Brian,
Hope you're doing well. We're circulating the draft USPI for the proposed psoriasis indication for Velonatib — we've now moved from Rev. 2 to what we're finalizing as Rev. 3, which is attached as a redline against the current approved USPI. Joel and I wanted to flag several items for Whitfield & Grange's review from an IP/patent perspective before we lock down the labeling language. I've organized these below for ease of reference.
**1. Orange Book Listings**
Per our prior discussions, it is our understanding that W&G's position is that the addition of the psoriasis indication does not necessitate any new Orange Book patent listings. As you know, the existing listed patents — the compound patent (U.S. Patent No. 10,412,XXX, expiring February 2034) and the formulation patent (U.S. Patent No. 10,891,XXX, expiring August 2036) — cover the product as currently marketed. We would ask that you confirm this view remains correct after reviewing the draft indication statement and dosing language in the attached Rev. 3 markup.
**2. Method-of-Treatment Patent — Provisional Application**
As you're aware, Penterra filed a provisional patent application in August 2022 (U.S. Prov. App. No. 63/XXX,XXX) directed to a method of treating chronic plaque psoriasis with velonatib. We want to be careful that the USPI language for Section 1.2 (Indications and Usage — Psoriasis) and Section 14.2 (Clinical Studies — Psoriasis) does not inadvertently narrow the scope of the claims in the provisional or any future non-provisional application. Could you or Eleanor review those sections and flag any language that could be construed as limiting the patient population or dosing regimen in a manner inconsistent with the intended claim scope? We want to make sure we're not boxing Penterra in on the patent side with how we draft the label.
**3. Skinny Labeling / Carve-Out Considerations**
We recognize that this is an sNDA for the originator product, so a Section viii carve-out is not directly at issue here. That said, we want to be mindful of future paragraph IV certification scenarios. If a generic applicant were to file an ANDA and attempt to carve out the psoriasis indication, the labeling language we choose now could become relevant in subsequent Hatch-Waxman litigation — particularly in terms of how the indication and clinical study descriptions are drafted and whether a carved-out label could still be argued to induce infringement of the method-of-treatment patent. We'd welcome any thoughts you or Eleanor may have on protective language or drafting considerations that would strengthen Penterra's position in that context.
**Timing and Logistics**
We are targeting completion of Rev. 3 by **October 15, 2022**, and would appreciate W&G's comments by **October 12** if at all possible. The draft is attached as a redline against the current approved USPI. The file is password-protected — I'll send the password separately.
Please don't hesitate to reach out if you'd like to set up a call to discuss any of these items. Thanks as always for the collaboration on this.
Best regards,
**Sean Morrissey** Associate
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