Site icon Duncan Bucknell

Pharmaceutical patent settlements – and what about patients?

Do patent settlements help or hurt patients?  What do you think?

There’s an interesting post over in the Pharmaceutical IP forum in LinkedIn.  It’s reproduced below with permission from Leighton Howard, the author.  Let me know what you think, or better still join the forum (it’s open to anyone) and get involved in the discussion there.

"Putting aside the benefits to either the innovator or generic company in settling pharma patent cases and the gripes of the FTC and other competition bodies that these settlements feel unfair (but there is nothing it can do to stop them) – shouldn’t this question be all about benefit for the patient and/or the health services that often foot the bill for the patient’s treatment?

The recent proposal by the Obama administration, as well as more recent investigations and action by the EU competition watchdog seem to approach settlements as being negative, but isn’t that throwing the baby out with the bath water?

Sure, any patent settlement that ‘delays’ entry of a generic will not benefit the patient because the higher cost ‘brand’ product has the monopoly for longer. However, often the timing of launch of a generic for a ‘settled’ case is just before expiry of the patent being challenged. This is later than if the generic patent challenge were successful (a delay), but earlier than if the generic challenge were unsuccessful (an acceleration).

So the real question here, is how do you know if a delay to generic launch has occurred until the case has been heard and the outcome of the validity, enforceability or infringement of the patent(s) in question is known with certainty?

I can understand that a settlement which ‘delays’ the worst generic launch case scenario (i.e. after expiry of the patent in question) is not in the interests of the patient, but this is also generally not in the interests of the innovator or the generic company as they would technically be delaying beyond the ‘free for all’ generic launch date, assuming no generic exclusivity is applicable.

Shouldn’t the legislators concentrate on closing loopholes that are used to delay generic entry rather than denying the established right of any party involved in legal proceedings to reach an agreement with the other party on terms that make sense to all parties?

I’d love to hear comments & further discussion around this topic."

Leighton Howard
CEO GenericsWeb

[Photo credit: Destinys Agent]


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