AstraZeneca Tries To Use 'Orphan Drug' Designation To Extend Patent Life Of Top-Selling Pill

from the evergreen-desire-to-hang-to-intellectual-monopolies dept

At the heart of copyright and patents there is — theoretically — an implicit social contract. People are granted a time-limited, government-backed monopoly in return for allowing copyright material or patented techniques to enter the public domain once that period has expired. And yet copyright and patent holders often seem unwilling to respect the terms of that contract, as they seek to hang on to their monopolies beyond the agreed time in various ways.

In the case of copyright, this has been through repeated extensions of copyright’s term, even though there is no economic justification for doing so. In the realm of pharma patents, a number of techniques have been employed. One is “pay for delay.” Another is the granting of “data exclusivity.” And a third is the use of “evergreening.” Techdirt wrote about the last of these a while back, so it’s no surprise that companies have continued to “innovate” in this field since then. For example, AstraZeneca is trying to use a variant of evergreening for its anti-cholesterol pill Crestor. As a New York Times article explains:

Crestor is the company?s best-selling drug, accounting for $5 billion of its $23.6 billion in product sales last year. About $2.8 billion in sales were in the United States, where the retail price is about $260 a month, according to

Here’s how AstraZeneca hopes to hold on to that lucrative market, even though its patent on the drug is now coming to an end, and it should be entering the public domain:

The company is making a bold attempt to fend off impending generic competition to its best-selling drug, the anti-cholesterol pill Crestor, by getting it approved to treat [a] rare disease. In an unusual legal argument, the company says Crestor is entitled to seven years of additional market exclusivity under the Orphan Drug Act, a three-decade-old law that encourages pharmaceutical companies to develop treatments for rare diseases.

In May, AstraZeneca won approval of Crestor to treat children with the rare genetic disease of homozygous familial hypercholesterolemia (HoFH ). That gives it an additional seven-year patent on the drug, but only for that particular — very small — market. However, the designation means that detailed prescription information about using Crestor to treat children in this way must not be included on the label. AstraZeneca’s clever lawyers are trying to turn that into an extended patent for all uses of the drug:

AstraZeneca immediately petitioned the F.D.A., arguing that if the correct dose for children with HoFH could not be on the generic label, then it would be illegal and dangerous to approve any generic versions for any use at all. That is because doctors might still prescribe the generic for children with HoFH and choose the wrong dose, posing “substantial safety and efficacy risks.”

Needless to say, AstraZeneca was only asking for generic versions to be kept off the market for another seven years for safety reasons, not because doing so would bring it billions more in exclusive sales to the general population. Of course.

The New York Times article goes into more detail about the fascinating legal background to AstraZeneca’s argument here, and notes that other drug companies have tried the same approach in the past, without success. Even if this particular ploy does fail again, we can be sure that pharma companies will be back with other sneaky ways of extending their patent monopolies — implicit social contract be damned.

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Comments on “AstraZeneca Tries To Use 'Orphan Drug' Designation To Extend Patent Life Of Top-Selling Pill”

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That Anonymous Coward (profile) says:

Re: How can it be orphaned if others want to make it?

The disease was orphaned by the drug industry.
The total income would never recoup the advertising budget & development, so they don’t bother looking.

So now a company went searching for one of those diseases to get their best seller approved to treat (something they never looked at until their billions might stop flowing) and then make moves to lock up 7 more years of being the only game in town. The R&D and the advertising budget was recouped long ago, and they have made huge profits… that they couldn’t be bothered to use to find a treatment for a disease, they just want to cling to this one for as long as possible.

Narcissus (profile) says:

The problem is now glaringly obvious

“Crestor is the company’s best-selling drug, accounting for $5 billion of its $23.6 billion in product sales last year”

It’s clear the patents make the companies lazy and averse to innovation. No sane company would make their business so dependent on one product that it accounts for more than 20% of their sales if they didn’t think they could keep that position.

It’s not like high cholesterol is the last disease in the world and there is nothing else to research. There exist plenty opportunities to diversify the portfolio a bit.

Anonymous Coward says:

The whole industry is corrupt and needs reformed

There is an asthma medicine, Breo, that has a pretty bad side effect. It may increase your risk of death by asthma. Why the #$%& is this even on the market? Oh you have asthma? Well take this it will cure you by making you dead!

Then there is Xyrem, a drug first synthesized over a hundred years ago yet is patented, made by a single company and can only be dispensed by a single pharmacy thanks to the war on drugs. About ten years ago Xyrem was about $3,000 a month, its now over $10,000 a month. Must be nice to have a 99.99% profit margin.

Anonymous Coward says:

Re: The whole industry is corrupt and needs reformed

Drugs having the potential to backfire is nothing new and is a sad hazard – not a reason to ban a drug in itself. Biology is very complicated and what is normally the right thing can turn wrong in niche circumstances.

For instance it is possible to die of a terribly ironic allergic reaction to an antihistamine used to treat another allergic reaction.

Will "scifantasy" Frank (profile) says:

I have to say, the gloss over the “fascinating legal argument” is interesting–the argument amounts to AstraZeneca saying, “sure, the last time someone in our position tried to do exactly this, the court threw them out so hard they cracked the pavement…but the court was wrong!” which I’m sure is going to get a lot of traction in the courts.

It’s not good that companies are trying to do this, but it’s important to note that they keep failing.

Vidiot (profile) says:

One statin among many... are the ALL orphans?

Pretty thin claim to make… Crestor (rosuvastatin calcium) is a fairly mainstream, run-of-the-mill statin… no unique mechanism of action; in other words, you could take any of about a half-dozen other common drugs to achieve the same effect. However, there are two actual orphan drugs approved — mipomersen and lomitapide — with novel mechanisms of action, totally unlike statins, and possibly more effective. If this one me-too drug qualifies as an orphan, so does Lipitor, Mevacor, Pravachol… patent extensions for everybody!

Rekrul says:

Drug prices are out of control. I was part of a clinical trial for a new psoriasis drug. It worked great and what I didn’t realize was that it was also keeping my psoriatic arthritis under control (I though the previous trial I was on had knocked it out). The trial ended around the start of May. A couple weeks later my arthritis started to come back. I saw my doctor about two weeks later (first appointment he had open), which makes it a month after the study ended.

The drug that I took during the trial, Xeljanz, was already approved for treating arthritis, so my doctor wrote me a prescription for it. Medicaid took an additional two weeks to approve it. Why? Maybe the fact that it’s $4,040.68 a month might have something to do with it!

Since I was off it for a month and a half, my arthritis got to the point where it may now take months to get back to where I was. If I get back there at all. During the study I was taking 20mg a day, but apparently it’s only approved for 10mg a day, which is what I’m taking now.

On the plus side, it has almost completely cleared up my psoriasis, so there’s that…

Anonymous Coward says:

Rosuvastatin is generic in Australia

I quote from the following website article at Win for generic pharmaceutical companies in Australia 18 August 2014

In a unanimous five-judge Full Federal Court decision handed down on 12 August, AstraZeneca once again failed to prevent generic companies from selling competing generic versions of its Crestor (rosuvastatin) cholesterol drug.

In 2011/2012, AstraZeneca, the holder of three Crestor-related patents, commenced infringement proceedings against generic pharmaceutical companies Watson and Ascent, both now part of the Actavis Group, and Apotex. AstraZeneca was relying on patents concerning dosage ranges, methods of treatment and pharmaceutical compositions respectively.

Last year, the Federal Court held that the generic companies’ products would not infringe AstraZeneca’s patents and, in any event, all three patents were partially or wholly invalid on numerous grounds.

The Full Federal Court has now upheld that earlier decision, finding that two of the patents were invalid (the trial Judge’s findings on the third patent were not appealed), dismissing AstraZeneca’s appeal and ordering it to pay 80% of the generic companies’ costs of the appeal.

Rosuvastatin is reportedly now Australia’s leading “genericised” drug. According to figures released by the Pharmaceutical Benefits Scheme (PBS), the Australian Government spent A$298.6 million on rosuvastatin in the 2013-14 financial year.

Commenting on the decision, Mr McMaster said: “The Full Court’s decision (12 August 2014) ensures that the generic market for rosuvastatin (and therefore the current cost to the Australian Government through the PBS) is maintained. It demonstrates that Australian courts will not permit an unwarranted extension of an innovator’s monopoly beyond the compound itself unless the patent appropriately covers patentable subject matter.”

And notice that they had to pay 80% of the costs of their opponents. They tried to be nasty and they suffered the consequences. America may be able to learn something from this, though you are so far away from actual fairness any more that that is probably now not possible.

Mayhaps your courts can follow in the same vein.

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