Posts Tagged: "COVID-19"

The business of the Patent Trial and Appeal Board (PTAB) continues on as most practitioners transition into another month of working from home. Like many courts, the PTAB has adapted its standard practices. For example, the PTAB has transitioned to remote hearings and encouraged remote depositions, but has otherwise continued to advocate for business as usual. The PTAB also appears to be accommodating requested scheduling changes. This article addresses the main highlights from recent PTAB actions to provide practitioners with additional resources as they navigate PTAB practice over the next weeks and/or months.

More than 30 leading conservative and libertarian organizations have joined on a letter to Congress, voicing “strong opposition” to principles, recently unveiled by four senior lawmakers, that would deny exclusivity to inventors of COVID-19 medicines. The legislators, U.S. Reps. Jan Schakowsky (D-Ill.), Peter DeFazio (D-Ore.), Rosa DeLauro (D-Conn.) and Lloyd Doggett (D-Tex.), say they aim “to ensure any COVID-19 drug will be accessible and affordable for all people.” The proposed items are expected to show up in a contemplated coronavirus economic recovery package, the fourth in three months.

It may seem odd, as unprecedented public/private sector R&D alliances work to discover and develop therapies to counter COVID-19, that some are trying to punish the companies trying to get us out of this mess. For example, House “Progressive” leaders unveiled the  “three protections”  they will try to insert in the next Congressional aid package, beginning with this: “NO EXCLUSIVITY: Pharmaceutical manufacturers should not be granted exclusivity for any COVID-19 vaccine, drug, or other therapeutic-whether it has been developed with U.S. taxpayer dollars and publicly funded, or not.” Consider the last phrase. They would take away rights to technologies developed entirely with private funding without evidence of any public need for doing so.

On April 28, the United States Patent and Trademark Office (USPTO) issued official Patent and Trademark notices announcing that it will be further extending certain patent and trademark deadlines that fall between March 27 and May 31, to June 1, 2020 in accordance with the agency’s temporary authority under the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The notices supersede the notices previously posted by the USPTO on March 31 and March 16, 2020. Andrei Iancu, Under Secretary of Commerce for Intellectual Property and Director of the USPTO, noted that “[i]nnovation and entrepreneurship will play a key role in our fight against this pandemic, and in the upcoming recovery of our country…accordingly, the USPTO continues to assess measures to support the work of inventors and entrepreneurs during this crisis and beyond.”

As COVID-19 continues to rapidly sweep the globe, government agencies at all levels are taking measures to curb the spread of the virus. Private companies have announced plans for and advancements in testing, antivirals and vaccines, leading some members of Congress to raise concerns about whether these medical countermeasures “will be affordable and accessible to the public” in light of companies’ ability to enforce their patent rights and exclude competitors. See Kevin J. Hickey, Cong. Research Serv., LSB10422,  COVID-19 Medical Countermeasures: Intellectual Property and Affordability (March 18, 2020). This, in turn, has led to concerns that the government may appropriate private intellectual property rights in order to combat the virus.

The novel coronavirus pandemic has upended our lives, creating a far-from-normal “new normal.” And it has also given rise to countless collaborations between and among universities, hospitals, medical centers, pharma companies and others to pool their talent and resources to discover, test, manufacture and distribute diagnostics, treatments, vaccines, personal protective equipment and other resources needed to fight the pandemic. Antitrust law poses no risk to these collaborations, so long as they remain focused on their core missions. But at the same time, antitrust law recognizes that in cooperating and exchanging information and insights for those missions there is the potential for “spill-over effects” that can create antitrust risk. The trick is to know where that dividing line is and to avoid crossing over it.

With two-thirds of the world in lockdown and no clear way out of the novel coronavirus crisis, it’s increasingly obvious that biopharmaceutical innovation will play a pivotal role. A new treatment that can mitigate the worst effects of COVID-19, and ultimately a preventative vaccine, could, literally, save the world. Such life-saving technology is less likely to be forthcoming if, in their panic, governments sacrifice intellectual property (IP) rights for new COVID-19 therapeutics and vaccines. The signs are not promising. IP-skeptic governments in Chile and Ecuador have taken preemptive measures by permitting compulsory licensing of any new COVID-19-related technology. Otherwise innovation-friendly Canada and Germany have passed legislation to issue compulsory licenses more easily. Even in the United States—the center of modern biopharmaceutical innovation and a major player in ongoing COVID-19 research and development (R&D) efforts—there is pressure to break patents.

On April 10, multinational corporation 3M filed a lawsuit alleging trademark infringement claims  against N95 respirator distributor Performance Supply, LLC, in the Southern District of New York. Central to 3M’s suit is the company’s desire to eliminate what it calls a false and deceptive price-gouging scheme being perpetrated by entities operating outside of 3M’s authorized supply chain and taking advantage of increased respirator demand caused by the COVID-19 crisis.

“The COVID-19 crisis has once more highlighted the need for incentivizing investment and innovation—and thus, for patent laws that duly “promote” and protect such “progress,” precisely as our Founders envisioned,” writes Chief Judge Paul Michel, now retired from the Federal Circuit. As he so often is, Judge Michel is absolutely correct. Many are asking why testing for the coronavirus that causes COVID-19 has been slow to roll out, and why tests in many countries are inaccurate. Those familiar with U.S. patent laws understand the problem. There has been a deemphasis on medical diagnostics in America as the result of a series of Supreme Court and Federal Circuit rulings, coupled with Congressional inaction.

The global coronavirus (COVID-19) pandemic is disrupting industry on an enormous scale, and its effects are likely to be significant and long-lasting. In response to shelter-in-place orders around the country, businesses are closing, sales of “non-essential” goods and services are declining, and many parties find themselves unable to meet their contractual obligations to business partners or incapable of receiving the benefit of contracted-for goods or services. Such businesses are turning to their contracts in search of provisions that might excuse breaches of contract under these circumstances. These contracts can include IP licenses. These licenses often contain agreements with sales minimums or royalty agreements that may be difficult, if not impossible, to meet during this time of interrupted business and sales. Licensees and licensors both have options under common licenses to either enforce, or excuse, provisions due to COVID-19.

The COVID-19 crisis has once more highlighted the need for incentivizing investment and innovation—and thus, for patent laws that duly “promote” and protect such “progress,” precisely as our Founders envisioned. See U.S. Const., Art. I., § 8, cl. 8. Indeed, those patent-based incentives over the years have helped produce life-saving medicines, tests, treatments, and cures; once-unimaginable computer technology, robotics, and nanotechnology; LASIK eye-surgery and cochlear implants; personal satellite-based navigation systems; handheld devices seemingly straight out of Star Trek; 3-D printer technology; and much, much more. Nevertheless, a series of judicial rulings over the past 15 years have steadily eroded U.S. patent protections. Consequently, once-innovative companies, including major innovative pharmaceutical companies, have divested in R&D, and investors more generally have diverted funding to non-inventive areas (like entertainment) or to countries (like China) whose patent laws offer protections more favorable than U.S. law. American innovation has fallen accordingly.

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.

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.

In the past week, the COVID-19 pandemic has led courts across the country to close buildings, postpone hearings, adjust filing rules, and revamp their typical approach to pending cases. These changes have created new uncertainties for litigants and their counsel in cases requiring emergency relief, but our initial survey of public statements and emerging practices from leading courts around the country provide some reassurance that courts are mostly continuing to function normally, with changes to filing procedures and arguments being heard by phone.