U.S. cybersecurity officials are being asked to take immediate steps to bolster defenses against health care-related cyberattacks following reports that China, Iran, North Korea, Russia and criminal groups are targeting the U.S. health care and medical research sectors with hacking campaigns. The attacks include spying on medical response and research, ransomware attacks aimed at hospitals and disinformation about health related to COVID-19. “Our country’s health care, public health and research sectors are facing an unprecedented and perilous campaign of sophisticated hacking operations from state and criminal actors amid the coronavirus pandemic,” five U.S. senators, from both political parties, said in a letter to the Cybersecurity and Infrastructure Security Agency and the U.S. Cyber Command. During the pandemic, the cybersecurity and digital resilience of the nation’s health care, public health and research sectors “are literally matters of life or death,” as disinformation, disabled computers and disrupted communications due to ransomware, denial of service attacks and intrusions result in critical lost time and diverted resources, according to the senators. The letter cited a report that China’s state-sponsored APT41 hacking group carried out one of the broadest U.S. hacking campaigns from China in recent years, beginning at the onset of the pandemic. Although it was aimed broadly at networking tools such as latest cloud software, the campaign included health care and biopharma companies bracing to respond to the coronavirus.
Even though a patent claim may be broader, the scope of a patent term extension only includes the active ingredient of the approved product, the U.S. Circuit Court of Appeals for the Federal Circuit ruled Tuesday in Biogen International GmbH v. Banner Life Sciences LLC. Thus, Banner’s multiple sclerosis (MS) drug, Bafiertam (monomethyl fumarate), a bioequivalent alternative to Cambridge, Mass.-based Biogen’s Tecfidera (dimethyl fumarate), doesn’t infringe Biogen’s 7,619,001 patent, which claims a method of treating MS with dimethyl fumarate, methyl hydrogen fumarate or a combination of the two. The patent was originally set to expire April 1, 2018, but the term was extended by 811 days due to the length of the FDA’s review of Tecfidera, giving it a June 20, 2020, expiration date. “The question in this appeal is whether the monomethyl ester, covered by the claim, is covered by the extension,” the appellate court said. “We conclude, consistent with the district court, that it is not.” Banner, of High Point, N.C., reported in January 2019 that the FDA had granted Bafiertam tentative approval pending the June 2020 patent expiration.
The FDA issued a draft guidance on technical considerations for demonstrating the reliability of emergency-use injectors submitted as part of a biologic or drug application. For injectable drug or biologic products intended to treat emergent, life-threatening conditions, “it is essential to ensure that the emergency-use injector will reliably deliver the drug or biological product as intended,” the FDA said. This is particularly critical when failure of the injector may prevent the adequate delivery of the drug to a patient. Comments on the draft should be submitted to Docket No. FDA-2019-D-5573 by June 21, 2020. The agency also issued a guidance Wednesday explaining its temporary policy on the repackaging or combining of propofol drug products by a licensed pharmacist in a state-licensed pharmacy, federal facility or outsourcing facility. Taken in response to a shortage of propofol products needed to treat patients with COVID-19 complications, the policy will end with the COVID-19 public health emergency.