By Paul Cole[1]

Both U.S. practitioners and their European colleagues will be concerned about a dictum in In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1338-39 (Fed. Cir. 2014) that any existing [micro]organism found in the wild is not patent-eligible.  That dictum is said to follow from Diamond v Chakrabarty, 447 U.S. 303 and Funk Brothers v Kalo Inoculant, 333 U.S. 127.  However, there are strong arguments that firstly that such a far-reaching categorical exclusion is supported neither by Funk Brothers nor by Chakrabarty if their actual holdings are correctly understood and secondly that it brings US domestic law into conflict with an express provision for microorganism patentability contained in Article 27 of the TRIPS Agreement.

The decision in Funk Brothers concerns U.S. Patent No. 2,200,532 (Bond).  Farmers had previously used inoculants of cultured Rhizobia bacteria packaged in a powder or liquid base for inoculating seeds of leguminous plants.  Mixed cultures of Rhizobia for field legumes were known, but they had proved unsatisfactory because the different species of the Rhizobia inhibited each other when mixed in a common base.  Bond had provided a mixed culture of Rhizobia capable of inoculating the seeds of plants belonging to several cross-inoculation groups.  In his concurring opinion, Justice Frankfurter identified two different claims of originality, (1) the idea that there were compatible strains and (2) the experimental demonstration that such strains in fact existed and had been found.  Bond's written description both disclosed the idea and provided evidence of its truth in the form of chemical analysis of plants grown from inoculated seeds and of photographs of the grown plants.  However, although compatibility testing procedures had been disclosed, the written description contained no details of experiments leading to the identification and isolation of compatible strains, and no individual strains were identified, had been deposited in a culture collection or had been claimed.  The skilled reader was left to his or her own devices to find compatible strains and was not told in advance whether the necessary tests would involve a few tens of samples and a few weeks or many thousands of samples and some years, although the dissenting opinion of Justices Burton and Jackson suggest that the necessary tests were in fact not difficult.  If the information contained in the specification had been presented for publication in a peer-reviewed journal, it should have been rejected by the referees for lack of supporting experimental detail, and it is unclear why anything less should satisfy the requirements for patentability.

A representative product claim read:

"An inoculant for leguminous plants comprising a plurality of selected mutually non-inhibitive strains of different species of bacteria of the genus Rhizobium, said strains being unaffected by each other in respect to their ability to fix nitrogen in the leguminous plant for which they are specific."

The principle of nature underlying the claim is the existence of a genus of mutually non-inhibitive bacterial strains.  A further requirement of the claim is that strains of different bacteria falling within the genus should be selected and incorporated into an inoculant, implicitly by placement in a powder or liquid base.  The only novelty is in the existence of non-inhibitive strains and the ability to achieve the specified result, which is entirely generic and functional.

Justice Douglas began his opinion with the commonplace that patents could not issue for the discovery of the phenomena of nature, citing Le Roy v. Tatham, 14 How. 156, 175.  He rightly described the qualities of the individual bacteria, like the heat of the sun, electricity, or the qualities of metals, as manifestations of laws of nature, free to all men and reserved exclusively to none.  That the inventor did not create the qualities of inhibition or non-inhibition of the individual bacteria which were the work of nature is also factually true, but would become manifestly untrue if extended to cover non-inhibitory bacterial mixtures for which selective isolation of the non-inhibitory strains and their mixing them together was the work of man, not nature.  Furthermore, his observation provides no authority for the proposition that isolated naturally-occurring microoganisms in biologically pure culture and with valuable properties are not patent-eligible.  As explained in Chakrabarty, the practice of the USPTO had been to grant such patents from Louis Pasteur's 1873 U.S. Patent No. 141,072 for germ-free yeast (see footnote 9) up to the 1970 Plant Variety Protection Act and no reason was given in Chakrabarty for that practice not to continue.

Justice Douglas continued with the further commonplace that was that if there was to be invention in such a discovery it had to come from the application of the newly discovered law of nature to a new and useful end.  It is submitted that there were two logical applications of the discovery:
    (a) selection, isolation and culturing of particular combinations of bacterial strains that were non-inhibitive.  It will be recalled that the information in the patent in issue was only at the highest level of generality and that specific strains were neither identified nor claimed.  Applications of this type were therefore not considered by the Court.
    (b) aggregation of the select strains of the several species into a single product.  The Justices were unanimous that this was an application of the newly-discovered natural principle and hence implicitly patent-eligible.

What then justified his holding that the product claims did not disclose an invention or discovery satisfying the test he had earlier set out in Cuno Engineering Corp. v. Automatic Devices Corp., 314 U. S. 84, 314 U. S. 90-91 (1941)?  It should be mentioned that although eligibility and obviousness arose under the same section of the pre-1952 statute, there is little doubt that the test explained in Cuno concerned obviousness now §103, not eligibility now §101 and its judicial exclusions, an automobile cigarette lighter not being a product of nature.

The Cuno opinion focused on whether the claimed subject matter was the result of invention, going beyond the skill of the calling and exhibiting "a flash of genius"[2].  In holding that the inventor's skill in making the relevant contribution did not reach the level of inventive genius required by the Constitution, Justice Douglas emphasized that the test was necessary "lest in the constant demand for new appliances the heavy hand of tribute be laid on each slight technological advance in an art."  He further explained his views about invention or discovery (which apparently remained unchanged between 1941 and 1950) at greater length in his concurring opinion in A. & P Tea Co v Supermarket Equipment Corp., 340 U.S. 147 (1950) where he again emphasized the standard written into the Constitution and observed that:

"Every patent is the grant of a privilege of exacting tolls from the public.  The Framers plainly did not want those monopolies freely granted.  The invention, to justify a patent, had to serve the ends of science — to push back the frontiers of chemistry, physics, and the like; to make a distinctive contribution to scientific knowledge.  That is why through the years the opinions of the Court commonly have taken "inventive genius" as the test.  It is not enough that an article is new and useful.  The Constitution never sanctioned the patenting of gadgets.  Patents serve a higher end — the advancement of science.  An invention need not be as startling as an atomic bomb to be patentable.  But it has to be of such quality and distinction that masters of the scientific field in which it falls will recognize it as an advance."

Justice Jackson dismissed the invention in A. & P. on the ground that merely speeding a supermarket customer on his or her way and reducing checkout costs did not make the claimed subject-matter patentable.  The opinion of Justice Douglas in Funk Brothers is an earlier instance of the same line of thought given his finding that what flowed from the application of the newly discovered natural principle was an important commercial advance in the packaging of inoculants, but nothing more.  Application of the discovery that non-inhibitory strains existed therefore did not in his opinion produce an advance of sufficient quality and distinction for patentability.

The following passage has been quoted in Chakrabarty and subsequently in in Roslin for the proposition that the mixture of bacteria was unpatentable because its qualities were the work of nature unaltered by the hand of man.  However, when read in context it was clearly intended to explain that the application was of insufficient distinction to meet the test in Cuno firstly because the benefit was for manufacturers and dealers but not for the wider benefit of agriculture, and secondly because when applied to plants the bacteria then acted as an aggregation of individuals rather than a combination:

"Each of the species of root-nodule bacteria contained in the package infects the same group of leguminous plants which it always infected.  No species acquires a different use.  The combination of species produces no new bacteria, no change in the six species of bacteria, and no enlargement of the range of their utility.  Each species has the same effect it always had.  The bacteria perform in their natural way.  Their use in combination does not improve in any way their natural functioning.  They serve the ends nature originally provided, and act quite independently of any effort of the patentee."

It will be apparent that Justice Douglas might well have taken a different view if the application of the discovery resulted in a bacterial mixture that provided a performance benefit for the farmer when applied to crops, e.g., increasing nitrogen fixation and crop yields and which would have been likely to be recognised as an agricultural and scientific and not merely a commercial advance.

A subsidiary reason why Justice Douglas refused to take the advantages of the claimed inoculant at the packaging stage into account may be the purely generic nature of the claimed subject matter.  His position is explained in the following language which is not free from difficulty:

"But once nature's secret of the non-inhibitive quality of certain strains of the species of Rhizobium was discovered, the state of the art made the production of a mixed inoculant a simple step.  Even though it may have been the product of skill, it certainly was not the product of invention.  There is no way in which we could call it such unless we borrowed invention from the discovery of the natural principle itself.  That is to say, there is no invention here unless the discovery that certain strains of the several species of these bacteria are non-inhibitive and may thus be safely mixed is invention.  But we cannot so hold without allowing a patent to issue on one of the ancient secrets of nature now disclosed."

If the underlying objection is not undue claim scope, then the opinion descends into self-contradiction since the existence of the non-inhibitory genus was not part of the state of the art at the time that the invention was made but was a secret known only to the inventor Bond, and there was no reason for a skilled person to have made the mixed inoculant without that knowledge.  In his recent paper Inventive Application: A History[3], Jeffrey A. Lefstin argues that in Neilson v. Harford, the famous "hot blast" case decided by the Court of Exchequer in 1841 Neilson's patent on the hot blast was sustained not because his application was inventive, but because it was entirely conventional and obvious.  In both England and the U.S., inventors could patent any practical application of a new discovery, regardless of the application's novelty or inventiveness.  To hold otherwise places a double burden on an inventor:  first discovering a new principle or rule of nature and secondly devising an inventive application of that discovery.  In the nature of scientific and technical advance there can be few occasions where both happen at the same time.

In summary, the reasons why the patent was held ineligible in Funk Brothers was lack of invention not lack of eligibility, the underlying discovery not giving rise to an application that represented a sufficient scientific advance, and the feature at the point of novelty being claimed in such generic functional terms that its benefits should not count towards satisfying the Cuno test.

Justice William O. Douglas has been accused by his critics, including his former law clerks, of hasty writing and his majority opinion in Funk Brothers as explained above is not free from difficulty.  It is surprising that this pre-1952 decision should have been applied with such enthusiasm given that it and the A. & P. case were the triggers for inclusion of §103 in the 1952 legislation and given the fractured nature of the decision with marked differences in the opinion of Justice Frankfurter and dissents by Justices Burton and Jackson.

A succession of later opinions has given Funk Brothers wide and doubtful interpretation.  In Chakrabarty Chief Justice Burger alleged that the Bond claim was merely to a hitherto unknown natural phenomenon.  However that opinion runs into the difficulty that Bond's claimed inoculant was a newly created composition of matter selected and mixed by the hand of man and meeting all the requirements of Hartranft v. Wiegmann, 121 U. S. 609, 121 U. S. 615 (1887) insofar as it had a new name (mixed inoculant), new characteristics (non-inhibition) and new utility (in the concise words of Justice Frankfurter, multi-service applicability).  In Myriad Justice Thomas attributed the Funk Brothers holding to the fact that the patent holder had not altered the bacteria in any way.  That opinion runs up against the difficulty that although the bacteria were naturally occurring, the claimed composition of matter had been produced by the hand of man and as understood by Justice Thomas was claimed in association with a solid or liquid carrier.  In Roslin the Federal Circuit takes doubtful interpretation a step further, arguing that "the natural organism itself — the mixture of bacteria — was unpatentable because its 'qualities are the work of nature' unaltered by the hand of man."  That interpretation encounters the difficulties that a mixture of bacteria is not a natural organism, that mixtures created by the hand of man fall into the eligible composition of matter classification as explained in Shell Development Co. v. Watson, 149 F.Supp. 279, 280 (DC 1957) (citing 1 A. Deller, Walker on Patents § 14, p. 55 (1st ed.1937)), both cited in Chakrabarty, and that all the Justices in Funk Brothers including Justice Frankfurter in his concurring opinion and Justices Burton and Jackson in their dissenting opinions held that what was claimed was a patent-eligible application of Bond's newly discovered natural principle.

In Roslin the Federal Circuit treats Myriad as providing a categorical exclusion that "isolated," naturally occurring DNA strands should not be eligible for patent protection.  It is inexplicable why such a broad holding should be given to the careful opinion of Justice Thomas, in which he summarised his holding both at the beginning and at the end of his opinion, including the limiting words "merely because", "merely hold" and "simply because".  As explained in an earlier posting Myriad — An Obvious and Patent-Friendly Interpretation[4] the ruling is to be understood in terms of reasons, not technical differences.  Naturally occurring DNA does not become patent eligible just because it has been isolated, but if when isolated it has new and valuable utility then it does not fall within the rule.  Any patent attorney should by virtue of his or her lifetime training be aware of the fact that the expression "one only" or words to the same effect does not cover two or three.

There are therefore compelling reasons for questioning whether the Roslin categorical exclusion is indeed supported by US domestic law.

In addition to the issues under US domestic law, the Roslin opinion arguably puts the US in contravention of TRIPS by categorically excluding naturally occurring microorganisms from patentability.  The US acceded to the WTO on 1 January 1995.  There must therefore be a strong presumption against any amendment to US intellectual property law, including patent law, that provides a categorical exclusion not existing in US law as of 1 January 1995.  That proposition is supported by the well-known substantive canon of interpretation in Murray v. The Charming Betsy, 6 U.S. (2 Cranch) 64 (1804) against interpreting US domestic law contrary to the law of nations, which arguably has much increased persuasive power where the US Government itself was the moving spirit behind the relevant treaty.  Article 27(3)(c) of TRIPS expressly permits the exclusion from patentability of plants whether cultivated or found in the wild but correspondingly forbids the exclusion of microorganisms.  They are widely and internationally treated as patentable and fall under heading C12N 1/00 of the Cooperative Patent Classification.  There is no reason to put a gloss on the term "microorganism" to exclude those that exist in nature.  The EPO has granted patents for naturally occurring microorganisms from its inception and continues to do so.  One example is provided by EP-B-1436380 (Wynne, Reading University) which is concerned with a probiotic strain of Lactobacillus isolated from the human gut and in addition to exhibiting characteristics typical of Lactobacilli in general having the further surprising properties that it can suppress the growth of Candida species to a degree never previously achieved through use of a probiotic and that it is unaffected by tetracycline and related antibiotics.  Since Candida in any region of the body is considered to be a causative factor in irritable bowel syndrome (IBS), the novel strain is useful in treating or preventing that disorder.  The granted main claim is directed to:  "A lactobacillus strain as deposited under accession number NCIMB 41114"; claim 1 of the corresponding granted U.S. Patent No. 7,125,708 is directed to "a biologically pure culture" of the same strain.  See also, e.g., granted EP-B-0029976 (Nakajima, Unitika) and granted EP-B-2785826 (Zielinska).

The newly expressed categorical exclusion set out in Roslin therefore amounts to a fundamental change in US domestic law from what was understood at the time when TRIPS was entered into, and if followed would put US grant practice and substantive law fundamentally at variance with practice and substantive law  before the EPO and in other major industrialised countries.

For all the above reasons, any future reliance on the Roslin microorganism dictum would therefore be a matter for concern.