by Dennis Crouch
Two prosecutions lessons from this case: (1) if you are concerned about obviousness, be careful of broadening statements in the specification; (2) if you want to claim a particular action, particularly claim it.
BTG Int’l. Ltd. v. Amneal Pharms. LLC (Fed. Cir. 2019) [BTG_Decision]
This is a consolidated appeal from four different district court cases and five different inter partes review cases. All the cases focus on BTG’s U.S. Patent No. 8,822,438 (hormone based chemotherapy). For once, the PTAB and District Court decisions meshed – all finding the claims invalid as obvious. On appeal, the Federal Circuit focused on one of the PTAB decisions and affirmed — with result of mooting the remaining appeals.
The ‘438 patent claims a method of “treatment” by providing a patient with (1) “a therapeutically effective amount of abiraterone acetate” and (2) “a therapeutically effective amount of prednisone.”
The patentee’s primary argument on appeal is that the “treatment” limitation in the preamble should be focused on anti-cancer treatment — and particularly that the “therapeutically effective amount of prednisone” should have an anti-cancer effect rather than ‘merely’ a palliative effect. The prior art apparently indicated a combination of chemo + prednisone, but did not specifically indicate that the prednisone had anti-cancer impact.
On appeal, the Federal Circuit agreed with the PTO that the “treatment” element should be broadly construed. This was seemingly a simple case because the patentee used traditional broad language in the specification:
The specification states that a “therapeutic agent” may be either “an anti-cancer agent or a steroid.”
What this means is that the prior art’s use of prednisone as a steroid (for palliative care) directly reads on the claims.
To be fair to the patentee, the patent focuses substantially on the reality that prednisone was found by the patentee to have anti-cancer effects itself. On appeal, the court effectively says – ‘if you wanted to claim that prednisone as an anti-cancer treatment, write it in the claims.’