Everyone can agree that innovation in medicine saves lives. But how to best protect these bright ideas with patents continues to stir vigorous debate among doctors and lawyers alike. In Europe, regulators are exploring whether legal changes are necessary to reduce patent infringement litigation and bring generic drugs to market more swiftly. Meanwhile, as Nature Medicine went to press, US lawmakers were considering reforms such as the Patent Reform Act of 2009—which could lead to a change from a 'first to invent' to a 'first to file' system and lower penalties awarded for patent violations.

The proposed changes to US patent law have pitted the biomedical industry against the information technology industry. Drug companies have voiced concerns about the move to weaken patents, as they spend millions developing drugs each generally covered by a single patent. Software developers, in contrast, churn out products that weave together numerous bits of patented computer code, creating a difficult and costly legal maze that they say stymies innovation.

In the following pages, Nature Medicine explores the changing landscape of biomedical patent law. The articles in this section look at a range of topics, such as the spate of upcoming patent expirations that threaten pharmaceutical companies' profits, and go further to ask whether alternative systems to replace patents make more sense for medicine.