Posts Tagged: "vaccine"

New Year, New Models: How the Pandemic May Forever Change Practice at the USPTO

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.

Breaking Down Moderna’s COVID-19 Patent Pledge: Why Did They Do It?

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.

IPW Webinar – The Race for a Coronavirus Vaccine: The Intersection of Science & IP Policy

Join Gene Quinn, patent attorney and leading commentator on patent law and innovation policy, on Tuesday, September 22 at 1pm ET. Gene will host a wide-ranging conversation on the topic of COVID-19 and the race toward a coronavirus vaccine. In addition to discussing the science and FDA processes involved, we discuss intellectual property rights and more. Joining Gene will be immunization expert Dr. Jonathan Temte, a Professor at the Wisconsin School of Medicine who also serves as a member of the CDC’s Board of Scientific Counselors, and Melissa Brand, Assistant General Counsel for Intellectual Property at the Biotechnology Innovation Organization.

Russian Cyber Espionage Group Targets COVID-19 Vaccine Research and IP

On July 16, the United Kingdom’s National Cyber Security Centre (NCSC) and Canada’s Communications Security Establishment (CSE), with the United States’ National Security Agency (NSA) in agreement, published a report titled: “Advisory: APT29 targets COVID-19 vaccine development.” The report provided details of Tactics, Techniques and Procedures (TTPs) recently used by a cyber espionage group known as APT29, “the Dukes” or “Cozy Bear”. The United States’ Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency (DHS CISA) endorsed the technical detail and mitigation advice provided in the report. According to a press release associated with the report, “NCSC are almost certain (95%+) that APT29 are part of the Russian Intelligence Services” and “NCSC assess it is highly likely (80 – 90%) that [APT29’s] activity was to collect information on COVID-19 vaccine research or research into the COVID-19 virus itself.”

How Misaligned Incentives Are Now Killing Us

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.

Pity the Patients if Exclusive Licensing is Undermined

We’ve learned from experience that just because a theory’s off base doesn’t mean it won’t take root, particularly when it involves patents and medicine. “No Vaccines Before the Next Zika Outbreak?: A Case for IP Preparedness”  by Professor Ana Santos Rutshman, a faculty fellow in Health Law and Intellectual Property at DePaul University, Co-Director of the Global Healthcare Innovation Alliances at Duke University, and consultant to the World Health Organization, previews  her upcoming UCLA law review article. It could be titled “Developing Treatments Without Patents: Let’s Give it a Try.” The article blames exclusive licensing for the lack of a Zika vaccine citing the failed deal between the Department of the Army and Sanofi. The remedy: banning exclusive licensing for federally supported inventions related to specific diseases while imposing price controls on other life science discoveries. Before this bandwagon rolls, let’s look at the quality of its construction.

The Plight of the Public Sector Entrepreneur

Being an entrepreneur isn’t easy. While it is a tough road for anyone, it’s particularly tough if you’re in the public sector and threatened by politicians… Rather, the march in provision is intended to insure that good faith efforts are being made towards commercialization and that sufficient quantities of resulting products are available to meet public health or safety needs. If the government is ever pressured to misapply the law for price control, the bottom would fall out of our public technology transfer system. Such a change would not be restricted to drugs but to any product commercialized under Bayh-Dole. What company would commercialize a federally funded invention if an agency could retroactively apply a completely arbitrary standard of fair pricing to justify taking the technology away through compulsory licensing? The answer is easy to guess.

Patent issued on vaccine for one of the most common causes of bronchiolitis and pneumonia

Respiratory syncytial virus, commonly referred to simply as RSV, is a highly contagious viral disease and is one of the most common causes of bronchiolitis and pneumonia. Up to 2.5 million infections occur in the U.S. each year. It is also the leading cause of childhood hospitalization globally. Nearly all children are infected with the virus at least once by the age of two to three years, and many develop pulmonary disease and/or asthma that persists throughout adult life, making them susceptible to re-infection. RSV particularly dangerous for premature babies, children with preexisting health conditions and the elderly, and is responsible for 16,000 deaths each year in adults over 65.

Passage of the 21st Century Cures Act and its Potential Implications on Biodefense

With the Cures Act now signed into law, the incoming Trump administration has an opportunity to advance the broad-spectrum medical countermeasure goal set forth by the U.S. Department of Health and Human Services (HHS) 2015 Public Health Emergency Medical Countermeasure Enterprise, otherwise known as PHEMCE. If achieved, the PHEMCE broad-spectrum goal would spur the advancement of innovative therapeutics to defend against the many pathogens that are not addressed with traditional disease-specific drugs or vaccines approved by the FDA.

Closer than ever to a malaria vaccine

The malaria vaccine may have the capability to prevent millions of cases of malaria, especially in young children who are incredibly susceptible to the parasitic disease. Studies from 2011 and 2012 dampened optimism about this malaria treatment as the vaccine stopped malaria episodes in less than half of those children younger than two years of age that received it. However, follow-up data showed that when a booster shot was applied a total of 1,774 cases of malaria were prevented per 1,000 vaccinations. Without a booster, the vaccination still prevented 1,363 malaria cases.

The Ebola Outbreak and Current State of Vaccine Development

It is tough to overstate the connection between the development of vaccines and public health, however. Since the use of vaccinations was first introduced by English physician Edward Jenner in 1798, many devastating diseases have either been eradicated or targeted for elimination, including smallpox, measles, rubella and mumps. The prevention of a wide spectrum of diseases by administering biological preparations of microorganisms meant to increase an immune response has been revolutionary for public health simply by reducing the costs incurred when treating diseases and caring for patients. It has been revolutionary in human terms by the number of lives saved, and lives significantly altered for the better. But the costs and time horizon are very real, as is the irrational vaccine fear that prevents many parents from immunizing their children.

Successful Phase 1 Trial for Parkinson’s Vaccine

The study looked at groups of patients receiving various levels of the PD01A vaccine and evaluated them over a 12-month period. Patients receiving the vaccine were given PD01A subcutaneously in four vaccinations, either in doses of 15 micrograms or 75 micrograms… Of those who were immunized, 15 patients out of every 24 saw an increase in alpha-synuclein-specific antibodies. Interestingly, the antibody response was greater in the group of patients receiving the lower 15 microgram dose as compared to the group receiving the 75 micrograms of PD01A per vaccination. Also important was the fact that the vaccination was tolerated at the dosage levels administered and that there were no signs of a negative autoimmune response…

Eli Lilly Obtains Patent on SARS Vaccine

Not all of Eli Lilly and Company’s developments are strictly related to human health. Today’s featured patent application discusses a form of dietary additive for animals that can reduce the chances of insect populations thriving on manure. The new dietary additive formula is much safer to animals and the environment than previous additives. Other patent applications include a few inhibitor treatments to reduce the progression of cancer, as well as an application that discusses improvements to medication dose delivery devices. We also look at a few issued patents that improve the portfolio of Eli Lilly’s patent holdings. Three of these patents protect improved methods of treating various diseases, including diabetes, tumors and hyperlipidemias. Another patent protects a method of creating a vaccine for the infectious viral disease SARS. Finally, we look at a patent that discusses a method of healing wounds that utilizes naturally occurring, low-toxicity spinosyns.

Patent Deals, Licenses and Settlements – December 2012

Without doubt, the biggest patent deal of the month related to Kodak’s sale of its non-core patent portfolio to Intellectual Ventures, RPX and others for $525 million. But there were other interesting patent business deals, including: (1) Microsoft and EINS Sign Android Patent Agreement; (2) NIH Awards Contract for Improved Anthrax Vaccine; (3) ARRIS To Acquire Motorola Home Business For $2.35 Billion; (4) Mylan Announces Comtan® Settlement Agreement; (5) Trovagene Licenses Duke University, Novartis; (6) Amgen Finalizes Agreement Resolving Federal Investigations; (7) GE Healthcare, CDI Agree to Sublicense for Cellular Assay Patents; and more.

Unprecedented T-Cell Immune Responses in Human Trial of DNA Vaccine for Cervical Dysplasia and Cancer Caused by HPV

While success in Phase I is critical, there are substantial hurdles to overcome yet before this vaccine could reach the market. Nevertheless, such a promising cancer vaccine ought to be heralded by everyone, right? Think again! Inovio actually has the audacity to have patents on its ground breaking innovation, which will lead the anti-patent non-thinkers to be more concerned with blowing up the patent system than rooting on Inovio and others as they attempt to eradicate cancer. Absolutely ridiculous if you ask me!