by Dennis Crouch
Amarin Pharma, Inc., v. Hikma Pharmaceuticals USA Inc. (Supreme Court 2021)
Obviousness is the key, the core, and the central doctrine of our US utility patent system. The Supreme Court’s doctrine in Graham v. John Deere (1966) and KSR v. Teleflex (2007) serve as the pillars along with the statutory language from the 1952 Patent Act.
A patent for a claimed invention may not be obtained … if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
35 U.S.C. § 103. Of course, in deciding Graham, the Supreme Court wrote that the new Section 103 ““was intended to codify judicial precedents” such as ” Hotchkiss v. Greenwood, 52 U.S. (11 How.) 248 (1851) and its progeny.
Objective indicia of Nonobviousness — do you call them "secondary factors?"
— Dennis Crouch (@patentlyo) February 17, 2021
In a bench trial, the district court invalidated Amarin’s patent covering a drug treatment for hypertriglyceridemia — finding the claims obvious over a combination of prior art references that had been previously considered by the USPTO. On appeal, the Federal Circuit affirmed without opinion (R.36). Now, the patentee has filed a petition with the US Supreme Court asking for clarification of the Graham analysis. In particular, what is the role of the objective indicia of non-obviousness. We sometimes call these “secondary factors” — and that is the focus of the particular dispute. Does the Federal Circuit err when it (sometimes) relegates the objective indicia to a secondary status.
This Court has made clear that objective indicia must be considered along with the other factors before concluding that any invention is obvious, so that real world indicators—which are often the strongest evidence of nonobviousness—may guard against the risk that patents will incorrectly appear obvious in hindsight.
The Federal Circuit has improperly relegated objective indicia of nonobviousness to a secondary role. Under the Federal Circuit’s framework, a court first considers only the three technical Graham factors and reaches a conclusion of “prima facie” obviousness. Only then does the court consider objective indicia, merely as a basis for rebutting a conclusion already reached. The result is over-invalidation of patents through hindsight bias and the suppression of innovation.
The question presented is: Whether a court must consider objective indicia of nonobviousness together with the other factors bearing on an obviousness challenge before making any obviousness determination.
The key case in point is likely Goodyear Tire & Rubber Co. v. Ray-O-Vac Co., 321 U.S. 275 (1944). In its decision, the Supreme Court explained that the patented “leakproof dry cell for a flash light battery” was within a crowded art which suggested that invention was obvious — especially when “viewed after the event.” But, the court looked also to the long-felt unmet need before negating patentability:
During a period of half a century, in which the use of flash light batteries increased enormously, and the manufacturers of flash light cells were conscious of the defects in them, no one devised a method of curing such defects. Once the method was discovered it commended itself to the public as evidenced by marked commercial success. These factors were entitled to weight in determining whether the improvement amounted to invention and should, in a close case, tip the scales in favor of patentability. Accepting, as we do, the findings below, we hold the patent valid and infringed.
Id. Goodyear was a 5-4 decision written by Justice Owen Roberts. Justice Hugo Black dissented with a quote from a 19th Century Court decision: “a shadow of a shade of an idea.” A. Works v. Brady, 107 U.S. 192 (1883) (“It was never the object of [the patent] laws to grant a monopoly for every trifling device, every shadow of a shade of an idea, which would naturally and spontaneously occur to any skilled mechanic or operator in the ordinary progress of manufactures.”). Black wrote:
If the patentee here has ‘discovered’ anything, it is that the creamy substance in a dry cell will not leak through a steel jacket which covers and is securely fastened to the ends of the cell. For that alleged discovery this patent is today upheld. I do not deny that someone, somewhere, sometime, made the discovery that liquids would not leak through leak-proof solids. My trouble is that, despite findings to the contrary, I cannot agree that this patentee is that discoverer. My disagreement is not based solely on the narrow ground that the record shows previous patents have been issued to others who put jackets of metal and other substances around dry cells. Antiquarians tell us that the use of solid containers to hold liquids predated the dawn of written history. That the problem of the quality and strength of the walls of such containers was one to which ancient people turned their attention appears from the widespread currency at an early age of the maxim that ‘new wine should not be put in old bottles.’ It is impossible for me to believe that Congress intended to grant monopoly privileges to persons who do no more than apply knowledge which has for centuries been the universal possession of all the earth’s people—even those of the most primitive civilizations.