Open Norway: Plasma cell aimed treatment with daratumumab in ME/CFS - Haukeland University Hospital

[V.R.T.]

The patent for Dara is apparently set to expire next year. A phase 3 for a biosimilar is planned by Celltrion. Which might explain why J&J doesn’t want to spend any money on it.

Mitigating Patent Cliff Fallout

Mitigating Patent Cliff Fallout

www.biospectrumasia.com

That's disturbing. So they don't stand to reap a sustained profit if it works because biosimilars might flood the market in a few years?

 

[Utsikt]

That's disturbing. So they don't stand to reap a sustained profit if it works because biosimilars might flood the market in a few years?

In a simplified manner, yes. The price tends to drop significantly once the patent expires.

 

[Jonathan Edwards]

The patent for Dara is apparently set to expire next year. A phase 3 for a biosimilar is planned by Celltrion. Which might explain why J&J doesn’t want to spend any money on it.

Well, there's your answer. No brainer.

 

[Utsikt]

Posted before posts on the topic in another thread were moved in to this thread

Crossposting from another thread. A plausible explanation for why the manufacturer doesn’t want to participate in the study:

The patent for Dara is apparently set to expire next year. A phase 3 for a biosimilar is planned by Celltrion. Which might explain why J&J doesn’t want to spend any money on it.

Mitigating Patent Cliff Fallout

Mitigating Patent Cliff Fallout

www.biospectrumasia.com

Well, there's your answer. No brainer.

The silver lining is that Dara (or it’s equivalents) might become significantly cheaper in the not too distant future.

 

[Jaybee00]

JNJ could change one minor component in the formulation to get a patent extension and thus an indication for MECFS

Evergreening - Wikipedia

en.wikipedia.org

 

[Jonathan Edwards]

JNJ could change one minor component in the formulation to get a patent extension and thus an indication for MECFS

It isn't that simple. (I have testified at several patent courts!)

 

[Utsikt]

JNJ could change one minor component in the formulation to get a patent extension and thus an indication for MECFS

Evergreening - Wikipedia

en.wikipedia.org

Fluge & Mella have already applied for a patent for ME/CFS. I have no idea of that impacts things as well.

WO2021038097A1 - Method for the treatment of chronic fatigue syndrome using an inhibitory or cytotoxic agent against plasma cells - Google Patents

The present invention relates in a first aspect to a method for the treatment of chronic fatigue syndrome (CFS) comprising administering to a patient in need thereof a therapeutically effective amount of inhibitory or cytotoxic agent against plasma cells. In a further aspect, the present...

patents.google.com

 

[Sasha]

Fluge & Mella have already applied for a patent for ME/CFS. I have no idea of that impacts things as well.

WO2021038097A1 - Method for the treatment of chronic fatigue syndrome using an inhibitory or cytotoxic agent against plasma cells - Google Patents

The present invention relates in a first aspect to a method for the treatment of chronic fatigue syndrome (CFS) comprising administering to a patient in need thereof a therapeutically effective amount of inhibitory or cytotoxic agent against plasma cells. In a further aspect, the present...

patents.google.com

What are the implications of them applying for a patent?

 

[V.R.T.]

I suppose the money will have to come from the Norwegian government or from charities/fundraising then.

 

[Braganca]

ChatGPT says;
Yes, the Norwegian team has successfully filed a method-of-use patent (WO2021038097A1) for daratumumab in ME/CFS. They’re using a well-established lifecycle extension strategy:

• Patent the new method-of-use (WO2021038097A1).
• Generate clinical safety/efficacy data to support the patent’s validity and commercial attractiveness.
• Progress through phased clinical trials—from pilot to Phase 2/3—to potentially establish an ME/CFS-specific indication exclusive under patent rights.
• If further trials confirm efficacy, they would hold exclusive IP for this application—strengthening potential licensing or commercial interest.

 

[Trish]

I don't trust anything chatgpt says without checking their source. Does it provide links to sources?

 

[Braganca]

I don't trust anything chatgpt says without checking their source. Does it provide links to sources?

Not specific to the patent process or IP law no.

 

[Sasha]

I trust Drs Fluge and Mella but I'm a bit surprised that anyone can patent a drug for a specific application, including the pharma company that created it. What is the purpose?

 

[butter.]

Hi @Jonathan Edwards, you have apparently been somewhat critical about the idea to use dara and/or cyclo in the past, what data/research/events made you change your mind? Thank you!