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Will the US Government, California and Health Insurers Produce Treatments for Covid-19 for the World?

Neil Wilkof wrote on the IPKat blog today that the Israeli government has essentially issued permits under Israeli law to import generic versions of a drug into Israel for the purpose of treating Covid-19 infected patients despite patents covering that drug in Israel.  Neil notes that there is a dwindling supply of the drug and that the Israeli government is acting quickly to acquire supply.  

Notably, one issue that exists is the production of useful treatments for coronavirus.  Prior to the pandemic, there was already a concern with the lack of production of many generic drugs.  The State of California as well as health insurers are looking into manufacturing generics.  Moreover, the U.S. Congress has legislation before it concerning the federal government’s ability to have generics manufactured on its behalf or to manufacture those generics itself. (Here's a nice list of the US FDA's actions concerning the virus.) Additionally, on Tuesday of this week, President Trump invoked the Defense Production Act.  This Act apparently allows the federal government to direct, to an extent, private industry concerning the production and pricing of items necessary for national defense, in part.  It will be interesting to see if President Trump uses this power to push the manufacture of treatments for coronavirus for the United States, and hopefully, the world, and if California and Congress move fast to produce and incentivize more potential treatments. (If they did, this could lead to the development of much stronger US based generic manufacturing.)

Legislation Introduced to Raise Manufacturing of Active Pharmaceutical Ingredients in the United States

On March 11, 2020, Senators Blackburn and Menendez introduced a bill, Securing America’s Medicine Cabinet, designed to raise the manufacturing of active pharmaceutical ingredients in the United States to stem reliance on China.  The Press Release notes that part of the reason for doing this is concerns with the safety and quality of active pharmaceutical ingredients from China.  The Press Release states: 

Blackburn, Menendez Lead Bipartisan Bill to Increase US Prescription Drug Manufacturing 

WASHINGTON, D.C. – Senators Marsha Blackburn (R-Tenn.) and Bob Menendez (D-N.J.) have introduced the Securing America’s Medicine Cabinet (SAM-C) Act to increase American manufacturing of active pharmaceutical ingredients (APIs), the building blocks of prescription drugs. Currently, only 28% of API-producing facilities are in the United States and the number of Chinese facilities has more than doubled since 2010. “When confronted with a serious challenge such as the corona virus, it is important to take stock, look at lessons learned and build upon them in order to respond better the next time,” said Senator Blackburn. “Currently, we are too reliant on foreign manufacturing of critical APIs. The SAM-C Act is one step on the right path to strengthen our drug supply chain.” “The COVID-19 is a real health emergency and we have to do everything in our power to increase our preparedness and response,” said Senator Menendez. “This bipartisan proposal will do that by encouraging drug manufacturers to partner with our best minds in higher education on new advancements, creating good jobs and increasing the national production of vaccines and drugs that can save lives. With New Jersey’s concentration of pharmaceutical companies and institutes of learning, we can lead the way and make a difference.” The corona virus outbreak has heightened concerns about dependence upon China and India for prescription medications. On February 27, 2020, the FDA announced the shortage of one drug used to treat patients with coronavirus. They attributed the shortage to difficulties obtaining the API from a site in China affected by coronavirus. Additionally, in its 2019 report to Congress, the U.S.-China Economic and Security Review Commission revealed “serious deficiencies in health and safety standards in China’s pharmaceutical sector.” Dependence upon China and others for prescription drugs combined with safety concerns needs to be addressed. This urgent health event provides an impetus to improve our pharmaceutical supply chain. The SAM-C Act will encourage pharmaceutical drug manufacturers to spur innovations similar to those in other industries such as automotive, aerospace and semiconductors and bring drug manufacturing back to the United States, where ingredients and processes can be more easily verified.  The legislation would expand upon the Emerging Technology Program within the Food and Drug Administration to prioritize issues related to national security and critical drug shortages, as well as bring pharmaceutical manufacturing jobs to the United States. In addition, the SAM-C Act authorizes $100 million to develop centers of excellence in advanced pharmaceutical manufacturing in order to develop these innovations as well as train the workforce needed in this industry. These centers will be partnerships between institutes of learning and the private sector.  RELATED Last month, Senator Blackburn wrote about how the coronavirus outbreak exposes the U.S.’s pharma supply chain vulnerability: “Without intervention, the FDA expects the pharmaceutical industry will continue to rely on Chinese companies to make active pharmaceutical ingredients… The status quo has made us vulnerable. The fix, however, is sitting right in front of us.”