Posts Tagged: "biopharmaceutical industry"

Artificial Intelligence in Drug Development: Patent Considerations

Artificial intelligence (AI) is a field of computer science that creates software or models that mimic human reasoning or inference. Machine learning is a subset of AI which uses algorithms trained on massive amounts of data to allow the computer to learn with gradually improving accuracy without explicitly being programmed. The biopharmaceutical and healthcare fields produce massive amounts of data, including properties and characteristics of drug compounds, biological, genomic, and clinical data, efficacy of treatments, adverse events and risks, and electronic health records. The data may come from many sources, both public and proprietary. AI systems trained on such data can streamline and optimize the drug development process, including drug discovery, diagnosing diseases, identifying treatments and risks, designing clinical trials, and predicting safety and efficacy profiles, leading to increasing efficiency and reducing costs. 

Will the Supreme Court Save Biopharma from CAFC Enablement Insanity?

The United States Supreme Court is soon poised to decide the fate of the enablement requirement, and the patent community is collectively holding its breath, wondering if the Court will strike a deathblow to the biopharmaceutical industry—simultaneously making all patents harder to get and even easier to challenge than they already are. The Supreme Court does not have a strong track record of objectively getting patent issues correct, at least not from a pro-innovation standpoint, although the Justices and their supporters likely would disagree. The undeniable truth, however, is that since the Supreme Court issued its decision in eBay v. MercExchange, virtually every decision of consequence to the patent system has made patent rights weaker and patents themselves easier to successfully challenge.

Calls for WTO to Suspend IP Rights for Vaccine Innovation Would Jeopardize Incredible Progress

The biggest vaccination effort in the history of medicine is underway to eradicate the global pandemic, with several strong prospects appearing poised for regulatory approval. As of December 2020, data from the World Health Organization showed over 50 vaccine candidates in clinical research, and 163 more in the preclinical stage. The wait could soon be over. Two separate vaccines – one from Pfizer and BioNTech and one from Moderna – are pending emergency use authorization from the U.S. Food and Drug Administration. The former is already being administered for the first time outside of clinical trials following its approval by the UK government. That’s why recent calls to strip away intellectual property protections are so dangerous. Specifically, some nations have asked the World Trade Organization (WTO) to waive intellectual property protections related to COVID-19 – including not only vaccines, treatments, diagnostics, and medical technologies, but all forms of IP – until the majority of the world’s population has developed immunity. They argue that the current global intellectual property system is a barrier to accessing said COVID-19 vaccines, treatments, diagnostics, and medical technologies.

The ‘Dragon’ Targets U.S. Biopharma Lead

Perhaps the report on China’s strategy for eclipsing the U.S. lead in biopharma from the Information Technology & Innovation Foundation (ITIF) resonated so strongly with me because of several articles in The Wall Street Journal. Taken together, they present a sobering picture of what we’re up against. The first was a book review of “Leadership and the Rise of Great Powers” by Yan Xuetong, a prominent Chinese professor. Characterized as “a window into Chinese elite thinking about the world; it is as much a political manual as an international-relations text book.”  The thesis is the inevitable rise of China as the world’s dominant power at the expense of the United States.