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« Conference & CLE Calendar | Main | PTAB Remains Hostile to Section 101 Appeals »

January 29, 2023

Comments

People still read NYT?

Kevin, I've said it before, and you guys have refused to print my conclusion because I don't phrase it nicely, but I'll try again: take away protection on people's investments, and there won't be new drugs, not small molecules and certainly not biologics. But we're not going to see change until the loved ones of people on SCOTUS or in Congress die from lack of treatment for something that might have had a treatment (or something that could have been detected earlier) had IP protections not been eviscerated by SCOTUS decisions and Congressional inaction.

The other possibility/ likelihood is that the Court will change its mind only when the WSJ has a headline "Supreme Court Guts US Industry"

Thanks for the comment

Kevin: There are two separate issues. Brand and Generics. Brand drugs will be sold at the highest price a customer who is part of our mutually subsidized healthcare system. No one can control that. Inefficiencies of the development and manufacturing are passed on. PBMs also capitalize on that pathway.

Generics is a totally different animal. They constitute the most medication used in USA. PBMs have and will prevent direct marketing of the FDA approved drugs as their profits will gravely suffer. FDA is part to blame as it has no play book to prevent less than quality drugs except for issuing 483s that have no TEETH to prevent poor quality drugs. System has to change from the current to the method outlined (http://bit.ly/34RYypH). Yes there will be some initial hiccups but everyone will shape up once strict controls are placed. FDA does not want to do anything as its ex folks become high priced consultants, a life long benefit.

Game rules have to change and till that happens the discussion will continue.

I'm with Mr. Feigelson, and indeed would go further that most ALL of what the Times attempts to pass off as news is nothing more than propaganda according to a desired narrative.

Not just patents -- pretty much ANY topic.

If 'journalism' were the 'there,' there would be NO there, there.

No one seems to have noticed a key event in the Humira patent litigations: the PTO refusing institution of IPR on several of Humira's super-broad formulation patents. One may criticize that decision, but I would bet that drove the settlements. The formulation patents could not be designed around (unusual for biosimilars) and only expired last summer.

ANDA conventions have carried over to some extent to BPCIA, and it seems like follow-ons have usually not launched at risk against formulation/MOT patents (vs. process).

Above comment about NYT and propaganda is spot on. And Kevin makes noteworthy points about Humira patents and actual dollars. But that said, there was some patent gamesmanship at Abbott/AbbVie in the early days. I have a McKinsey presentation that Abbott commissioned in 2010 laying out the planned Humira patent thicket strategy, namely a staggered rollout of patents claiming anything and everything that a "biosimilar company might possibly need" to develop and manufacture a biosimilar for Humira, even if "there is no intention of ever using the patent." The presentation includes slides from an Oct. 2010 company brainstorming session that resulted in the “Humira Idea Submission Program” kicked off in Dec. 2010...it was designed to incentivize the company’s scientists to increase the patent coverage for Humira. One of the slides list the incentive prizes – free I-pad for a patent submission, free Apple computer for patent award. Might fall under Gottleib's list of shenanigans.

Bob: I think your comments illustrate something pharma companies need to consider - you don't want to become another Myriad that acts within the law but run afoul of contemporary mores. Acting aggressively against competitors is fine, but when it can be made out that the public suffers the strategy becomes fraught with causing more trouble than it's worth.

Ironically, the complexity of biologic drugs and the "similarity" aspect has chilled acceptance by the front-line doctors who often have sick patients for whom the biologic drug has alleviated the worst symptoms of their illnesses and for whom doctors are understandably leery of changing their medication for fear that it won't work as well. And while biosimilars provide a cost reduction there are no $4/prescription sources of any biologic drug or biosimilar. Ultimately patents aren't significant enough to cause the price inequities unless they can be seen to be so by thicket behavior or other practices.

Going forward, the 12 year market exclusivity on the drug itself will likely be the way "profitability" will be measured. But in the face of a biosimilar pathway being enacted at the end of the drug patent life and 12+ years after approval, building a wall, or a thicket, or the metaphor du jour makes economic even if not societal sense.

Thanks for the comment.

Outside of "Pharma," the so-called gamesmanship is known by a different phrase:

Strategic competition.

It is ONLY when there is a nanny-like, "but this is about human health" that the notion of competition is made to suffer.

Like MOST ALL OTHER competition, if one does not like what one's competitor's have done, there are several options:

1) pay the innovator their asking price.
2) use what was there before the innovator provided the advance.
3) INNOVATE ANOTHER WAY.

Something that the nanny-folk forget is that the blocking aspect of the negative right of patents is EXPLICITLY there for the very reason that option 3) provides the quantum benefit beyond the mere Quid Pro Quo.

So while I 'get' the tendency to have a (somewhat myopic) Pharma view, it is critical to keep in mind that patents serve a purpose well beyond Pharma, and indeed - talk to the very essence of human nature.

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