Dupixent patent infringement

Quote

anonymous

Guest
In the latest 10-K, released yesterday, REGN has provided more detail about risks to Dupixent (p. 38) than it provided in the 2015 10-K (p. 35). It now specifically references Dupixent as potentially infringing an AMGN (!) patent, #8,679,487. This patent, issued in 2014, is titled Anti-interleukin-4 receptor antibodies; the first claim begins:

1. An isolated human antibody that competes with a reference antibody for binding to human IL-4 interleukin-4 (IL-4) receptor...

Does that cover Dupixent, and if so, is the claim valid?

Now that management has staked a lot on disproving that AMGN claims that it admitted it infringed with Praluent, and failed to persuade a jury, is there any reason to trust the company if there is a second such trial with AMGN involving Dupixent?
 






from page 35 of the 10-k...

We are also aware of patents and pending applications owned by others that respectively claim antibodies to IL-6R and IL-4R and methods of treating rheumatoid arthritis and uveitis and atopic dermatitis and asthma with such antibodies. In addition to Praluent, our late-stage antibody-based pipeline includes sarilumab, an antibody to IL-6R, for the treatment of rheumatoid arthritis and non-infectious uveitis; dupilumab, an antibody to IL-4R, for the treatment of atopic dermatitis, asthma, nasal polyposis, and eosinophilic esophagitis; REGN2222, an antibody targeting RSV-F; and fasinumab, an antibody to NGF. Although we do not believe that any of our late-stage antibody product candidates infringes any valid claim in these patents or patent applications, these other parties could initiate a lawsuit for patent infringement and assert their patents are valid and cover our late-stage antibody product candidates, similar to the patent infringement proceedings initiated by Amgen referred to above. As described in Part I, Item 3. "Legal Proceedings" of this report, we and Sanofi-Aventis U.S. LLC initiated invalidity actions against patents jointly owned by Genentech and City of Hope relating to the production of recombinant antibodies by host cells. We currently produce our antibody product and antibody product candidates using recombinant antibodies from host cells and may choose to produce additional antibody product candidates in this manner. Neither ARCALYST nor EYLEA is a recombinant antibody

Is this a pretty commonscenario in the industry nowadays? In almost 20 years in pharma I have never seen so many patent infringement suits as I do here.
 




































Schleifler and Yancoupolis built this drug from the ground up over TWENTY YEARS AGO. The only thing they are guilty of is not having loophole-finding asshole lawyers like Amgen. This is absolutely ridiculous and I would be embarrassed to work for a company like Amgen who makes strategies like this to stop companies from selling drugs they developed from inception.

Hopefully Regeneron has learned their lesson and will start spending more money on legal during drug discovery.

SHAME ON AMGEN.
 






anonymous said:
Schleifler and Yancoupolis built this drug from the ground up over TWENTY YEARS AGO. The only thing they are guilty of is not having loophole-finding asshole lawyers like Amgen. This is absolutely ridiculous and I would be embarrassed to work for a company like Amgen who makes strategies like this to stop companies from selling drugs they developed from inception.

Hopefully Regeneron has learned their lesson and will start spending more money on legal during drug discovery.

SHAME ON AMGEN.
Click to expand...

Well, you just admitted Regeneron's mistake and then ended with SHAME ON AMGEN. Maybe you meant shame on you??
 






anonymous said:
Please tell me this isn't really a concern for Dupixent?!? Are they waiting until we get approval to file a lawsuit? Any honest replies appreciated.
Click to expand...

Maybe they'll have more to capitalize and damages then? Exactly what any Trump supporter will do!

Suit you out of house and home. Go Capitalism and intellectual property!
 






























anonymous said:
The FDA does not make decisions based on patent law.

Praluent (approved despite Amgen lawsuit), Inflectra (at risk launch despite J&J patent lawsuit), biosimilars for etanercept (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518639.htm), adalimumab (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522243.htm), etc.

Do not confuse the FDA with the US Patent Office.
Click to expand...
True. FDA approval does not permission to launch either. The court may prevent commercial sale.
 






anonymous said:
Schleifler and Yancoupolis built this drug from the ground up over TWENTY YEARS AGO. The only thing they are guilty of is not having loophole-finding asshole lawyers like Amgen. This is absolutely ridiculous and I would be embarrassed to work for a company like Amgen who makes strategies like this to stop companies from selling drugs they developed from inception.

Hopefully Regeneron has learned their lesson and will start spending more money on legal during drug discovery.

SHAME ON AMGEN.
Click to expand...
Looks like REGN did it again!
 






anonymous said:
The FDA does not make decisions based on patent law.

Praluent (approved despite Amgen lawsuit), Inflectra (at risk launch despite J&J patent lawsuit), biosimilars for etanercept (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518639.htm), adalimumab (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522243.htm), etc.

Do not confuse the FDA with the US Patent Office.
Click to expand...
True. Even post FDA approval, the court may prevent commercial sales due to patent infringement.
 












anonymous said:
Well, you just admitted Regeneron's mistake and then ended with SHAME ON AMGEN. Maybe you meant shame on you??
Click to expand...

Cry foul about Amgen as much as you want these are businesses to make a profit and provide medicines to patients ....in that order (if you want to be in a different order than you shouldn't be a public company with shareholders) At the end of the day Regeneron has a track record and approach to science that is incomparable in the industry and everyone tries to take shots at them..; they are innovative and creative and . have a big target on their back because of it - they need to pay more attention to IP on the front end to create less risk on the backend for these kind of fiascoes to be possible by competitors. Sanofi should know better as well - they invested 1 billion dollars on Praluent and probably 100 million on lawyers and may not be able to market in the US...thats straight up bad judgement and management. sorry
 












Top Bottom
Back
Quote