RE: Avidimab11 Sep 2019 11:05
I think inananco mentioned it.... anyways on that note here is a really worthy read about Abbies blockbuster MaB humira and how they keep it from going over the patent cliff :)
'How was the company able to rack up so many patents on a single product? Much of it has to do with the type of drug that Humira is—a “biologic.” Unlike chemically synthesized drugs, biologics derive from actual biological material, making them significantly more complex than standard chemical medicines. And therein lies the key to AbbVie’s IP strategy, explains Feldman. For instance, a company may be able to file patents on obscure steps in the production and manufacturing process, or adjustments in dosing. '
And that’s precisely what AbbVie has done. AbbVie, in an emailed statement, says the U.S. Patent and Trademark Office (USPTO) has granted the company more than 30 patents on the ways in which the drug is administered; more than 25 patents on various formulations of the drug; more than 50 patents related to Humira’s manufacturing processes; and about 20 patents on the delivery devices that customers use to take the medicine.
To be sure, creating a monoclonal antibody isn’t easy work, explains Goodwin Procter attorney Robert Cerwinski. “The manufacture of adalimumab [Humira’s scientific name] occurs through a process called fermentation, and it involves a cell line that’s genetically engineered to secrete large amounts of adalimumab from a huge vat of cells growing in, like, a 15,000-liter bioreactor,” he tells Fortune.
Then things get even more complicated. Afterward, the treatment must go through purification processes to take out unnecessary by-products, modifications in dosage for different diseases, and all sorts of incremental tweaks. Amid all these procedures, Cerwinski says, “branded product sponsors like AbbVie have found many more opportunities to conclude that little wrinkles in the manufacturing process are innovative and can be protected by patents.”
https://fortune.com/longform/abbvie-humira-drug-costs-innovation/