Against Monopoly

defending the right to innovate

Drug Patents

Monopoly corrupts. Absolute monopoly corrupts absolutely.

Copyright Notice: We don't think much of copyright, so you can do what you want with the content on this blog. Of course we are hungry for publicity, so we would be pleased if you avoided plagiarism and gave us credit for what we have written. We encourage you not to impose copyright restrictions on your "derivative" works, but we won't try to stop you. For the legally or statist minded, you can consider yourself subject to a Creative Commons Attribution License.


Maybe generic drug makers will be sueable

In a highly speculative piece the New York Times suggests that a possible change in labeling requirements risks generic drug makers being sued link here. This comes just two years after the Supremes decided the reverse i.e., that they couldn't be sued as the law required they use the same warning label as the brand-name makers (see our piece posted on 06/26/2013 at 08:40 AM.

Apparently the change is prompted by the FDA's discovery that users harmed by a generic drug should be able to sue if their drug fails to perform correctly.

This all seems a stretch. The warning labels are framed based on what is known at the time it is approved. Subsequent experience could quite reasonably have shown the need for amending approved uses and thus, labeling. Like most of us, when the facts change, the FDA changes its opinion or so we can hope.


John Bennett: One portion of your post is imprecise.

You state that "warning labels are framed based on what is known at the time it [the drug] is approved." That statement is imprecise, at best. After a drug is released by the FDA for use by the public, if the patent holder is aware of potential side effects, the patent holder is required by law to update the drug labeling. Thus, the drug label in fact changes with time.

However, generic manufacturers are not bound by any such requirement. Thus, if a generic manufacturer learns of a hazardous side effect, they are not required to update the warning label. The situation becomes potentially dangerous to the public when the original patent holder leaves the market. At that point, no one is responsible for updating warning labels and there is no mechanism for updating warning labels.

It is true that by changing the rule the FDA could be opening generic manufacturers to potential lawsuits. However, by not changing the rule, the public may be placed in danger. Which approach is ultimately in the best interest of the public? Your statement indicates that you think they public is just going to have to suffer through as best as they can without knowing about all the dangers a drug might present. That seems unfair.

It seems reasonable to place primary burden on maintaining warning labels on the original patent holder during the life of a patent. After all, the patent holder gains from having the patent, so they should also bear the responsibility. Once the patent holder leaves the market, the generic manufacturers need to take the responsibility to the safety of the drug, even if it increases the costs of generic drugs.

Submit Comment

Blog Post


Email (optional):

Your Humanity:

Prove you are human by retyping the anti-spam code.
For example if the code is unodosthreefour,
type 1234 in the textbox below.

Anti-spam Code



Most Recent Comments

Some history

Killing people with patents SYSSY

IIPA thinks open source equals piracy rerwerwerwer

IIPA thinks open source equals piracy Thank you for this great

Questions and Challenges For Defenders of the Current Copyright Regime Eu acho que os direitos autorais da invenção ou projeto devem ser

IIPA thinks open source equals piracy https://essaywritingsolutions.co.uk/

Your Compulsory Assignment for Tonight rerrerrr

IIPA thinks open source equals piracy rwerwewre

An analysis of patent trolls by a trademark lawyer

Questions and Challenges For Defenders of the Current Copyright Regime It is one of the finest websites I have stumbled upon. It is not only well developed, but has good

Killing people with patents I'm not really commenting the post, but rather asking if this blog is going to make a comeback

The right to rub smooth using a hardened steel tool with ridges Finally got around to looking at the comments, sorry for delay... Replying to Stephan: I'm sorry

Let's See: Pallas, Pan, Patents, Persephone, Perses, Poseidon, Prometheus... Seems like a kinda bizarre proposal to me. We just need to abolish the patent system, not replace

The right to rub smooth using a hardened steel tool with ridges I'm a bit confused by this--even if "hired to invent" went away, that would just change the default

Do we need a law? @ Alexander Baker: So basically, if I copy parts of 'Titus Andronicus' to a webpage without

Do we need a law? The issue is whether the crime is punished not who punishes it. If somebody robs our house we do

Do we need a law? 1. Plagiarism most certainly is illegal, it is called "copyright infringement". One very famous

Yet another proof of the inutility of copyright. The 9/11 Commission report cost $15,000,000 to produce, not counting the salaries of the authors.

WKRP In Cincinnati - Requiem For A Masterpiece P.S. The link to Amazon's WKRP product page:

WKRP In Cincinnati - Requiem For A Masterpiece Hopefully some very good news. Shout! Factory is releasing the entire series of WKRP in Cincinnati,