The U.S. Supreme Court has ruled unanimously against Amgen Inc. in its closely watched patent dispute with Sanofi and Regeneron Pharmaceuticals over cholesterol drugs.
The ruling affirms the narrow scope of a requirement that patents must contain enough information to enable an expert in a relevant field to make and use the invention. According to the court, Amgen’s patents covering its Repatha drug didn’t contain enough information to meet this requirement.
Both Amgen and Sanofi make patented drugs based on monoclonal antibodies that lower LDL cholesterol by binding to a particular sweet spot on a particular protein and blocking that protein from binding to LDL receptors. This case does not involve those antibody-specific patents, but rather much broader Amgen “genus” patents that cover every antibody that binds to the same sweet spot and works the same way — potentially including millions of antibodies.
Amgen sued Sanofi for infringing these broader patents, and Sanofi insisted that Amgen’s patent was invalid because it failed to satisfy the enablement requirement of 35 U.S.C. §112(a).
The Supreme Court agreed. “If a patent claims an entire class of processes, machines, manufactures, or compositions of matter,” Justice Neil Gorsuch wrote in the Court’s ruling, “the patent’s specification must enable a person skilled in the art to make and use the entire class.”
Amgen failed this test, the Court concluded. Its patents described 26 specific antibodies in detail, and had the patent covered only those 26 examples it would presumably have passed the enablement requirement and be valid. But Amgen’s genus patents cover an entire universe of potential antibodies. For the rest of the antibodies, Amgen gave what it called a “roadmap,” which essentially entails generating random antibodies and checking to see which ones work. Gorsuch called this “trial and error” or “a hunting license,” rather than enablement.
This does not mean, Gorsuch wrote, that a patent must explain “how to make and use every single embodiment within a claimed class.” A patent could give examples along with identifying specific characteristics that would allow someone else to make and use everything the patent claims. The ruling also doesn’t forbid some level of experimentation for enablement to exist. But a patent may call for only a reasonable level of experimentation, which the court said “will depend on the nature of the invention.”
In a statement, Sanofi applauded the court’s decision. “The justices rejected an attempt to radically change the longstanding legal standard for patent validity under the enablement doctrine,” the company stated.
Sources: Bloomberg Law and SCOTUS Blog
