Effective life cycle management is crucial for pharmaceutical companies, yet it can be difficult. The challenge is to find ways of achieving the right balance between adequate protection of the interests of those who invest substantial sums of money in research, and the need to make medicines available to patients at a fair price. This article examines non-patent legal issues, including regulation and anti-trust, and patent issues, including the use of patents, obtaining patents and SPCs, enforcement and preliminary injunctions. The article also looks at India as an example of how patent issues affect life cycle management in the broader global context.