[HN Gopher] FTC warns pharma companies about sham patent listing...
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FTC warns pharma companies about sham patent listings designed to
delay generics
Author : rntn
Score : 143 points
Date : 2023-09-18 20:38 UTC (2 hours ago)
(HTM) web link (www.techdirt.com)
(TXT) w3m dump (www.techdirt.com)
| ConceptJunkie wrote:
| [flagged]
| HankB99 wrote:
| Key phrase from the first paragraph:
|
| > ... FTC is now warning pharma that it _might_ finally start
| cracking down.
|
| Sounds like a fishing expedition.
| Daishiman wrote:
| Regulatory agencies have a knack for warning market players
| to clean up their act before stepping in.
| munk-a wrote:
| It legitimately tends to be the cheaper way to regulate.
| You've basically got two options: 1) give a big warning and
| hope you get a majority change in the industry because they
| can see the writing on the wall or 2) change the rules and,
| as immediately as is appropriate, open a bunch of
| lawsuits... then spend the next decade in the courts
| spending immense amounts of money while every one of the
| offending parties runs a big PR campaign about being
| singled out to comply with a rule that most of the other
| companies aren't complying with.
|
| Politics is ugly and rarely will the straightforward
| approach be the easiest and cheapest.
| [deleted]
| adolph wrote:
| At first I thought this was about minor changes to formulations
| that can be granted new patents, a problem which seems to me to
| be to be outside the FTC's purview. It looks like the problem is
| more like out and out fraud:
|
| _Brand drug manufacturers are responsible for ensuring their
| patents are properly listed. Yet certain manufacturers have
| submitted patents for listing in the Orange Book that claim
| neither the reference listed drug nor a method of using it._
|
| _. . . courts have recognized that improperly listing patents in
| the Orange Book may constitute an "improper means" of
| competition. Accordingly, improperly listing patents in the
| Orange Book may also be worthy of enforcement scrutiny from
| government and private enforcers under a monopolization theory._
| SuperNinKenDo wrote:
| These people won't stop lobbying to have this kind of exclusivity
| respected in other jurisdictions as well. Whether through the US
| government or directly, they've constantly pressured us here in
| Australia to "respect" the same privileges they enjoy in the US.
| Thank God we have largely resisted these efforts so far. Generics
| here are highly available for almost anything at the consumer
| level. Those who can afford to often buy name brand anyway,
| because of psychological reasons I guess, so pharmaeceutical
| companies still make stacks of cash, without poor people jeeding
| to spend half their weekly income on basic meds.
|
| I understand and appreciate that the US government doesn't
| arbitrarily begin semi-retributive campaigns, and instead
| attempts to have companies self-correct. But in instances like
| this of obvious, wilful abuse of the law, there should be some
| drawing of blood frankly. It strikes me as a little pathetic that
| these agencies are always issuing "warnings" that they might
| actually start enforcing regulations. It's exactly this that
| makes these companies feel they have license to behave this way,
| because they know they'll have plenty of time to clean up if the
| laws actually start getting enforced, and they'll have made a
| tidy profit at everybody else's expense in the meantime.
| virgulino wrote:
| I've been taking the "blockbuster drug", Humira/Adalimumab, for
| more than 10 years. Humira alone is estimated to have generated
| US$200 billion in profits for a single company. Its history, its
| legal and commercial maneuvers are appalling and possibly the
| poster child for what is wrong with the patent system. And how
| public money originally funds much of the research into these
| drugs.
|
| This year I finally started taking a biosimilar. Still extremely
| expensive. I don't have to pay for it, I sued the government to
| get it, here in Brazil. Unfortunately, this is not an uncommon
| situation. Our constitution guarantees our right to health and
| the government's obligation to provide it.
|
| https://www.npr.org/sections/health-shots/2023/07/20/1188745...
|
| https://en.wikipedia.org/wiki/Adalimumab#Patent_litigation
| NeuroCoder wrote:
| As much as I'd love to see ridiculous parent laws in medicine get
| under control, I have very little confidence that Lina Kahn would
| accomplish anything. She doesn't have a great track record. You
| really need someone with a good background in patent law
| specifically for pharmaceuticals to take this on
| [deleted]
| [deleted]
| [deleted]
| rsashwin wrote:
| Definitely, experience matters. However, I am used to an FTC
| that turns a blind eye on these Pharma antics. So, as long as
| FTC takes these kind of cases on, I am all for it. Even the
| price of generics are way out of line when compared to the
| generics you get outside of US. Similarly, a lot of Mergers
| have resulted in fewer competition in the market, leading to
| rampant price inflation. Federal institutes like FTC need to
| step up their game here.
| NeuroCoder wrote:
| I guess increasing awareness on the issue is better than
| nothing. I've just noticed that she has a gift for
| identifying problematic industries but struggles to come up
| with clear criticisms that could translate into pragmatic
| solutions.
| thenerdhead wrote:
| Maybe they can add a third clause to be "safe, effective, and
| accessible"?
|
| The history of the FDA is pretty interesting and disappointing to
| say the least. Especially with the supplement craze.
| jacquesm wrote:
| Why warn them? Just do it already.
| [deleted]
| munk-a wrote:
| I like the sentiment - but this is probably the "just do it
| already". Real warnings happen behind closed doors - this is
| probably a "We're going to create a PR nightmare if you don't
| fix your act, this is the first step on the public being very
| very mad. And we'd rather like to avoid going to court against
| your super-lawyers."
| jacquesm wrote:
| Just revoke a corporate charter or two of the most frequent
| abusers. That will certainly get the attention of those that
| remain. _Then_ you can warn them that they 're next if they
| don't change tack pronto. Big companies are next to
| invulnerable when you treat them using the same playbook as
| you would a jaywalker or a person the runs a red light. They
| _love_ their court cases because they have lawyers on
| retention and it helps them build an even stronger moat: the
| moat made up out of negligible legal costs at scale that
| would criple smaller players. So only smaller players remain.
| But revoking a corporation 's charter instantly crushes that
| angle of defense and it is used far too sparingly.
|
| After that the shareholders get to pick over the leftovers.
| It's the corporate equivalent of the death penalty and since
| these companies are responsible for the lives of those that
| depend on affordable medication this sort of money grab is a
| reason people have reduced quality of life or die. It's
| beyond disgusting and such abuses deserve the harshest
| penalties available, not a slap on the wrist or a 'stop being
| soooo naughty' message.
|
| Corporations exist by the grace of governments recognizing
| them as such. They want to be 'people' when it suits them and
| eternal constructs with zero responsibility when that suits
| them instead. I think we should treat them a bit more like
| people and kill a couple of the worst abuses. See if that
| angle yields the right response.
| droopyEyelids wrote:
| I followed Lina Kahn (FTC chair) on Twitter before Biden
| appointed her, and I was kind of blown away that it happened. She
| had a very clear philosophical opposition to a lot of the way
| things are done in this country.
|
| And I mean, I followed her because I agreed! But my preferences
| are not mainstream. Amazing to see her slinging rocks at giants
| from this position.
| HDThoreaun wrote:
| Khan's utter failure to execute on her goals has imo set back
| the anti-trust movement in this country heavily. Now every time
| anti trust gets brought up people think about how the
| government lost 5 cases in a row and consider it a waste.
| nobodyandproud wrote:
| More a warning of how stacked the rules are against anti-
| trust, after 20-30 years of profitable M&A and other anti-
| competitive behavior.
| jauntywundrkind wrote:
| I hear this bandied about so much, but I've never heard
| justification that the cases weren't well built or that they
| weren't good cases to bring.
|
| The wicked thing about case law is that it builds and builds.
| The courts have been extremely pro big business for a long
| time, and it's hard to figure out how anything ever changes
| or gets better from here.
|
| Trying to right this hell is going to take a lot of miserable
| attempts that go nowhere. That's what happens when the titans
| already have all the case law in their favor. Yes that means
| we need to be very well prepared when we go to battle - try
| to overturn their legalistic dominance - but I'm glad we are
| trying, and I'm not sure what better paths are available, not
| sure what the actual lessons are, not sure what should have
| been better. It feels like such a slim chance. And trying
| feels necessary, feels like it has a chance, even if odds
| aren't great.
|
| Something has to be done to let us revisit the past, but
| that's not how the courts especially operate. The courts are
| the primary upkeeper of existing decisions, and this feels
| sometimes like ossification, sometimes feels like it eats
| away from the flesh of the nation.
| HDThoreaun wrote:
| cases that lose are not well built. No excuses. Losing a
| case further entrenches the precedent against you, there's
| no silver lining.
| 2OEH8eoCRo0 wrote:
| It's also been a mere ~2 years since she was appointed.
| Guvante wrote:
| With the current stagnated Congress session possibly but now
| whenever better legislation comes up any attempts to claim
| existing rules are "good enough" is objectively wrong.
| HDThoreaun wrote:
| "objectively wrong" no longer exists in politics, if it
| ever did.
| throe37848 wrote:
| Maybe it was her surname. This "hipster antitrust" approach is
| a nice smoke screen big pharma needs. India and other countries
| already make generics, there is no need to wait several years
| for US manufacturers. FTC is just a road block that prevents
| cheap medical imports.
| emodendroket wrote:
| Is it really though. Even with the current level of
| regulation we have more than enough scandals with, say,
| artificial tears that blinded people who used them.
| partitioned wrote:
| FDA should be able to make sure imports are safe
| alwayslikethis wrote:
| It's all a trade off. We can have more affordable medicine
| by importing it. This means more people will be able to
| access it, meaning less bankruptcies, which isn't any good
| for one's health. Will it be less safe than the ones you
| can currently get for an exorbitant prices? Marginally,
| probably. Overall, society can benefit from letting people
| import their medicine. It will also drive down prices and
| force big pharma to drop their prices.
| throwaway128128 wrote:
| Biden's had a number of appointments that have been
| surprisingly on point. I really like how antitrust enforcement
| is finally, FINALLY getting some teeth.
| AlbertCory wrote:
| I have to admit I didn't know how the Orange Book worked, so I
| had to do some research. Do I have this right?
|
| "An Orange Book listing shows "approved prescription drugs,
| related patent and exclusivity information, and therapeutic
| equivalence evaluations, along with other information."
|
| https://www.fda.gov/drugs/news-events-human-drugs/our-perspe...
|
| So a pharma company can insert a listing saying that, for a bogus
| example, "Vioxx has no approved generics, because all substitutes
| are under patent or patent pending." when that is untrue.
|
| This seems clearly illegal and abusive.
|
| From the headline, I thought Kahn was saying that filing a
| trivial patent "improving" Vioxx would be illegal. But that's not
| it.
| pixl97 wrote:
| I believe the word you are looking for is fraudulent. And yea,
| why aren't we prosecuting for that.
| whymauri wrote:
| Not only bogus, but if you get a hit on a scaffold you can
| combinatorially modify that scaffold and file it with the
| patent. This effectively blocks the small permutation space
| around the drug from further investigation or development.
|
| There's lot of promising science that can't be done because
| incumbents are so adversarial about patent space for structures
| they don't even care about. To make matters worse, patent data
| and notation is:
|
| * Poorly structured and defined,
|
| * Difficult to parse,
|
| * Uses combinatorial/wildcard notation (Markush structures [0],
| which is what modern drug patent law is based on).
|
| So it's a total mess. The best analogy I could give for
| software is: imagine if you could patent closed source code
| (the literal code) and also attach a wildcard to every branch
| in logic within that closed source code, but all you publish
| are the filenames (as screenshots of directories, not text).
| You don't have to run due diligence that the permutations are
| run to spec or even compile, but now nobody can write logic
| infringing on your hypothetical code (which you never wrote).
|
| If your reaction is 'what the fuck?', yes I agree.
|
| [0] https://en.wikipedia.org/wiki/Markush_structure
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