Contract analysis

From: Sean Morrissey <smorrissey@calderwoodharkness.com> To: Brian Takata <btakata@whitfieldgrange.com> Cc: Joel Strauss <jstrauss@calderwoodharkness.com> Date: Mon, 03 Oct 2022 02:47:00 -0000 Subject: Velonatib Psoriasis sNDA — Draft USPI Language and Patent Considerations

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 eas

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 wo

**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 n

**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

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.

**Sean Morrissey** Associate | Healthcare & Life Sciences Calderwood & Harkness LLP 1120 Avenue of the Americas, 32nd Floor New York, NY 10036 Direct: (212) 506-4422 Email: smorrissey@calderwoodharkness.com

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