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3D Patent Legislation

Gerard Magliocca

Gerard N. Magliocca is the Samuel R. Rosen Professor at the Indiana University Robert H. McKinney School of Law. Professor Magliocca is the author of three books and over twenty articles on constitutional law and intellectual property. He received his undergraduate degree from Stanford, his law degree from Yale, and joined the faculty after two years as an attorney at Covington and Burling and one year as a law clerk for Judge Guido Calabresi on the United States Court of Appeals for the Second Circuit. Professor Magliocca has received the Best New Professor Award and the Black Cane (Most Outstanding Professor) from the student body, and in 2008 held the Fulbright-Dow Distinguished Research Chair of the Roosevelt Study Center in Middelburg, The Netherlands. He was elected to the American Law Institute (ALI) in 2013.

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21 Responses

  1. AndyK says:

    With respect to (2), it’s also worrying, things of this nature; http://legalnewsline.com/issues/big-pharma/239717-brand-name-drug-makers-ask-ala-sc-to-rehear-case-over-innovator-liability.

    Courts need to be careful not to fashion rules that will attach product liability to patentees when folks 3D print those (let’s say) devices and someone gets hurt.

  2. Shag from Brookline says:

    3D or not 3D, is that the question? Gun nuts may assert the Second Amendment in the manner of Hamlet:

    “Whether ’tis nobler in the mind to suffer
    The slings and arrows of outrageous fortune,
    Or to take arms against a sea of troubles
    And by opposing end them. ”

    in addressing concerns noted in point 2 of the post..

  3. prometheefeu says:

    AndyK,

    The article you linked to does not speak of creating liability for patentees. Here, Pfizer is alleged to have breached a duty to inform doctors of the side-effects of the product it sells. It seems pretty clear that merely holding the patent would not cause liability to attach. The only weird thing here is that the person suing purchased another identical product. But if Pfizer wanted to free itself of that liability, it could stop producing the drug. It is a little weird that the presence of the generic version in effect multiplies Pfizer’s liability, but it is inaccurate to say that it is Pfizer as a patentee that is liable.

  4. Richard says:

    Just came across your blog and found it really interesting. I have just started a blog with a colleague and are looking for inspiration – keep up the good work – cheers!

    Richard

  5. A.J. Sutter says:

    With respect to (1), what’s new about “the fact that liability is possible could chill a lot of useful research and tinkering”? Hasn’t that been the case prior to the spread of 3D printing as well?

    And given the safety concerns you mention in (2), might the chilling effect actually be a good thing? Or is the post’s last sentence actually intended to be read as if the clause “used by vested interests in the 2D patent system” were stricken? Would safety concerns categorically not be a valid reason to limit the spread of the technology? Would you prefer to regulate safety by limiting the availability of fair use/de minimis infringement exemptions? Or do you take the Milton Friedman position, of leaving safety issues to the market?

    More broadly, why have a bias in favor of the proliferation of the technology at all? How about a more precautionary approach, whereby the technology’s release is heavily regulated at first, until we can get a better handle on what kinds of social problems it raises? I realize that this bias is widely shared, and is aggressively promoted by Cass Sunstein and others, but it ought to be questioned. (Cf., e.g., Douglas Kysar’s eloquent defense of the precautionary principle in the environmental context.)

    (BTW, what is the “2D patent system” — isn’t this a misplaced modifier? There are plenty of patents on 3D things already, and I don’t expect the PTO is going to start sculpting the patents it issues, as opposed to issuing paper versions of them, anytime soon.)

  6. AF says:

    Like AJ Sutter, I’m not understanding the novel issue here. Why do you anticipate that 3D printing will bring on a groundswell of socially beneficial patent infringement beyond what currently exists?

  7. Gerard says:

    Well, I could turn the question around and ask why you think it won’t? The VCR and digital distribution of music examples, I submit, support my view.

  8. AF says:

    Professor Magliocca, that is one of the stranger attempts at burden-shifting I have ever seen. Is the idea that all technological innovations are presumptively likely to upend patent law and require a legislative response? If not the burden would seem to be on you to explain why 3D printing is likely to do so.

    Your reference to VCRs and digital distribution suggests that you see 3D printing’s impact on patent law as analogous to the digital revolution’s impact on copyright law. I don’t think the analogy holds for a variety of reasons, eg, that the portion of 3-dimensional objects that are patent-protected is far lower than the portion of digital content that is subject to copyright; and, even more fundamentally, that 3D printers seem far less capable of producing serviceable copies of patented products than VCRs and computers are of producing acceptable copies of movies and music (anyone interested in a 3D-printed iphone? Segway? Lipitor pill?)

    What would be an example of a product currently under patent protection that could be replaced by a 3D printer in the foreseeable future?

  9. Gerard Magliocca says:

    Well, it’s fine to say that no legislative response is necessary now. The paper is an attempt to lay down some markers for the future. If 3D printing turns out to be a bust, then no harm is done.

    Plenty of people, I think, are going to want 3D printed pills someday, especially if they can’t easily get to a pharmacy and need medicine. You may not trust them, but then again many people are still skeptical of buying things on Amazon.

  10. AF says:

    How in the world would a 3D printer facilitate the creation of patented pharmaceuticals? What raw material would be used? Are these printers going to double as state-of-the-art chemistry labs? Even if they were, patent law would hardly be their biggest obstacle. Any company that distributed the raw materials for 3D-printed medicines (patented or unpatented) would get a very quick visit from the FDA.

    I can’t imagine how 3D printing technology could be used for anything besides relatively simple mechanical products; the manufacture of other products (chemical, electronic, biological, etc.) requires much more than effectively fabricating 3-dimensional shapes. And there just aren’t that many relatively simple mechanical products that are under patent. Certain medical devices and components I guess. But it’s very hard to imagine widespread patent infringement.

    If anything, 3D printing seems to raise more significant copyright, trademark, and trade dress issues than it does patent issues.

  11. AW says:

    Hi there,

    wondering whether this paper has been published already, would love to read a bit more about this.

    Thanks! Keep it going.

  12. Brett Bellmore says:

    “How in the world would a 3D printer facilitate the creation of patented pharmaceuticals?”

    I suppose the idea is that 3d printers could eventually become something like Drexlerian nano-factories, in the same manner adding machines eventually became desktop computers. Increasing in power and versatility until they were capable of producing arbitrary molecular structures. It’s not entirely infeasible.

  13. AF says:

    Fair enough, Brett Bellmore, but that’s science fiction. Nothing like that is on the horizon.

  14. Brett Bellmore says:

    Science fiction

    A lot of pharmaceuticals, some of them quite illegal, are not all that complex in their synthesis. An automated chem lab capable of churning out single dose amounts in a matter of hours does not strike me as infeasible. Probably end up regulated up the wazoo, though.

  15. Shag from Brookline says:

    Brett’s “meth-odd” goes beyond sci-fi based upon his claim of non-infeasibility. (How about a chorus of “Nothing’s Impossible.”)

  16. AF says:

    Brett: The fact that you can use 3D printers loaded with silicone-based sealant to print custom labware hardly suggests that the technology will exist in the foreseeable future to print patented drugs — ie, drugs discovered within the past 20 years — more cheaply than buying them.

    I agree that the printing of pharmaceuticals that are “not all that complex in their synthesis” is easier to imagine. However, few such pharmaceuticals are patented. And as you suggest, this sort of technology will butt up against pharmaceutical regulations long before it runs into patent law.

  17. A.J. Sutter says:

    I’m happy to be corrected by a chemical engineer, but I think the pharmaceuticals are a distraction here. One needs to distinguish among fabrication processes. Printing is a deposition process, and deposition per se doesn’t involve any chemical changes. There may be some simple chemical changes that can be initiated by using a light source, such as the “curing” of certain polymer resins; but even there, the same light source won’t necessarily work for all resins. Granted that there may be ways to print successive layers of substances that chemically interact in a safe and controllable way; but in general, the chemical synthesis of a complex molecule from simpler materials may require many different steps, using a variety of catalysts, other reagents, and physical conditions (temperature, pressure, etc.). Different chemical bonds often need quite different conditions in order to form — chemistry isn’t like Drexlerian TinkerToys.

    This is especially true of pharmaceuticals, which often include rings with bonds that aren’t so easy to form. E.g., compare the simple structure of methaphetamine to the more complicated structures of Lipitor or LSD.Plus, forming bonds isn’t enough — you often need to get a particular stereoisomer for the molecules to have the desired effect. Only one of the 2 forms of meth (the link shows a version with a carbon coming out of the page; there’s also a form where that carbon sticks out behind the page) and only one of the 4 stereoisomers of LSD are psychoactive. Even if ingesting an unpurified mixture of the forms of a particular drug doesn’t have worse health consequences than ingesting the purified form, that isn’t true for all pharmaceuticals. (Actually, illegal meth is usually a mixture, and I’m not sure that it is so benign.) I doubt that 3D printing is the right way to characterize this, nor does it seem likely that the 3D printers to be commercialized will include such sophisticated and multi-product chemical reactors and product purification means.

  18. A.J. Sutter says:

    Correction: the L-enantiomer of methamphetamine is an over-the-counter nasal decongestant, so racemic meth (a mix of the L- and D-forms, the latter being the stimulant) doesn’t seem to be radically worse for health than the pure D-form.

  19. Brett Bellmore says:

    AF, while there currently isn’t any desktop appliance that will take simple chemicals, and output complex ones under software control, there certainly trends in that direction. Polypeptide synthesis, DNA synthesis, “lab on a chip systems”, they likely will converge in time to produce such an appliance.

    And while no desktop machine is going to manufacture any given chemical more cheaply than a dedicated factory, there are already plenty of drugs which can be manufactured on a small scale more cheaply than they’re *sold*; Why, when I went through chemo a few years ago, one of the drugs cost so much I could have tooled up the synthesize it for the cost of a couple doses.

    Not that I was being robbed, I understand quite well that each successful drug must carry the load for many drugs which failed to reach the market.

    But it has to be understood that, while synthesizing novel chemical structures requires a fair amount of intelligence, following a cookbook recipe for an old structure is well within the capacity of robotics. It’s only a matter of time before chemical fabbers join 3d printers.

    The legal obstacles will be bigger than the technical ones.

  20. AF says:

    Brett, I’ll defer to you on how far we are away from desktop drug manufacturing. But for unskilled consumers to be able to manufacture a particular drug (or any other complex technology) at home, someone with skill in the technological field is going to have to provide software and kits of raw materials that are specifically designed to allow consumers to create that product. Creating complex technology “from scratch” at home using general purpose machinery and materials, even with the benefit of a “cookbook,” takes a level skill and dedication that is always going to be relatively rare in the general population.

    From the perspective of patent law, the possibility that skilled technologists will be able to recreate patented technology at lower cost than the monopoly prices charged by patent-holders or to distribute products that allow consumers to do so (which would be inducement of infringement), doesn’t strike me as a particularly novel or difficult problem. The whole point of patent law is to provide inventors with legal protection against such technologically-feasible competition. I suppose the use of software could change things a little given how easy it is to distribute, but you would still need someone to write a specific program for each patented product, knowing that doing so constitutes inducement of patent infringement (and therefore that there is no money in it), and consumers would still have to go out and find the raw materials, which, even if commercially available, are unlikely to be particularly easy or simple to procure for the average consumer. It doesn’t strike me as something that’s going to happen on anything like the scale as digital-music downloading.

  21. Shag from Brookline says:

    Can a 3D printer compete with a table-top still producing my drug of choice?

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