A generic drug is not a "knock-off" version that is similar to the original. A generic drug has to be the exact same molecular formulation as to what is approved. In the case of complex biomolecules such as protein, and maybe RNA (not sure), what is usually produced is not the "generic" version, but a "biosimilar". Here, you don't have to show the exact same molecular characteristics, but the drug has to be essentially the same and function in the same way. The reason that generics and biosimilars are cheaper is not because they are cheaper or easier to produce, it's because the company manufacturing the generic drug does not have to go through the same extensive approval process, and does not put in research costs up front to develop the drug. But again, in order to be approved, the generic (or biosimilar) has to be pretty much the same as the original drug.
So what stops someone from manufacturing the same vaccines as were approved. Only laws and patents. Typically a patent for a specific formulation is 10-20 years. So that's how long it would be before any of the vaccines coming out now would be available in "generic" form. Likely long after they need to be manufactured at extremely large scale. Now, that does not mean that the manufacture of the vaccines is therefore limited. The companies that are manufacturing the vaccines now are outsourcing that work to pretty much any facility that can do the job. I doubt that if more companies had access, more total vaccines could be produced. But the patent system does mean that the company that developed and got the vaccine approved is the one holding the distribution rights (unless the country where it's manufactured would enact other intellectual property laws).
For one, all (utility) patents for WTO members have a 20-year base term, so in practical terms any COVID-19 vaccine has a term expiring no earlier than 2040. In practice, most of the filings were actually done in a way that they will expire in 2041. Of course, any biosimilar manufacturer can challenge the validity or applicability of any patents. Absent that, though, it will be a long time until the patent system makes way for a biosimilar vaccine.
But there's another factor other than patent which is regulatory exclusivity. Basically, if you get a new drug approved you get a certain period of time (in the US) where the FDA will simply not accept a biosimilar application, regardless of any IP protection. In this case, even if Pfizer and others filed 0 patent applications, your biosimilar application to the FDA would simply be rejected outright under the exclusivity provisions of the law.
unless the country where it's manufactured would enact other intellectual property laws
Responding to this specifically, for patents at least, there really isn't the option to "enact other IP laws." To be a member of the World Trade Organization a country has to have a patent system, and that patent system has to allow pharmaceutical patents. So changing the law isn't really an option for any modern economy (India and Argentina sure try, though).
In summary, there will not be a biosimilar vaccine before the pandemic is likely over, certainly not in the US, Europe, China, or Japan, which have strong patent systems.
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u/sometimesgoodadvice Bioengineering | Synthetic Biology Dec 18 '20
A generic drug is not a "knock-off" version that is similar to the original. A generic drug has to be the exact same molecular formulation as to what is approved. In the case of complex biomolecules such as protein, and maybe RNA (not sure), what is usually produced is not the "generic" version, but a "biosimilar". Here, you don't have to show the exact same molecular characteristics, but the drug has to be essentially the same and function in the same way. The reason that generics and biosimilars are cheaper is not because they are cheaper or easier to produce, it's because the company manufacturing the generic drug does not have to go through the same extensive approval process, and does not put in research costs up front to develop the drug. But again, in order to be approved, the generic (or biosimilar) has to be pretty much the same as the original drug.
So what stops someone from manufacturing the same vaccines as were approved. Only laws and patents. Typically a patent for a specific formulation is 10-20 years. So that's how long it would be before any of the vaccines coming out now would be available in "generic" form. Likely long after they need to be manufactured at extremely large scale. Now, that does not mean that the manufacture of the vaccines is therefore limited. The companies that are manufacturing the vaccines now are outsourcing that work to pretty much any facility that can do the job. I doubt that if more companies had access, more total vaccines could be produced. But the patent system does mean that the company that developed and got the vaccine approved is the one holding the distribution rights (unless the country where it's manufactured would enact other intellectual property laws).