Thread by @VincentRK

Covert Patent Evergreening: How Pharma can effectively make patents last forever. Read on.

This form of patent evergreening is the most effective & enduring modus operandi. Best example of this is Insulin. #Insulin4All
@DavidP4AD @aholdenj

Here is how it works. 1/ 👇

1923 Insulin first patented
1946 Improved NPH patented
1950s Improved Lente versions patented
1970s Improved pure insulin patented
1980s Recombinant Human insulin patented
1990s Analog insulin patented
2000s Long Acting analog insulin patented

@Jandelliott #Insulin4All 2/

Although each improvement took a lot of money, scientific research & regulatory studies, & vastly improved life & quality of life: They effectively made insulin a NEW drug over and over again prolonging the patent life from 1923-Present

@SarahKarlin @GilmerHealthLaw
@mtmdphd 3/

Now just as insulin patents are expiring, there are major barriers to entry of biosimilars that can greatly reduce cost. How?

Basically there are endless lawsuits by the insulin companies against any company wanting to introduce a biosimilar alleging patent infringement.

4/

Now if all of this sound familiar to cancer doctors it is because you have seen it before with cancer drugs. @BldCancerDoc @peterbachmd @MikkaelSekeres @DrAnasYounes

Imatinib, Dasatinib, Nilotinib, Ponatinib, Bosutinib

Thalidomide, Lenalidomide, Pomalidomide

Etc 5/

With each iteration, the new version is better, but usually ends up prolonging patent life.

Typically, the older cheaper product loses favor over time, & the new patent prolonging drug is marketed as better.

End result: Covert Patent Evergreening

6/

New improved products are often timed perfectly to launch when the patent life of the older drug is on the line. To maximize profit.

This process needs to be modified. 1) Patent life of new versions cannot be so long 2)regulatory process cannot be so expensive & cumbersome 7/

This thread is not meant to say that the improvements to drugs over time are unimportant. They are. In the case of insulin the benefits to quality of life is incalculable.

It’s mainly to respond to people who wonder how a 100 year old drug is still patented. 8/

I have been writing about this problem for a while as it pertains to cancer drugs. There is a great review in the @NEJM that tracks the insulin story. nejm.org/doi/full/10.10…

I call this “covert patent evergreening” to distinguish it from “overt patent evergreening”which is when Pharma uses various methods including paying off generic competitors to delay generic entry (Pay for Delay), frivolous lawsuits alleging patent infringement, & patenting REMS