Is it legal to make (or give instructions to make) your own personal supply of a patented drug?

General Questions
#1

I was watching this video. The guy apparently has a decent background in organic chemistry. In this video, he is making propionic acid, with the ultimate aim of making Pyrimethamine. Though he doesn’t discuss it, Pyrimethamine is the drug that is the subject of the recent controversy where a hedge fund bought the sole rights to it and then jacked the price up sky high. See the article on wiki for more information.
My questions are:

  1. Let’s say hypothetically, the guy in the video is HIV positive and is in need of the drug. Is he legally allowed to produce and consume this drug provided he is not selling it or providing it to anyone else? Would it matter if he had a prescription for it?
  2. Would there be any legal ramifications to him giving detailed instructions on how consumers could potentially acquire their own supply of a patented product on the cheap?

Feel free to give answers for your specific location/jurisdiction etc.

#2

It’s not patented. As I understand it, this new company can’t stop you making it, or telling someone else how to make it. What they can do is stop you from selling it under the Daraprim name, and make it difficult to prove to the FDA that your drug is the same as their drug and so it is safe for sale as an alternative.

#3

The patent has the recipe in it. See US2576939 A.

#4

The part of a patent before the claims is called “the teaching.” It is specifically intended to show anyone how to “practice” the patent. Patent protection is granted for the price of allowing the invention into the public domain after it has expired. Teaching that does not adequately explain how to make the invention is one way to defeat a patent.

So publishing a “recipe” is in principal only echoing what is contained in the patent which is publicly available.

#5

Obviously if something is patented, you cannot sell it (or use it in the pursuit of your business?).

The problem with making your own pharmaceuticals, too, is that you have no quality control - if you are that good a chem engineering expert, you can probably afford the doses. Most complex organic molecules are made by inducing reactions in feedstock and then refining out the specific result you want. You may have to repeat this process several times to reach the required purity, and some more complex molecules require multiple steps to make precursors first.

(I have been told by LSD proponents that “bad trips” are the result of impurities in badly formulated batches from amateur chemists. Similarly there’s the case where someone making some drug (badly) in the 70’s in California managed to cause artificial Parkinsons in otherwise healthy druggies. You monkey with you body chemistry at your peril.

#6

Keep in mind that the Patent Act expressly grants the patent holder the right to exclude other “from making” the invention, independent of the right to exclude one from “selling” it.

(emphasis added).

So a person can be liable of patent infringement if he makes a chemical compound that is still under patent protection (subject to some safe harbor provisions). But whether the patent holder will pursue any action against the theoretical infringer is a different story.

#7

To summarise and add info:
(1) It is illegal to make the drug yourself in the country where the drug is patented. If you want to make it in that country where it is patented you have to either get a license from the owner or wait until the patent expires or is invalidated etc. You can however go to another country where no patent for the drug exists and make it all you want.

(2) It is prima facie not illegal to tell someone how to make the patented drug, as the information is already public knowledge due to the requirement that an invention must be disclosed in order to be patented.

#8

The patent on the chemical formula itself expired long ago. Turing has the excluse rights to sell a trademarked drug that uses that formula and is presently the only company to have FDA approval to do so.

Within a month or two of Turing’s anticipated monopoly coming to light a compounding pharmacy was already offering a generic equivalent of Daraprim at less than one dollar per pill (compared to Turing’s $750) with the following disclaimer:

So even without FDA approval as a generic drug, it’s already legal to sell the unbranded chemical compound as an alternative to the trademarked drug with the proper disclaimers.

Any legal lines that might get blurry in a home-brewed venture like this (as opposed to a licensed compounding pharmacy doing the same thing) would be health and safety laws or pharmacy regulations in general, but not patent infringement.

#9

There is a “research exemption”, but it’s pretty narrow.

#10

Correct. Martin Shkreli bought up the only U.S. production capacity for the drug, and it’s the only producer that has FDA approval. There are producers outside the United States, but it will take time any considerable expense for someone to compete with Shkreli.

Correct. A patent holder has exclusive rights to “practice” the patent. That means you can’t make it even for your personal use. That is, if there is a valid patent at issue. The patents on Daraprim all expired decades ago.

Correct.

#11

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.

#12

But then, unless the law has changed recently - patent violation is a civil offense. Doesn’t that mean they can only sue you for actual damages, and if you don’t sell it to others (or give it away) you have not interfered with their commerce and so they would have minimal or no damages to claim?

#13

Monetary damages might be limited to reasonable royalties—in essence the theoretical amount you would have had to pay to obtain a license to make the pills for yourself. If it’s a very small number, it might be calculated based on lost sales for those number of pills.

However, they would very likely be entitled to injunctive relief—a court order telling you to stop it. And if you violate such an order, your would be subject to punishment for contempt of court.

#14

The lack of difference between certain research grade chemicals and certain drugs is well known to those to whom it matters. Lots of people buy meds from chemical supply houses.

In many cases, the only difference between a drug and a “chemical” is that the drug has a trademarked name and has FDA approval to be sold as safe and having medicinal benefits. Research chemicals come with no such advertising, or protections.

As md2000 correctly reminds us, screwing around with your body chemistry is not something to be done lightly and I’m certainly not endorsing that anyone do such a thing, but it happens.

#15

Even if the patent for the chemical itself is expired, there might still be a patent on a particular technique to make that chemical. If that’s the case, you’d be infringing if you used that technique to make it, but not if you made the same chemical using some other technique.

#16

The reason most patent infringement cases are where people are selling the patented product rather than making it for their own use in their own home is that enforcement of your patent is up to you. You have exclusive rights to the invention for the term of the patent. But there aren’t any patent police. If someone is infringing your patent it’s up to you to find out about it and tell them to stop and if they don’t stop to sue them.

A guy making small amounts of the product for his own use in his own home is going to be very difficult for the patent owner to discover. Unless you, like, make a youtube video explaining what you’re doing. But doing it quietly in your own home means you will probably avoid getting caught, for the same reasons that other violations of the law that you do quietly in your own home aren’t very likely to be discovered. When you try to sell your illicit products you involve third parties and there’s no telling how quiet they’ll be or how much they stay at home.

#17

My girlfriend wants your phone number!

#18

That brings up a different issue. There are various schedules of controlled substances. Making, extracting or purifying some of these may make it a federal case.

Not sure if the same applies to prescription drugs, not controlled substances but only dispensed with a doctor’s prescription.

#19

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?

#20

As mentioned upthread, the patent holder has the exclusive rights to prevent an unauthorized person from “making” (not just selling) the patented invention. So if the patent for the paper clip is still valid (it’s not and has long expired) the person making the paper clip at home is liable for infringement, even if he does so only for personal use.