As is often the case, when a novel drug or method for preparing the essentials of one is invented, the entire industry bellies up to the bar, and pays their respective tabs, to be able to stay at the cutting edge. That’s been true for 40 years, on what are called the Cabilly II and III patents in favor of Roche/Genentech. [We’ve mentioned this tech here before, beginning about nine years ago, through around seven years ago.] So — is a 40-45 year law-sanctioned monopoly… too long?

But now, not that long ago, the Cabilly patents expired, and yet a dispute remains: should the patent payments ALSO be made by companies who are only now selling off stock-piled inventory — since the patents are dead (but the product was manufactured and stored while the patent was still in force)? It is likely not just Biogen — the learning here, however it comes out, likely applies to Merck and others, on all drugs synthesized using the lessons of Cabilly. So we will watch this one… pretty closely. It is an at least eight figure discussion, overall.

Here is the complaint in full, from the federal courthouse in San Francisco.

…Because the process for manufacturing antibodies is complex and the consequences of a stockout potentially catastrophic, it is customary for biopharmaceutical firms that make and sell therapeutic antibodies to stockpile at least several calendar quarters worth of product, and often more than that. Therefore, on information and belief, most or all of the natalizumab in the Tysabri that Biogen sold in 2019 and beyond was made in or imported into the United States prior to the expiration of Cabilly, and therefore is “Licensed Product.” Notwithstanding this, and in breach of the License Agreement, Biogen has not paid Genentech any royalties on these “Net Sales….”

Biogen entered into a binding and enforceable contract with Genentech to license the Cabilly patents. Though Elan Pharmaceuticals was initially also a party to the agreement, Biogen assumed the role of Genentech’s sole counterparty to the License in 2013 and, under the protection of the License, Biogen continued manufacturing and selling Tysabri and making royalty payments to Genentech in accordance with the License until March 2019.

Genentech materially performed all of its obligations under the License….

Do stay tuned (we will update it from time to time). Have a safe and warm weekend, and stay out of the wind… we are hiding from the snows here, as night falls. Grin.

नमस्ते