Attachment
Gates Package, p.1041 · gates:exh:00451
Page text: p.1041 · original PDF
- Date
- — (unknown precision)
- Type
- attachment · document
- Topics
- Vaccines
products--maybe they want to use the same process to make a cancer vaccine--they will
hesitate to release it.
If A proceeds anyway but deviates from B's manufacturing process in even the slightest
way, they'll have to go through new clinical trials, defeating the purpose of getting B's recipe in
the first place. And in the end, the two companies will release two seemingly similar products
that may have different levels of safety and effectiveness--creating confusion about vaccines at
a time when what everyone needs is clarity. Company A benefits because it can't be sued by B,
but otherwise, it has not gained much.
What's more, making a vaccine is typically more complicated than making a drug.
Remember that many drugs are made using chemical processes that are well defined and
measurable. But many vaccines don't work that way. Manufacturing them often involves living
organisms--anything from bacteria to chicken eggs.
Living things don't necessarily act exactly the same way every time, which means that
even if you follow the same process twice, you might not get the same product both times, and
it's much harder to tell whether the generic version matches the original in all the important
ways. The process of making a vaccine typically involves thousands of steps! Even an
experienced vaccine maker finds it difficult to duplicate another company's process and is most
successful when it gets technical assistance from the original producers.
This is why we have generic drugs but not generic vaccines. Although the situation might
change in the future, particularly as the mRNA vaccine technology matures, it's not a realistic
possibility right now. In 2021, waiving intellectual property protections would not have
meaningfully increased the supply of COVID vaccines.