> Even though insulin treatment itself can’t be patented, improvements in delivery mechanisms can be. These incremental improvements, no matter how small, can be used to extend the 20-year patent on a drug, a process called “patent evergreening.”
I'm confused - wouldn't the new patent only cover the improved method, and the patent on the original, un-improved version would still expire?
The article says some people need up to 6 of those vials per month. So, it can still end up being $1,800 per year.
Other non-US countries are able to provide a yearly supply of the newer biosimilar insulin for just $72-133 per year: https://gh.bmj.com/content/3/5/e000850
Your 2nd reference talks about the theoretical lowest price that a hypothetical manufacturer could manufacture longer-acting insulins at. It doesn't identify any manufacturer actually producing at those prices.
Scoundreller wanted a manufacturer producing "the newer biosimilar insulin for just $72-133 per year". That link doesn't appear to provide that information.
“Evergreening” is a term made up by journalists that has no basis in patent law, and is also actively misleading.
The real issue is that nobody has an incentive to prescribe the older, less good but still acceptable drug. (In the case of insulin, note, it’s not only the delivery mechanisms that have improved, but the insulin itself.) the insurance company, in particular, under the ACA, have no incentive to cut costs to improve profits.
The older albuterol inhalers are no longer sold because they used CFCs as a propellant. CFC usage was banned internationally by the Montreal protocol in 1987. The propellant could not be immediately replaced due to strict FDA safety guarantees so they carved out a temporary exemption for medical usage. Research and development was done to find a replacement (HFAs) and that work is now being paid for by the patents granted from that process (more expensive inhalers). Whether this was a valid trade-off is a separate discussion but company lobbying is not the reason why they are no longer distributed.
I think his point is that evergreening isn't a feature of the patent system; there's no mechanism to extend a patent, and "extension" patents of minor modifications don't extend the legal monopoly on a drug, but rather function as a marketing mechanism that preys on the industry's willingness to prescribe whatever the newest iteration of a drug is, regardless of evidence.
I fail to see how the term "evergreening" is misleading. It seems to me to be an accurate term that precisely describes an industry practice responding to market and regulatory incentives. I think journalists are spot on for this one, "evergreening" is an accurate and completely truthful assessment of the situation, and perhaps you are thinking too narrowly within the scope of legal terms in patent law and not enough about real world effects.
There may be some confusion about "delivery mechanism" here. In this context the only relevant definition would be referring to chemical components in updated formulas for the injectable solution. Delivery _devices_ would have no relevance to the patent of the injectable solution.
This breaks the site guidelines badly. Personal attacks are not allowed here. Accusations of shilling are not allowed here. We ban accounts that do these things. Please read the rules and don't do them again.
As mentioned in the article they are very effective at preventing smaller companies from producing generic versions based on expired patents. Then they just stop manufacturing the old drugs so there is no supply.
That's not the issue. As long as a brand drug is listed by the FDA -- whether or not it's actually being manufactured -- physicians can write prescriptions for generic equivalents.
However, if a brand manufacturer has an old product delisted, then physicians can no longer prescribe generic equivalents. That's become more and more common.
However, there is a workaround: compounding pharmacies. To my knowledge, accredited compounding pharmacies can make, on a customer-by-customer basis, any product that the FDA has ever approved. And many of them are mail-order pharmacies. In my experience, prices are comparable to mass-market generics, or lower.
>As long as a brand drug is listed by the FDA -- whether or not it's actually being manufactured -- physicians can write prescriptions for generic equivalents.
>However, if a brand manufacturer has an old product delisted, then physicians can no longer prescribe generic equivalents. That's become more and more common.
Why is the ability to prescribe a drug tied to whether the branded version in still "listed"?
Physicians can only prescribe FDA-approved drugs. Only brand drugs are approved on their own. Generic drugs are approved, with much less documentation required. There's no need to demonstrate effectiveness, safety, etc. Applicants must only demonstrate that products are therapeutically equivalent to approved brand drugs. That's mainly about chemical identity, purity, and rate and degree of absorption.
At Drugs@FDA, search for a brand name. If there are generics, you'll see "Therapeutic Equivalents for NDA ...". Clicking that will display links to them.
If there's no listed brand drug, there's nothing for a generic to be equivalent to.
I'm not sure what the requirements for delisting products are. It might be as simple as "this is old, and we don't want to be associated with it". Or as specific as "we've learned that it's not as safe and/or effective as it should be, and should be delisted for health and safety reasons."
But the real reason is almost always that they have a new version, which costs much more, and they don't want competition from inexpensive generics to their old product.
There have been some antitrust suits over that. I don't know how they turned out.
Compounding pharmacies are brilliant. In the course of my treatment, my doctor and I worked with a compounding pharmacist to prescribe me lower dosage amounts of buprenorphine than the major drug companies have ever produced -- which allowed my taper to go smoother than expected.
Yes, the new patent can only cover the new improvement.
The issue is that doctors keep proscribing the newer, slightly improved methods.
Trying to evergreen on purpose is also dangerous since your competitor can patent an improvement on your invention. I somewhat doubt it is a purposeful strategy. But rather it just reflects the iterative nature of invention.
Yes, the old drug patent will expire, and when this happens the company typically pulls an "oh our old version is now magically unsafe!" to wrestle away competition.
Plus developing a product from the old patent still requires extensive FDA approval. Very expensive stuff.
Do you have references for that claim? If a company goes out with a claim their old product is unsafe it’s not like it’s rocket science to test the claim. And if their lying and you could literally corner a billion dollar industry by testing the claim I’d expect every producer of generics to do so. On the other hand if the product is actually unsafe that opens up liability claims from costumers.
I've seen companies create "extended release" formulations of their old formulation 1 year before the patent expires to get everyone to switch over to the patented version before the generic comes out.
I've even seen it done when the previous version and the new version were still both once daily (tamsulosin, I'm looking at you!)
Yes, some insurers will hesitate to cover the new formulation when it comes out, but not all.
Sometimes the insurer will make a deal with the manufacturer so that the manufacturer is only getting paid the generic-equivalent price. But who knows what happens behind closed doors.
Changing the release profile of a drug from once daily to once weekly isn’t a minor thing, and no one is forcing customers to pick the once weekly over the once daily. Now with respect to the original claim, are you saying that once there was a new version of tamsulosin the company issued a statement claiming the old version was unsafe? Do you have a reference for that?
1. The consumers aren’t really choosing, their prescribers are, with a lot of friction required to change against their initial decision.
2. While they still had the patent on the regular tamsulosin formulation, they stopped making it. Effectively forcing everyone onto the XR formulation unless they wanted to change molecules entirely.
The data showed little difference as I recall in terms of effectiveness because the half life was long enough to take once daily, regardless of formulation.
I'm confused - wouldn't the new patent only cover the improved method, and the patent on the original, un-improved version would still expire?