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Very software focused. In biotech, patent protection of composition of matter (and less so process) is important to ensure the ability to capture economic value
by DrAwdeOccarim 6y ago
Very software focused. In biotech, patent protection of composition of matter (and less so process) is important to ensure the ability to capture economic value of your research.
But keep in mind the safe harbor clause (Safe Harbor provision of 35 U.S.C. § 271(e)(10)) allows any other company/lab to use your compound/process "in support of submissions to the FDA". This is taken very broadly in the field to mean if you are pre-commercial you can basically use anything you want, no one will sue you because if you're starting-up, everything can be claimed to support an eventual filing. Plus, if you have no revenue a patent fight has no value to the other party.
Obviously every marketed drug has IP around it preventing generics until the patents expire. A lot of inventions that lead to commercial products are actually derived from academic institutions. The Bayh–Dole Act did absolute wonders for the US in terms of biotech innovation. Pre-Bayh-Dole, any research using federal grant money had to go through a Byzantine process to determine IP ownership with a lot typically residing with the US federal government. Post-Bayh-Dole, it simply stayed with the inventor/inventing institution. Some people now consider this bad because evil drug companies are "privatizing the gains", but without that economic payout, they wouldn't have invested to bring the invention to market to begin with.
You could argue it moved the large biopharma companies to become development/networking/marketing companies, which is a fair point, but it simply moved the innovation to universities and nimble start-ups--which is better anyway for actual disruption and more equitably spreading economic gain.
- Abishek_Muthian 6y agoAuthor here. I agree that it's more software focussed and I would be adding the role of IP in other industries in my upcoming updates. But, the main reason I explicitly didn't go into Biotech/Pharma is because living in India which has been at the receiving end of the US Pharma's patent protections and on the other hand witness generic medicines save lives everyday; I didn't want my biases to affect the content.
- DrAwdeOccarim 6y agoTotally understandable. There is a minority of non-CS commenters on HN, so I always try to expand the conversation. Wasn't meant as pejorative. Re your comment on generics saving lives, yea, this is a pickle question between sovereigns in negotiating trade agreements. The US pharmaceutical behemoths make too much money in my opinion. The inability of Medicare to negotiate on drug pricing was an insane give away from Bush that effectively allows drug companies the ability to set their desired profit targets. But with other nations catching up in terms of Quality and manufacturing tech transfers, most small molecules will be easily riffed. The era of blockbuster small molecules is coming to an end with a lot of the space/targets explored. More complicated biological and gene/cell therapies are the next frontier and it's going to be a lot harder to riff these technologies because "the product is the process" a lot of time. It's a lot harder to steal process without hiring know-how.
- Abishek_Muthian 6y agoW.r.t India, it has mostly accepted the patent obligations of US Pharma as it gets to export generic medications to US and I think 50% of Indian generic medications get through FDA approval. But this was pre-COVID, not sure how new found gold rush in Pharma industry worldwide would affect the future of Generic medications and patentability of pharma products. It could go either way of improving manufacturing and availability of generic medications (or) Pharma behemoths could take advantage of current situation and derail generic medicine development indefinitely.
- lowdose 6y agoGenerics ARPU is still above $300 / year. New generic only requires 24 people to get FDA approval.