May 12, 2023
On April 28 the Supreme Court heard oral arguments on Amgen’s petition of the Federal Circuit’s decision affirming the district court’s decision on JMOL that Amgen’s antibody claims lacked an enabling disclosure. Much of the argument revolved around what was the quantum of experimentation that was too much for a claim to be enabled. At the end of Sanofi’s argument its counsel cited the Morse case where the Supreme Court invalidated Morse claim 8 which defined the transmission of symbols in solely functional terms:
“Eighth. I do not propose to limit myself to the specific machinery or parts of machinery described in the foregoing specification and claims; the essence of my invention being the use of the motive power of the electric or galvanic current, which I call electro-magnetism, however developed for marking or printing intelligible characters, signs, or letters, at any distances, being a new application of that power of which I claim to be the first inventor or discoverer.”
The Supreme Court in deciding that claim 8 was not patentable noted:
It is impossible to misunderstand the extent of this claim. He claims the exclusive right to every improvement where the motive power is the electric or galvanic current, and the result is the marking or printing intelligible characters, signs, or letters at a distance.
If this claim can be maintained, it matters not by what process or machinery the result is accomplished. For aught that we now know some future inventor, in the onward march of science, may discover a mode of writing or printing at a distance by means of the electric or galvanic current, without using any part of the process or combination set forth in the plaintiff's specification. His invention may be less complicated — less liable to get out of order — less expensive in construction, and in its operation. But yet if it is covered by this patent the inventor could not use it, nor the public have the benefit of it without the permission of this patentee.
Nor is this all, while he shuts the door against inventions of other persons, the patentee would be able to avail himself of new discoveries in the properties and powers of electro-magnetism which scientific men might bring to light.
Amgen’s claims were similar:
1. An isolated monoclonal antibody, wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, 1154, P155, R194, D238, A239, 1369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDLR.
Since Morse is a Supreme Court decision it seems reasonable that the Court would seize upon it to decide the Amgen case and avoid the metaphysical consideration of how much experimentation is too much under the Wands factors, In re Wands, 858 F.2d 731, 736-37 (Fed. Cir. 1988). Further by the late 19th century it was black letter law that one could not claim what an invention did but only what the invention was, Robinson on Patents, §518, Book 3, page 131. Means plus function claims encompass only the means disclosed in the specification and their equivalents are very limited in scope.
Since the purpose of the patent system is to advance the progress of the useful arts, how is that furthered by a claim which identifies the invention not by its structure but by what it does. One cannot know if what he has made infringes or not until he has made it and tested it. The claim scope is not found in the claim but is based on later developments. How does this further innovation if another holds a dominant patent by virtue of it claiming what the invention does rather than what it is. In the case of antibodies it is the antibodies sequence. The evidence was there -- three antibodies developed by three groups, each antibody very different from the other two and from the sequences disclosed in the Amgen patent.