Precision Medicine in India: How Sotorasib is Changing Oncology Access and Understanding EPO T 0137/24: Patenting Genetically Modified Cannabinoid Production

API and IP News Update: 2026 Pharmaceutical Trends & Legal Rulings This comprehensive update covers the latest CDSCO approvals, significant pharmaceutical trademark litigation in India, and pivotal EPO patent decisions impacting biotechnology and precision medicine. New CDSCO & DCGI Approvals (Q1 2026) The first quarter of 2026 has seen major regulatory milestones in the Indian healthcare market, specifically within neuropsychiatry and oncology. Brexpiprazole: Expanding Neuropsychiatry Access On February 16, 2026, the DCGI approved Brexpiprazole tablets, a second-generation atypical antipsychotic.

• Indication: Primarily used for schizophrenia, with future potential for MDD and Alzheimer ’s-related agitation.
• Market Impact: With the Indian patent (IN 251204) expiring on April 12, 2026, the pathway is clear for affordable generic entry.
• Key Players: Torrent Pharmaceuticals is a lead contender following successful Phase III trials, while MSN Laboratories secured bulk drug approval in late February.

Sotorasib: Breakthrough in Precision Oncology Approved on March 10, 2026, Sotorasib (240mg) is the first-in-class KRAS G12C inhibitor registered in India.

• Indication: For adult patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC).
• Supply Chain: The shift from Named Patient Programs (NPP) to formal registration ensures a more stable and cost-effective supply for Indian patients.

General Pharmaceutical News & Litigation

Bombay High Court: Sun Pharma Trademark Victory

The Bombay High Court recently ruled in favor of Sun Pharmaceutical Industries Limited regarding a trademark dispute with Meghmani Lifesciences.

• The Conflict: The court found the marks RACIRAFT and ESIRAFT to be deceptively similar.
• The Ruling: Despite visual differences, the phonetic similarity posed a risk of confusion in medicinal products, leading the court to grant an injunction.

FDA FY 2027 Legislative Proposals The FDA has outlined several "game-changing" proposals for the life sciences sector:

• Eliminating the two-tier system for Biosimilar Interchangeability.
• New pathways for Abbreviated Licensure of biological products.
• Incentives for domestic generic drug manufacturing and increased API sourcing transparency.

Intellectual Property Highlights

EPO Decision (T 0137/24): Cannabinoid-Producing Yeast On January 22, 2026, the European Patent Office issued a crucial decision regarding EP 3 615 667, held by The Regents of the University of California.

• The Technology: Genetically modified yeast cells engineered to produce cannabinoids.
• The Main Request: Focuses on chromosomal integration of heterologous nucleic acids encoding a GOT polypeptide with at least 90% sequence identity to specific markers.
• Novelty Established: The Board found the patent novel because prior art did not specify the copy number range (one to eight copies) required for precise enzymatic tuning.
• Outcome: The patent is to be maintained in amended form.

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New CDSCO approvals in the first three months of 2026

We follow DCGI approvals.

 

Brexpiprazole

The DCGI's approval of Brexpiprazole tablets on February 16, 2026, marks a pivotal expansion of the Indian neuropsychiatry market. As a second-generation atypical antipsychotic indicated for schizophrenia, Brexpiprazole offers a refined therapeutic profile through its partial agonism of dopamine D2 and serotonin 5-HT1A receptors. With the critical Indian patent (IN 251204) set to expire on 12 April 2026, the regulatory pathway is now clear for a robust generic market entry, promising enhanced affordability for a treatment that has traditionally faced high intellectual property barriers.

 

Clinical and regulatory records highlight Torrent Pharmaceuticals as a frontrunner, having secured an SEC recommendation following successful Phase III trials. Other major players, including MSN Laboratories and Exemed Pharmaceuticals, are also poised to enter, with MSN likely securing the bulk drug approval granted on 24 February 2026. While the current focus remains on schizophrenia, the eventual expansion into adjunctive Major Depressive Disorder (MDD) and Alzheimer’s-related agitation represents a high-growth trajectory for India’s competitive CNS portfolios.

 

Sotorasib

In the oncology segment, the DCGI’s approval of Sotorasib 240mg tablets on 10 March 2026, introduces the first-in-class KRAS G12C inhibitor to the domestic market. Targeted at adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), this approval marks the transition of the molecule from restricted access to a full-scale commercial launch. This is a significant milestone for precision medicine in India, moving beyond the limitations of individual patient imports to a standardised treatment protocol for a historically difficult-to-treat mutation.

 

Prior to this formal nod, Sotorasib was primarily available through Named Patient Programs (NPP), a regulated pathway allowing clinicians to import unapproved medicines for specific patients with life-threatening conditions. The shift from NPP to formal DCGI registration not only validates domestic clinical demand but also ensures a more stable, cost-effective supply chain. For healthcare providers and patients alike, these 2026 approvals represent a major step forward in accessing cutting-edge genomic and psychiatric therapies within the Indian healthcare ecosystem.

 

List is here.

General information

Bombay HC Grants Relief to Sun Pharma in RACIRAFT Row, Flags Risk of Confusion with ESIRAFT

In a significant ruling on pharmaceutical trademark disputes, the Bombay High Court has allowed an appeal filed by Sun Pharmaceutical Industries Limited, holding that the rival marks RACIRAFT and ESIRAFT used by Meghmani Lifesciences Limited are deceptively similar.

The Court ruled that despite some visual differences, the phonetic similarity and likelihood of confusion, especially in the context of medicinal products, warrant protection of the appellant’s trademark and grant of injunction.

News here

FDA’s FY 2027 Legislative Proposals Include Game Changers for Life Science Private Equity

1. Biosimilar Interchangeability: Eliminating the Two-Tier System
2. New Abbreviated Licensure Pathway for Biological Products
3. Expedited IND Pathway for Phase 1 Clinical Trials
4. Permanent Reauthorization of the Rare Pediatric Disease Priority Review Voucher Program
5. Generic Drug-Device Combination Products: Clarifying the ANDA Pathway
6. Domestic Generic Drug Manufacturing Incentive
7. API Sourcing Transparency and Civil Monetary Penalties
8. Cracking Down on Misleading DTC Drug Advertising and Compounded Drug Marketing
9. Data Retention and Fraudulent Data: New Enforcement Tools to Protect Product Integrity

News here

Intellectual Property 

T 0137/24: Cannabinoid-Producing Yeast Cells

The Technical Board of Appeal of the European Patent Office (EPO) issued its decision on 22 January 2026 regarding EP 3 615 667. The patent, held by The Regents of the University of California, concerns genetically modified yeast cells and methods for producing cannabinoids and their derivatives.

Procedural History

The patent was originally granted based on an international application (WO 2018/200888). Two oppositions were filed by Dr Andrea Schussler and JA Kemp LLP, citing grounds of lack of novelty, lack of inventive step, insufficiency of disclosure, and added matter.

In November 2023, the Opposition Division rejected these oppositions, finding that the patent met all EPC requirements. Opponent 2 (JA Kemp LLP) subsequently appealed this decision, challenging added matter, sufficiency, and priority. During the appeal's oral proceedings, which the appellant did not attend, the respondent (patent proprietor) withdrew its main request and auxiliary requests 1–3, making auxiliary request 4 the new main request.

The Main Request: Technical Scope

The primary claim of the main request involves a genetically modified yeast cell designed to produce cannabinoids. Key technical features include:

• Chromosomal Integration: One or more heterologous nucleic acids are integrated into a chromosome of the yeast cell.
• Enzymatic Specificity: These nucleic acids encode a geranyl pyrophosphate: olivetolic acid geranyltransferase (GOT) polypeptide.
• Sequence Identity: The polypeptide must have at least 90% sequence identity to SEQ ID NO: 110 or SEQ ID NO: 100.
• Copy Number: The modification must comprise one to eight copies of the heterologous nucleic acids.

Legal Findings of the Board

1. Amendments and Added Matter (Article 123(2) EPC)

The appellant argued that the combination of features in the main request, specifically the choice of yeast, chromosomal integration, and increased sequence identity, constituted an unallowable selection from multiple lists.

The Board disagreed, finding a clear basis in the original application:

• Yeast and Integration: The Board noted that the application explicitly singled out yeast as a preferred eukaryotic cell and taught chromosomal integration in both the claims and the examples.
• Sequence Identity: The shift from 65% to 90% identity was deemed allowable. Citing an earlier decision, the Board ruled that selecting a higher degree of identity from a convergent list (e.g., 65%-100%) for a functionally defined polypeptide does not create new subject matter.

2. Sufficiency of Disclosure (Article 83 EPC)

The appellant contended that the patent provided insufficient guidance, claiming that many sequences within the 90% identity range might be non-functional, thereby placing an undue burden on the skilled person to identify working embodiments.

The Board rejected this, stating that the claims are limited to cells for producing a cannabinoid and polypeptides defined by their enzymatic activity. Therefore, non-functional variants are excluded by definition. Furthermore, the Board found that generating and testing enzyme variants are routine techniques in biotechnology, and the appellant provided no evidence that such work would be an undue burden.

3. Novelty (Article 54 EPC)

The appellant argued the patent lacked novelty over document D3. While D3 disclosed similar yeast cells and GOT polypeptides with high sequence identity, it was silent on the specific copy number (one to eight copies) integrated into the chromosome. Because D3 did not directly and unambiguously teach this copy number range, the Board found the main request novel.

If I were to oversimplify, copy number refers to the exact number of copies of a heterologous (foreign) gene inserted into the host organism's genome, in this case, a genetically modified yeast cell. Generally, increasing the copy number of a gene results in higher mRNA levels and, subsequently, more of the encoded protein or enzyme. According to this patent specification, having 1 to 8 copies of the GOT gene allows precise tuning of the enzymatic activity required to produce cannabinoids.

4. Inventive Step (Article 56 EPC)

The appellant did not challenge the Opposition Division's findings on inventive step during the appeal. Consequently, the Board concluded the requirements of Article 56 EPC were met.

Final Order

The Board set aside the original decision and remitted the case to the Opposition Division, ordering that the patent be maintained in amended form based on the claims of the main request (formerly auxiliary request 4). 

Decision here