NY Times Editorial Board Gets It: Drug Patents Are Bankrupting Americans & It Needs To Be Fixed
from the fix-the-system dept
There has been a push over the last few months by some pro-patent academics and (of course) the pharmaceutical industry to insist that high drug prices and high healthcare costs have nothing whatsoever to do with our broken patent system that grants drug and device makers a full on monopoly. That claim doesn’t just defy logic, it defies all evidence and reality. As we noted last year, an investigation by the House Oversight Committee found some incredibly damning examples of how drug companies exploited the patent system to jack up prices — with the most damning being the story of how AbbVie hired McKinsey to come up with a sneaky plan to effectively extend the patent monopoly of Humira, an important drug for many, many Americans.
They deliberately did some shady stuff to extend the life of the patent monopoly while jacking up prices to insane levels.
Anyway, it appears that the Editorial Board at the NY Times has been paying attention to all of this as well, and has published a fantastic piece calling for significant fixes to the patent system to stop this nonsense and to lower drug and healthcare costs. The article is called “Save America’s Patent System,” but it might just as easily have been called “Save America’s Healthcare.” Because it can do both.
Drugmakers for decades have argued that patents are essential to American innovation. For all that lip service to medical advancement, though, a recent investigation by the House Oversight Committee concluded that market share is more likely the point. Twelve of the drugs that Medicare spends the most on are protected by more than 600 patents in total, according to the committee. Many of those patents contain little that’s truly new. But the thickets they create have the potential to extend product monopolies for decades. In so doing, they promise to add billions to the nation’s soaring health care costs — and to pharmaceutical coffers.
And for all the hand-wringing over how to lower prescription drug costs in recent years, little has been said about the patent system or its many failings. Put simply: The United States Patent and Trademark Office is in dire need of reform.
The editorial comes up with some pretty straightforward suggestions for fixing the patent system. First, stop granting patents for minor changes. The law requires that a patent be new and nonobvious to those skilled in the art. Yet it regularly approves new patents on very minor updates to long-existing ideas.
The pharmaceutical industry is a good example. Nearly 80 percent of the drugs associated with new patents between 2005 and 2015 were not new. But the issue is not confined to drugmakers. The Theranos debacle, to take just one other example, was touched off by officials who granted scores of patents for a device that had never been built and that turned out not to work. The company was able to secure those patents without disclosing almost any technical information about its product.
It also suggests a move that I’ve been arguing for for many years: there needs to be a point at which patent rejections are final. While there is something called a “final rejection,” it’s not actually final. Patent applicants can adjust and keep appealing. And this bogs down the system, and actually encourages patent examiners to eventually approve a patent just to get it off of their pile. We’ve been calling out this problem for nearly two decades, and it hasn’t yet been fixed.
Importantly, the NY Times also highlights that the process to challenge bad patents needs to be improved:
Bad patents have steep costs. They gum up the wheels of innovation by making it harder for would-be inventors to proceed with their work. They strain budgets by preventing cheaper products from entering the market. And they leave honest inventors vulnerable to patent trolls — people who buy up weak patents not to create anything new or useful but to hold legitimate inventions ransom. But the process of weeding these patents out once they’ve been granted remains fraught: It can take years and many thousands of dollars to challenge a bad patent in court, and even when the case seems obvious, success is never guaranteed.
This is big and important for a number of reasons. In the US’s last big patent reform, they enabled some better methods of invalidating bad patents, via the Patent Trial and Appeal Board (PTAB) and the “inter partes review” process, allowing for at least some path to revisiting granted patents to see if they should have never been granted in the first place.
Yet, many in Congress are actually looking to go in the other direction, and to make it much, much harder to challenge bad patents. So it’s great to see the NY Times pushing Congress to actually move the needle in the other direction and to strengthen the PTAB process.
The next suggestion is really great, and surprising. It notes that too many Patent Office directors come directly from industries that rely heavily on patent monopolies, and that they’re biased towards ever more patents, regardless of the quality. And that should stop.
Too many patent office directors have come from or gone to industry jobs within months of holding the federal post. This revolving door poses a real risk to the integrity of the patent office. The most recent example of that comes from the Trump administration appointee Andrei Iancu. During his tenure, the patent office used its discretionary powers to deny a challenge to a patent held by a company that his former law firm represented. He then returned to that firm as soon as his time in government was up.
And then my favorite suggestion of them all — recognizing that under the Constitution, the patent system is supposed to be for the benefit of the public, not the corporations holding the patents. And thus, the public should be a part of the process:
For too much of its history, the patent office has treated inventors and companies as its main customers while all but ignoring the people whose lives are affected by patenting decisions. That needs to change. Officials can start by appointing more public representatives to the patent office’s public advisory committee. Right now, six of the committee’s nine members are attorneys who represent commercial clients or private interests; only one works in public interest.
Officials should also establish a public advocate service similar to the one that exists at the Internal Revenue Service and should make a concerted effort to ramp up their public outreach. “The patent system has gotten so complicated that it’s impossible for anyone who’s not an inventor or a lawyer to penetrate it,” said Mr. Duan.
There’s much more in the piece, but it’s one of the rare NY Times editorials that I think is 100% on point, and hopefully the Patent Office and Congress move towards doing what’s in there to not only help save the patent system, but to fix America’s continuing healthcare debacle.
Filed Under: drug patents, ipr, patent system, patent thicket, patents, ptab, uspto
Comments on “NY Times Editorial Board Gets It: Drug Patents Are Bankrupting Americans & It Needs To Be Fixed”
* checks calendar *
…huh. The 22nd, you say? Huh.
Re: NY Editorial is good on IP
The New York Times Editorial is really good when it comes to intellectual property (or rather, government-granted monopolies). For instance, they came out against the Sonny Bono Copyright Term Extension Act back in the 90’s. See here (paywall warning). The NYT Editorial being good may seem unusual, but not when it comes to copyrights and patents.
Re: Re:
Just goes to show that even a blind squirrel finds a nut every once in a while.
How does that happen, as there are only twelve or so compounds, and maybe an innovative synthesis route or two. The rest is well known practice in compounding and making drugs available, and while changes may need some testing, it is treading well known paths, rather than any innovation.
Re:
Corruption. That’s how it happens.
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Making one slight change in a drug’s formulation to extend the patent by another twenty years. That’s how it happens.
Re: Re: Just because a patent exists doesn't mean generics can't enter
Those new patents don’t automatically block generics. They tend to only protect the “slight change in formulation”, or whatever other tweak was made. I wrote a blog post on this (https://www.drugpatentwatch.com/blog/does-drug-patent-evergreening-prevent-generic-entry/ ) and in all the cases I looked at, generics entered on schedule. The add-on patents didn’t block generic entry; they just protected the new sub-invention.
Re: Re: Re:
That leaves out how this normally works. As the pharma starts to approach end of patent life, and they work up the “tweak,” they then phase the former version out of the market before the patent expires, and push the tweaked version onto the market, with often greatly exaggerated claims of benefits.
So, for example, there’s a slightly different delivery mechanism or whatever. The patients start getting that new formulation for a couple of years. Then the generic finally enters the market, and everyone says “why would I go to the ‘worse’ delivery mechanism, I’m used to this other one…”
Re: Re: Re:2 don't forget about payers
The product switch you described worked with Nexium (https://www.wsj.com/articles/SB1023326369679910840#:~:text=The%20heartburn%20drug%20Prilosec%20is,price%3A%20about%20%244%20per%20pill. ) but isn’t all that common.
Payers reimburse for clinical outcomes, independent of patient perspectives. So simply tweaking a product doesn’t guarantee that patients will be able to switch. Of course, if they opt not to get reimbursement they can pay out of pocket, but the new patents don’t block generic entry, which is what the NYT article strongly implies.
Re: just because a drug is patented doesn't mean it has high prices
Aspirin is still patented ( https://www.drugpatentwatch.com/p/ingredient/aspirin ), yet it’s very affordable. While patents enable drugs to have high prices, they don’t necessitate high prices.
Re: Re:
From the page you linked:
“Aspirin is the generic ingredient in fifty-three branded drugs…”
If aspirin were branded, then it couldn’t rightly be described as ‘generic’. Want another source? Search ‘aspirin Wikipedia’. Aspirin is cheap because its patent ran out decades ago.
Re: Re: Re: Aspirin still has patents
Branding is a trademark issue, not a patent issue. I’m not sure how else I can be more clear. Aspirin still has patents.
Re: Re: Re:2
Look, I’m autistic. I get words mixed up sometimes even when I’m communicating online. Of course I meant patented, not branded.
Re: Re: Re:2
Look, I’m autistic. I sometimes get my words mixed up even when I’m communicating online. Of course I meant ‘patented’ rather than ‘branded’. And aspirin still doesn’t have any patents. If you still don’t believe me, follow the link: http://www.ipdigit.eu/2011/10/bayers-aspirin-a-lasting-success-without-patent-and-trademark-protection/
Re: Re: Re:3 Patents covering aspirin
9,987,231
https://patents.google.com/patent/US9987231B2/en
Relevant claim: “1. A method for delivering a pharmaceutical composition to a patient in need thereof, comprising orally administering to said patient a pharmaceutical composition in unit dose form comprising acetylsalicylic acid…”
9,539,214
https://patents.google.com/patent/US9539214B2/en
Relevant claim: “1. A method for delivering a pharmaceutical composition to a patient in need thereof, comprising administering to said patient a pharmaceutical composition in unit dose form comprising acetylsalicylic acid…”
9,226,892
https://patents.google.com/patent/US9226892B2/en
Relevant claim: “6. The method of claim 1, wherein the NSAID is selected from the group consisting of ibuprofen, piroxicam, salicylate, aspirin…”
Re: Re: Re:4
Patents on specific sub-types of aspirin made by specific companies do not create a patent on aspirin itself, just as a copyright on a specific version of a fairytale doesn’t take the original out of the Public Domain. Now get back to taking your heroin*, or is that ‘patented’ too?
*Also patented by Bayer way back when, and now generic.
The NYT probably “gets” it in this case because those same 12 drugs are costing them a lot of money in terms of insurance premiums.
It is important to note that while patents are an important fraction of healthcare costs (and in many cases, the dominant one), drug costs are by no means the only offender.
One step at a time, though.
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Actually, the high cost of patented drugs are the main reason healthcare costs are so high around the world. For example, when the Oxford/AstraZeneca COVID jab was taken off the market due to the rare chance of blood clots in a specific age group, that left only the patented Moderna and Pfizer/BioNTech vaccines available, massively raising the cost of protection for the NHS, even taking into account all the ignoramuses that are going for a collective Darwin Award.
Patent Applications
First my disclosures, I’m not a patent expert of patent lawyer, AND, I don’t have the time to do searches to get the relevant quotes.
Now that said, Part 1., my recall is that a HUGE piece of the original purpose of patent legislation included that there must be enough information included in a patent application that those “experienced in the art” could reproduce the invention.
Part 2., the patent application therefore became a repository of knowledge so that how to recreate the invention would not be lost.
Part 3., in Physics, when something is newly proved, then others set out to reproduce the experiment and confirm the proof.
Part 4., how do we go about getting labs to do a similar operation with patents? First to prove that the patent actually contains enough information to reproduce that “new invention” and whether or not there is anything non-obvious in the patent that should not be patented.
So my suggestion is that instead of losing so much money trying to license basic research, they could set up these labs. It will help train next generation inventors, next generation patent examiners, and in the process validate that the described inventions a) contain enough information to build the described invention, b) works as described, c) actually is something new and d) provides an additional repository of that knowledge so that it doesn’t get lost.
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Not quite. The worry was more that the knowledge would never become public in the first place. Like, some company would figure out a useful way to make something, and then they’d use it but never tell anyone. Which actually sounds a lot like the worries some people have about “software as a service” (or, let’s say, medical testing as a service).
This reasoning doesn’t apply to a lot of what’s patented. If you have a drug, or a complete product, probably someone could reverse-engineer it, which makes the patent a one-sided deal: the patent holder gets a monopoly, and we learn nothing we couldn’t have figured out.
Re: Re:
“Like, some company would figure out a useful way to make something, and then they’d use it but never tell anyone.”
Like KFC and the Coca Cola Company do with their secret recipes? Good job they’re unlikely to go out of business, barring an ingredients shortage more severe than the last one.
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I don’t think a pure list of ingredients could be patented—or at least it shouldn’t be allowed—but that’s otherwise a decent example. Society could evaluate whether 20 years of exclusivity would be a good price for learning KFC’s recipe. Spoiler: probably not, because (1) a number of “copycat recipe” books already have decent versions and (2) secrecy of the recipe is mostly a gimmick, whereas convenience is the real selling point (McDonald’s published a video, a while ago, showing how to make a Big Mac, including the “secret sauce”; didn’t hurt business).
Coca-Cola is somewhat more interesting, in that they do in fact have a legal monopoly. Only one American company—Stepan Company—is licensed to import coca leaves, which they sell only to Coca-Cola after removing the cocaine. Nobody else can get the necessary ingredients.
Re: Re: Re:2
Actually, the recipes for KFC and Coca Cola are trade secrets. If they were patented, they would have to be published, and they wouldn’t then be secret. A little research on your part required, methinks.
Re: Re: Re:3
Yeah, that was the point of the preceding message. I’m not sure which part you have a problem with. The idea of patents is exactly to encourage inventors to publish, rather than using trade secrets. The deal is that they get 20 years or so of exclusivity. I don’t think it would be a good deal for the public, even if allowed.
Re: Re: Re:4
As you said yourself: “I don’t think a pure list of ingredients could be patented.” Hence the secret recipes.
Re: Re: Re:3
On a side-note, didn’t This American Life find the recipe in an old newspaper containing a photo of a notebook where it was written down?
Re: Re: Re:2
“Only one American company—Stepan Company—is licensed to import coca leaves, which they sell only to Coca-Cola after removing the cocaine.”
The license comes from the DEA, not the Coca-Cola Company, and the reason the Stepan Company sells its cocaine-free extract to the Coca-Cola Company is because that’s the only cola manufacturer that uses it. As Autie said, you need to do more research.
All of this coming to a head?
NOPE.
WONT HAPPEN.
Corps will drown this out so fast.
You want see a followup in any other news.
You wont see a debate take place unless its behind closed doors.
I still loved the old days, as the USA would grant People int he USA CR, but never acknowledge other countries. Until we went international, Which is because the Corps ran away from the USA and made business’s in other countries, and to HOLD patents in those countries that the USA would abide, The corps made it so they HAD to acknowledge CR from around the world, but mostly THEIRS.
And now China has gotten into the boat, as they figured it out and has been buying up Patents like crazy. ANd China as a country has enough backing and money to Goto court.
The Fun of all of this coming to a head. I give it 10 years before the USA corps decide to Cut CR off, at a Specific time frame AS IT WAS. and try to Cut off all the CR that China has taken.
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What is “CR”? Corporate rule?
Drug patent schemes
Robin Feldman is a good reference on this. She’s written a couple of books on it and has done two Econtalk interviews. Good counterpoint to the popular narrative on drug prices.
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Patents last for twenty years. Aspirin was first formulated in 1853. You do the math.
Re: Re: Patent don't necessarily mean no generics, not do they necessitate high prices
That’s exactly the point I’m trying to make. Aspirin, which was invented over 100 years ago, still has patents.
This is inconsistent with a worldview where patents = high prices and no generics. If you follow the links in my other response, which directly show the claims on currently valid patents, you’ll see the point I’m trying to make.
Re: Re: Re:
Now I’m really puzzled. How, exactly, is a patent on a ‘medical composition containing aspirin’ (such as Anadin or gastro-resistant formulas) a patent on aspirin itself? You really need to stop digging this hole because you’re only showing how much I’ve pwned you and have won this debate a hundred times over already.
Re: Re: Re:2 BTW
For your next trick, would you like to claim that there’s a patent on paracetamol/acetaminophen?
Re: Re: Re:
“This is inconsistent with a worldview where patents = high prices and no generics.”
That worldview exists only in your mind. What several commenters are actually saying is quite different: That patent holders are able to exploit the law in ways that extend the patent and block the entrance of competition for much longer than should be the case.
Not as simple as it sounds
The loose sylogism tieing drug patents to healthcare prices masks a lot of regulatory and commercial factors which can be far more important than patents.
I’m not going to try and explain it in a comment box, but I’ll provide some examples:
1) Daraprim’s tremendous price hike occurred when the drug was off patent. If patents control drug prices, how was this possible?
2) Aspirin still has patents today. If patents control drug prices why is Aspirin so affordable?
Insulin is the usually brought up as an example of patents out of control, but it’s actually a regulatory problem. Google “product hopping” if you want to go down the rabbit hole.
tldr: Insulin has patents, but these aren’t keeping prices high on their own. The brands are pulling stale drugs off the market and ‘hopping’ to new ones, meaning that would-be biosimilar makers have no reference materials to use for making biosimilars.
Re: Not as simple as it sounds
The problem is not drug patents as such, it is US patent law, which enables various schemes by which drug companies can extend their monopoly power for their benefit, not that of the consumer. Patent law needs reform to stop these practices, and consumers need to be made aware of the extent to which government is contributing to high drug prices – the very problem legislators claim they want to fix.
Re: Re: Yes
Yes, but it’s not just patent law. The FDA regulations have to balance supporting innovation while also enabling lower priced entrants (not just generics; there are other alternatives), all the while maintaining safety and efficacy. And interested parties (brand and generic alike) have strong motivations to find and leverage any regulatory inefficiencies they can find.
Re: Re: Re: etc
I was only commenting on the patent issue, not the rest of whatever is wrong with the FDA.