Biotech Values

[DewDiligence]

Can ABBV block US Humira FoBs until 2022?

For a starting point, let’s take the information disclosed by ABBV on its recent CC, which can be found in the links referenced in #msg-118144295.

As a first-order approximation, I’ll put all of ABBV’s indication-specific method-use-use patents on Humira (e.g. use of Humira at a specified dose for treating RA) into a single bucket and opine that the patents for each individual indication have an 80% chance to be invalidated for obviousness and/or double-patenting. But since Humira has so many approved indications, even 80/20 odds of patent invalidation on each individual indication make it fairly likely that at least one indication-specific patent survives challenge.

However, the survival of one or more of ABBV’s indication-specific patents wouldn’t be sufficient to block a Humira FoB from entering the US market, IMO; to accomplish that, ABBV would have to prevail on the patents for all of Humira’s approved indications (or, at a minimum, all of the non-orphan indications). Therefore, I think ABBV’s chance of keeping Humira FoBs off the US market by blocking all of the indications for which Humira FoBs might be approved is remote.

That leaves ABBV’s second line of defense to Humira FoBs: the collection of formulation and manufacturing-process patents on Humira (see links in #msg-118144295). Although these patents have a good chance of being found valid and enforceable, vendors pursing Humira FoBs ought to be able to design around these patents in most cases, IMO.

So, putting it altogether, I would say ABBV’s chance of blocking all Humira FoBs from entering the US market until 2022 or later is pretty slim—probably less than 15%.

Feedback welcome.