In Amgen vs. Sanofi, SCOTUS asks if breakthrough drugs require an impossibly high 35 USC 112(a) enablement test for patent protection.
Many of us owe our lives to breakthrough inventions (often drugs) in biotechnology and pharmacology. These advances usually require years of work and billions of dollars; without patent protection, they won’t happen. The Federal Circuit recently applied somewhat unusual (i.e., sketchy) 35 USC 112(a) reasoning to invalidate two essential Amgen patents on cholesterol-lowering antibodies. Amgen (a major biotech) appealed to the Supreme Court (SCOTUS); Amgen argued that the Federal Circuit’s sketchy reasoning could potentially shut off the flow of future breakthrough innovations.
SCOTUS asked the executive branch of the US government (the Solicitor General) for its opinion. The Solicitor General argued against taking the case. However, other pharmaceutical companies did not agree. GlaxoSmithKline (now GSK), another major drug company and Amgen competitor, filed a brief saying that they agreed with Amgen. GSK affirmed that the Federal Circuit’s approach could devastate the pharmaceutical industry.
SCOTUS lives for the chance to smack down the Federal Circuit! If protecting the US pharmaceutical industry from potential devastation isn’t a good cause, what is? So rather unusually, on November 4, 2022, SCOTUS ignored the Solicitor General and decided to hear the case anyway.
Based on personal experience, I think that SCOTUS made a good call. The Amgen and GSK briefs convincingly argue that the Federal Circuit has gone off the rails concerning patent enablement (35 USC 112a) law. (The Solicitor General may have dropped the ball here.)
Who sets the standards, and why?:
As previously discussed, patents are a bargain between the inventor and society. Society will grant a limited monopoly in exchange for adequately disclosing the invention. This monopoly (patent) is limited in scope (defined by the claims) and time (20 years or less).
“Adequate disclosure” is defined by statute (e.g., 35 USC 112a) and by hundreds of years of US and English case history. Notably, both the law and case history teach that “adequate disclosure” is based on facts and must be determined by a Jury.
The Federal Circuit took a different path. They created a non-standard “fork” of patent enablement law that imposed impossibly high standards for Genus claims. A genus claim is a claim that encompasses many possible variants. Unfortunately, most breakthrough biotech and drug discoveries require genus claims. The Federal Circuit argued that their non-standard approach was justified because it was “long in the tooth.” (Is “long in the tooth” shorthand for “citation needed?”) The Federal Circuit further argued that their non-standard approach was a question of law. Thus, they could ignore previous Jury verdicts in favor of Amgen and invalidate Amgen’s patents without a jury.
In America, only SCOTUS has the clout to screw up patent law this badly! I don’t think that Amgen and GlaxoSmithKline are overstating the case. This strange Federal Circuit patent enablement interpretation must go if we want more breakthrough drugs.