But who is actually saying “We’ll see you in court Gilead”?
I guess that might be us.
If you read this https://en.wikipedia.org/wiki/Patent
You will note that:
Under the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights, patents should be available in WTO member states for any invention, in all fields of technology, and the term of protection available should be a minimum of twenty years.
That does make changing patents per se hard.
One option governments could consider is the notion of patent re-examination and putting a patent back into pending status.
https://en.wikipedia.org/wiki/Reexamination
https://en.wikipedia.org/wiki/Patent_pending
Such a step would send a powerful message to Big Pharma and reexamination of the Sofosbuvir patent might well be appropriate and given it was deemed non inventive in India there is a good pretext. We suggested exactly this to the Department of Health.
Reexamination has been actioned before, for example:
http://www.bioworld.com/content/pto-patent-rejection-may-leave-remicade-vulnerable-early-competition-0
Medicans du monde has already lodged a re-examination challenge in Europe:
http://www.medecinsdumonde.org/gb/Doctors-of-the-World-Medecins-du-Monde-is-filing-a-patent-challenge-to-Gilead-s-patent-on-sofosbuvir-at-the-European-Patent-Office
So that’s a maybe but government and insurers have other tools to force pricing issues with that they deploy with variable success.
As the payers they can simply refuse to pay and say “sharpen your pencils and come back next year” – this works but patients suffer delay in access.
As payers they can also say “We need 2 good treatments for this condition, there are 5 of you with products, so who’s offering the best price?” New Zealand does exactly this and enjoys drug prices 1/8th as much as Australia despite being only 1/4 the size.
Express scripts for example has dropped Gilead in favour or Abbvie:
http://www.reuters.com/article/us-express-scripts-abbvie-hepatitisc-idUSKBN0K007620141222
Government agencies, ie the TGA and FDA approve drugs for sale after patents have been issued. In Australia our TGA could link pricing to approval. In the USA a 1000 page bill, passed after a brief debate, at 3 am in the morning, included words to the effect “When a drug is approved the company can set any price it likes”
http://www.ncpssm.org/EntitledtoKnow/entryid/2061/negotiating-for-lower-drug-costs-in-medicare-part-d
“The pharmaceutical lobbyists wrote the bill,” says Jones. “The bill was over 1,000 pages. And it got to the members of the House that morning, and we voted for it at about 3 a.m. in the morning,” remembers Jones.
Why did the vote finally take place at 3 a.m.?
“Well, I think a lot of the shenanigans that were going on that night, they didn’t want on national television in primetime,” according to Burton.
So the US have a legislative problem they created and need to fix.
But there is another option. A sovereign country can impose such taxes as it sees fit. I propose a new plan for pricing negotiations:
http://fixhepc.com/blog/item/30-a-new-plan-for-pbs-pricing-negotiations.html
In short calculate a fair price based on some metrics and apply a 100% super profits tax to pricing that exceeds that.
If Big Pharma fails to see the wisdom of pricing reasonably parallel import, just like the South African government did for HIV medications 15 years ago until the drug companies decided that 1000% profit on many sales was preferable to 100,000% profit on 0 sales.
And for the record we have suggested all these strategies to our Minister for Health. To date, deafening silence.
So Happy for you both!! I agree, Good Mother, I know what I would do if it was my dear son and you overcame fears and doubts, did the best thing. Super Mom too.
