CDC reports on cases, sequencing

Rochelle Walensky, director of the U.S. CDC, said in a Feb. 1 press briefing that nearly 26 million COVID-19 cases have been reported to the CDC as of Jan. 30, 2021, and that in the last week of January, 149,000 new cases were reported daily. This represents a decrease of about 14.5% over the prior week, although the seven-day average of deaths increased 2.4% to roughly 3,100 per day. The U.K. variant of the SARS-CoV-2 virus, the so-called B.1.1.7 variant, has been diagnosed in 467 U.S. residents in 32 states, while another three cases were from the B.1.351 variant, first diagnosed in South Africa. Two of those cases were diagnosed in Maryland and the third in South Carolina. Walensky said the P1 variant, first detected in Brazil, has been confirmed in the U.S. in a patient in Minnesota. State health departments and other public health agencies have been sending virus samples to CDC for sequencing and further analysis since November for entry into the National SARS-CoV-2 Strain Surveillance (NS3) system, but the federal government has also contracted with large commercial labs to conduct much of this work. These labs are analyzing 3,000 samples weekly and have committed to analyzing 6,000 samples per week by mid-February. Walensky said these efforts have increased the federal government’s volume of sequencing by a factor of 10 in recent weeks, rising from 251 sequences the week of Jan. 10 to more than 2,200 sequences the week of Jan. 24. Thanks to collaboration with additional entities, sequencing volumes should reach 7,000 per week, she said.

NICE says savings seen with Cytosorb

The U.K. National Institute for Health and Care Excellence said the evidence for the Cytosorb system for removal of a blood thinning agent could reduce resources needed to manage patients undergoing cardiac or emergency surgery, and possibly reduce length of stay. The system, by Cytosorbents Inc., of Monmouth Park, N.J., is indicated for removal of ticrelagor for this health technology assessment, and would be used in lieu of management or a delay of five to seven days in urgent surgeries. The key issues surrounding the system’s use are that the evidence is based on a trio of “small comparative observational studies focusing on emergency cardiac surgery,” but none of the studies was conducted in the UK. The cost of the system is pegged at £1,500 (US$2,049) per unit, although NICE acknowledged that a U.K. cost-utility analysis reported a cost saving of £3,941 for Cytosorb compared with no removal of ticagrelor.

IP at issue as WTO pushes for global pandemic effort

As countries around the globe scramble for a limited number of COVID-19 vaccine doses, the World Trade Organization’s (WTO) deputy directors-general urged members Feb. 1 to step up cooperation to ensure worldwide access to the vaccines, even as some member countries are pushing a proposal to indefinitely eliminate WTO obligations to grant intellectual property (IP) protection on a range of technologies related to the pandemic. “The pandemic is a global problem. This challenge calls for heightened international cooperation, including ensuring the global availability of vaccines,” the WTO deputy directors said in a statement. The statement reinforced the WTO’s April call for members to implement policies facilitating COVID-19 R&D and promoting the rapid dissemination of vaccines, tests and therapies across borders to ensure equitable access. At that time, the WTO issued a joint statement with the World Health Organization encouraging initiatives including targeted investment, open access to clinical trial results, the sharing of relevant IP rights, increased manufacturing capacity, open and transparent procurement, the elimination of tariffs on relevant health technologies, and trade measures intended to reduce costs and delays. The latest WTO statement came just a few days after the European Commission (EC) adopted a measure requiring member states to authorize the export of COVID-19 vaccines. The new requirement is intended to “ensure timely access to COVID-19 vaccines for all EU citizens and to tackle the current lack of transparency of vaccine exports outside the EU,” according to the EC. The scheme will be in effect through March 31 and only applies to exports from companies that have EU advanced purchase agreements for the vaccines. It excludes vaccine supplies exported for humanitarian aid or destined to countries under COVAX commitments, the EC said. “For the best part of the last year we worked hard to get advance purchase agreements with vaccine producers to bring vaccines to the citizens, in Europe and beyond. We gave upfront funding to companies to build the necessary manufacturing capacity to produce vaccines, so deliveries can start as soon as they are authorized,” Commissioner for Health and Food Safety Stella Kyriakides said. “We now need transparency on where the vaccines we secured are going and ensure that they reach our citizens. We are accountable towards the European citizens and taxpayers,” she added. Meanwhile, the Pharmaceutical Research and Manufacturers of America (PhRMA) is raising concerns about a WTO proposal, sponsored by India and South Africa, that it says is using the pandemic as an opportunity to erode IP rights. “The proposal marks a significant escalation in anti-IP global activism” that will polarize discussions on combatting the pandemic, PhRMA said in its Special 301 submission to the U.S. Trade Representative. “The proposal will do nothing to address the production and distribution challenges for making COVID-19 vaccines globally available,” PhRMA continued. “If anything, the proposals threaten to undermine the ability to respond to another pandemic and will inevitably affect IP discussions in countries around the world.”

Researcher gets prison time for trade secret theft

Li Chen, a former researcher at the Research Institute at Nationwide Children’s Hospital in Columbus, Ohio, was sentenced Feb. 1 to 30 months in prison for conspiring to commit wire fraud and to steal at least five exosome-related trade secrets related to research, diagnosis and treatment of a range of pediatric medical conditions such as necrotizing enterocolitis. Chen and her husband, Yu Zhou, who worked in separate research labs at the institute, were arrested in 2019 and both pleaded guilty last year to the conspiracy charges, according to the U.S. Department of Justice (DoJ). Citing court documents, DoJ said Chen profited from one of the stolen trade secrets by creating exosome isolation kits and then starting a company in China to sell the kits. She received benefits from the Chinese government, including the State Administration of Foreign Expert Affairs and the National Natural Science Foundation of China. She also applied to various Chinese talent plans used to transfer foreign research and technology to the government. In addition to the prison sentence, Chen was ordered to pay $2.6 million in restitution and to forfeit $1.25 million plus 500,000 shares of Avalon Globocare Corp., of Freehold, N.J., and 400 shares of its subsidiary Genexosome Technologies Inc. Zhou is still awaiting sentencing.

USPTO responds to COVID-19 challenge

Since IP offices in some countries are not issuing paper certified copies of patent applications due to the COVID-19 pandemic, the U.S. Patent and Trademark Office (USPTO) is suspending its requirement for filing a certified copy of the foreign application under certain conditions. For instance, the foreign application must have been filed in an IP office that doesn’t participate in a priority document exchange program with the USPTO. Also, before paying the issue fee, the applicant must have requested a certified copy from the foreign IP office, but was unable to get it as a result of the pandemic, according to a USPTO notice that details other conditions.