Posts Tagged: "coronavirus"

Draft legislation has emerged that ostensibly would boost rapid innovation to combat the coronavirus. Bottom line: The bill is a mixed bag with a lot of questions… The Facilitating Innovation to Fight Coronavirus Act appears to be an attempt to bring any and all viable medical inventions to bear, as quickly as possible, in our fight to defeat COVID-19, which is absolutely to be commended. Despite attempts to mitigate the harm that outright eminent domain on patent rights (vigorously advocated by some) would certainly cause, the legislation needs more work.

Today, like so much of the rest of the world, the United States is faced with many shortages due to the coronavirus pandemic, including personal protective equipment, basic medical supplies, and qualified medical staff. Of course, the lack of treatments or vaccine is a huge problem. Another secular problem is the lack of a quick, inexpensive, reliable test for the virus. But a test for the virus is a diagnostic method, and that is a big problem for U.S. patent laws because diagnostic methods are simply not patent eligible in the United States. This is also a big problem for the world because ever since the veil of patent eligibility was lifted for the life sciences sector in 1981 by the U.S. Supreme Court in Diamond v. Chakrabarty, the U.S. has dominated the biotechnology sector, specifically, and life science sectors more generally speaking. In 1981, the Supreme Court opened the floodgates saying that what was created by man could be patented, and if it could be owned it could be invested in, and investors rushed in and the biotechnology industry that we know today was born. But what the Supreme Court gave they can, and ultimately did, take away.

Is Unified a war profiteer?  Of course, they are. But they are only one cog in the larger worldwide scheme of the most powerful multinational corporations whose goal is to monopolize technologies by destroying patents and innovation. This recklessness to preserve their monopolies has brought utter destruction to our nation’s innovation engine – startups.  

Since China announced the first fatality caused by a virus about which little was known at the time, coronavirus and the disease it causes, COVID-19, has grown to pandemic proportions. In the less than three months since that first death, this new strain of the severe acute respiratory syndrome-related (SARS) coronavirus has shuttered social gatherings, precipitated a mandatory work-from-home revolution and decimated large parts of the world’s economy. As of the afternoon of March 27, the Coronavirus Resource Center at Johns Hopkins University reports that more than 585,000 cases of COVID-19 infection have been confirmed worldwide, resulting in a total of 26,819 deaths. Those figures have been increasing exponentially each day.

An essential element of trade secret protection is that the owner has made “reasonable” efforts to keep the information a secret. But as the Uniform Trade Secrets Act tells us, those efforts must be reasonable “under the circumstances.” When circumstances change, as they have recently, we need to recalibrate. In fact, when things return to whatever normal turns out to be, this will be an excellent opportunity for every organization to revisit the way in which it approaches management of its most important information assets.

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.

Unfortunately, some simply cannot help themselves but to use every opportunity – real or imagined – to take a cheap shot at a patent owner for having the audacity to seek to enforce patent rights, so it should come as no surprise that false and misleading reports would surface in the life sciences world relating to the latest coronavirus (named SARS-CoV-2) and the disease it causes (named “coronavirus disease 2019” abbreviated COVID-19). It was only a matter of time. The true story begins in 2018, when Fortress Investment Group acquired the patent assets of Theranos Inc. Fast forward to March 9, 2020, when Labrador Diagnostics LLC filed a patent infringement lawsuit against BioFire Diagnostics, LLC and bioMerieux S.A., asserting U.S. Patent No. 8,283,155 and U.S. Patent No. 10,533,994, patent assets acquired by Fortress Investment Group from Theranos. This patent infringement lawsuit was not directed to testing for COVID-19, and instead focuses on activities by the defendants over the past six years that are not in any way related to COVID-19 testing.

Subsequently, two days after being sued for infringing the ‘155 patent and the ‘994 patent, on March 11, 2020, bioMerieux announced the forthcoming launch of three different tests “to address the COVID-19 epidemic and to meet the different needs of physicians and health authorities in the fight against this emerging infectious disease.”

As outside general counsel to over 150 emerging growth companies in recent years, as well as to their venture capital and growth equity investors, and as someone who represents buyers and sellers in M&A transactions, I am often asked how to protect businesses from interruption to their key customer and supplier relationships. Specifically, in the age of COVID-19, now characterized by the World Health Organization as a “global pandemic,” I am being asked whether a counter-party can trigger a “material adverse change” clause to terminate a contract.

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.

The recent White House meeting with leaders from American pharmaceutical companies sought their help in solving the coronavirus that originated in Wuhan, China and is currently gripping the globe. The meeting was part of the U.S. government marshaling our nation’s private and public medical research and development (R&D) resources in a race to create therapeutics, vaccines, diagnostic tools and cures. The Wall Street Journal has noted that “a core U.S. strength is the breadth of its private medical resources. That’s on display now as the government is calling on private actors to buttress the federal response.” Ironically, the same U.S. government urging the same private industry whose intellectual property rights enable it to develop medical miracles to help is targeting American pharmaceutical firms with a number of IP-killing policy proposals. One such bad idea comes from the Food & Drug Administration in a rulemaking titled “Importation of Prescription Drugs Proposed Rule (Docket No. FDA-2019-N-5711).”

We have great news to share with all of our IPWatchdog CON2020 Speakers, Sponsors, Exhibitors and registrants. We have finally worked out an amicable resolution with the hotel. Although we will still hold a Virtual Program of some sort on Monday, March 16, IPWatchdog CON2020 is no longer canceled. We have rescheduled for Sunday, September 13 through Tuesday, September 15, to be held at the Renaissance Dallas Richardson. The program will be nearly identical to the live program we had scheduled for next week. More details to follow. 

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.

We are in the final preparations for IPWatchdog CON2020, which is scheduled for March 15-18 in Dallas, Texas. We have been receiving inquiries regarding the latest coronavirus (named SARS-CoV-2) and the disease it causes (named “coronavirus disease 2019” abbreviated COVID-19).  These questions and concerns are understandable given that many events around the world have been canceled, and several major events inside the United States have been recently canceled as well. Unlike the several other major conferences canceled in the U.S., approximately 98% of those registered for IPWatchdog CON2020 are coming from within the Continental United States. We did have some early registrants from Asia, who were in communication with us as the virus was developing and decided it was unlikely they would be able to attend. We do suspect the virus is responsible for so few international registrations, but with over 300 people expected in Dallas for the event we will proceed as scheduled.