BioMarin Pharmaceutical Inc. v. Ascendis Pharma, Inc. et al.

I'll research this case thoroughly before drafting.

Now let me dig into the patent specifics, IPR activity, the district court case, and the ALJ.

Let me verify the district court case, PTAB proceedings, the ALJ, and the patents' lineage.

Case Overview

Parties and accused product. Investigation No. 337-TA-1447, Certain Drug Products Containing C-Type Natriuretic Peptide Variants, and Components Thereof, was instituted on May 8, 2025 (90 FR 19532‑33) on a complaint filed April 2, 2025 by BioMarin Pharmaceutical Inc. of Novato/San Rafael, California (Nasdaq: BMRN) — a commercial-stage rare-disease biopharma and, critically for the ITC's domestic-industry requirement, the manufacturer of its flagship achondroplasia drug VOXZOGO (vosoritide) at a 553,000-sq-ft cGMP facility in Novato, CA (USITC News Release 25‑054; FR notice of institution). The original respondents were Ascendis Pharma A/S (Hellerup, Denmark; Nasdaq: ASND), its subsidiary Ascendis Pharma Growth Disorders A/S, its U.S. affiliate Ascendis Pharma, Inc. (Palo Alto, CA — later renamed Ascendis Pharma, LLC by Order No. 45, 91 FR 29169 (May 19, 2026)), and CDMO Wacker Biotech GmbH (Jena, Germany), which Ascendis's own 20‑F describes as the supplier of TransCon CNP drug substance. Bachem AG (a peptide/linker-intermediate supplier) was added as a fifth respondent by Order No. 15 (Aug. 14, 2025), unreviewed Sept. 12, 2025 (90 FR 44843). The Office of Unfair Import Investigations is participating. No party here is an NPE/PAE, university, or shell plaintiff — this is an operating-company-vs-operating-company pharmaceutical competition case, with two European suppliers pulled in as respondents. The accused article is Ascendis's TransCon CNP / navepegritide (brand YUVIWEL), a once-weekly prodrug of CNP‑38 built on Ascendis's TransCon carrier/linker platform, approved by FDA in February 2026 for children ≥2 with achondroplasia (first commercial sale April 2026), with the drug substance made by Wacker and the vialed drug product by Vetter Pharma (Germany) (Ascendis 6‑K, Aug. 31, 2026; Ascendis 20‑F, Feb. 11, 2026).

Patents asserted and technical sketch. The sole patent BioMarin asserted at the ITC was U.S. Reissue Patent No. RE48,267 ("RE'267"), Variants of C-type natriuretic peptide (Wendt et al., assignee BioMarin, issued Oct. 20, 2020 from reissue application 15/646,822) — it claims engineered CNP analogs with extended half-life, including variants coupled to a synthetic polymeric group through a hydrolyzable linkage (claim 15), sustained-release CNP variant formulations (claims 40‑48), and methods of stimulating cGMP production via NPR‑B, including a claim reciting CNP‑38/SEQ ID NO:160, the active moiety in Yuviwel (claims 21, 50) (RE48,267 PDF; Staff/party claim-construction positions, Order No. 21). The second listed patent, US 8,377,884, the earlier BioMarin/Wendt CNP patent in the same family, was not asserted by BioMarin; per the case metadata it was deployed by Ascendis as prior-art Exhibit 32 — I could not independently verify the exhibit's contents in the public record, so treat that use characterization as sourced to the case file rather than confirmed. BioMarin also attacked the patent through reissue proceedings at the USPTO before trial ("Ascendis tried to knock out the RE'267 patent during contested reissue proceedings, but failed") per BioMarin's PI brief (N.D. Cal. dkt. 75‑2).

Posture and why the forum matters. This is an ITC § 337 case (in rem exclusion relief), not a district-court docket, and the presiding judicial officer was the Chief ALJ (the Federal Register notices identify only "the presiding Chief administrative law judge"; I could not verify his name from a reliable source). The target date was set at 17 months — October 8, 2026 (Order No. 5, unreviewed June 20, 2025) and later extended to November 30, 2026, with a final initial determination due June 8, 2026 (Order No. 17, unreviewed Sept. 15, 2025) (FR notice); a Markman hearing was held Dec. 5, 2025; the evidentiary hearing was set for April 2026 per Ascendis's 20‑F. On Feb. 24, 2026 BioMarin moved to partially terminate, and Order No. 36 (Mar. 3, 2026), unreviewed Mar. 23, 2026, terminated claims 15‑22, 31, 33, 35‑40, 42, 44 and 45‑48, leaving a narrower set (the parallel district-court PI motion focused on claims 32, 34, 41, 43, 50 and 55) (90 FR notice). Forum mattered enormously: the accused supply chain sits in Germany and Switzerland, so only the ITC could reach imports directly; and the ITC filing simultaneously triggered the mandatory district-court stay under 28 U.S.C. § 1659, which generated the case's most notable appellate ruling — Ascendis filed a DJ action in N.D. Cal. (Ascendis Pharma A/S v. BioMarin, No. 4:25‑cv‑05696‑YGR, Judge Yvonne Gonzalez Rogers, Oakland Division; earlier 3:25‑cv‑03302), tried to reset the 30-day clock by voluntarily dismissing and refiling, and the Federal Circuit affirmed denial of the mandatory stay in Ascendis Pharma A/S v. BioMarin Pharmaceutical Inc., No. 26‑1026 (Fed. Cir. Mar. 26, 2026), while the district court entered a discretionary stay (VitalLaw/IP Law Daily, Mar. 27, 2026, listing Jones Day and Latham & Watkins as counsel — counsel attribution not independently confirmed).

Why the case is notable, and outcome. Three features stand out. First, it is a leading example of Section 337 being used as a pharmaceutical life-cycle/competitive tool between two branded biologics-style franchises rather than in the usual electronics/consumer-goods setting — the same conflict was litigated across the UPC (BioMarin's EP 3 175 863, revoked in its entirety by the EPO Boards of Appeal on Oct. 16, 2025, leading the UPC Munich to dismiss on Dec. 29, 2025), Denmark (Ascendis entitlement claims to divisional applications), Korea (Ascendis IPTAB invalidation petition against BioMarin's KR 2033680, filed Oct. 21, 2025), Brazil and Germany, plus an FDA § 505(q) citizen petition filed by BioMarin on June 12, 2025 seeking to block approval of any human CNP analog until VOXZOGO's orphan exclusivities expire (all per Ascendis's 20‑F). Second, it produced a PTAB/ITC "collision course" dispute: Ascendis's post-grant petition against a related BioMarin CNP patent (referred to in the papers as "the '106 patent") drew a Patent Owner Preliminary Response arguing discretionary denial because the ITC would reach a final Commission determination before any Final Written Decision, and challenging Ascendis's failure to name Wacker and Bachem as real parties in interest (PTAB POPR excerpts). Third, the global settlement announced Aug. 30–31, 2026 is unusually rich for biotech patent peace: a non-exclusive worldwide license at 20% of U.S. net sales and 18% in the EU, Brazil and South Korea, retroactive to first commercial sale and running through May 20, 2030, plus a covenant not to sue and BioMarin's waiver of certain regulatory rights/exclusivities; BioMarin agreed to dismiss the ITC investigation and all proceedings in N.D. Cal., Germany, Denmark, Korea and Brazil (BioMarin 8‑K/press release, Aug. 30–31, 2026; Ascendis release). Analysts (BMO, Stifel via BioSpace) flagged the high-teens/20% rate as at the high end for such settlements. Market context: VOXZOGO (daily, approved Nov. 2021 under accelerated approval) is losing share to weekly Yuviwel, which booked ~€8M in Q2 2026; BioMarin has a VOXZOGO full-approval PDUFA of Feb. 28, 2027, positive Phase 3 hypochondroplasia data (May 2026) and a next-gen weekly CNP (BMN 333), while BridgeBio's infigratinib is a third entrant.

Sourcing caveats. (1) The settlement is described in the parties' SEC filings as a binding term sheet, with a definitive agreement targeted for Sept. 24, 2026; I found no public confirmation that the Commission has formally terminated the investigation before its Nov. 30, 2026 target date, so the "settled/dismissed" status reflects the announced dismissal commitment rather than a verified Commission order. (2) A "proposed order" granting BioMarin a preliminary injunction appears at N.D. Cal. dkt. 75‑3; because it is a proposed order, I cannot confirm the court actually entered a PI. (3) I could not verify the name of the presiding Chief ALJ, the specific PTAB proceeding number, or counsel of record from a primary source within the search budget; those items above are flagged as unconfirmed.