# Is it legal to make (or give instructions to make) your own personal supply of a patented drug? **URL:** \ **Category:** Factual Questions\ **Created:** [December 15, 2015, 9:06am UTC](https://boards.straightdope.com/t/is-it-legal-to-make-or-give-instructions-to-make-your-own-personal-supply-of-a-patented-drug/740515 "2015-12-15T09:06:34Z")\ **Posts on this page:** 15\ **Page:** 2
**Author:** ![Acsenray](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/acsenray/32/4519_2.png) [@Acsenray](https://boards.straightdope.com/u/Acsenray)\ **Post date:** [December 16, 2015, 8:26pm UTC](https://boards.straightdope.com/t/is-it-legal-to-make-or-give-instructions-to-make-your-own-personal-supply-of-a-patented-drug/740515/21 "2015-12-16T20:26:59Z")
> [@jtur88](#): > > Take the case of the Paper Clip, US581901, Patented May 4, 1897. Would it be a patent infringement or illegal in any other way for a person, in the privacy of his home, to bend a piece of scrap wire in such a manner that it could be used to function as a paper clip, for his own personal use? > > How would that differ from the scenario of a pharmaceutical? The difference is that the paper clip patent expired in 1914. Has it not, then it would be an infringement. ( As an aside, Note that this patent is not for the familiar “gem” style paper clip.) ---
**Author:** ![ftg](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/ftg/32/2801_2.png) [@ftg](https://boards.straightdope.com/u/ftg)\ **Post date:** [December 18, 2015, 9:36pm UTC](https://boards.straightdope.com/t/is-it-legal-to-make-or-give-instructions-to-make-your-own-personal-supply-of-a-patented-drug/740515/22 "2015-12-18T21:36:40Z")
> [@Ruken](#): > > There is a “research exemption”, but it’s pretty narrow. > [Research exemption - Wikipedia](https://en.m.wikipedia.org/wiki/Research_exemption) It’s not really all that narrow. The case law is over 200 years old now. You can make something that might otherwise infringe a patent if you are trying to study it. E.g., figure out how to make it better, whether it will suit your needs, etc. As long as the “research” aspect is clear and you don’t use the device for any useful purpose or try to distribute it, you’re good. As to the particular case of drugs, there’s a [specific law](https://en.wikipedia.org/wiki/Drug_Price_Competition_and_Patent_Term_Restoration_Act) written to make sure that companies are in a position to start distributing a drug once the patent expires. This is because FDA approval and all takes a long time. Too many people equate “research use” with drugs when it is a much broader exception. But as regards to the OP: Is the OP a pharma company? Are the samples produced intended to be tested only and not used on oneself? I don’t think so. ---
**Author:** ![Little\_Nemo](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/little_nemo/32/3120_2.png) [@Little\_Nemo](https://boards.straightdope.com/u/Little_Nemo)\ **Post date:** [December 18, 2015, 10:32pm UTC](https://boards.straightdope.com/t/is-it-legal-to-make-or-give-instructions-to-make-your-own-personal-supply-of-a-patented-drug/740515/23 "2015-12-18T22:32:52Z")
Eli Whitney lost a fortune over this issue. If you remember your school lessons, Whitney invented the cotton gin, which made the mass production of cotton as a commodity possible. And Whitney naturally patented his invention. His problem was that while it took some brilliance to invent a cotton gin, it was one of those simple obvious ideas once it had been invented. Anybody who was moderately handy with tools could build a cotton gin once they had seen one. So cotton gins became really popular machines but Whitney hardly sold any of them. ---
**Author:** ![usedtobe](https://avatars.discourse-cdn.com/v4/letter/u/ec9cab/32.png) [@usedtobe](https://boards.straightdope.com/u/usedtobe)\ **Post date:** [December 19, 2015, 6:35am UTC](https://boards.straightdope.com/t/is-it-legal-to-make-or-give-instructions-to-make-your-own-personal-supply-of-a-patented-drug/740515/24 "2015-12-19T06:35:45Z")
> [@kayaker](#): > > After a complicated cholecystectomy, my surgeon sent Acetaminophen with codeine for pain. The two drugs are combined, in part, to make misuse more difficult. > > I didn’t want to take all that acetaminophen, so I did some home chemistry to remove most of it. > > I wonder if that was illegal. Actually, codeine is available at the pharmacy window - no script required. I remember my father signing a book and getting it back when I was about 6 or 7. Just for giggles, I asked the pharmacist if it was still available. She said yes. (of course, I had just picked up a script for morphine, so she might have been more forward with me than with a complete stranger) ---
**Author:** ![usedtobe](https://avatars.discourse-cdn.com/v4/letter/u/ec9cab/32.png) [@usedtobe](https://boards.straightdope.com/u/usedtobe)\ **Post date:** [December 19, 2015, 6:44am UTC](https://boards.straightdope.com/t/is-it-legal-to-make-or-give-instructions-to-make-your-own-personal-supply-of-a-patented-drug/740515/25 "2015-12-19T06:44:10Z")
Look up the patent for the ballpoint pen - it took a while to get to market, but when it did, it was instantly copied and the patent ignored. ---
**Author:** ![kayaker](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/kayaker/32/441_2.png) [@kayaker](https://boards.straightdope.com/u/kayaker)\ **Post date:** [December 19, 2015, 12:30pm UTC](https://boards.straightdope.com/t/is-it-legal-to-make-or-give-instructions-to-make-your-own-personal-supply-of-a-patented-drug/740515/26 "2015-12-19T12:30:15Z")
> [@usedtobe](#): > > Actually, codeine is available at the pharmacy window - no script required. In Pennsylvania, US codeine is a schedule II narcotic. Acetaminophen with codeine is schedule III. ---
**Author:** ![md2000](https://avatars.discourse-cdn.com/v4/letter/m/73ab20/32.png) [@md2000](https://boards.straightdope.com/u/md2000)\ **Post date:** [December 19, 2015, 4:26pm UTC](https://boards.straightdope.com/t/is-it-legal-to-make-or-give-instructions-to-make-your-own-personal-supply-of-a-patented-drug/740515/27 "2015-12-19T16:26:19Z")
> [@kayaker](#): > > In Pennsylvania, US codeine is a schedule II narcotic. Acetaminophen with codeine is schedule III. Just heard something on the news that you will not be able to by acetaminophen-codeine (T1?) over the counter any more as a lot of addicts were overconsuming acetaminophen with all the medical problems that caused. ---
**Author:** ![md2000](https://avatars.discourse-cdn.com/v4/letter/m/73ab20/32.png) [@md2000](https://boards.straightdope.com/u/md2000)\ **Post date:** [December 19, 2015, 4:35pm UTC](https://boards.straightdope.com/t/is-it-legal-to-make-or-give-instructions-to-make-your-own-personal-supply-of-a-patented-drug/740515/28 "2015-12-19T16:35:17Z")
> [@Little\_Nemo](#): > > Eli Whitney lost a fortune over this issue. If you remember your school lessons, Whitney invented the cotton gin, which made the mass production of cotton as a commodity possible. And Whitney naturally patented his invention. > > His problem was that while it took some brilliance to invent a cotton gin, it was one of those simple obvious ideas once it had been invented. Anybody who was moderately handy with tools could build a cotton gin once they had seen one. So cotton gins became really popular machines but Whitney hardly sold any of them. This is the heart of the OP’s question. It’s not “illegal” it’s a civil case. Eli could have gone after every plantation in the south, one by one, and sued. Assuming he got a fair trial, suing some rich people in their home state, in states legendary for their justice, he would have barely collected enough to pay his lawyers. Plus, he’d need to somehow prove that they had copies of his device; most of the witnesses would be property and not qualified or motivated to testify. Rinse and repeat 10,000 times. This is the problem - yes, you are not allowed to do so, but it’s not worth the pharma company going after you, unless you are going to be a life example to others or you have plenty of assets. Copyright used to be the same until digital music and video, and the internets, made it possible for an amateur, with minimal cost to themselves, to share movies and music with a few million of their closest friends. Now much of copyright violation is not just a civil wrong but a criminal wrong. I assume if pharam-copying becomes a serious drain on their profits the big businesses will buy the necessary criminal laws, as the music and movie industry have. ---
**Author:** ![Acsenray](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/acsenray/32/4519_2.png) [@Acsenray](https://boards.straightdope.com/u/Acsenray)\ **Post date:** [December 19, 2015, 5:21pm UTC](https://boards.straightdope.com/t/is-it-legal-to-make-or-give-instructions-to-make-your-own-personal-supply-of-a-patented-drug/740515/29 "2015-12-19T17:21:47Z")
> [@md2000](#): > > Copyright used to be the same until digital music and video, and the internets, made it possible for an amateur, with minimal cost to themselves, to share movies and music with a few million of their closest friends. Now much of copyright violation is not just a civil wrong but a criminal wrong… I don’t understand what you mean by “now” here. Criminal copyright infringement has been part of the law since before widespread use of the Internet. ---
**Author:** ![ftg](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/ftg/32/2801_2.png) [@ftg](https://boards.straightdope.com/u/ftg)\ **Post date:** [December 19, 2015, 10:06pm UTC](https://boards.straightdope.com/t/is-it-legal-to-make-or-give-instructions-to-make-your-own-personal-supply-of-a-patented-drug/740515/30 "2015-12-19T22:06:07Z")
> [@Acsenray](#): > > I don’t understand what you mean by “now” here. Criminal copyright infringement has been part of the law since before widespread use of the Internet. The twisted history of US Copyright law makes those kinds of statements commonplace. In particular how the law changes differently for different types of works. Misdemeanor criminal offense goes back over a hundred years, starting with performances of music (I think). Other forms got protected later. Most felony infringement laws got added in 1982 and 1992. It’s the 1992 amendment that really changed things for most people and is linked to online sharing as that is when things really started to take off. So “New felony copyright laws started in 1992.” gets morphed into “Criminal copyright laws started when the Internet began.” ---
**Author:** ![md2000](https://avatars.discourse-cdn.com/v4/letter/m/73ab20/32.png) [@md2000](https://boards.straightdope.com/u/md2000)\ **Post date:** [December 21, 2015, 7:16am UTC](https://boards.straightdope.com/t/is-it-legal-to-make-or-give-instructions-to-make-your-own-personal-supply-of-a-patented-drug/740515/31 "2015-12-21T07:16:52Z")
> [@ftg](#): > > The twisted history of US Copyright law makes those kinds of statements commonplace. In particular how the law changes differently for different types of works. > > Misdemeanor criminal offense goes back over a hundred years, starting with performances of music (I think). Other forms got protected later. Most felony infringement laws got added in 1982 and 1992. It’s the 1992 amendment that really changed things for most people and is linked to online sharing as that is when things really started to take off. > > So “New felony copyright laws started in 1992.” gets morphed into “Criminal copyright laws started when the Internet began.” This is what I find: not 1992 but 1997, and only then (with sharing sites, then Napster in mind) - the law added non-profit infringement to the criminal compendium. So yes, a change pretty much directly aimed at internet sharing. Before then, only willful for profit violations were criminal. [http://www.unc.edu/~unclng/copy-corner66.htm](http://www.unc.edu/~unclng/copy-corner66.htm) > [@](#): > > The most recent amendment to criminal copyright infringement was the No Electronic Theft Act of 1997 (NetAct) which made it a felony to reproduce or distribute copies of copyrighted works electronically regardless of whether the defendant had a profit motive. Thus, it changed the 100-year standard regarding profit motive but retained the element of willfulness. The ease of infringement on the Internet was the primary reason for criminalizing noncommercial infringement as well as recognition of other motivations a nonprofit defendant might have such as anti-copyright or anti-corporate sentiment, trying to make a name in the Internet world and wanting to be a cyber renegade. > > So, the infringement must be either: (1) for purposes of commercial advantage or private financial gain or (2) involve the reproduction or distribution of one or more copies of a work or works within a 180-day period with a total retail value of $1,000. Commercial infringers are subject to higher penalties, however. A commercially motivated infringer can receive up to a five-year federal prison term and $250,000 in fines; a noncommercial willful infringer is subject to up to a one-year prison term and $100,000 in fines. The prison term maximum for repeat infringers is up to 10 years for commercially motivated ones and up to six years for noncommercial infringers ---
**Author:** ![ftg](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/ftg/32/2801_2.png) [@ftg](https://boards.straightdope.com/u/ftg)\ **Post date:** [December 21, 2015, 9:56pm UTC](https://boards.straightdope.com/t/is-it-legal-to-make-or-give-instructions-to-make-your-own-personal-supply-of-a-patented-drug/740515/32 "2015-12-21T21:56:12Z")
> [@md2000](#): > > This is what I find: not 1992 but 1997, and only then (with sharing sites, then Napster in mind) - the law added non-profit infringement to the criminal compendium. So yes, a change pretty much directly aimed at internet sharing. Like I said, there history of copyright law is complicated. A _lot_ of changes over the years. You need to be some sort of legal thingee person to know all about them. The one I was referring to, The Felony Copyright Act of 1992, is discussed at length in [this](http://ipmall.info/hosted_resources/CyberCrime/CFAleghist.pdf) PDF. ---
**Author:** ![Acsenray](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/acsenray/32/4519_2.png) [@Acsenray](https://boards.straightdope.com/u/Acsenray)\ **Post date:** [December 22, 2015, 5:19am UTC](https://boards.straightdope.com/t/is-it-legal-to-make-or-give-instructions-to-make-your-own-personal-supply-of-a-patented-drug/740515/33 "2015-12-22T05:19:28Z")
So criminal penalties for massive infringement through non-profit-generating file-sharing were created after massive infringement through non-profit generating file-sharing became technologically easy to do and people started doing it more often. That sounds much less dire than something like “criminal copyright infringement was created after the Internet became popular.” Indeed it sounds much like almost any other kind of crime—laws are created once people become aware that a problem is arising. ---
**Author:** ![md2000](https://avatars.discourse-cdn.com/v4/letter/m/73ab20/32.png) [@md2000](https://boards.straightdope.com/u/md2000)\ **Post date:** [December 22, 2015, 5:34am UTC](https://boards.straightdope.com/t/is-it-legal-to-make-or-give-instructions-to-make-your-own-personal-supply-of-a-patented-drug/740515/34 "2015-12-22T05:34:01Z")
> [@Acsenray](#): > > So criminal penalties for massive infringement through non-profit-generating file-sharing were created after massive infringement through non-profit generating file-sharing became technologically easy to do and people started doing it more often. > > That sounds much less dire than something like “criminal copyright infringement was created after the Internet became popular.” > > Indeed it sounds much like almost any other kind of crime—laws are created once people become aware that a problem is arising. Well yeah. If your business was selling CDs for a goodly markup, wouldn’t you freak when people start sharing them electronically with a few million of their closest friends - for free, and just by letting their computers sit there? before that, nobody made enough money to sue over private copying unless they had industrial-scale production facilities. One of the guys I worked with went to school with a fellow who was sued by Playboy. Apparently in the early days of BBS’s, when CD’s were just becoming standard on PC’s, these guys collected a wad of porn from various BBS’s, bought a CD burner, and advertised a CD full of images for sale in the back of assorted computer magazines. I’m told they made thousands of dollars mail-ordering these. Of course images were scanned from magazines, usually - so when Playboy tracked them down, they made them sign over their profits and sign a fairly thick legal agreement that they would refrain from violating Playboy’s copyright ever again. (I remember him razzing the guy when he tried to correct us on some computer question - “How thick was that agreement with Playboy you were forced to sign?”) the point is, that sort of thing is possible when you can recover thousands of dollars from some teenagers with a little legal negotiation and some fancy suited lawyers, but fails utterly when there’s no money to be recovered and it’s a million whack-a-moles at a time. Then it’s time to use the congresscritter you bought, and make it criminal. ---
**Author:** ![Acsenray](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/acsenray/32/4519_2.png) [@Acsenray](https://boards.straightdope.com/u/Acsenray)\ **Post date:** [December 22, 2015, 5:45am UTC](https://boards.straightdope.com/t/is-it-legal-to-make-or-give-instructions-to-make-your-own-personal-supply-of-a-patented-drug/740515/35 "2015-12-22T05:45:00Z")
Again, something is made criminal when it becomes a problem. Why was it necessary to throw in a slur about “bought … Congresscritter”? [Previous page](https://boards.straightdope.com/t/is-it-legal-to-make-or-give-instructions-to-make-your-own-personal-supply-of-a-patented-drug/740515.md?page=1)