Recent Paragraph-IV filings and Merck vs Hopewell : Mavenclad (cladribine)

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Recent Paragraph-IV filings

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Merck vs Hopewell : Mavenclad (cladribine)

Recent Paragraph-IV filings

We follow ANDA filings with P-IV certificates. The FDA published the recent list on December 15.

Avacopan Three ANDAs seems to have been filed on the NCE-1 date. While the specific names of the generic filers are typically withheld in initial FDA listings, major generic players such as Teva and Sandoz are often among the first to file (FTF) for such high-growth orphan drugs. Sandoz has filed a patent family for the crystalline form, WO2022263263. Teva filed a patent family for Avacopan intermediates, WO2023158722A2. Tavneos is a first-in-class oral C5a receptor antagonist used as an adjunctive treatment for adults with severe active ANCA-associated vasculitis (specifically GPA and MPA). The drug has seen explosive commercial growth; global sales for 2024 reached approximately $283 million, and with quarterly revenues hitting $107 million by Q3 2025, the product is on a clear trajectory toward "blockbuster" status (exceeding $1 billion annually). The generic filers must circumvent the capsule composition patent US 11951214 (exp 2040) and the amorphous form patent US 11603356 (exp 2039) to pursue an earlier launch opportunity before these patents expire. Dabrafenib Mesylate Novartis is the innovator of Tafinlar (Dabrafenib mesylate). One generic company submitted an ANDA for capsules on November 13, 2025. Tafinlar is a precision medicine used primarily to treat BRAF V600E/K mutation-positive melanoma, non-small cell lung cancer (NSCLC), and anaplastic thyroid cancer. While the specific filer has not been officially named, Apotex could be the First-to-File for such a high-value oncology product. MSN is the only DMF filer and has exported the API to Apotex. Hence, one could conclude that Apotex has likely filed the ANDA. But this is an educated guess. Commercially, Tafinlar global sales for the Dabrafenib segment (Capsules and Tablets) reached approximately $1.45 billion in 2024, with 2025 projections showing continued growth as it maintains a dominant 30% share of the BRAF kinase inhibitor market. There is a high chance of litigation and a 30-month stay. For an ANDA filing in November 2025, the 30-month stay would likely expire around May 2028. This gives Novartis a protected window to defend its Orange Book (OB) patents. Though OB patents currently extend till 2038, key patents that protect the product would expire in July 2030. During this period, the generic filer typically pursues a Tentative Approval from the FDA. In view of these timelines, one can expect a generic launch of capsules in 2030-2031, as most of these cases would be settled. Atogepant This will be a very competitive market—six ANDA filers filed on the NCE-1 date. Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist used explicitly for the preventive treatment of episodic and chronic migraines in adults. While the specific names of the filers are typically protected during the initial 45-day notice period, major generic manufacturers with strong portfolios in neurological agents, such as Teva, Viatris, or Sandoz, are likely candidates for these early submissions. In addition, MSN is very active and has filed a patent family for the manufacturing process; Apotex is importing API from Indian companies, and hence, some of these companies could have been potential ANDA filers. The generic filers must have either circumvented or would have challenged the OB-listed composition patent US 10117836. This must cover the marketed tablet formulation and remain valid until 2035.

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Intellectual Property

Merck vs Hopewell : Mavenclad (cladribine)

This write-up is for a memorandum opinion from the United States District Court for the District of Delaware addressing Hopewell Pharma Ventures, Inc.'s motion to lift a regulatory stay in a patent infringement case. The case involves Plaintiffs Merck KGaA, Merck Serono SA, and Ares Trading SA (Merck) and Defendants Hopewell Pharma Ventures, Inc., Aurobindo Pharma USA Inc., Aurobindo Pharma Limited, Apotex Inc., and Apotex Corp. (Defendants). This is an interesting story about the 30-month statutory stay for FDA approval. Merck sued the defendants for infringing U.S. Patent Nos. 7,713,947 and 8,377,903, relating to generic versions of Merck’s MAVENCLAD product. OB listed patents

Background: Hopewell successfully challenged Merck's asserted patent claims through inter partes review (IPR) proceedings. The Inter Partes Review (IPR). IPR is a trial-like administrative proceeding conducted by the Patent Trial and Appeal Board (PTAB) at the USPTO to challenge the validity of an existing patent. Any person who is not the patent owner can initiate the process by filing a petition, provided they demonstrate a "reasonable likelihood" of successfully invalidating at least one challenged claim. The scope of the review is strictly limited to issues of novelty and non-obviousness based only on prior art consisting of patents or printed publications. Once a trial is formally instituted, the PTAB is generally required by statute to issue a final written decision within 12 months. This process serves as a faster and more cost-effective alternative to traditional federal district court litigation for resolving patent disputes. In a very simplistic form, this is like Post-Grant oppositions in India. In this case, PTAB invalidated claims as obvious on September 18, 2024. In response, Hopewell filed an Emergency Motion to Stay the Case pending resolution of any appeal of these IPR decisions. On December 23, 2024, the Court granted Hopewell's motion and, critically, tolled the 30-month statutory stay of FDA approval (Regulatory Stay) for Hopewell's ANDA product. Subsequently, on January 16, 2025, the Court ordered a global stay for Merck's action against all remaining defendants. However, the Court explicitly noted that it did not toll the 30-month statutory stay for Apotex's ANDA product, meaning Apotex's regulatory clock continued to run. On October 30, 2025, the Federal Circuit affirmed the PTAB's decision invalidating all the asserted claims. Still, as of the date of this opinion (December 4, 2025), the Federal Circuit had not yet issued its mandate. Hopewell's Emergency Motion to Lift the Regulatory Stay: Hopewell filed an Emergency Motion to Lift the Regulatory Stay, arguing two primary points: Irreparable Competitive Harm: Hopewell contended that maintaining the Regulatory Stay would cause irreparable competitive harm and needlessly warp the competitive environment. Because its 30-month stay was tolled while Apotex's was not, Apotex's stay had expired, potentially allowing Apotex to launch its generic product at-risk before Hopewell. Hopewell, being the first ANDA filer and having successfully invalidated the patents, argued that this outcome was an injustice and contrary to the goals of the Hatch-Waxman Act. Merck's Failure to Cooperate: Hopewell asserted that Merck failed to reasonably cooperate in expediting the action on appeal to the Federal Circuit, which under 21 U.S.C. § 355(j)(5)(B)(iii) should warrant lifting the stay. Hopewell pointed to Merck's alleged delay in filing its notice of appeal and providing its portion of a joint status report. Court's Reasoning and Decision: The Court denied Hopewell's Motion, addressing each argument: Authority to Lift Stay for Injustice: The Court firmly stated it lacked the power to lift the Regulatory Stay merely to prevent an alleged injustice. It emphasised that the Regulatory Stay is a statutory creation under the Hatch-Waxman Act. The statute provides specific conditions under which the duration of the stay can be altered: if the patent is found invalid or not infringed, if it is infringed, or if a party fails to reasonably cooperate in expediting the action. Since the Federal Circuit had not yet issued its mandate, the Court could not formally declare the patents invalid. The Court also expressed scepticism regarding Hopewell's claim of injustice, noting that Hopewell itself requested the initial litigation stay, fully aware of Apotex's timeline. Merck's Cooperation: The Court rejected Hopewell's argument that Merck failed to cooperate reasonably. It clarified that filing a document on a deadline, even the "last permissible moment," does not constitute a failure to cooperate reasonably. The Hatch-Waxman Act provisions concerning cooperation pertain to expediting the infringement action itself, not related to IPR appeals. Furthermore, the Court highlighted that Hopewell, not Merck, initially sought to stay the infringement action pending the IPR appeals. This act suggests that Hopewell itself was not reasonably cooperating in expediting the litigation. Conclusion: The Court concluded that it lacked the authority to lift the Regulatory Stay under the circumstances. Even if it had such discretion, it would decline to do so, considering Hopewell's role in requesting the initial stay. While sympathetic to Hopewell's predicament, the Court deemed it a situation of Hopewell's "own making." The Court therefore DENIED Hopewell's Emergency Motion to Lift the Regulatory Stay. It ordered the parties to file a joint status report, including a proposed final judgment (if applicable), within one day of the Federal Circuit’s issuance of its mandate in the IPR Appeals. It is interesting to note what happened in this case and how Hopewell was unlucky. Hopewell's 30-Month Stay (was tolled): Hopewell filed an Emergency Motion to Stay the Case pending the resolution of any appeals from the IPR decisions. Merck (the plaintiffs) opposed this but alternatively requested that if the Court granted Hopewell's motion to stay the litigation, then Hopewell's 30-month statutory stay of FDA approval should also be tolled. The Court granted both Hopewell's request for a litigation stay and Merck's alternative request to toll Hopewell's 30-month statutory stay, stating that Hopewell's request for a litigation stay implied a delay that should impact its regulatory timeline. Apotex's 30-Month Stay (was NOT tolled): When the Court later informed the parties of its intention to impose a global stay on all defendants, Apotex opposed the global stay if it meant their 30-month statutory stay would also be tolled or extended. Apotex specifically argued that, "Unlike Hopewell, Apotex has not requested a litigation stay, and there is therefore no basis to toll or extend its 30-month stay." The Court respected Apotex's position and explicitly stated that "By entering the global stay... the Court did not toll[ the Apotex Defendants' thirty month statutory stay from receiving FDA approval of their ANDA product.” Hopewell's 30-month stay was tolled because Hopewell initiated the request to stay the litigation, and Merck successfully argued for tolling as a condition of that stay. Apotex's 30-month stay was not tolled because Apotex did not request the litigation stay and actively opposed any tolling of its statutory period. This created a "predicament" where Apotex's 30-month stay expired, potentially allowing them to launch their generic product "at-risk" before Hopewell, despite Hopewell being the one who successfully challenged the patents in the IPR. Next Steps for Hopewell Following the Court's denial of their motion to lift the stay on December 4, 2025, Hopewell's path forward is primarily tied to the completion of the appellate process:

1. Await the Federal Circuit Mandate: The Court held it cannot lift the stay or declare the patents invalid until the Federal Circuit issues its formal mandate.
2. One-Day Filing Requirement: Within one day of the Federal Circuit issuing that mandate, Hopewell must file a joint status report and a proposed final judgment with the Court.
3. Final Judgment and FDA Approval: Once the District Court enters a final judgment of invalidity, the regulatory stay will lift, allowing Hopewell to seek final FDA approval for its generic version of MAVENCLAD.
4. Crucially, even though the Court denied the motion to lift the stay now, it acknowledged that Merck has agreed the stay should be lifted once the mandate is actually issued. To ensure this happens quickly, the Court ordered the parties to file a joint status report within one day of the mandate’s issuance.

Decision here