Patent term extension (PTE) is a statutorily-based mechanism to compensate inventors for patent term loss due to regulatory delay during the drug approval process at the United States Food and Drug Administration (FDA). In the context of pharmaceutical products, PTE is only available for the active ingredient of a drug formulation.
Tag: Patent
Since 1996, the annual spending on drugs per capita in the U.S. has been the highest among all the developed countries. In 2017, the number reached $1220 per person in the U.S., making the U.S. pharmaceutical industry a $400 billion market. One of the fastest growing segments of the pharmaceutical industry is biologic drugs, accounting for almost 40% of the U.S. prescription drug spending in 2015.
There is a latent conflict between the law of employee invention assignment contracts and the Copyright Act’s work for hire doctrine. Countless employees sign contracts specifying that, in most cases, the employer will own trade secrets and patentable inventions, as well as copyrightable works. When employees create in the workplace, these rules are largely uncontroversial. But when employees create something outside the workplace for a new venture, there can be a conflict between these two areas of intellectual property law.