patents medical
Could a charity manufacture patented medications for free?
<p>Let's say there is a patented medication that is very effective and very expensive at the pharmacy, say $1,000/dose. But also assume that the medicine only costs $1 to formulate - most of the "cost" was in the research.</p>

<p>I understand that a competing company cannot legally manufacture and sell a patented medicine to consumers. However, could a nonprofit legally manufacture and give away the patented medicine for free?</p>

<p>No, they could not. The conditions of violating a patent don't revolve around monetary gain, so regardless of compensation they would be in violation of the patent.</p>

<p>I am in no way an expert on patent law. However I do know for a fact that in my home country, the Netherlands, some hospitals started making their own medicines to circumvent patents/high prices. </p>

<p><a href="https://www.nu.nl/gezondheid/5811003/waarom-sommige-ziekenhuizen-zelf-medicijnen-maken.html" rel="nofollow noreferrer">https://www.nu.nl/gezondheid/5811003/waarom-sommige-ziekenhuizen-zelf-medicijnen-maken.html</a></p>

<p><a href="https://www.volkskrant.nl/nieuws-achtergrond/inspectie-amc-mag-duur-medicijn-zelf-produceren~bfd40126/" rel="nofollow noreferrer">https://www.volkskrant.nl/nieuws-achtergrond/inspectie-amc-mag-duur-medicijn-zelf-produceren~bfd40126/</a></p>

<p><a href="https://www.trouw.nl/nieuws/ziekenhuis-mag-dure-medicijnen-namaken~b5fc184a/?referer=https%3A%2F%2Fwww.google.nl%2F" rel="nofollow noreferrer">https://www.trouw.nl/nieuws/ziekenhuis-mag-dure-medicijnen-namaken~b5fc184a/?referer=https%3A%2F%2Fwww.google.nl%2F</a></p>

<p><a href="https://www.dutchnews.nl/news/2018/04/dutch-hospital-challenges-big-pharma-by-making-own-version-of-very-pricey-drug/" rel="nofollow noreferrer">https://www.dutchnews.nl/news/2018/04/dutch-hospital-challenges-big-pharma-by-making-own-version-of-very-pricey-drug/</a></p>

<p>So it seems, at least in my jurisdiction, a charity would in theory be permitted to manufacture their own medicine and give it away. However they would need to have the knowledge and resources to actually produce these medicines. Also those medicines would need to meet quality/safety standards. So it's not a simple thing to do I guess.     </p>

<p><a href="/questions/tagged/german" class="post-tag" title="show questions tagged &#39;german&#39;" rel="tag">german</a> patent law means in general that a license needed if the drug is only offered or put into circulation, the price doesn't enter this consideration <a href="https://www.gesetze-im-internet.de/englisch_patg/englisch_patg.html#p0073" rel="nofollow noreferrer">§9 PatG</a>:</p>

<blockquote>
  <p>[...] In the absence of the consent of the proprietor of the patent, any third party shall be prohibited from</p>
  
  <ol>
  <li><p>producing, offering, putting on the market or using a product which is the subject-matter of the patent, or from either importing or possessing such a product for the purposes referred to;</p></li>
  <li><p>using a process which is the subject-matter of the patent or, if the third party knows or if it is obvious from the circumstances that use of the process is prohibited in the absence of the consent of the proprietor of the patent, from offering the process for use within the territorial scope of this Act;</p></li>
  <li><p>offering, placing on the market or using a product which is produced directly by a process which is the subject-matter of the patent, or from either importing or possessing such a product for the purposes referred to.</p></li>
  </ol>
</blockquote>

<p>But there is an exception for pharmacies producing individual drug formulations in <a href="https://www.gesetze-im-internet.de/englisch_patg/englisch_patg.html#p0092" rel="nofollow noreferrer">§11 PatG</a>: </p>

<blockquote>
  <p>The effect of a patent shall not extend to</p>
  
  <p>[...]  </p>
  
  <ol start="3">
  <li>the extemporaneous preparation in a pharmacy, for individual cases, of a medicine in accordance with a medical prescription or acts concerning the medicine so prepared;</li>
  </ol>
</blockquote>

<p>So if the charity is a volunteering pharmacy that fulfils individual prescriptions, they are fine (just that it is in all probability still far more expensive than the question supposes, see below).</p>

<hr>

<p>If the charity wants to produce the drug on a larger scale, they need a license (plus regulatory approval). There are limits to the patent owner arbitrarily denying to license because the charity may apply to a court to get a compulsory license according to <a href="https://www.gesetze-im-internet.de/englisch_patg/englisch_patg.html#p0149" rel="nofollow noreferrer">§ 24 PatG</a></p>

<blockquote>
  <p>(1) The non-exclusive authorisation to commercially use an invention shall be granted by the Federal Patent Court in an individual case in accordance with the following provisions (compulsory licence) where</p>
  
  <ol>
  <li><p>a licence seeker has, within a reasonable period of time, unsuccessfully attempted to obtain permission from the proprietor of the patent to use the invention on reasonable commercial terms and conditions, and</p></li>
  <li><p>the public interest calls for the grant of a compulsory licence.</p></li>
  </ol>
  
  <p>[...]</p>
  
  <p>(6) [...] The compulsory licence may be granted subject to limitations and made dependent on conditions. [...] The proprietor of the patent shall be entitled to remuneration from the proprietor of the compulsory licence, such remuneration being equitable in the circumstances of the case and taking into account the economic value of the compulsory licence. [...]</p>
</blockquote>

<p>The equitable remuneration would include research costs, of course.</p>

<hr>

<p>Finally, the charity could lobby with the government to void the patent according to <a href="https://www.gesetze-im-internet.de/englisch_patg/englisch_patg.html#p0105" rel="nofollow noreferrer">§13</a>: </p>

<blockquote>
  <p>(1) The patent shall have no effect in a case where the Federal Government orders that the invention is to be used in the interest of public welfare. </p>
</blockquote>

<hr>

<p>That being said, I do suspect that you seriously overestimate the possibility for a pharmacist to produce these individual drugs for low price, even if they were to volunteer their work time. </p>

<p>The argument would look quite different to me had you said that the charity is able to produce a drug that is sold for 100k$ for only 10k$ per dose. The Dutch university hospital's pharmacy in <a href="https://law.stackexchange.com/a/49526/9286">thieupepijn's answer</a> who probably also have some other departments [pharmaceutical &amp; chemistry] at hand with additional required knowledge or instrumentation if I read the news posts correctly are cited to produce a drug that commercially costs 150 - 200 k€ per patient and year for 25 k€ (presumably also per patient and year; for 2 patients).
  Still, for a charity aiming to this also means that they decide against a whole lot of lower hanging fruit which are also worthy of charitable work.</p>

<p>Now, I'm not a pharmacist but analytical chemist. I.e., I work in the subfield that is specialized on step 4 and the proof of substance identity in the third bullet point below), but here's the insight I have:</p>

<ul>
<li><p>AFAIK, individual prescriptions are typically formulated from ingredients the pharmacy buys. Thus, they'd need to buy the active ingredient - and if the ready-made drug is sold for big $$$, I don't see why the active ingredient would be sold cheaply.  AFAIK, the patent typically covers the ingredient rather than the drug. (The formulated drug must pass the regulatory approval, though.)  </p></li>
<li><p>If  the pharmacy would instead set up an organic synthesis lab to synthesize the active ingredient, they'd need to</p>

<ol>
<li>synthesize the ingredient. This <em>is</em> comparatively cheap for <em>some</em> drugs.</li>
<li>purify it: we cannot have impurities as they can pose known or unknown dangers to the patient, in some cases even the other <a href="https://en.wikipedia.org/wiki/Enantiomer" rel="nofollow noreferrer">enantiomer</a> cannot be in the drug. Purification is typically a whole lot of work and rather expensive. Particularly for drugs that are cheap to synthesize, this step can be orders of magnitude more expensive.<br>
Related to this is that you also need to do a whole lot of cleaning the labware to make sure you don't get contamination*.  </li>
<li>make sure you have the correct modification and/or possibly particle size</li>
<li>Prove that they have the correct substance (incl. modification/particle size) in the correct concentration and at the required purity (and this also involves that they prove that the instruments they use work as they are supposed to).  Again, a whole lot of work, and/or specialized lab instrumentation required.</li>
</ol></li>
<li><p>In contrast, when buying the ingredient, they must only prove identity, i.e. check that the white powder is what it says on the label. This is relatively easy and fast and thus not too expensive. Basically this checks that they  did not accidentally get the wrong white powder and are otherwise allowed to trust the statement of product purity that accompanies the ingredient. (The measurements they can do for this react also to impurities, though not as sensitively as required for the quantitative testing outlined above)      </p></li>
</ul>

<p><em>I may add that whenever I've met the argument that so many expensive drugs are cheap to produce the numbers given always estimated synthesis costs on the basis that the educts (starting substances for a chemical reaction) are cheap. They  may not even have considered with that that you probably want to start from purified educts in pharmaceutical synthesis - but I've never so far encountered an argument that did consider steps 2 - 4 above.</em></p>

<hr>

<p>*I once visited an industrial production line for drugs (tablets). When they change the product that is produced (which for the pharmacy happens all the time as we're talking individual prescriptions), they first clean everything very thoroughly. Then a dummy substance goes through, and is also cleaned away. The dummy substance is one where traces are visible (either by itself or via fluorescence), so that every little leftover trace is easily spotted and cleaned. For the production line they told us this takes several days.</p>

<p>Not in the US. From 35 U.S. Code § 271 – Infringement of patent:</p>
<blockquote>
<p>Except as otherwise provided in this title, whoever without authority
<strong>makes</strong>, uses, offers to sell, or sells any patented invention, within the United States or imports into the United States any
patented invention during the term of the patent therefor, infringes
the patent.</p>
</blockquote>
<p>So even if you cook your own medicine at home for yourself, you are already infringing.</p>
<p>In other jurisdictions you might only infringe on a patent if you sell something or use a patent as part of your business. <a href="https://en.wikipedia.org/wiki/Patent_infringement" rel="nofollow noreferrer">That seems to be the case in Japan</a>:</p>
<blockquote>
<p>Infringement under the patent law in Japan is defined by Article 101
of Patent Act (Act No. 121 of 1959), which shows the following
acts shall be deemed to constitute infringement of a patent right or
an exclusive license:</p>
<p>(i) where a patent has been granted for an invention of a product, acts of producing, assigning, etc., importing or offering for
assignment, etc. any product to be used exclusively for the producing
of the said product as a business;</p>
<p>(ii) where a patent has been granted for an invention of a product, acts of producing, assigning, etc., importing or offering for
assignment, etc. any product (excluding those widely distributed
within Japan) to be used for the producing of the said product and
indispensable for the resolution of the problem by the said invention
as a business, knowing that the said invention is a patented invention
and the said product is used for the working of the invention;</p>
<p>(iii) where a patent has been granted for an invention of a process, acts of producing, assigning, etc., importing or offering for
assignment, etc. any product to be used exclusively for the use of the
said process as a business; and</p>
<p>(iv) where a patent has been granted for an invention of a process, acts of producing, assigning, etc., importing or offering for
assignment, etc. any product (excluding those widely distributed
within Japan) to be used for the use of the said process and
indispensable for the resolution of the problem by the said invention,
knowing that the said invention is a patented invention and the said
product is used for the working of the invention as a business.</p>
</blockquote>

<p>Look into <strong>Compounding Pharmacies</strong>. Imagine you need a particular medication, but for whatever reason the medication you need is not commercially available, or the standard version available isn't suitable for some reason. For that, you would go to a compounding pharmacy, who have the equipment to manually manufacture whatever it is you need, instead of being restricted to just commercially-available medications.</p>

<p>Now, they are required not to "compound regularly or in inordinate amounts (as defined by the Secretary) any drug products that are essentially copies of a commercially available drug product", but this is a somewhat blurry line compared to standard patent law.</p>

<p>Note that this doesn't require an actual charity to be involved when the actual drug costs are very low, just for a sympathetic doctor to be writing prescriptions that can't be fulfilled by a regular pharmacy.</p>
