Amgen is the Answer to Alice

The Supreme Court decided Amgen Inc. v. Sanofi on May 18, 2023, nearly nine years after its decision in Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014). Amgen was concerned with the enablement statute of the patent law, 35 U.S.C. § 112. In comparison, Alice was concerned with the eligibility statute of the patent law, 35 U.S.C. § 101, and has been highly criticized for creating a mess of patent eligibility. At first glance, these cases are distinguishable from one another, since they deal with different aspects of the patent laws. However, statutory interpretation and analysis should be the same in both instances.

The Amgen Decision Supports No Judicial Exceptions to Statutes

As the Court acknowledged in Amgen, the U.S. Constitution (Article I, section 8, clause 8) vests Congress with the power to “promote the Progress of Science and useful Arts.” Pursuant to this power, Congress enacted the patent statutes, including sections 101 and 112.

The Amgen Court quoted the section 112(a) requirement that the patent specification describe the invention “in such full, clear, concise, and exact terms as to enable any person skilled in the art” to “make and use” the invention. Then, most importantly, the Court states that “Judges may no more subtract from the requirements for obtaining a patent that Congress has prescribed than they may add to them,” citing Bilski v. Kappos, 561 U.S. 593, 602-603, 612 (2010). Thus, judges and courts must apply the patent statutes as written by Congress, without adding or subtracting from the express statutory language. The Court explained that its decision in Amgen is entirely consistent with Congress’s directive regarding enablement, which has been a mandate for obtaining a patent since 1790.  The Court further stated that patent policy judgment belongs to Congress. In conclusion, the Court explains that its “only duty in this case lies in applying that mandate faithfully.”

The Court’s rationale in Amgen can clear up the decade-long confusion created by Alice. Enablement and eligibility are entwined, in that both derive from the patent statutes prescribed by Congress. Accordingly, both section 112 enablement and section 101 eligibility should be analyzed and applied equally by the courts. The judicially created exceptions (abstract, laws of nature, and physical phenomena) to eligibility do not comply with the Court’s Amgen rationale. In particular, section 101 must be applied as written by Congress, without adding exceptions that were not expressed by Congress. The policies underlying the judicial exceptions to patent eligibility, which have existed for more than 150 years, did not originate with Congress, and therefore should be discarded as being outside of the judgment which belongs to Congress, not to the courts.

The Supreme Court’s Bilski Analysis is Internally Inconsistent

In Bilski, the Court ruled that the claimed subject matter was an abstract idea, and thus not patentable.  The Court’s analysis explained that it has “more than once cautioned that courts should not read into the patent laws limitations and conditions which the legislature has not expressed,”  citing Diamond v. Diehr, 450 U.S. 175, 182, 101 S.Ct. 1048, 67 L.Ed.2d 155 (1981), The Bilski Court also acknowledged that the three exceptions to eligibility under section 101 are not required by the statutory text. But then the Bilski Court irreconcilably flip flopped and concluded that these exceptions have defined the reach of section 101 as a matter of statutory stare decisis going back 150 years. See Le Roy v. Tatham, 14 How. 156, 174-175, 14 L.Ed. 367 (1853).

SCOTUS Arbitration Case Also Answers Alice

In the 2019 Supreme Court decision in Henry Schein, Inc. v. Archer & White, Inc., 139 S.Ct. 534 (2019), the statute being considered was the 1925 Federal Arbitration Act, and judicially created exceptions to the statutory language. The Court reasoned that it could not redesign the statute, and that they could not engraft their own exceptions onto the statutory text. More specifically, the Court stated, “We may not rewrite the statute simply to accommodate that policy concern” of preventing frivolous motions to compel arbitration. In Schein, the Supreme Court concluded that public policy cannot supersede statutory text approved by Congress to support a non-statutory exception.

The Answer is Simple

Since:

• Patent policy judgment belongs to Congress (U.S. Constitution);
• The Supreme Court cannot add or subtract from Congress’s requirements for patents (Amgen);
• The Supreme Court should not read limitations into the patent statutes not expressed by Congress (Bilski); and
• There cannot be judicially created exceptions to Congressionally enacted statutes (Schein);

Then, Alice should be overruled, and the long-standing abstract idea exception should be stricken from section 101 patent eligibility analysis.

When there are inconsistencies in decisions from different Circuit Courts, the Supreme Court will often grant certiorari to consider the conflicting rulings and then provide consistency. Likewise, the Supreme Court should reconsider their own inconsistent decisions, and provide clarity by following the express language of section 101 as enacted by Congress,  without judicially created exceptions to patent eligibility.

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