast-track the examination of certain patent applications related to the pandemic. While the typical turn-around time for an Examiner to provide an initial review of a new application is about two years after filing, payment of an extra fee to accelerate examination is also an option. Small businesses and startup companies, however, typically can’t take advantage of this program due to the substantial increased initial cost. To remove this impediment, the new program enables business with less than 500 employees to request accelerated examination of certain COVID-19-related applications with no additional upfront payment. If an application qualifies for the program, the Patent Office promises to fully examine it within a year of being granted prioritized status.
The program is further limited to therapeutics, vaccines and diagnostic tests that are subject to FDA approval for COVID-19 related uses. FDA approvals include, for example, Investigational New Drug (IND) applications, Investigational Device Exemptions (IDE), New Drug Applications (NDA), Biologics License Applications (BLA), Pre-market Approvals (PMA), and Emergency Use Authorizations (EUA).
As of Thursday, August 20th, there have been 274 applicants with 146 requests having been granted. The program is limited to the first 500 approved applicants.
Can Technology Help Us Return to Work?
Coronavirus restrictions are both easing and tightening in cities around the country, and a nationwide return to work seems further off than it did a month ago. But it is never too early to plan ahead. As the United States looks to safely return to work, offices are preparing for a radical shift, accelerating a need for emerging technologies to address challenges in the workplace. Separation, space, health, and cleanliness concerns are paramount, in an abrupt about-face from the pre-virus trends towards flexible workspaces and open floor plans. This has created a host of novel issues for business administrators, who are leveraging technology to keep work environments safe while maintaining a semblance of business normalcy in these unprecedented times.
Regulatory Challenges to Fully Utilizing Existing Technology
On May 1st, Amazon Prime premiered Upload, the story of a software engineer whose consciousness is transferred to the cloud after his fully autonomous vehicle (AV) rear-ends another car. The accident takes place in 2033. By then, the show imagines, vehicles that drive themselves will be the default. We won’t spoil the ending. But, in the fictional 2033 only 13 years from now—the public is astounded when the vehicle is involved in a wreck. It is an entertaining take on the future. In reality, however, we’ve got a lot of regulations to update if autonomous vehicles (AVs) are going to play the role imagined in Upload.
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Opportunities: Leveraging Technology to Meet New Demands
Most of the world is staying home, but businesses must still pay their bills. In late April the federal government estimated the U.S. economy contracted by 4.8 percent in the first quarter of 2020, mostly due to the Coronavirus pandemic. Because the real economic consequences of social distancing occurred in April, future numbers will likely be as bleak, if not worse.
Yet, some businesses are taking bold steps, innovating in communications with their customers, and leveraging pre-existing tools to retool how their customers interact with the company and its product. Companies that never before offered delivery are experimenting with last mile logistics. Farms whose regular restaurant or hotel customers are closed due to public health orders are retooling their supply chains to supply local households. And companies that previously relied on face-to-face interactions are turning to virtual solutions to bring their product to market, even in a field like wine production—where taste is an essential part of the purchasing decision. These companies described here provide just a few examples of how creatively leveraging existing technologies can allow a company to maintain operations.
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The COVID-19 crisis has revealed numerous legal issues that entrepreneurs and business leaders hadn’t faced before. Christian Farmakis, chairman of Babst Calland explains what c-suite executives should be thinking about, including giving a new level of scrutiny to contracts.
Click here to listen.