Finch wins US jury trial against Ferring over fecal-transplant patents (Aug 2024, Rebyota) Article 

Michael Harrop

Michael Harrop

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https://www.reuters.com/legal/litigation/finch-wins-us-jury-trial-against-ferring-over-fecal-transplant-patents-2024-08-09/

Interesting.

Rebyota, a rectally delivered product developed by Ferring Pharmaceuticals, that secured FDA approval in November 2022.

The jury agreed with Finch that Ferring's fecal-transplant therapy Rebyota infringes patents covering related inventions that Finch licensed from the university.

A federal jury in Delaware said on Friday that Swiss biopharmaceutical company Ferring Pharmaceuticals infringed patents for fecal transplant technology belonging to Finch Therapeutics (FNCH.PK), and the University of Minnesota, and should pay $25 million in damages and future royalties.

Ferring argued in the case that its technology worked differently than Finch's and that the three patents at issue in the trial were invalid.
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Format correct?
  1. Yes
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SFBayFMT5 said:
Why do you consider Rebyota "not FMT"? Is it simply the fact that it's pooled-donor and not single-donor?
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As far as I know, the FDA does not allow pooling donors' stool. I haven't been able to find what is in Rebyota. If anyone has a link, I'll take a look.
 
Michael Harrop said:
As far as I know, the FDA does not allow pooling donors' stool. I haven't been able to find what is in Rebyota. If anyone has a link, I'll take a look.
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I couldn't find any info on the content of either company's "FMT." I forget which company it was but one of them has a "donor" page where you can apply, but they don't go into specifics ANYWHERE which drives me nuts because obviously I think it should all be open source, including the stool bacteria makeup. Even in a worst case scenario, where they're using poor donors and having mixed at best results, I want to know what they're using and what their success rate is. I'm simply too curious to not want that info. I guess my thinking is something along the lines of: what if they're using a fairly simple blend of basic microbes, and it's just quorum sensing that starves out C Diff? If that's the case, would it work for other pathological strains? Would a kefir enema have a similar effect if quorum sensing is the active mechanism? What do you guys think about quorum sensing in general? Sorry if this isn't the thread to ask just glad other people are as interested as me.
 
Michael Harrop said:
As far as I know, the FDA does not allow pooling donors' stool. I haven't been able to find what is in Rebyota. If anyone has a link, I'll take a look.
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From the prescribing information, "Description" (Section 11):
https://www.ferringusa.com/wp-content/uploads/sites/12/2022/12/9009000002_REBYOTA-PI_11-2022.pdf

"REBYOTA (fecal microbiota, live – jslm) is an opaque fecal microbiota suspension for rectal administration. REBYOTA is manufactured from human fecal matter sourced from qualified donors. The human fecal matter is tested for a panel of transmissible pathogens. Donors do not have dietary restrictions with respect to potential food allergens. The fecal microbiota suspension is the filtrate generated by processing the fecal matter in a predefined ratio with a solution of polyethylene glycol (PEG) 3350 and saline. Each 150mL dose of REBYOTA contains between 1x108 and 5x1010 colony forming units (CFU) per mL of fecal microbes including >1x105CFU/mL of Bacteroides, and contains not greater than 5.97 grams of PEG3350 in saline."

Aside from the substitution of glycerol with PEG, this looks no different from what OpenBiome did and what Microbioma and Gezonde Darmflora are doing.
 
Would it be worth trying to contact Finch? About improving the quality of their donors and getting their product approved for other conditions (i.e. IBS)

From their website it seems like they are trying to patent FMT for C. diff, autism, IBD, Parkinson's, etc, and they have 70 patents related to this. Their website says they use both donor-derived and donor-independent methods so I think it's possible they are interested in doing more than just a multi-strain probiotic like VOWST.
 
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indigo34 said:
Their website says they use both donor-derived and donor-independent methods so I think it's possible they are interested in doing more than just a multi-strain probiotic like VOWST.
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Their latest clinical trial mentions a "full spectrum" microbiome therapeutic, which would support this: https://pubmed.ncbi.nlm.nih.gov/39366468/

The question I would have is, what's the difference between the various products in their pipeline (CP101, FIN-524, FIN-525, FIN-211)? Are some of these NOT full-spectrum, but specific strains like VOWST? Or is the dosage or method of administration different?
 
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