As I've repeatedly said, there is much in the wrangling of US patent laws that Rahway can and will undertake, to push the generification out to about 2032 minimum.
Chief among these moves is one called "product hopping". Merck will introduct a subcutaneous version of pembrolizumab -- which only requires four visits a year to a hospital, as opposed to weekly IV drips. Halozyme has claimed its patents cover this tech, but the USPTO has agreed to re-evaluate the breadth of the claims in that patent. This likely means Merck will (at a minimum) owe Halozyme nothing, to produce the subcutaneous version -- and stay in the driver's seat on a perhaps $30 billion a year revenue stream through the early 2030s. Here's Ed's fine piece at his subscription only STAT property (and a bit):
. . .In a boost for Merck, a U.S. Patent and Trademark Office panel agreed to reconsider a patent granted to another company that could affect plans to broaden use of its franchise product, the Keytruda cancer treatment.
The dispute with Halozyme Therapeutics occurs as Merck plans to sell a new [subcutaneous] injectable version of Keytruda that the company is betting will sustain a medicine that has accounted for nearly half of its sales. Patent protection for the treatment, which is currently administered intravenously and generated $29.5 billion in revenue last year. . . .
Nominally, the generics may enter at 2028 -- but practically they will be largely thwarted through 2032 or so. There Ed and I diverge slightly in our analysis of the matter. Onward, smiling.
नमस्ते






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