Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

For biotech, much is riding on the Supreme Court’s Amgen v. Sanofi decision

By Brian Buntz | November 15, 2022

Supreme Court

[Image courtesy of Joe Ravi via Wikimedia Commons]

The U.S. Supreme Court’s decision in Amgen v. Sanofi could have far-reaching consequences for the biotech industry.

The court will consider how much a patent must disclose to comply with enablement requirements.

In February 2021, the Federal Circuit ruled that two Amgen patents (8,829,165 and 8,859,741) for the cholesterol drug Repatha (evolocumab) do not meet enablement requirements because the patent claims require “undue experimentation.”

Now, the Supreme Court will consider whether to uphold the ruling, overrule it or send it back down to the lower court.

Suppose the Supreme Court’s justices choose to uphold the Federal Circuit’s ruling in Amgen v. Sanofi. The consequences could be devastating to the molecular biology and biotechnology industry, said Patrice Jean, chair of Hughes Hubbard & Reed’s life sciences practice. Her law firm is not involved in the case.

Such a ruling could weaken the intellectual property protections for many biotech inventions. “Many of those inventions are protected by claims like this, these functional genus claims,” Jean said.

The Amgen patents cover a functional genus of monoclonal antibodies that block the PCSK9 enzyme. The enzyme binds to low-density lipoprotein (LDL) receptors to cause them to degrade.

When developing evolocumab, Amgen screened more than 3,000 human monoclonal antibodies. Sanofi’s and Regeneron’s research on PCSK9 resulted in the development of Praluent (alirocumab).

FDA approved both evolocumab and alirocumab in 2015.

A year earlier, Amgen filed a lawsuit against Sanofi and Regeneron, arguing that the two companies infringed on its PCSK9 intellectual property related to evolocumab when they sought approval for alirocumab.

The Federal Circuit concluded that the evolocumab patents were based on the function of antibodies that bind to a given therapeutic target rather than their structure.

Patrice Jean

Patrice Jean

U.S. Solicitor General Elizabeth Prelogar recommended the Supreme Court decline to hear the case. Prelogar reasoned that when “a patent exclaims an entire genus based on its function, the patent must enable the entire genus.”

A Supreme Court upholding of the ruling could be ‘devastating’

If the Supreme Court were to ultimately agree, it would upend decades of precedent and thus create unpredictability, Jean said. In addition, such a ruling could make it more difficult for biotech companies to protect their inventions.

Such a ruling could inspire biosimilar and generic companies to attack similar biotech patents. Such litigation would be expensive for patent holders but could lead them to lose core patents, Jean said.

“Other companies could come in and make tiny alterations to your technology because you didn’t claim the exact monoclonal antibody that ultimately ended up on the market,” she said. “That can be devastating to your research and development strategy.”

A need to rethink IP strategy?

If the Supreme Court sides with the Federal Circuit in Amgen v. Sanofi, biotech inventors may respond to such a ruling by rethinking their patent strategy.

Many biotech companies would traditionally begin by filing a broad patent application. “If you’re in a lab, and you find a broad category of things that you think can resolve a problem, then that’s what you’re going to claim,” Jean said.

As research progresses and biotech companies identify candidates with clinical promise, they tend to file narrower patent applications. “Ultimately, you get something as narrow as your compound of interest that’s going to go through a clinical trial,” Jean said. “And if the first one doesn’t work, you go to something else. So the whole process of science is just starting big and then narrowing and finding something that will ultimately be on the market that will save lives.”

If forced to retool their patent strategy, biotechs could respond by filing patent claims covering smaller groups of inventions. Such a move could result in an increase in overall patent applications. “It could create a real bottleneck through the patent office because now you’ve got a gazillion more patents because companies are uncertain whether their foundational patents are enough to protect them.”


Filed Under: Drug Discovery and Development, Women in Pharma and Biotech
Tagged With: Amgen v. Sanofi, Supreme Court
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

Related Articles Read More >

Collage of close-up male and female eyes isolated on colored neon backgorund. Multicolored stripes. Concept of equality, unification of all nations, ages and interests. Diversity and human rights
How a ‘rising tide’ of inclusivity is transforming clinical trials
Mary Marcus appointed CEO of NewAge Industries
DNA double helix transforming into bar graphs, blue and gold, crisp focus on each strand, scientific finance theme --ar 5:4 --personalize 3kebfev --v 6.1 Job ID: f40101e1-2e2f-4f40-8d57-2144add82b53
Biotech in 2025: Precision medicine, smarter investments, and more emphasis on RWD in clinical trials
Data analytics tools help doctors analyze trends in patient outcomes and population health.
External comparator studies: What researchers need to know to minimize bias
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE