Insights

The loss of exclusivity for a blockbuster biologic is no longer a theoretical risk management exercise. It is a discrete, […]

Every year, pharmaceutical companies quietly authorize hundreds of millions of dollars in new formulation work before a single press release

The Bayh-Dole Act of 1980 is arguably the single most consequential piece of legislation in the history of American biomedical

The Hatch-Waxman Act was supposed to make generic pharmaceuticals a reliable business. File an Abbreviated New Drug Application (ANDA), prove

The ‘grand bargain’ of pharmaceutical patents is one of the most consequential, most contested, and most misunderstood arrangements in modern

The rivalry between India and China in pharmaceuticals is the most consequential industrial contest of the next decade. It will

Patent litigation is where drug revenue is won or lost. For a blockbuster product generating $5 billion annually, a single

Every five years or so, the pharmaceutical industry rediscovers the patent cliff as though it is a new emergency. It

Every major pharmaceutical revenue event, from a blockbuster’s first generic competitor to a biosimilar’s delayed U.S. launch, traces back to