Posts Tagged: "COVID-19"

As is customary, President Joseph R. Biden has spent much of his first month in office building out his administration’s Cabinet. His nominations for Secretary of State, Treasury and Defense have already been confirmed by the U.S. Senate. Now, short lists are being assembled for who may fill his non-Cabinet-level positions. Much time and focus has been duly spent on Cabinet-level positions, but there are other government agencies that have a major impact on the U.S. economy. There have been a lot of rumors surrounding Biden’s pick to head the United States Patent and Trademark Office (USPTO), and for good reason. Today, as America continues to recover from COVID-19 and its consequences, this position may be more important than ever before.

India and South Africa recently urged the World Trade Organization to suspend intellectual property protections for COVID-19 vaccines and treatments. The claim is that this would allow developing countries to manufacture “cheap” COVID-19 therapeutics and vaccines, hastening the end to the pandemic—at least, that’s what proponents claim. They’re wrong. Dangerously wrong. Gutting IP protections won’t make COVID-19 medications more readily available but it will set a terrible precedent that will chill future medical innovation.

Pfizer and BioNTech have hit back at Allele Biotechnology and Pharmaceuticals, Inc.’s October 2020 complaint accusing the COVID-19 vaccine manufacturers of infringing Allele’s U.S. patent covering a particular “tag” used to track vaccine in a patient’s blood…. U.S. regulatory approval requires Pfizer and BioNTech to show that their vaccine is safe and effective against SARS-CoV-2 infection. To meet the Food and Drug Administration’s (FDA’s) requirements, Pfizer and BioNTech have been and “continue to be engaged in large scale clinical trials to evaluate, among other things, whether individuals who receive the vaccine are less susceptible to COVID-19 infection.” As part of these trials, the results of laboratory tests on blood samples drawn from patients in the clinical trials who received the vaccine are evaluated. One of these tests is a “neutralization assay,” which is a laboratory procedure to detect the presence of antibodies in the blood of a patient after receiving a vaccination capable of neutralizing the SARS-CoV-2 virus. As part of the assay mentioned above, a fluorescent “tag” is used to track the vaccine in a patient’s blood. Allele alleged in its complaint filed in October 2020 that Pfizer and BioNTech infringed their patent for their particularly engineered tag.

The new Presidential Administration has hardly settled in before being confronted with a stark choice: will they continue policies that foster public/private sector R&D partnerships or be diverted down a path that’s been a dead-end? President Biden faces two herculean tasks: getting the COVID-19 pandemic under control while reviving the economy. The problems are intertwined and require continuous innovation to overcome, which means tapping the best minds in our public and private sectors. We’ve just witnessed a modern miracle, as such partnerships seamlessly came together to create effective COVID-19 vaccines and therapies in record time. But the policies these collaborations depend on are now being questioned.

The United States is not even two weeks into the administration of President Joe Biden and it’s likely that the administration’s selection for Director of the U.S. Patent and Trademark Office (USPTO) will not become clear for a few months yet. Many members of the U.S. innovation community, however, are well aware of the high stakes in play with that selection. The tenure of outgoing Director Andrei Iancu was lauded across many sectors of the U.S. patent system, perhaps with the exception of the tech sector. As we consider candidates for the next USPTO head, perhaps we should look to the political moment in which we find ourselves to guide our search.  

Last year brought unprecedented changes as to how the United States Patent and Trademark Office (USPTO) conducts business. Prior to the pandemic, the USPTO was already a trailblazer with employees teleworking. As of 2018, 8,824 patent positions, roughly 94% of the total positions eligible for telework, already worked from home. On March 15, 2020, however, the USPTO closed all of its offices to the public, and subsequently transitioned its entire workforce of roughly 13,000 people (which includes patent examiners, trademark examiners, and other staff), to full telework, practically overnight. Since the majority of these positions were already teleworking, the transition was almost seamless.

While the COVID-19 pandemic has changed every aspect of our lives, digital transformation in healthcare has accelerated above others. The pandemic has changed the healthcare delivery paradigm from human to digital platforms faster than Klaus Schwab could have imagined. In 2016, the World Economic Forum chairman coined the phrase “Fourth Industrial Revolution,” envisioning the combination of fourth industrial-era technologies in hardware, software, and biology, or cyber-physical systems. These new technologies, leveraging advances in communication, connectivity, and computing power, would usher in a more efficient way to live, work, and socialize. Who knew how the horrific circumstances triggered by a global pandemic could accelerate an evolution that might have taken 20 years and condensed into a single year. Healthcare has gone digital, and there is no going back now.

On January 12, patent database provider IFI Claims published its Top 50 U.S. patent grant recipient list for 2020, as well as its Global 250 list of top owners of active patent assets worldwide. The Top 50 list includes many of the usual suspects among top patent filing organizations, including IBM, which takes the top spot among all firms receiving U.S. patents for the 28th year in a row. Perhaps the most surprising finding from the study is that patent application filing activity increased slightly during 2020 despite the massive disruptions to daily life caused by the COVID-19 pandemic.

Some businesses, as a result of the pandemic, have been pressed to discontinue manufacture or sale of products or have otherwise limited the scope of their business activities. As a result, in 2020 the use of one or more of the trademarks owned by your business may have stopped. Under U.S. trademark law, in the fifth year of a trademark registration term, and every ten years thereafter, a post-registration maintenance filing at the USPTO is required (e.g., evidence and a sworn statement about continuous trademark use in U.S. commerce). If sustained discontinuity of trademark use has occurred what options are available to keep a trademark registration active?

Greek philosopher Heraclitus is credited with saying “the only thing that is constant is change.”  In 2020, life for everyone changed, including for those in the intellectual property (IP) sphere. There were changes at the U.S. Patent and Trademark Office (USPTO), in IP litigation, client activities and business development. Looking into the crystal ball, we believe some of those changes are here for good, while others are not.

The biggest vaccination effort in the history of medicine is underway to eradicate the global pandemic, with several strong prospects appearing poised for regulatory approval. As of December 2020, data from the World Health Organization showed over 50 vaccine candidates in clinical research, and 163 more in the preclinical stage. The wait could soon be over. Two separate vaccines – one from Pfizer and BioNTech and one from Moderna – are pending emergency use authorization from the U.S. Food and Drug Administration. The former is already being administered for the first time outside of clinical trials following its approval by the UK government. That’s why recent calls to strip away intellectual property protections are so dangerous. Specifically, some nations have asked the World Trade Organization (WTO) to waive intellectual property protections related to COVID-19 – including not only vaccines, treatments, diagnostics, and medical technologies, but all forms of IP – until the majority of the world’s population has developed immunity. They argue that the current global intellectual property system is a barrier to accessing said COVID-19 vaccines, treatments, diagnostics, and medical technologies.

As Pfizer and BioNTech announced this week that results of their COVID-19 vaccine have exceeded expectations, the technology behind the vaccine (messenger RNA, or mRNA) has taken center stage. Last month, Moderna Therapeutics, one of the global leaders in the race to produce a COVID-19 vaccine using mRNA, made the following statement regarding enforcement of its patents: “We feel a special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible. Accordingly, while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic. Further, to eliminate any perceived IP barriers to vaccine development during the pandemic period, upon request we are also willing to license our intellectual property for COVID-19 vaccines to others for the post pandemic period.” This post examines why Moderna made this patent pledge by examining its mRNA technology, go-to-market status, patent landscape, and market position.

The worldwide COVID-19 pandemic has dampened many commercial operations in countries around the world, including the United States. Although the U.S. stock market underwent a historical pull-back and rebound in a matter of a few short months, new unemployment filings are still at record highs and corporate budgets have been slashed to minimize expenses. In a large sense, corporate profits for the first half of 2020 are down for many companies compared to the end of 2019, though the technology sector is down less than others. As companies scramble to reduce expenses, IP budgets may be on the chopping block. One approach for reducing IP expenditures is to cut prosecution costs by abandoning applications, and patent application abandonments have indeed increased. Another approach for reducing expenditures is to file fewer patent applications (which may offer added cost savings as USPTO fees have now risen – with some fees increased by 25%-200%). Some predicted that new patent application filings would drop significantly, possibly as high as a year-over-year decline of 20% vs. 2019.

At the onset of the U.S. COVID-19 pandemic in early March 2020, the legal community immediately became concerned about its economic prospects. Particularly in the intellectual property (IP) legal community, bad memories from the 2007-2009 mortgage crisis and Great Recession surfaced, and fears of losing clients, billable hours, and jobs mounted. However, due to a variety of factors, the legal market has been unexpectedly resilient and, in many ways, has thrived during these extremely uncertain times.

Allele Biotechnology and Pharmaceuticals, Inc. (Allele) has accused Regeneron Pharmaceuticals, Inc. (Regeneron); Pfizer, Inc. (Pfizer); and BioNTech SE and BioNTech US, Inc. (collectively BioNTech) for allegedly infringing U.S. Patent No. 10,221,221 (the ’221 patent), which is directed to an artificial flourescent, i.e. mNeonGreen, used for testing COVID-19 assays against vaccine candidates.  Allele argues that Regeneron, Pfizer and BioNTech have been infringing the ‘221 patent by taking mNeonGreen “for their own unauthorized commercial testing and development.” Regeneron has been in the news lately for famously providing the “antibody cocktail” given to President Donald Trump shortly after he tested positive for COVID-19 last week. The cocktail is name in the complaint as one of the allegedly infringing technologies.