© 2024 MJH Life Sciences™ and Center for Biosimilars®. All rights reserved.
Tahir Amin, DipLP, co-founder and director of intellectual property of Initiative for Medicines, Access, and Knowledge, discusses reforming the patent system.
Transcript:
Are there some specific reforms in patents that you would like to see the United States implement to help encourage competition in drug pricing?
One of the key areas that I think needs to be improved upon is the standard of what is patentable. I feel the law has not kept up with the advances with how [research and development, R&D] is done, and how scientific knowledge has been accumulated over the last 50 years. Unfortunately, in order to get your patent, you’re judged by whether it’s novel, based on what’s known in the field, or if it is obvious to someone in the field.
The obviousness standard is not applied in the correct way. It’s almost as if techniques from 50 years ago are still not obvious to people, and I think the law hasn’t kept up.
One of things my organization and other organizations has talked about is bringing that standard up to where science is today, and we’ll find that a lot of things are obvious. Patents would not be granted so readily, and only the really high-end inventions would be. That’s where a lot of the focus needs to be on, unfortunately the court systems are in this old sort of thinking, “Oh it’s what it was 20 [or] 30 years ago.”
I think the other area is we need more public participation in the patent system, the public actor or patient group cannot challenge a case in court unless its infringing the actual product in question. Which means, therefore, only commercial actors have the right to challenge a patent. Which is why the Oil States case is important, because that forum allows any person—any public person or a group like ours can go in there without infringing. Getting rid of this would be catastrophic, because it means only the rich get to play in a rich playground.