In the coming weeks, the U.S. Supreme Court is expected to decide whether to review a wonky, but exceedingly important, debate over patents that has the pharmaceutical industry on edge.
At issue is the extent to which a drug company must describe how to replicate its newly invented medicines when applying for patents, notably biologics. These treatments constitute a highly lucrative market because they are used to help the body fight cancer, infection, and a wide array of other diseases — and often carry considerable price tags.
Drug makers regularly spar over patents, but over the past decade, a federal appeals court has increasingly ruled in favor of stricter standards for patent filings for monoclonal antibody drugs, and more recently, CAR-T therapies. And the trend has caused controversy, because a variety of patents have subsequently been invalidated on numerous big-selling medicines.
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