Tuesday, July 12, 2016

One Impertinent Question: Is 35 Years Too Long, For A Broad -- And Ferociously-Disputed -- Basic Biotech Patent, To Live?

If not addressed, these long-simmering disputes might artificially inflate the prices of both Keytruda®, and Opdivo®, to patients and end-of-line payers -- for these revolutionary immuno-oncology treatments. And they might artificially reduce the price of the Genentech/Roche offering branded as Tecentriq®.

But first -- a small bit of the 35 year history, here: Genentech has claimed, over all these years, via various PTO interference proceedings, confidential settlements and complicated federal court maneuvers -- including (allegedly) "buying off" other patentees -- that its so-called Cabilly I, II and III patents cover "any method for producing any immunoglobulin molecule in any type of host cell." And that is a breath-takingly broad claim.

And so, Kenilworth has decided to preempt yet another set of one-sided "negotiations", with Genentech/Roche, over the amount of license royalties Merck must pay, under the newly issued continuation patent called Cabilly III, to Genenetech -- in order to manufacture and sell pembrolizumab (branded as Keytruda).

Last week, on Thursday, Merck asked a federal District Court judge sitting in Central California to declare the Cabilly III patent invalid -- for double patenting, and laches -- i.e., the 35 years Genenetech has already enjoyed. Alternatively, Merck asks the court to declare that Merck's methods do not infringe these old patents -- even if they are still valid.

Here is just a bit of the full 20 page complaint at law (a PDF file) -- do take a look; it recites a very nicely-detailed history of these Cabilly I, II and III patents -- and how they've been used as a bludgeon -- against most of the important players in biotech, over these three decades:

. . . .Defendants [Genentech/Roche/City of Hope] have asserted that the Cabilly patents broadly cover the use of certain well-known, conventional recombinant methods to produce any antibody product in any type of host cell. Defendants have filed infringement claims under the Cabilly III patent against numerous companies who have made and sold antibody products that were produced using recombinant methods similar to the recombinant methods used by Plaintiff [Merck] to make Keytruda® (pembrolizumab), and bezlotoxumab. . . .

Defendants have also previously initiated patent license negotiations with Plaintiff concerning the Cabilly patents with respect to Keytruda (pembrolizumab), bezlotoxumab and other Merck antibody products indevelopment. Given Defendants’ acts and statements, Plaintiff’s manufacture and sale of Keytruda (pembrolizumab) and Plaintiff’s manufacture and expected future sale of bezlotoxumab in the United States, a real, immediate, and substantial dispute exists between the parties concerning the Cabilly III patent for which Plaintiff now seeks declaratory relief. . . .

As ever, we will keep an eye on this potentially multi-billion dollar piece of patent litigation -- as it could well have industry-wide implications. Earler versions, against other players, have been pending since 2015, brought offensively by Genenetech, in the same District Court, in California. Now you know. Smiling broadly, on a sweltering but joyful Tuesday early morning, here. . . Onward.

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