It’s that time of year when the U.S. Trade Representative asks for help as it prepares its list of notorious markets for counterfeiting and piracy. While it’s not exhaustive, the annual list is composed of online and physical markets around the world that deal in commercial-scale counterfeiting and piracy across all sectors, including biopharma and med tech.
Noninvasive electrical stimulation of the brain for 20 minutes per session over four days has been demonstrated to improve both working- and long-term memory for at least one month, in people ages 65 to 88.
After nearly four decades as director of the U.S. NIH’s National Institute of Allergy and Infectious Diseases (NIAID), 81-year-old Anthony Fauci will be stepping down in December. He also announced Aug. 22 that he will be handing over the reins as chief of the NIAID Laboratory of Immunoregulation and as chief medical adviser to President Joe Biden.
Western Australia’s private investment group Tattarang has launched a new AU$250 million (US$173.6 million) investment fund called Tenmile that will invest in early stage Australian biotech and med-tech companies. One of Australia’s largest private investment groups, Tattarang is owned by the Forrest family and has five business divisions made up of real estate, agriculture, energy, mining and hospitality.
The field of artificial intelligence (AI) is beginning to mature, but this is also becoming a competitive space, with several governmental entities declaring their intent to develop policies to maintain national competitiveness. The U.S. has now entered the fray with a request for information by the International Trade Administration seeking information on policies that might foster the export of AI products developed by U.S. companies, but also on the policies that might enable small and medium enterprises to remain competitive.
“It’s now law,” U.S. President Joe Biden said after he signed H.R. 5376 Aug. 16. His signature made Medicare drug pricing negotiations a near-term reality, along with new inflationary rebates, new caps on annual out-of-pocket drug spending and monthly insulin copays for Medicare beneficiaries, and tax changes that could affect the bottom line for several multinational drug and device companies beginning next year.
As expected, the U.S. House of Representatives passed, on a 220-207 party-line vote, a legislative package Aug. 12 that, for the first time, allows Medicare to directly negotiate some prescription drug prices, while imposing severe penalties and an excise tax on companies that refuse to negotiate or don’t comply with the government price.
The question of whether an artificial intelligence (AI) algorithm should enjoy the status of an inventor has been making the rounds in various nations, but the U.S. Court of Appeals for the Federal Circuit has rejected the notion based on a plain reading of the statute. The court said that the statute is unambiguous in that only natural persons can claim inventorship, but the question will be appealed to the Supreme Court, which will have an opportunity to put this debate to rest.
Despite new laws and enforcement efforts, protecting intellectual property (IP) rights in China remains a big challenge for companies based in the U.S. and other countries. A case in point is China’s new patent law that came into effect in June 2021. The law provides for patent term extensions and adjustments, an important consideration for the biopharma industry since the launch of drugs in China could be hampered by long regulatory review times.
As biopharma and med-tech companies grapple with restrictive data privacy laws in the EU and China while trying to meet the demand for greater diversity reflective of the U.S. population, there’s been more of an interest in conducting clinical trials in the U.S., Stacy Amin, a partner at Morrison & Foerster LLP, told BioWorld.
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