What Happened
Amgen had patents on a class of antibodies that lower cholesterol by blocking a protein called PCSK9. The problem: Amgen only disclosed 26 specific antibody sequences, but their claims covered all antibodies that performed this function—potentially millions of different molecules. Sanofi developed its own antibody and got sued. Sanofi argued Amgen's patents were invalid because they didn't teach how to make all the antibodies they claimed.
Why It Matters
This is about the basic bargain of the patent system: you get exclusive rights in exchange for teaching the public how to use your invention. If you claim more than you actually disclose, you're getting something for nothing—exclusive rights without the corresponding public benefit.
The Federal Circuit agreed with Sanofi. Finding all the antibodies within Amgen's claimed scope would require too much trial and error. Amgen disclosed a few working examples and a general method for finding more, but that wasn't enough to enable the full scope of the claims.
This affects far more than just antibodies. Any patent that claims a broad genus—chemical compounds, genetic sequences, software functions—faces the same question: did you disclose enough to enable the full scope of what you're claiming?
What You Should Know
If you're filing patents, disclose as much as you can. More examples, more embodiments, more detail. Don't try to claim everything under the sun if you've only invented a few specific things. Match your claim scope to your actual disclosure.
If you're challenging patents, enablement is a powerful tool, especially for broad claims in unpredictable fields like biotechnology. Look for gaps between what's claimed and what's actually described.
The Amgen decision will shape how much disclosure is enough for years to come.