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« FDA Approves Another Interchangeable Biosimilar | Main | Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc. (Fed. Cir. 2023) »

January 02, 2024


Re: "..we have come very far from the simple rubric that "anything under the sun made by man" as a rational workable, subject matter eligibility standard."
Let's not continue perpetuating that misleading partial quote from Diamond v. Chakrabarty, 447 U.S.303 (1980) by ignoring the critical rest of it - the immediately following listing of its long established exceptions.

Well, the statute doesn't have a long list, and the list produced by the Supreme Court is limited to laws of nature, natural phenomena, and abstract ideas. I admit that those three categories have been expanded in the past decade (by the Federal Circuit, which is the point), but I don't think that this expansion has provided any benefit in the short or long term that wouldn't have been achieved using the other portions of the statute. I daresay Judge Rich, who wrote the statute and had little patience with fuzzy-minded pronouncements from the Supreme Court in this regard (see In re Bergy) would agree. Another instance of the Court being infallible because they are final, with all the attendant dysfunction introduced into the patent system thereby.

Thanks for the comment.

I concur with Kevin's rebuttal - the Supreme Court was chastised with the writing of the Act of 1952.

Pretending otherwise is exactly why we have repeated the history, and (largely) returned to the (self-made) description of the Supreme Court of "The only valid patent is one that has not yet appeared before us."

Yes, we can all agree that the Sup. Ct. "exception" of "abstract" to patentable subject matter could have been better handled by better statutory enforcement of §112. That was even done in this very case, as you reported: "The District Court also found that all asserted claims were invalid for failure to satisfy the written description requirement of 35 U.S.C. § 112(a).."
P.S. What statutory basis of rejection or invalidity would you prefer to have seen used more instead of the "laws of nature" and "natural phenomena" judicial exceptions?

Paul: I would have had little issue with the decision if the specification failed to demonstrate that the purified enzyme could in fact produce >50% conversion of RebD to RebM - then the objection would be that the basis for the eligibility distinction was not established and thus was "abstract." Indeed, a claim to purified EPO was invalidated because while the claim recited an activity of X U/mg it was established at trial that the most pure the patentee had produced was ~45% having an activity of X/2 U/mg and the patentee just extrapolated the activity to "pure" preparations (the case was Amgen v. Genetics Institute as I recall, which on appeal was Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 1203, 1215-17 (Fed. Cir. 1991).

This decision is contrary to the principle that a natural product can be eligible if it has properties it doesn't have in nature; indeed, the basis for the Myriad decision was that the isolated gene had the same biological properties and activity as it had in nature (while I don't agree the Court saw things that way).

The 112 analysis was fine as far as it went in this case; the problem was that the claim to the specific enzyme was adequately described and enabled and should be valid.

Thanks for the opportunity to clarify.

As to:

P.S. What statutory basis of rejection or invalidity would you prefer to have seen used more instead of the "laws of nature" and "natural phenomena" judicial exceptions?

Laws of nature are not nature - the map is not the land, this is not a pipe.

Phlogisten, aether, and the like.

Natural Phenomena - if claimed as previously existing, should be rejected under 102. That being said, patents for certain man-made elements ARE proper.

These SHOULD NEVER BE judicial exceptions, as the very nature of judicial exceptions is a violation of separation of powers.

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