The Biopharma Crossroads

How India's Patent Revolution is Reshaping Global Medicine

The Generics Giant's Evolution

India's pharmaceutical journey began with a bold experiment: the 1970 Patents Act, which recognized only process patents—not product patents. This allowed Indian companies to reverse-engineer drugs using alternative methods, transforming the nation into the "pharmacy of the Global South." Today, India supplies:

Global Generic Drug Supply

India's dominance in global generic drug and vaccine supply ³ ⁷ .

Market Opportunities

A $150 billion biologics patent cliff (2025–2029) and a $63.7 billion small-molecule expiry wave position India to dominate next-generation biosimilars and complex generics ¹ .

Biologics $150B

Small-molecule $63.7B

The Patent Pendulum: From Process to Product

The 1970 Advantage

India's original patent strategy prioritized accessibility:

Reverse engineering freedom: Companies like Cipla and Sun Pharma developed cheap alternatives to patented drugs by tweaking manufacturing processes.
Compulsory licensing: Under Section 84 of the Patents Act, India can override patents for public health needs (e.g., the 2012 Nexavar license for Bayer's cancer drug) ³ ⁹ .

The 2005 TRIPS Pivot

Joining the WTO required recognizing product patents for 20 years. Critical safeguards emerged:

Section 3(d): Blocks "evergreening" by requiring new forms of known drugs to demonstrate enhanced therapeutic efficacy.
Pre-grant opposition: Allows challenges before patent approval, though recent rules tighten eligibility ³ ⁷ ⁹ .

Patent Law Evolution Timeline

1970 Patents Act

Recognized only process patents, enabling reverse engineering

1995 WTO TRIPS Agreement

India committed to product patent recognition

2005 Patent Amendments

Implemented product patents with safeguards like Section 3(d)

2024 Patent Rules

Faster examinations and specialized IP courts

The Patent Cliff Gold Rush (2025–2029)

Blockbuster Biologics Going Off-Patent

Table 1: Key Expiries and Market Impact ¹
Year	Drug (Company)	Use	Global Sales
2025	Perjeta (Genentech)	HER2+ breast cancer	$4.1 billion
2027	Keytruda (Merck)	Immuno-oncology	$25.0 billion
2029	Darzalex (J&J)	Multiple myeloma	$12.5 billion

India's Biosimilar Arsenal

Companies like Biocon, Lupin, and Intas have 30+ biosimilars in development targeting these drugs. Regulatory wins include:

Biocon's Trastuzumab

Ogivri approved in the U.S./EU

Zydus's Adalimumab

Exemptia priced 70% lower than Humira ¹ ⁶ .

Legal Battlegrounds: Patent Law in Action

Landmark Court Rulings

Vifor v. MSN Labs (2023): Delhi High Court upheld product-by-process claims for Ferric Carboxymaltose, blocking generic copies ⁸ .
Genmab A/S v. Patent Office (2024): Madras High Court allowed antibody patents, ruling synthetic monoclonal antibodies (e.g., Darzalex) aren't "natural substances" under Section 3(c) ⁸ .

Evergreening vs. Incremental Innovation

Section 3(d) remains contentious. In Novozymes v. Patent Office, the court clarified that improved thermostability in enzymes does demonstrate efficacy—a win for biotech patents ⁸ .

Section 3(d) Incremental Innovation Evergreening

Biosimilars vs. Generics: India's Dual Challenge

Table 2: India vs. China in the Biosimilar Race ¹ ⁶
Criteria	India	China
Regulatory approvals	35+ USFDA/EU biosimilar licenses	<10 approvals
Cost competitiveness	30–40% lower manufacturing costs	10–15% lower than the West
Government support	Moderate (PLI schemes)	High (Made in China 2025)

Manufacturing Hurdles

Biologics cost 30–50% of product expenses vs. 5–10% for small molecules due to:

Complex Development

Complex cell-line development (e.g., CHO cells)

Stringent Requirements

Stringent purity requirements ² ⁶ .

The Innovation Imperative

Beyond Copycats: Homegrown Biologics

India's first novel mAbs:

Nimotuzumab (BIOMAb): For head/neck cancer (Biocon, 2006)
Itolizumab (Alzumab): For psoriasis (Biocon, 2013) ⁶ .

Skill Gaps

70% of biopharma graduates lack industry-ready skills. Solutions include:

DBT-USP partnerships: Training on WHO-prequalified standards
Uchchatar Avishkar Yojana: Industry-academia R&D funding ² ⁶ .

The Future: Precision Medicine & Global Leadership

Cell/Gene Therapy Pipeline

ImmunoACT: CAR-T therapy for leukemia (IIT Bombay spin-off)
Sun Pharma: Licensing Philogen's immuno-oncology assets ⁶ .

Policy Levers

Patent Rules 2024: Faster examinations (31 vs. 48 months)
IP Divisions: Specialized courts in Delhi/Madras High Courts cleared 60% of backlog cases ⁷ ⁸ .

India's Biopharma Odyssey

India stands at a crossroads: replicate its generics triumph in biologics or pioneer novel therapies. With the patent cliff unlocking $180 billion in opportunities, companies blending biosimilar scale (e.g., Lupin's Etanercept) and innovation (e.g., Biocon's CAR-T bets) will lead. As Kiran Mazumdar-Shaw (Biocon) asserts: "Affordable innovation isn't an option—it's India's destiny as the pharmacy of the world" ¹ ⁶ .

India's biologics revolution will be forged not in imitation, but in the alchemy of access and ingenuity.