Baked into Bayh-Dole is the policy expectation that a holder of a patent on a subject invention will offer products based on that invention as if there were competition, even if a patent is used to suppress that competition. In the case of medicines, this policy reduces to: offer products as if they were generics.
The logic becomes evident: if one doesn’t offer products as if they were generics, then the terms are “unreasonable” and the federal government is authorized–expected–to protect the public by requiring licensing to introduce “free competition.” It actually works. You just have to get over all the nonsense you hear from people who have a vested interest in making sure Bayh-Dole’s public bargain never operates. To timely achieve practical application then means to provide patented product or benefit from using a patented process to the public on terms, including price, as if what’s offered has competition from others also practicing the invention. It’s not just that there’s competition from other companies holding their own patents and charging what amounts to a patent monopoly price–their pain killer uses a different compound, but we both have patents to stifle competition for each of our compounds (and any analogues), so we both can charge monopoly prices. Bayh-Dole’s licensing remedy would not address such competition. No, the remedy of compulsory licensing works only if the patent holder (or ilk) is required to break up the patent monopoly and receive compensation for use by others, in competition with the patent holder and with each other (and with the federal government). Continue reading