---
title: "Patent Games: How Big Pharma Uses New Drug Forms to Beat the Generic Clock"
description: Merck’s Keytruda gains FDA approval for a subcutaneous shot, dodging the patent cliff and stoking evergreening row as US costs, rivals and investor mood shift.
author: Darie Nani (Editor-in-Chief)
date: 2025-09-26T12:54:40.000Z
updated: 2026-03-31T13:20:04.184Z
canonical: https://www.sovereignmagazine.com/article/patent-games-how-big-pharma-uses-new-drug-forms-to-beat-the-generic-clock
image: https://cdn.nanimediahouse.com/x2cooe_mag8.jpg
categories: Economy
content_type: Analysis
region: United States
publication: Sovereign Magazine
---

Merck’s blockbuster cancer drug Keytruda just secured a crucial FDA approval on 19 September — not for treating cancer better, but for protecting billions in revenue from generic competition through a simple injection method switch.

The pharmaceutical giant now offers Keytruda as a [one-to-two-minute subcutaneous injection](https://www.fiercepharma.com/pharma/merck-scores-fda-approval-subcutaneous-keytruda) instead of the traditional 30-minute intravenous infusion. Patients get faster treatment. Merck gets extended patent protection potentially until 2039.

## The $30 Billion Patent Cliff Problem

Keytruda generates over $30 billion annually for Merck, representing nearly 60% of the company’s total revenue. The original intravenous formulation faces patent expiration in 2028, opening the floodgates for cheaper biosimilar competition that typically cuts branded drug sales by 80–90%.

The new subcutaneous version — branded Keytruda Qlex — carries separate patents that could extend Merck’s monopoly for another decade. [Reuters reported](https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-mercks-new-injectable-version-keytruda-2025-09-19/) the FDA clearance covers most solid tumour indications already approved for the IV version.

Merck expects 30–40% of Keytruda patients to switch to the subcutaneous form within two years. That’s roughly $10–12 billion in annual revenue protected from biosimilar erosion.

## Evergreening Goes Mainstream

This isn’t just Merck playing defence. Pharmaceutical companies increasingly rely on formulation switches to extend patent monopolies as their blockbuster drugs approach the dreaded ‘patent cliff.’

Bristol Myers Squibb and Roche are pursuing similar subcutaneous strategies for their own cancer immunotherapies. The industry calls it ‘lifecycle management.’ Critics call it evergreening — artificially extending patent protection through minor modifications rather than genuine breakthroughs.

This trend extends beyond established Western markets, as [global drugmakers transform their clinical trials strategy](https://www.sovereignmagazine.com/article/big-pharma-bets-on-india-how-global-drugmakers-are-transforming-clinical-trials-strategy) to maintain competitive advantages across diverse regulatory environments.

Managing these complex patent strategies requires sophisticated tracking systems, which is why many pharmaceutical companies invest heavily in [pharma CRM solutions](https://blog.pulsehealth.tech/the-best-pharma-crm-solution/) to monitor competitive timelines and regulatory milestones across multiple formulations.

US lawmakers aren’t buying the innovation argument. [Senators Elizabeth Warren and Bernie Sanders](https://www.warren.senate.gov/oversight/letters/senators-warren-sanders-representatives-jayapal-and-porter-urge-uspto-to-scrutinize-mercks-abuse-of-patent-applications-for-cancer-drug-keytruda) recently urged the USPTO to scrutinise Merck’s patent applications, arguing they constitute ‘anti-competitive evergreening’ that keeps drug prices artificially high.

## Patient Convenience vs Healthcare Costs

The subcutaneous version offers genuine patient benefits. Cancer patients get faster infusions with less time spent in treatment centres. Healthcare systems reduce chair time and staffing costs.

This patient-centric approach reflects broader industry evolution, where [digital platforms reshape patient-led drug development](https://www.sovereignmagazine.com/article/digital-platforms-reshape-patient-led-drug-development-as-rare-disease-market-approaches-200-) to better address unmet medical needs.

Yet the convenience comes at a steep price. While biosimilar versions of IV Keytruda could slash treatment costs by thousands of dollars annually per patient, the new subcutaneous form maintains Merck’s premium pricing power.

Merck faces patent litigation with Halozyme over the enzyme technology enabling rapid subcutaneous delivery. The outcome could determine whether competitors can launch similar formulations or face their own patent barriers.

## The Next Decade of Cancer Costs

Keytruda’s formulation switch represents a broader industry trend that will define cancer treatment costs through the 2030s. As more biologics approach patent expiration, expect pharmaceutical companies to deploy similar strategies — extended-release versions, combination therapies, new delivery methods.

The regulatory landscape continues evolving as companies explore [healthcare innovation through genetic data acquisition](https://www.sovereignmagazine.com/article/genetic-data-acquisition-raises-critical-questions-for-healthcare-innovation) and alternative approval pathways to maintain market exclusivity.

Each provides real or perceived patient benefits. Each also extends patent protection and delays affordable alternatives. The question facing regulators and policymakers is whether these modifications justify decade-long monopoly extensions on life-saving treatments.

[Investor’s Business Daily](https://www.investors.com/news/technology/merck-subcutaneous-keytruda-approved/) noted Merck’s stock jumped following the FDA approval, reflecting Wall Street’s appreciation for patent cliff mitigation strategies.

The Keytruda case highlights the tension between rewarding pharmaceutical innovation and ensuring healthcare affordability — a balance that will determine whether cancer patients access cutting-edge treatments or affordable alternatives in the years ahead. This challenge mirrors broader efforts to [fund new therapies for hard-to-treat diseases](https://www.sovereignmagazine.com/article/from-skin-to-brain-japanese-funding-backs-new-therapies-for-hard-to-treat-diseases) while maintaining sustainable healthcare economics.