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 GoodRx.com.
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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Filed Under: blocking, competition, crestor, evergreening, fda, generics, new uses, patents
Companies: astrazeneca


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  1. identicon
    Anonymous Coward, 15 Jul 2016 @ 3:12pm

    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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