Biotechnology innovations face strict legal standards worldwide. Two recent decisions, one in the United States and one in Europe, illustrate how courts and patent offices are tightening requirements for patent disclosure.

In the United States, the Supreme Court’s Amgen Inc. v. Sanofi, 598 U.S. 594 (2023), reshaped enablement rules. In Europe, the Enlarged Board of Appeal’s decision in G 2/21 reinforced the need for plausibility at the filing date. Together, these cases show a global move toward requiring stronger, earlier technical support in biotechnology patents.

In Amgen v. Sanofi, the dispute involved patents on antibodies that bind to the PCSK9 protein. Amgen claimed a broad genus of antibodies defined by their function, blocking PCSK9 from interacting with LDL receptors, without specifying detailed structures for all covered antibodies.

The Court held that the patent specification must enable a person skilled in the art to make and use the full scope of the claimed invention without undue experimentation. Providing only a limited number of examples and a general screening method was not enough when the claims covered potentially millions of variations.

This decision emphasizes that in biotechnology, broad functional claims require equally broad technical disclosure. Applicants must include representative species, structural information, and practical guidance that span the entire claim.

In Europe, the principle of “sufficiency of disclosure” under Article 83 of the European Patent Convention requires that a skilled person can carry out the invention based on the application as filed.

In G 2/21, the Enlarged Board of Appeal addressed whether post-filing evidence can be used to prove a claimed technical effect. The Board held that while post-filed data may be considered, the application must already make the claimed effect “plausible” at the filing date. This means applicants must include enough detail and supporting information in the original application to make the technical effect credible to a skilled person.

For biotechnology, where experimental confirmation is essential, G 2/21 highlights the importance of submitting relevant data with the initial filing.

Both Amgen and G 2/21 show that patent offices and courts are skeptical of claims that are broader than their supporting disclosure. In both jurisdictions:

• Applications must contain enough detail for a skilled person to practice the invention without undue effort.
• Functional claims require structural examples and experimental support.
• Later-generated data cannot replace an insufficient disclosure at the filing date.

These principles apply especially strongly in biotechnology, where results are often unpredictable and small changes can have major effects.

While the two systems share similar goals, they frame the requirements differently:

• U.S. enablement under 35 U.S.C. § 112 focuses on whether the skilled person can make and use the invention’s full scope without undue experimentation.
• EPO sufficiency and plausibility under Article 83 EPC focus on whether the invention is credibly disclosed and can be carried out based on the filing content, with plausibility judged at the time of filing.

The practical impact is that the U.S. test often turns on the breadth of claims versus the examples given, while the EPO test turns on whether the invention’s effect is believable and supported at filing.

Biotechnology companies filing in both jurisdictions should consider:

• Providing a range of representative examples covering the full breadth of the claim.
• Including structural and sequence information for multiple embodiments.
• Filing experimental data with the initial application whenever possible.
• Drafting claims to balance ambition with the level of disclosure.
• Coordinating claim strategies so they satisfy both U.S. enablement and EPO sufficiency requirements.

Weak enablement or plausibility can lead to invalidation during litigation or post-grant proceedings. Strong, well-supported patents are more defensible and more valuable for licensing and enforcement.

Companies that invest in comprehensive technical disclosure from the outset are better positioned to secure enforceable rights across multiple jurisdictions.

The Amgen and G 2/21 decisions reflect a shared global trend toward demanding stronger patent disclosures in biotechnology. Although the legal tests differ, the message is the same: match claim breadth with proportionate technical support at the time of filing.

For biotechnology innovators, this means early planning, careful drafting, and data-backed applications. Twisdale Law, PC helps clients develop filing strategies that meet these evolving standards in the United States, Europe, and other key markets.