Drug patents are legion, and they are prone to flock together. In ancient times, a patent would describe A molecule that cured . . . the dancing plague (?) and that would be the end of that. But one bright fellow after another came up with new ways to extend the life of a drag patent, from formulation, to method of treatment, to the new hip thing -- interaction patents.
The gist of these patent claims is pretty basic
- You've got a drug that you normally give in amount A.
- You've got atypical patient with whose taking drug B, or has condition C (these pretty much always have something to do with the liver, don't ask me why, I was a chemistry person and livers are gross)
- You give the atypical patient amount D because they're atypical.
The first time I noticed one of these was in Judge Andrews' decision last year in Genentech, Inc. et al v. Laurus Labs, Ltd., C.A. No. 19-78-RGA ( D. Del. Mar. 22, 2022) (Trial Op.). Following the formula above, the plaintiff had several patents on the use of a drug to treat a lung disease along the lines of -- if patient has liver trouble, give less or stop for a while, or, if patient is taking fluvoxamine, make them stop before giving them the lung disease drug.
I swear, I'm really not oversimplifying these.
My initial thought when I first saw these come about was that they were good targets for a 101 motion. The holding in Genentech, however, was based on non-infringement. Judge Andrews found that the drug labels -- which clearly stated that the drug should not be given if, for instance, you have a bum liver or are taking fluvoxamine -- did not clearly instruct doctor to direct the patient to stop taking fluvoxamine before taking the lung drug:
Direct infringement of the DDI patents requires that a patient either take fluvoxamine and pirfenidone concurrently or stop fluvoxamine treatment in order to begin pirfenidone treatment. There was no evidence at trial of any patient receiving pirfenidone after being prescribed fluvoxamine, or of any patient taking fluvoxamine and pirfenidone concurrently. In fact, all three medical experts testified that in the seven years pirfenidone has been available for treatment in the United States, none of them has had a single patient receive fluvoxamine before taking pirfenidone or receive both concurrently.
Id. at 33.
Moreover, even if it were more likely than not that there would be a patient who is prescribed both pirfenidone and fluvoxarnine, Plaintiffs have not proven that infringement of the Asserted Claims would likely ensue. I find Dr. Morrow' s testimony that a physician presented with such a situation would likely choose a non-infringing treatment adjustment over any of the claimed methods to be credible and persuasive.
Id. at 34.
So far, an interesting fact pattern, but you hate to draw too strong a conclusion from a post-trial opinion which is naturally fact intensive.
This week, though, we got a quite similar ruling from Judge Fallon on a motion to dismiss in Zogenix, Inc., v. Apotex, Inc., C.A. No. 21-1252-RGA (D. Del. June 16, 2023) (R&R). There again, the claim boiled down to, "if patient is already being treated with drug B, give them less of drug A."
In this case, the ANDA applicant made a unique carve out of interfering drug B from its label -- including a dosing schedule "setting forth an initial and maintenance dosing schedule for patients taking [the drug we care about] 'without concomitant [interfering drug]," but including nothing for the patented lower dose method for those not taking drug B.
Judge Fallon found this enough to warrant dismissal under 12(b)(6), holding:
These dosing instructions cannot plausibly be construed to encourage a physician to prescribe [drug A] in conjunction with [drug B] . . . . Viewing these provisions of the ANDA label in the light most favorable to Zogenix, it is plausible to infer that some users might infringe. But this is not enough to adequately plead that the ANDA label actively induces or instructs users to perform the patented method.
Id. at 14, 17.
I'm intrigues to see how long we continue to see these interaction patents asserted in the district. If anyone knows of a case where the Court found one infringed let me know and I'll update the post.
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