USPTO Patent Eligibility Guidelines – A Step Too Far For Natural Products?

Guest Post from Paul Cole, Lucas & Co., UK

New Prometheus/Myriad guidance appeared on the USPTO website on 4March under the weighty title 2014 Procedure For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws Of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products. A profound, and it is submitted unjustified, change is introduced in Example B of that guidance which concerns chemical substances purified from nature.

In 1900 Dr Jokichi Takamine succeeded in isolating and purifying adrenalin in fine crystalline form from the adrenal glands of sheep and oxen, for which he was granted US Patent 730176 in June 1903. The new product was said to be storage stable when dry and when injected into an animal to bring about a rise in blood pressure. A number of product claims were granted of which the following is representative:

“A substance possessing the herein described physiological characteristics and reactions of the suprarenal glands, having approximately the formula C10H15NO3 and having an alkaline reaction.”

Patentability of adrenalin was affirmed by Judge Learned Hand in a paradigm-defining ruling in Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95 (C.C.S.D.N.Y. 1911), aff’d in part, rev’d in part, 196 F. 496 (2d Cir. 1912) as follows:

“[E]ven if [Adrenalin] were merely an extracted product without change, there is no rule that such products are not patentable. Takamine was the first to make it available for any use by removing it from the other gland-tissue in which it was found, and, while it is of course possible logically to call this a purification of the principle, it became for every practical purpose a new thing commercially and therapeutically. That was a good ground for a patent.”

It goes without saying that adrenaline continues in medical use to this day, and sufferers from a range of conditions including notably peanut and similar allergies owe their lives to Dr Takamine’s invention.

Some 48 years later Waksman and Schatz isolated a new antibiotic from Actinomyces griseus cultivated under controlled conditions, for which they were awarded US Patent 2449866. Claim 13 states their invention with admirable brevity:

“Streptomycin”.

The new antibiotic was successful both medically and commercially, gained Professor Waksman a Nobel prize, and created an endowment for the Waksman Institute of Microbiology at Rutgers University. If you have the misfortune to suffer from tuberculosis, your life may well be saved by the invention of Waksman and Schatz.

Now we learn that grant of these and similar patents were mistakes, that 100 years of consistent practice in the field of patents was wrong, that what was invented was no more than products of nature without significant structural difference from the naturally-occurring materials, and that the USPTO will endeavour to avoid such mistakes in future. The scenario that makes this apparent is set out below:

“The Amazonian cherry tree is a naturally occurring tree that grows wild in the Amazon basin region of Brazil. The leaves of the Amazonian cherry tree contain a chemical that is useful in treating breast cancer. However, to be effective, a patient must eat 30 pounds of the leaves per day for at least four weeks. Many have tried and failed to isolate the cancer-fighting chemical from the leaves. Applicant has successfully purified the cancer-fighting chemical from the leaves and has named it amazonic acid. The purified amazonic acid is structurally identical to the amazonic acid in the leaves, but a patient only needs to eat one teaspoon of the purified acid to get the same effects as 30 pounds of the leaves…”

In the view of the USPTO a claim to purified amazonic acid is not patent-eligible because there is no structural difference between the purified acid in the claim and the acid in the leaves, and the claim does not include features that demonstrate that the recited product is markedly different from what exists in nature. The inconvenient truth that the purified product provides a practical and useful treatment for breast cancer whereas the leaves are not is not commented upon.

Whatever workable rule of law is derivable from Prometheus, it is apparent from the opinion of Justice Breyer that it was not the Court’s intention to bring about a radical change in pharmaceutical practice. The opinion gives a warning against undue breadth:

“The Court has recognized, however, that too broad an interpretation of this exclusionary principle could eviscerate patent law. For all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.”

The Court was specific in relation to pharmaceutical discoveries and acknowledged that its approach ought not to be interpreted to cover newly discovered first or subsequent medical indications for a known substance (slip opinion at page 18):

“Unlike, say, a typical patent on a new drug or a new way of using an existing drug, the patent claims do not confine their reach to particular applications of those laws.”

In Myriad the Court’s key task, in the words of Justice Thomas was to determine whether Myriad’s patents claimed any “new and useful . . . composition of matter,” §101, or instead claimed naturally occurring phenomena. In that regard, it was significant that the claims were not expressed in terms of chemical composition but simply focused on the genetic information contained in the BRCA1 and BRCA2 genes. The isolated gene has no new utility. In the words of Judge Bryson in the Federal Circuit its utility is merely a consequence of its possession and the gene must function in the laboratory in the same way as in the human body.

In the terms of the USPTO example, there is an abundance of distinctions between a claim to purified amazonic acid and a claim to an isolated BRCA1 gene. The acid claim is in structural rather than functional terms and is to a defined chemical substance. That substance represents a new composition of matter in which the acid exists in a concentrated form and has a new function and new utility not possessed by the naturally occurring substance insofar as it can treat breast cancer where the leaves cannot. It is to say the least unclear that any rule derivable from Myriad was intended to apply to the dissimilar factual matrix put forward in the example, or that the long-standing practice derived from Parke-Davis was intended to be overruled.

Support from that position can be derived from the oral argument in Myriad which relates essentially to the scenario set out by the USPTO but points towards the opposite conclusion:

 “JUSTICE ALITO: Can I take you back to Justice Ginsburg’s question, because I’m not sure you got at what troubles me about that. Suppose there is a substance, a chemical, a molecule in the leaf – the leaves of a plant that grows in the Amazon, and it’s discovered that this has tremendous medicinal purposes. Let’s say it treats breast cancer. A new discovery, a new way is found, previously unknown, to extract that. You make a drug out of that. Your answer is that cannot be patented; it’s not eligible for patenting, because the chemical composition of the drug is the same as the chemical that exists in the leaves of the plant.

MR. HANSEN [for ACLU]: If there is no alteration, if we simply pick the leaf off of the tree and swallow it and it has some additional value, then I think it is not patentable. You might be able to get a method patent on it, you might be able to get a use patent on it, but you can’t get a composition patent.

JUSTICE ALITO: But you keep making the hypotheticals easier than they’re intended to be. It’s not just the case of taking the leaf off the tree and chewing it. Let’s say if you do that, you’d have to eat a whole forest to get the value of this. But it’s extracted and reduced to a concentrated form. That’s not patent — that’s not eligible?

MR. HANSEN: No, that may well be eligible, because you have now taken what was in nature and you’ve transformed it in two ways. First of all, you’ve made it substantially more concentrated than it was in nature; and second, you’ve given it a function. If it doesn’t work in the diluted form but does work in a concentrated form, you’ve given it a new function. And by both changing its nature and by giving it a new function, you may well have patent …”

It is uncontroversial that amazonic acid falls within §101 because it is a composition of matter. Where statute defines eligibility, narrow rather than expansive interpretation of judge-made exceptions is arguably more prudent. Neither Prometheus nor Myriad provides authority for a focus on structural differences to the exclusion of all other types of difference e.g. a difference in utility, and it is hoped that early appeals to the PTAB or to the Federal Circuit will result in a more satisfactory guideline for this still important area of research.

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One Response to “USPTO Patent Eligibility Guidelines – A Step Too Far For Natural Products?”

  1. Robin says:

    An excellent essay on the contradictory, short-sighted, and foolish mess that has been created by the ACLU (whom I generally like) and the Supreme Court (not so much).