Posts Tagged: "vaccines"

Almost two weeks after election day, it’s still not entirely certain who won (has there ever been a crazier year than 2020), but it appears increasingly likely that a new administration will take office in January. They are going to run smack into two overarching problems: how to gain control over the COVID-19 pandemic and how to reignite the U.S. economy. These problems are interrelated. We will only get out of this mess through American ingenuity and that’s already hard at work 24/7 developing promising solutions to protect public health, which releases the brake on the economy. So, here’s some advice: don’t listen to those who want to throttle down the engine driving that effort—don’t mess with the Bayh-Dole Act.

The Defend COVID Research from Hackers Act was introduced on Tuesday by Senators Thom Tillis (R-NC) and Marsha Blackburn (R-TN) with the goal of authorizing the President to “take swift action and add sanctions to countries trying to disrupt or hack COVID-19 research.” This bill is the Senate companion to legislation introduced in the House of Representatives in July by House Minority Leader Kevin McCarthy (R-CA).

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.

IPWatchdog’s most recent webinar focused on the role of IP in the development of the most promising vaccines to combat COVID-19 and included speakers from the medical community, the U.S. Food and Drug Administration (FDA) and the biopharmaceutical industry. The upshot was: wear masks, get the vaccine when it’s available to you, trust the FDA, and stop targeting IP rights, since there’s no evidence they have hindered the process and, in fact, IP has so far played a crucial role in collaboration efforts.

On July 16, 2020, the U.S. Chamber of Commerce and national business associations of the UK, France, Germany, Korea, and Canada, published an Open Letter to Heads of States and Government leaders titled “Working Together to Discover and Deliver Innovative and Creative Solutions to the Pandemic’s Challenges”.  The letter highlighted the contributions made by businesses in response to COVID-19, noting that businesses have expended a considerable amount of time and resources to “accelerate the research, development and manufacture of protective equipment, advanced diagnostics, disinfection products, medical devices and potential treatments and vaccines.”

As governments around the globe fight the COVID-19 outbreak, pharmaceutical companies race to develop a vaccine and potentially secure a patent for it. To speed the process, much of that effort builds on known drugs for other diseases. The World Economic Forum reports that 70 potential vaccines are currently in development around the world. According to a BBC report, research is in progress on more than 150 additional drugs globally, with many pre-existing drugs being trialed for potential usefulness in combatting COVID-19. Those which can are giving it their best shot—for people as well as profit. In the wake of this COVID-19 vaccine and patent sprint, questions arise concerning affordable and universal access: will governments, especially poorer ones, be able to secure affordable access to a vaccine if and when one becomes available? Can a patent owner actually be forced to license a COVID-19 vaccine for the benefit of the greater good? The answers are likely yes to both, depending where you are.

The world is teetering on the brink of a public health and economic catastrophe, depending on emergency partnerships between our public and private sectors to develop a successful treatment for the coronavirus. If there was ever a time to be thankful that we have policies in place making that possible, it’s now. But there are those who want to use this crisis to return to the failed policies of the past. Here’s the bottom line: the Bayh-Dole Act works. It allows the private sector to collaborate with universities and federal laboratories, like the National Institutes of Health, knowing that intellectual property they bring into such partnerships will be protected. It also allows academic institutions and federal labs to determine what type of license is best suited to promptly commercialize their inventions.

Almost a third of the recently signed $8.3 billion bill to fund the United States response to the coronavirus outbreak is devoted directly to vaccine research and development. And while the realities of drug development and FDA approval mean it is unlikely any vaccine will be available before next year, the government has numerous tools at its disposal in seeking to reduce the strain on the nation’s health care system. As many as nine different pharmaceutical companies worldwide are rushing to develop a safe and effective vaccine. Some are using traditional vaccine methods, including testing previously developed vaccines for other viruses. Others are using new technology to address the outbreak. The rush to find and deploy a coronavirus vaccine raises several interesting legal and regulatory issues, including balancing speed with efficacy, understanding ownership, and vaccine costs.

To say that the world’s been deeply shaken by the coronavirus (and the disease it causes, known as COVID-19) is no exaggeration. Our stock market has plunged, world trade is disrupted and people around the globe are fearful about confronting a disease that’s erupted out of the blue. Eyes are turning to the United States of America for a solution. There’s a good reason for that: we are far and away the best at developing new therapies to combat the scourge of disease. In all likelihood, a vaccine for the coronarivus will come out of a partnership between our National Institutes of Health (NIH) and the private sector. We have tried and true mechanisms for facilitating these arrangements, which NIH has effectively employed in the past. Our political leaders are well advised to leave them alone. Adding more unpredictability at this stage of the game, such as imposing “reasonable pricing” provisions on a vaccine that doesn’t exist, only adds more uncertainty to the equation. And there’s plenty of that already.