It Is Unlikely That Halozyme Will Win Substantial Keytruda® Patent Damages From Merck -- As Merck Is Licensing Entirely-Independent Tech In The Subcutaneous Field.

Last week, Halozyme was pushing a narrative that Merck would need to pay it very large license fees, for Halozyme's patented formulation of human hyaluronidase, in order to introduce a subcutaneous version of pembrolizumab (branded as Keytruda^®).

What Halozyme failed to mention was that Merck has already licensed a Alteogen invented, separate human hyaluronidase variant, one not mentioned in any of the Halozyme patents, either as a claim, or as known prior art.

That would, in turn, mean that Halozyme is likely to only get a tiny "buy peace" payment from Merck, of a few pennies per dose -- or nothing at all, when the dust settles. In any event, here's Fierce's fine reporting on it all, from mid-week:

. . .To develop the new product, Merck licensed a hyaluronidase variant from Alteogen. Called ALT-B4, the variant was independently developed by Alteogen scientists, and its sequence is not disclosed in any Halozyme patent, the Merck spokesperson noted.

Halozyme’s claim stems from its Mdase group of modified human hyaluronidases, which the company publicized in October. Halozyme came up with its Mdase tech to sign more partners who may not be able to tap into the company’s well-established Enhanze subcutaneous drug delivery platform thanks to existing exclusive licensing pacts.

The Mdase portfolio includes about 100 patents with protection extending into 2032 in Europe and 2034 in the U.S., according to Halozyme. . . .

Now you know -- and for its part, Merck intends to have its subcutaneous formula on market in the US by the end of 2025, according to CEO Davis. [This is in no small part why I've repeatedly said that Merck has clear sailing with Keytruda through 2032.]

I am in "my high dungeon" -- as more NCAA March madness is on tap on this otherwise gray but warming Sunday afternoon. . . smile.

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