INSIGHTS

Practice Group Insights

In its decision, the Court clarified that the specification does not have to describe in detail how to make and use every embodiment, but because antibodies are deemed a relatively unpredictable field, a greater level of detail in the application, including more extensive experimental data, may be required to support a genus claim of antibodies.

The Amgen decision is likely to impact small companies and start-up companies looking for funding from external sources, as it will be more difficult to achieve protection of broad genus claims and, thus more difficult to incentivize external investment.

The decision may also affect the patent landscape and freedom-to-operate assessments in biotech and related fields, as companies should consider a thorough assessment of the validity of third-party patents with broad genus claims in view of the enablement standard put forth in Amgen.

Some companies may see the Amgen decision as an opportunity to seek out and review third-party patents with broad genus claims and then explore the use of certain species of those claims (e.g., antibodies) that the patent specification may not properly enable.