598 U.S. 594
U.S.2023Background
- Amgen obtained two 2014 patents (’165 and ’741) claiming a broad genus: every antibody that (1) binds to specific residues on PCSK9 and (2) blocks PCSK9 from binding LDL receptors.
- The patent specification disclosed the amino acid sequences of 26 exemplar antibodies and depicted the 3-D structures of two.
- Amgen also described two methods for producing additional functional antibodies: a screening “roadmap” (generate and test many candidates) and “conservative substitution” (make small amino-acid changes to known antibodies and test).
- Amgen sued Sanofi for infringement of the 2014 patents; Sanofi countered that the claims are invalid under 35 U.S.C. §112(a) (enablement) because the specification does not enable the full claimed genus.
- The district court entered judgment for Sanofi; the Federal Circuit affirmed, holding Amgen’s specification did not enable the full scope of the claims beyond the 26 examples. The Supreme Court affirmed.
Issues
| Issue | Amgen's Argument | Sanofi's Argument | Held |
|---|---|---|---|
| Whether §112(a) is satisfied where claims cover a broad genus of antibodies defined by function | The specification plus the roadmap and conservative-substitution methods enable a person skilled in the art to make and use all claimed antibodies | The specification only enables the 26 exemplars; the claimed genus includes millions of undisclosed antibodies and the methods only require impermissible trial-and-error | The specification does not enable the full claimed genus; claims are invalid under §112(a) |
| Whether the Federal Circuit improperly measured enablement by cumulative time/effort to make every embodiment | The appellate court conflated enablement with the total time/effort to exhaust the genus | The roadmap and substitution approaches amount to trial-and-error, leaving skilled artisans to unpredictable discovery | Court found no error in outcome; lower courts did not rest on a rule about cumulative time but on lack of adequate guidance beyond trial-and-error |
| Whether a single statutory enablement standard can be applied to genus claims without a heightened test | There is one universal enablement standard; it should not be stricter for genus claims | More expansive claims require correspondingly more enabling disclosure—consistent with the statutory text and precedent | One statutory standard governs, but broader claims necessarily require more enabling disclosure; Federal Circuit’s approach aligned with precedent |
| Whether invalidating Amgen’s claims will harm innovation incentives | A ruling against Amgen undermines incentives for breakthrough biologics | The enablement requirement is part of the statutorily calibrated patent bargain and must be enforced to protect the public’s post-expiration benefit | Enforcement of §112(a) preserves the patent quid pro quo; policy trade-offs belong to Congress |
Key Cases Cited
- O’Reilly v. Morse, 56 U.S. 62 (1854) (upheld limited claims; rejected overly broad functional claim that lacked enabling disclosure)
- The Incandescent Lamp Patent, 159 U.S. 465 (1895) (invalidated broad claim to all fibrous materials absent disclosure of a common enabling quality)
- Minerals Separation, Ltd. v. Hyde, 242 U.S. 261 (1916) (recognized reasonable experimentation may be required; enablement depends on nature of the art)
- Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245 (1928) (held a claim to all starch glues invalid where specification described ingredients functionally and required extensive experimentation)
- Continental Paper Bag Co. v. Eastern Paper Bag Co., 210 U.S. 405 (1908) (observed that the claims measure the invention)
- Brenner v. Manson, 383 U.S. 519 (1966) (described claims that leave only discovery by others as a "hunting license" and discouraged such patents)