Increased invalidation makes drug patents near-unattainable

Specifically, regarding drugs, pharmaceuticals, and other medical devices, the AIA solidified the strength of already-existing corporations regarding the development and patenting of new drugs. Some have argued that the change from a first-to-invent to a first-to-file system will benefit larger businesses more than smaller ones,107Link to the text of the note as the bigger companies will already have set standards and either a relationship with an outside patent firm or in-house attorneys. Smaller ones, on the other hand, are unlikely to have these types of resources,108Link to the text of the note creating a better environment for patenting drugs for larger companies while smothering the smaller competitors that may attempt to enter the market. Because of this, the AIA's changes have largely been held as positive with some scientists holding a hopeful outlook for the future of medical patents; nonetheless, others grow worried as they recognize that challengers will experience even higher success rates in invalidating patents.109Link to the text of the note

The geographic expansion of what counts as prior art has made the invalidation of drug patents since the AIA much easier, stifling the invention of new drugs;110Link to the text of the note however, the focus on a date of filing, rather than a date of invention, set a more stringent standard for what is counted as prior art temporally, counterbalancing this geographic expansion effects on ease-of-invalidation.111Link to the text of the note While the AIA shortened the process for obtaining a patent on a pharmaceutical product or medical device, invalidating these patents both during the application and after the grant has become easier, making litigation over things like enforcement much risker since a defense can end up with one's patent being invalidated and lost. Since these changes affecting [*91] the patentability of pharmaceuticals came into effect, however, drug prices have remained largely the same when disregarding inflation; this is in part due to the strong influence of the insurance market here in the United States and the lack of regulation around drug prices. However, by using a government-supported patent enforcement entity as an incentive, it may be possible to reduce the burden on drug patentors while requiring them to reduce prices for end-users in turn. This will also have the effect of supporting smaller pharmaceutical companies that are attempting to reach the market but need that little bit of enforcement or licensing support that they currently lack.