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The fact that this is necessary, should invalidate any patent protection that Moderna (and Pfizer) have on the vaccine. Patents are supposed to work as a quid q
by gpm 5y ago
The fact that this is necessary, should invalidate any patent protection that Moderna (and Pfizer) have on the vaccine. Patents are supposed to work as a quid quo pro, you disclose the invention in exchange for a temporary monopoly. If it takes significant work to reverse engineer the invention, that quid quo pro hasn't been met, the patent should be considered invalid.
If Moderna and Pfizer want to protect the vaccine via trade secrets, from an intellectual property that's fine, but they shouldn't have any government defence against reverse engineering.
(Note: Talking in moral terms here, there is some legal support for the argument, at least in Canada (not sure about the US), but I wouldn't suggest that I could predict which way the case would go without a lot more information. For an example case along these lines from Canada, see: https://www.pharmainbrief.com/2017/08/fca-upholds-gilead-victory-invalidating-idenix-patent-relating-to-anti-hcv-compounds/ https://www.pharmainbrief.com/2017/08/fca-upholds-gilead-vic...)
- deleted 5y ago[deleted]
- mlyle 5y ago> If it takes significant work to reverse engineer the invention, that quid quo pro hasn't been met, the patent should be considered invalid. So, company A patents something and discloses how to make it. It's an enabling patent, best-mode, etc. Company A then makes significant further improvements needed to make the thing at scale. You're saying they should have to disclose this subsequent work?
- gpm 5y agoTaking this article at face value, the company has not disclosed how to make the thing at all, not just how to make it at scale. I would not suggest that the most efficient way to make it must be disclosed (if you want to patent the finished good but not the efficient manufacturing process), just a way.
- JumpCrisscross 5y ago> the company has not disclosed how to make the thing at all, not just how to make it at scale They’ve also not patented everything, choosing to retain some of the most sensitive techniques as trade secrets. If this persists, we’ll see more pharmaceutical companies taking a Muskian approach to patents.
- dctoedt 5y agoFrom the USPTO's Manual of Patent Examination Procedure: (quoting the patent statute): "The specification. . . shall set forth the best mode contemplated by the inventor of carrying out his invention." And the Manual's explanation: "The best mode requirement is a safeguard against the desire on the part of some people to obtain patent protection without making a full disclosure as required by the statute. The requirement does not permit inventors to disclose only what they know to be their second-best embodiment, while retaining the best for themselves." https://www.uspto.gov/web/offices/pac/mpep/s2165.html https://www.uspto.gov/web/offices/pac/mpep/s2165.html
- mlyle 5y agoNote that all the teeth are gone from best mode, though. You're now "required" to disclose best mode, but don't face invalidation of a patent for failure to disclose best mode.
- dctoedt 5y agoAgreed — but I'd imagine that intentional failure to disclose best mode could still be a basis for an inequitable-conduct holding. (It's been a few years since I did patent work; a quick search in scholar.google.com didn't reveal any case law on point.) And in a close case, in jurors' minds, evidence of a best-mode failure might help tip the balance against validity on other grounds.
- hcknwscommenter 5y agoThe very act of providing the product to the market place is a sufficient disclosure of "how to make the thing at all" for anyone with a modest level of skill in this field. Moreover, there are plenty of detailed descriptions in Moderna's patent filings and other publicly available sources on how to make the thing at all. The issue is very much one of scale and I would wager that Moderna doesn't quite have the expertise either to reproduce their manufacturing pipeline at will. I have have personally witnessed a massive project failure in moving a therapeutic molecule from one manufacturing site to another, presumed identically equipped, manufacturing site. These things are not easy. It may be that this South African startup actually cannot use much of the information Moderna has on how to manufacture at scale because it only reproduces in Moderna's hands at Moderna's sites. This would be the expected outcome really.
- tshaddox 5y agoThey should have to disclose the subsequent work if they want patent protection for that subsequent work, right?
- frenchy 5y agoWell lets say you have a process that requires stage A and then stage B to make product C, but stage B can't be done without A, and the result of B isn't useful by itself. Then you patent stage A and keep stage B secret. I'm not a patent expert, but this seems to break the social contract of patents. Perhaps there is something in the patent law that prevents this?
- hcknwscommenter 5y agoStage A must be provably useful, provably non-obvious, and provably new.
- virgilp 5y ago[edit] Apparently, I'm wrong, "utility" is an explicit requirement. But let me tell you, nobody ever asked me to justify the utility, not even a little bit. I think it's just assumed that if you're willing to pay the patent fees, it's likely to have some utility. ---- AFAIK there's isn't. You can patent a leash for rodents, and PTO is not going to say "it's not acceptable, nobody wants to put rodents on a leash". The only questions are whether your invention is novel and non-obvious, not whether it's useful. As such, if you can patent stage A that produces <unuseful stuff B>, nobody will tell you that it's unacceptable because B isn't useful. The usefulness is a completely separate question, to be decided by the market.
- tshaddox 5y agoA company could do that, but what advantage is there to doing that over simply keeping stage A a secret? By patenting stage A, you are awarded a temporary monopoly over stage A but also giving competitors a head start to reverse engineer stage B. By not patenting stage A, you don't get the temporary monopoly, but you also don't publicize anything about stage A that would give competitors the head start on stage B. So it's the same tradeoff that always exists with patents.
- dctoedt 5y ago> It's an enabling patent, best-mode, etc. It'd be interesting to dig into the inventor's and patent attorney's files on that score.
- DangerousPie 5y agoPresumably there are parts which are patented and public (how the vaccine works in principle), and then there are parts which are not patented but a trade secret (how to actually manufacture it at scale). This kind of thing is very common.
- flyinghamster 5y agoI've seen this thing in other areas too. One particular radio telemetry system has all sorts of patents surrounding it dating to the 1980s, all of which leave out critical details of the system.
- clairity 5y agonot just common, but encouraged by the regulatory and competitive environment. big companies like ibm offer patent bounties, so employees are incentivized to break improvements up into the smallest possible elements that will pass muster with the patent office so that they can maximize the amount of bounty granted per advancement. similarly, companies like to lay minefields of patents around any given technology so that if they’re the market leader, they can slow down competition, but if they don’t have the winning version, they’re at least likely to get some royalties for the patents they have. it’s perverse.
- mattnewton 5y agoMy (limited) understanding here is that the US patent doesn't grant a monopoly to Moderna internationally and that breaks down the quid quo pro here. Other countries can and probably will nationalize the vaccine production and not pay Moderna licensing fees, or offer a take-it-or-leave-it pittance. I agree this is a major breakdown though and given the circumstances I wish Moderna could have just been paid off some small licensing fees and collaborated with this other company instead of wasting time reverse engineering a lifesaving vaccine.
- gpm 5y agoFrom an IP perspective, if Moderna doesn't think the benefit of disclosing the invention is worth the value of the patent (and you present a coherent argument for that), that's ok, they can not have a patent. But we shouldn't let them have their cake (the patent) and eat it to (not disclose the invention). From a broader world perspective it's also pretty terrible that time is being wasted reverse engineering this instead of licensing it during a pandemic, but that's largely a separate discussion.
- Retric 5y agoThey have publicly agreed not to go after anyone that uses that patent. Patent trolls effectively force their hands into applying for a patent, but they only bothered in the US due to how crazy our IP system is. The only way they could have made this more open is to actively sent people to train other companies, but frankly their are several different vaccines available so it’s hardly in them.
- olalonde 5y agoThere is no such thing as a worldwide patent. A US patent only grants protection in the US. Presumably they have applied for patents in several countries though.
- FemmeAndroid 5y ago> There is no such thing as an international patent. Sure there are: - ARIPO patents can protect in Botswana, Eswatini, Gambia, Ghana, Kenya, Lesotho, Liberia, Malawi, Mozambique, Namibia, Rwanda, Sao Tome and Principe, Sierra Leone, Somalia, the Sudan, the United Republic of Tanzania, Uganda, Zambia and Zimbabwe. - GCC patents can protect in United Arab Emirates, Saudi Arabia, Qatar, Oman, Kuwait and Bahrain. - Eurasian patents can protect in Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russian Federation, Tajikistan and Turkmenistan. - EPO patents can protect in too many countries to list. - Hague design patents can protect in too many countries to list. The point that patents are regional is definitely true, and country specific patents tend not to provide protections in other countries. but I figured I'd mention that there are many multi-country regions which are certainly international patents. :) I should also point out that while a 'US patent' might not provide international protection, most people looking for international protections will probably be using the PCT (Patent Cooperation Treaty) or other mechanisms for multi-country filings, with is another mechanism through which you can make one international application to most countries. For some basics of how the PCT works, see: https://www.wipo.int/pct/en/faqs/faqs.html https://www.wipo.int/pct/en/faqs/faqs.html
- folli 5y agoI'm not sure I follow your line of argumentation. I would expect that any product with some degree of complexity (such as in Biotech) you have on the one hand patent protection of the application of the product and on the other hand hard earned knowledge on how to actually produce the product with efficient yield and consistency etc. (which you could consider trade secrets).
- Cerium 5y agoIn theory a patent is where you provide full details such that another practitioner of the same art can replicate your efforts and in exchange you receive government protection from competition for a period of time. According to the US patent office [1]: The specification must include a written description of the invention and of the manner and process of making and using it, and is required to be in such full, clear, concise, and exact terms as to enable any person skilled in the technological area to which the invention pertains, or with which it is most nearly connected, to make and use the same. If the patent is not detailed or clear enough to enable replication, then it has not met the requirements of the patent office. [1] https://www.uspto.gov/patents/basics/general-information-patents https://www.uspto.gov/patents/basics/general-information-pat...
- Arnt 5y agoRight. But there's no requirement that if you're a skilled practitioner of the art and you read all of the patents (seven in this case), then you'll be able to replicate any particular product that uses those seven (and perhaps many other patents). You have to know those seven to replicate the Moderna vaccine, but there's no guarantee that knowing those seven will be enough. Moderna is allowed to use unpublished information as well, or unpatentable inventions, or patentable but unpatented parts/processes, or outsourcing, or purchased parts.
- stonemetal12 5y agoIf they want a patent on the vaccine then they must provide "full, clear, concise, and exact terms as to enable any person skilled in the technological area to which the invention pertains, or with which it is most nearly connected, to make and use the same." So the one patent on the vaccine should be enough, the other seven tools of the trade patents are a red herring. "use unpublished information as well" nope that would fail the "full and clear" terms of a patent.
- dekhn 5y agothe patents in question don't cover all the details required to make a working vaccine. I do generally believe that patent owners should be required to license their technology for reasonable fees but many decide to set fees which are too high so nobody licenses it.
- Arnt 5y agoAIUI they have no patent protection on their vaccines, but rather on some patented inventions (processes or whatever). That is, there is no requirement to make a product from exactly one single invention, or to disclose details of unpatented processes or parts of a product. Do you think there should be such a requirement?
- eganist 5y agoso to simplify: they have patent protection on some elements of the vaccine, but the formulation or method for formulation (i.e recipe) is a trade secret? am I understanding correctly? because if so, then yeah it doesn't seem like Moderna's actually doing anything wrong.
- gpm 5y agoPart of the benefit of making a moral argument (rather than a legal one), is I can avoid giving an exact test for what should and shouldn't be patentable. Yes, I think there should be some minimal "unit of invention", and that in this case it's pretty clearly the vaccine as a whole. "Part of the vaccine" isn't of benefit to society, so disclosing how to make that isn't meeting your end of the bargain. Yes, I also think that there are probably other cases where a single product has two unrelated subsystems, and it makes sense you could have patents on both of them. For example in a cell phone, a different patent on the antenna and the barometer would make sense, since they really haven nothing to do with eachother and disclosure of each individually benefits society.
- Arnt 5y agoIs that clear? The contrapositive of that is that Moderna invented nothing in its first nine or ten years — none of the research that led to this vaccine counts as a patentable invention.
- gpm 5y agoMorally, yes. A patent needs to have utility for the quid quo pro to make any sense, it's the end products that have utility. Patenting necessary intermediates without disclosing the end products serves to retard innovation by everyone else without giving them the reward once the temporary monopoly expires. Legally, I would not be at all surprised to find out you were right.
- credit_guy 5y agoOn the contrary, if you read carefully the article, you'll see that Moderna went out of their way to maximize the good they can do. They stated multiple times that they will let anyone who wants to manufacture their vaccine to do so, without them pursuing patent protection. They also went into some details how do make the vaccine. Now, no matter how many details one gives, for someone without manufacturing expertise in that domain, the details will be insufficient. Think for example at the famous Saturn V engines F1. Almost one hundred were produced, quite a number of them are still around in various museums, all the blueprints exist, yet no one can make them again, because some know-how was lost [1]. I don't think it's so easy for Moderna to just "share the vaccine recipe". At least not to such a degree to enable someone who admits they "never formulated a liquid nanoparticle" to start doing that just following a few pages of explanation. [1] https://ourplnt.com/remake-rocketdyne-f-1-engine-humans-moon/ https://ourplnt.com/remake-rocketdyne-f-1-engine-humans-moon...
- alex_young 5y agoIsn't it absolutely insane that we are resource constrained on solving a pandemic nearly 2 years into it? The fact that the resource in question is a secret recipe is just astounding. If all of humanity worked to end this collectively, we would all be immensely better off. There shouldn't be moral questions about getting a third dose or sending it to countries without supply. The reason for this is astounding and unbelievable profit based on decades of US federal research funding. Moderna's most recent financial results: "Total revenue was $6.3 billion for the six months ended June 30, 2021, compared to $75 million for the same period in 2020" https://investors.modernatx.com/news-releases/news-release-details/moderna-reports-second-quarter-fiscal-year-2021-financial#:~:text=Total%20revenue%20was%20%246.3%20billion,a%20lesser%20extent%2C%20grant%20revenue https://investors.modernatx.com/news-releases/news-release-d....
- lotsofpulp 5y agoWhile you might have a point about private companies profiting from US taxpayer funded research, I do not understand the purpose of comparing a company's revenue before their product was being sold to their revenue after their product started to be sold.
- jdavis703 5y agoThere are many cases where a manufacturing process is not at all innovative but the end product is. Consider the humble computer mouse. There was no manufacturing ingenuity needed to build it. I don’t know enough about pharmaceutical manufacturing, but it’s quite possible Moderna and Pfizer don’t own any manufacturing IP (if I understand correctly some of their specialized equipment is developed by other companies). That means all they can really patent is their chemistry.
- adrr 5y agoYou can have patent on the end product but manufacturing details are trade secrets.
- justinzollars 5y agoNo it should not. The only reason it exists is because of the free market and private sector. Government produces nothing. Forced technology transfer to a criminal gang (government), will reduce future tech availability and reduce innovation. We will literally have fewer vaccines. The reward for producing the vaccine, will provide more vaccines in the future. Moderna is a better capital allocator than the criminals in government.
- MattRix 5y agoThen why did Moderna require a billion dollars of government money?
- justinzollars 5y agoThey would have financed it, and created it with or without the government. However government cash, without Moderna would have never created a vaccine. Similar to how California, after 10 years and 20 billion dollars never created a high speed rail.
- SllX 5y agoSorry, but why can’t a complex invention be covered in part by patents and in part by trade secret and maybe some other parts of it is just public domain knowledge? I understand you are attempting to make a moral argument and not a legal one, but I’m not seeing your position because I don’t understand from what you have commentated so far why this is immoral.