Patents in relation to microbiology.

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Annu. Rev. Microbiol. 1975.29:319-332. Downloaded from www.annualreviews.org Access provided by Technische Universiteit Eindhoven on 01/26/15. For personal use only.

PATENTS IN RELATION TO

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MICROBIOLOGY Edward S. Irons and Mary Helen Sears Irons & Sears, 1801 K Street NW, Washington DC

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CONTENTS INTRODUCTION . .... .. .... ..... .. " " " ." ." " " " "

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APPROPRIATENESS OF PRODUCT PATENT PROTECTION FOR MICROORGANISMS, '" , , ..,' ',...,' , ,,..., " ,,,,,.....,' ,,,.,,..,,,,.

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" .." "

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" ."

" "

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Utility Patents .....,,..,,..,....,,....,,............., ... , .......,,,..,,

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Culture deposit supplementation 0/ the written description ....,,.., ....,,...,

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Microorganisms: Not uniquely "unstable': ..... ,,.........,,,........,...,

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The ''product 0/ nature" rationale,. .. ,,,......,........,,.......,.,,.,,,

Patentability 0/ "animate" material within the technological arts ......,,...., Asexually Reproduced Plant Patents. ,....,......,,,......,,,,.......,,,...,

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PROMULGATION OF LEGISLATION AUTHORIZING MICROORGANISM PRODUCT PATENTS ..,.,....." ..." ...,',....,.......," " ,.....,.," ,." ..,',.

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INTRODUCTION Microbiology is currently of considerable commercial importance because microbio logical processes alford quick, clean, and relatively inexpensive methods of making a variety of useful chemicals, including antibiotic drugs and food additives. Com mercial potential for the synthesis of human nutrients and a variety of other prod ucts now in short supply, accomplishment by environmentally unobjectionable means many of the tasks now elfected by chemical insecticides, fungicides, herbi cides, and other similar poisons, and disposal of industrial and municipal wastes to mention only a few promising applications of microbiology--cannot be underesti mated. Notwithstanding its ever-expanding importance, useful and ingenious advances in microbiology are treated less generously than similar advances in chemistry, physics, engineering disciplines, and agriculture, with respect to the availability of United States patent protection. Because many questions have not yet been satisfac torily answered, neither judicially nor legislatively, as to whether microorganisms per se are patentable subject matter under the United States Constitution and

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existing patent statutes, the patent protection presently granted by the United States Patent Office for the invention of a new microorganism is usually in equivocal, rather than straightforward "product per se," claim language.' At the same time, patent coverage is available for microbiological processes and the resulting chemical products, but this protection is often less than adequate. Process patents are notoriously difficult to police against infringers. The chemical


products of microbiological processes usually are not new, hence patent protection will result only in the relatively rare instances in which a microorganism acts to produce a previously unknown chemical, such as a new antibiotic, which would support a product patent regardless of the way in which it was made. The availability of patent protection for new microorganisms per se should be firmly established in the interests of both encouraging their development for practi cal industrial and consumer uses and also insuring that microbiologists are afforded the same possibilities of reward as workers in other technological fields. Availability of this protection under the present patent laws could be established in the courts, either in connection with the review of Patent Office decisions under 35 U.S.C. 141 or in patent infringement actions arising under 35 U.S.C. 281. A definitive court determination, however, can be rendered only in a genuine controversy,2 which would present the issue of whether a microorganism is patentable subject matter. Unless such determination were made by the Supreme Court, several holdings by different courts would be needed before the principle could be deemed estab-

lPor example U.S. patent 3,651,215, granted March 21, 1972, contains product claims to a "bacterial mosquito larva-killing agent" made up of spores of Bacillus cereus var. jurol. ATCC 21281 admixed with a carrier-yet the invention is in the microorganism per se, because carriers are old and conventional ingredients of insecticides generally. If microbiologi cal inventions were on the same footing as those in other branches of technology, a claim to the new bacillus per se, without any particularized use limitation, should have been granted. Similar examples of current patent protection for microorganism product inventions ap pear, inter alia, in the following: U.S. patent 3,683,068, which is directed to a poultry medicine comprising a diluent in admixture with a strain of Scopulariopsis brevicaulis (Sacc.) Bainier;' U.S. patent 3,642, 982, which covers an insecticide made from a mixture of an inert carrier and either Serratia piscatorum ATCC No. 17999 or Streptococcus/aecalis ATCC Nos. 15335, 14336 and 19000; U.S. patent 3,420,742, which covers a frozen, stabilized, neutralized concen trate, either of Streptococcus citrovorus or S. paracitrovorus. that contains a stabilizing agent and a nutrient medium; U.S. patent 3,133,066, which contains claims directed to an insecticide made from Bacillus thuringiensis spores plus an oil carrier; U.S. patent 3,080,285, which has one claim directed to seeds covered with medication; and U.S. patent 2,851,006, which has claims directed to eggs inoculated with Salmonella phages. In re Maney, 499 P.2d 1289 [the Court of Customs and Appeals (CCPA) 1974] emphasizes the anomalous circumstance that, in the chemical field, a process involving the use of a novel catalyst to produce an old product supports two patent claims, one for the catalyst and one for the process, whereas in the analogous situation, in which an old product is produced by a new microorganism, only the process (not the microorganism) may be protected. 2The Constitution (Article III, Section 2) limits the jurisdiction of federal courts to adjudica tion of genuine cases and controversies; resolution of hypothetical questions and rendering of advisory opinions is interdicted.

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lished.3 The result is that the outlook for judicial resolution of microorganism product patentability, though optimistic, is unpredictable in timing and may be very long-range. Since 1966, Congress has continuously considered various versions of proposed new patent legislation,4 and it may confidently be predicted that an overall revision of the patent statute will be made within the next several years, if not sooner. Before


Congress settles on the precise provisions of this revised patent statute, professional and industrial microbiological societies, associations, and trade groups ought to suggest that positive legislative authorization for microorganism product patent claims be included, based on the apposite legal considerations developed herein as well as the underlying technical and commercial facts. Such positive legislation alone would effectively settle the lurking uncertainties responsible for the present unsatisfactory situation relative to the procurement of patent protection for microbi ological inventions.

APPROPRIATENESS OF PRODUCT PATENT PROTECTION FOR MICROORGANISMS The Constitution restricts Congressional power to legislate in the patent field by requiring that patents be granted only to inventors, to "promote the progress of science and useful arts."s It is settled doctrine under controlling Supreme Court precedent that this constitutional limitation implicitly requires that patents may be granted only for subject matter that is new, useful, and inventive-i.e. sufficiently ingenious that, when achieved, it would not have been obvious to one of ordinary skill in the apposite art.6 The ambit of subject matter within "science and the useful arts" that may be patented if the aforesaid criteria are met has been left in large part to legislative judgment.1

3In particular, the CCPA, which hears appeals from denials of patent protection by the Patent Office, is largely out of step on many patent issues with the federal courts of general jurisdiction, which hear patent infringement and validity questions. In addition, federal circuit courts of appeals sometimes reach opposite conclusions on the same legal issue. Hence, in the absence of authoritative Supreme Court precedent, a concurrence among the CCPA and several federal circuit courts would be essential to establish firmly the principle of microorgan ism product patentability. 4President Johnson's Commission to study the patent system issued a report in 1966 that made specific recommendations for legislative reform and was the basis for a proposed new patent statute; the many other proposed versions considered since have evolved from this statute. SArticle I, Section 8, clause 8. 6See Graham v. John Deere Co., 383 U.S. I ( 1966); Thompson v. Boisselier, 114 U.S. 1 (1885). 1See, for example, Gottschalk v. Benson, 409 U.S. 273 ( 1972), wherein the Court recom mended that Congress study the question of whether availability of patents for computer programs would accord with the constitutional purpose to promote progress of science and useful arts.

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Two separate sections of the present patent law, Title 35 of the United States Code, afford a basis on which to sustain the grant of microorganism product pat ents.8 Specifically, 1. Section 101 of Title 35 of the United States Code authorizes utility patent protection for "any new and useful process, machine, manufacture or composition of matter . . . " It is settled that a microbiological transformation constitutes a


patentable process within the meaning of this statutory section9 and that the result ing product is a "manufacture" or "composition of matter," and hence patentable "subject matter." In contrast, microorganisms per se have not squarely been ruled either eligible or ineligible for product patent coverage in any reported court or Patent Office decision.lO 2. Under Section 161 of Title

35, patent protection is available for a distinct and

new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings, other than a tuber propagated plant or a plant found in an uncultivated state . . ." In 1940, the CCPAII rendered a questionable decision holding that bacteria are not plants within the meaning of Section 161's similarly phrased prede cessor statute.12

8The plant variety protection act of 1970, 7 U.S.c. 2321, et seq., which specifically excludes fungi and bacteria (Section 48) is irrelevant. 9E.g. See Edelblute (I). IOJudge Rich, speaking for the Court of Customs and Patent Appeals, recently stated: ". . . we presume (without deciding)" that the patent applicants whose application was in issue "would . . . be unable to obtain . . . a claim to the novel strain of Streptomyces used in their process ... because the strain, while new . . . is, as we understand it, a 'product of nature'." In re Maney, 499 F.2d 1289 (1974). An unexplained suggestion that bacteria per se cannot be the subject of utility patents was made in Gu aranty Tru st Co. v. Union Solvents Co., 54F.2d 300 (D. Del. 1931) afj'dpereuriam 61 F.2d 1041 (3 Cir. 1932). The issue in that case was not whether a bacterium is patentable, however, but whether a process for "Production of Acetone and Alcohol by Bacteriological Processes" (fermentation of starch), granted in 1919, was a proper subject for patent. The court, in holding the patent valid, said: Lastly the defendant contends that the invention of the Weizmann patent is unpatentable because it

is for the life process of a living organism. Were the patent for a bacteria per se. a different situation

would be presented. As before stated, the patent is not for bacteria per se. It is for a fermentation process emphasizing bacteria discovered by Weizmann under

conditions set forth in the specification (54 F.2d at 410).

and claims. Undoubtedly there is patentable subject matter in the invention

Significantly, the court's opinion indicates that the novelty in the invention-and the gist of the scientific contribution-was in the bacteria, not the fermentation (process) conditions. See 54 F.2d at 403; 410. ttSee footnote 3. t2Applieation of Arzberger, 112 F.2d 834 (1940). It is doubtful that the decision would be followed by the same court today (e.g. see footnote 33 et seq., cf In re Maney, foot note 10).


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Utility Patents A microorganism may be considered as either a "composition of matter"l3 or a

"manufacture"14 within the meaning of 3S V.S.c. WI's subject matter categories. Heretofore various arguments have been advanced as obstacles to patenting mi croorganisms per se under 35 V.S.C. 101. Foremost among these are the contentions that (a) a microorganism cannot be made the subject of a precise written description


in patent specification or claim as required by 35 V.S.c. Section 112;15 (b) microor ganisms are "unstable" and fail to reproduce identically, thereby creating uncer tainty as to patent claim coverage and hence confusion on the issue of infringement;

(c) microorganisms are "products of nature" and hence are not "novel" within the meaning of the patent laws; and (d) animate materials, including microorganisms, are excluded from the statutory classes of patentable subject matter. These arguments are not valid. CULTURE DEPOSIT SUPPLEMENTATION OF THE WRITTEN DESCRIPTION

The Section 112 or "precise description" argument has been overcome in the context of existing patents in the microbiological field by the Patent Office requirement for the deposit, in an established repository, of a culture at or before the time the patent application is filed.16

13A suggestion is made in Daus et al (2) that a microorganism is patentable subject matter because it constitutes a "composition of matter" within the meaning of Section lOt. 14The Supreme Court has held that a product, in order to qualify as a manufacture under either the tariff or patent laws, must satisfy the dictionary definition of the word, i.e. must constitute a "new and different article, having a distinctive name, character, or use" from that of its precursor. See Hartranft v. Wiegmann, 121 U.S. 609 ( 1887); Anheuser-Busch Brewing Assn. v. United States, 207 U.S. 556 ( 1908); American Fruit Growers v. Brogdex Co., 283 U.S. 1 ( 193 1). A microorganism created by deliberate or accidental mutation of a preexisting microorganism and having different characteristics or use from its parent seems clearly to fit this definition. Wegner (17) suggests that "The question of whether the microorganism is a 'composition of matter' under 35 USC Section 101 can be avoided altogether by claiming a 'manufac ture' .. IlSection 112 provides in part that: ,"

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.

16Section 608.01 (p) of the Manual of Patent Examining Procedure (Revision 39, January 1974). Substantially the same procedure is followed in other countries and would be codified as a subsection of Section 112 of the various versions of patent law revision bills that Congress has considered since 1969.

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Under the present Patent Office practice the deposit must be irrevocable, of a permanent character, and made under conditions which insure free availability of samples of the microorganism to the public at the time that a patent actually issues. 17 This procedure is equally effective to provide an adequate "written descrip tion" in a patent specification without regard to whether the claims cover a microor

ganism per se, a composition of which the microorganism is a major ingredient, 18


or a process for using the microorganism to produce a desired product.19

MICROORGANISMS: NOT UNIQUELY "UNSTABLE"

The instability argument

arose before adoption of the practice of placing a culture in a depository at the time the application is filed. It must be viewed in context with the difficulty of identifying the precise microorganism described in a written specification when no sample was available for verification.

17The present Patent Office practice rests on the CCPA decision in Application 0/Argoudelis, 434 F.2d 390 (1970); Application 0/Hawkins, 486 F. 2d 564 ( 1973); and Application o/Glass, 492 F. 2d 1228 ( 1974). By analogy to 35 U.S.c. 122, which requires the Commissioner of Patents to maintain the content of applications secret during pendency before the Patent Office unless another statute requires otherwise or the Commissioner finds special circumstances to exist, these decisions hold that unlimited public accessibility to a microorganism culture may be reserved until the date of issuance of a patent referring to the culture, instead of being afforded at the application filing date. 35 U.S.C. 122 only has effect relative to the Patent Office, however, and since that Office has no control over culture depositories, the analogy is of questionable relevance. The issue of the correct public accessibility date has not yet arisen in any federal court of general jurisdiction in connection with a patent validity adjudication. Until the Supreme Court has occasion to adopt the CCPA rationale or until the matter is clarified by legislation (see footnote 16, last sentence) it would seem safer to make microorganism culture deposits on the condition that public access be afforded at the filing date of the first relevant United States patent application. 18See footnote I. 19Historically, working models were required by the Patent Office as an aid to describing mechanical and electrical devices. The Patent Office up to the present time requires drawings under 35 U.S.C. 113 and 37 CFR 1.81 in any case which admits of them, for the same purpose of augmenting written description. In addition, working models (37 CFR 1.91) or specimens of chemicals (37 CFR 1.93) may be required to be furnished if the Patent Office deems either would aid in promoting understanding of the invention. A similar situation prevails with respect to asexually propagated plants: drawings are required in every application (37 CFR 1. 165), and specimens, at any growth stage, may be required at the discretion of the Patent Office (37 C.F.R. 1. 166). The use of a reference to a permanent, publicly accessible culture deposit to similarly augment and complete a written description of a microorganism in a patent specification is wholly analogous. Before the principle of incorporation-by-reference of a culture deposit in a patent specifica tion became accepted practice, the problem of describing microorganisms for patent purposes was acute. See Levy & Wendt (3).


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In addition, the science of microbiology has sufficiently progressed that instabilit y is now no more a problem than it is in other branches of technology.2o Microorgan isms are routinely reproduced true to form. Indeed, true reproduction is essential to practical commercial procedures. THE "PRODUCT OF NATURE" RATIONALE

The suggestion that a product of


nature may not be patented is fundamentally premised upon the thesis that a product that is old in nature lacks novelty.21 The great preponderance of practically useful microorganisms, however, are not natural products. Rather, such microorganisms either (a) do not exist in nature but are created by the application of an external force to alter characteristics of a known microorganism, or (b) are found in nature only in very low population density in association with relatively high populations of different organisms, rather than in essentially pure cultures. In the latter case, the pure or essentially pure culture generally possesses characteristics-particularly capabilities in practical use which are not apparent in or predictable from an original natural culture. In both cases, the products are not products of nature but are per se novel. Patents have in general been granted and sustained on products derived from natural precursors which exhibited a new or greatly improved utility, a new struc ture, or new characteristics. For example, in International Patents Development Co. v. Penick and Ford, 15 F.Supp. 1038 (D.Del. 1936), atrd per curiam 94 F.2d 1018 (3 Cir. 1938), the court affirmed the validity of a product claim to cerelose-a hydrated form of natural dextrose in composition and structure-made by hydrat ing natural cornstarch (from which natural dextrose is itself derived), because cerelose was commercially competitive with the different, more expensive, naturally produced human food sugar sucrose.

2°An identical argument, advanced and refuted in 1933 in respect to the asexually repro duced plant patent statute now codified in 35 U.S.C. Sections 161-164, was most recently rejected in 1970 incident to enactment of the Plant Variety Protection Act. See footnote 28. Similar instability arguments could be made with equal facility relative to products in certain branches of chemistry-yet patentability of inventions in these fields is adjudicated on individ ual merit and is not based on convenient categorical overgeneralizations such as this instability shibboleth. 21In the context of products that are actually old in nature, the Supreme Court has elabo rated upon the lack of novelty rationale, e.g. in The American Wood Paper Co. v. The Fiber Disintegrating Co., 90 U.S. 31 ( 1874), and in Cochrane v. Badische Ani/in und Soda Fabrik, III U.S. 293 (1884). In Cochrane it was particularly pointed out that the dyestuff alizarin could not be patented as a product when newly synthesized in view of the fact that the synthetic product had the same chemical composition and use as an identical natural product. Some examples of applications of the same rationale by the Patent Office may be found in Ex parte Shell, 86 USPQ 496 (P.O. Bd. App. 1950), wherein claims to synthetically produced pyridoxamine were rejected because the product was identical in structure and use to a form of naturally produced Vitamin B-6, and in Ex parte Foster, 90 USPQ 16 (P.O. Bd. App. 1951), discussed in footnote 3 1.

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Manifestly, microorganisms exhibiting properties or uses markedly different from those of the naturally occurring microorganisms from which they were produced or to which they are most closely related should equally be entitled to protec tion. A similar rationale has been applied in the courts to validate or permit the


patenting of highly purified chemical compounds or compositions that had existed in nature in an impure state and had distinctly different characteristics or functions. For example, the CCPA in Application

ofDoyle, 327 F.2d 513 (1964), held patenta

ble a product identified as nonhygroscopic 6-aminopenicillanic acid (6-APA), with a melting point of about 209-21OoC, notwithstanding the prior existence of a prod uct having the same chemical formula and name which melted at 158-159°C. The court noted that it was "disclosed that use of a substantially pure 6-APA [melting at 209-21O°C) in solid nonhygroscopic form results in a greater quantity of pure antibiotic with a lesser quantity of added reagent than is obtainable with impure 6-APA [melting at 158-159°C]" and it was further shown "that when 6-APA with a purity of less than 90% [i.e. the product melting at l 5 8-159°C) is acylated, the amount of an antibiotic of requisite quality obtained is reduced in yield too far for commercial acceptance" (327 F.2d at 518).22

Similarly, in Merck and Co. v. Olin Mathieson Cir. 1958), the following claim was in issue:

Chemical Co., 253 F.2d 156 (4

A vitamin Bn-active composition comprising recovered elaboration products of the fer mentation of a vitamin Bl2-activity producing strain of Fungi selected from the class consisting of Schizomycetes, Torula, and Eremothecium, the L.L.D. [Lactobacillus lactis Dorner factor] activity of said composition being at least 440 L.L.D. units per milligram and less than 11 million L.L.D. units per milligram. The court noted that the substance now known as Vitamin BI2 is produced in minute quantities in the bodies of cattle .. . [and] by certain microorganisms" (253 F.2d at 161), but concluded that "the patentees have given us for the first time a medicine which can be used successfully in the treatment of pernicious anemia, a medicine which avoids the dangers and disadvantages of the liver extracts ... , a medicine subject to accurate standardization and which can be produced in large quantities and inexpensively, a medicine which is valuable for other purposes as well as for the treatment of pernicious anemia . . . [which] did not exist in nature in the form in which the patentees produced it ... " (253 F.2d at 164), and so held the claim valid. By analogy, an essentially pure culture is a proper subject for a utility patent if the prior existence of the microorganism was only in a disperse association with other microorganisms that exhibited different properties and had a different use.

22For later rulings by the same court to the same effect, 664(CCPA 1966); Application of Wakefield, 422 F.2d 897 (CCPA 1970); and Application of Bergstrom, 427 F.2d 1394 (CCPA 1970).


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There is no contrary Supreme Court precedent.23 No legal basis has been sug gested that should prompt that Court to take a contrary view if the "product of nature" question were presented in a proper case involving a microorganism prod uct. PATENTABILITY OF "ANIMATE" MATERIAL WITHIN THE TECHNOLOGICAL ARTS There is no language in 35 U.S.C. 101 which restricts patentability to


inanimate subject matter. Moreover, no published case law at administrative or judicial levels suggests that animate materials are for any reason implicitly excluded from the scope of 35 U.S.C. 101. A few patents have been granted by the Patent Office with claims drawn to compositions including animate materials as compo nents, thereby evidencing an administrative view that 35 U.S.c. 101 is inclusive of such subject matter.24 Moreover, the CCPA, which functions as an appellate authority to review Patent Office refusals of patent protection, has recently opined in the context of various computer programs that 35 U.S.C. 101 includes all of the "technological arts"2S and hence is of a scope which includes microbiological subject matter. This CCPA view could be expected to find favor in federal courts of general jurisdiction, includ ing the Supreme Court, in the microbiological context.26

Asexually Reproduced Plant Patents The Plant Patent Act of 193027 was the first statute enacted anywhere in the world to provide patent protection for plants. The demand for plant patent protection 23 Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 ( 1946), often cited as representing a contrary Supreme Court view, involved the invalidation of product claims covering mixtures of specified "selected mutually noninhibitive strains of different species of bacteria of the genus Rhizobium." The Court pointed out that "no new bacteria" were produced and that the novelty, if any, lay in "methods of selecting and testing noninhibitive strains," because the patentee did not change the bacteria to "create a state of inhibition or noninhibition" but only determined which known strains were naturally noninhibitive. In this context, the Court observed that the qualities of the bacteria "are the work of nature . . . [which] are of course not patentable . . ." Importantly, however, Funk Brothers does not suggest that bacteria are per se unpatentable because they are products of nature. Rather, it leaves the door open for the patenting of any new, useful, and inventive contribution in the science of microbiology. For other commentary on Funk Brothers and antecedent precedent relating to patenting of natural phenomena, see Kip (6) and Note (7). 24Typical patents are cited in footnote I. 25Application o/Musgrave, 431 F.2d 882 ( 1970); Application o/Foster, 438 F.2d lOl l (197 1); and Application 0/ Waldbaum, 457 F.2d 97 (1973). 26Notably, the Supreme Court in Gottschalk v. Benson, (footnote 7) reiterated, citing Funk Brothers (footnote 23), that the "process" category of patentable subject matter under 35 U.S.C. 101 does not include mere abstract ideas, such as principles of mathematics-i.e. "mental processes"-in any form including that of computer programs. Significantly, how ever, the Court did not reject the proposition that 35 U.S.C. 101's patentable subject matter is broadly inclusive of all "technological arts." 27The Plant Patent Act, 46 Stat. 376, amending R.S. 4886, 35 U.S.C. 31 ( 1930).

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originated primarily from rose and fruit tree breeders, to whom only asexual propa gation was of commercial importance. The legislation was opposed by farmers who raised only Irish potatoes asexually (grain crops are propagated sexually by seeding). It was contended that sexually reproduced plants did not propagate true to form (i.e. were "unstable") and hence could not be made the subject of valid patents.28 As a result, the Plant Patent Act of 1930 provided for the grant of only limited


patent protection to anyone who "invented or discovered and asexually repr oduced

any distinct and new variety of pla nt other than a tuber-propagated plant. "29 The purpose of the statute was "to afford agriculture so far as practicable, the same opportunity to participate in the benefits of the patent system as has been given industry" and to afford "a sound basis for investing capital in plant breeding."3o The statute remained unchanged until January 1953 when, as an incident to the general recodification of the patent laws, the provisions relating to plant patents were included in Sections 161-164 of Title 35.31 28A contention successfully reiterated as late as 1968: "Asexual reproduction is specified in the Plant Patent Act because this method of propagation generally insures the continuation of the new and distinct characteristics of the plant through succeeding generations." (Patent Law Revision, "Hearings Before the Subcommittee on Patents, Trademarks and Copyrights of the Committee on the Judiciary," U. S. Senate, 90th Congress, 2d Session, Part 2, January 30, 31 and February I, 1968, p. 651.) The same argument was rejected incident the enactment of the Plant Variety Protection Act . of 1970: In the 37 years which have passed since the enactment of the Plant Patent Act improved breeding techniques and seed multiplication procedures have become established whereby many plant varieties may be reproduced from seeds true to form. Such ability of plant varieties to reproduce true to form from seeds is now acknowledged in existing legislation. such as the Federal Seed Act which was enacted August 1939, and 'seed certification. It accordingly follows that the distinction drawn in the Plant Patent Act between plants which reproduce asexually and plants which reproduce sexually is aJtific al [sic), and that the act should be broadened to include plants which reproduce sexually. (Statement of Floyd S. Ingersoll. Patent Law Revision. "Hearings Before the Subcommittee on Patents. Trademarks and Copyrights of the Committee on the Judiciary," U. S. Senate, 90th Congress, 2d Session, Pursuant to S. Res. 37 On S. 2, S. 1042. S. 1377, S. 1691, S. 2164 and S. 2597, Part 2. January 30, 3 1 and February I, 1968, p.

640.

29See Hayman (8) and Daus (9). A chronological history of the 1930 Act appears in Magnuson (10). 30Senate Report No. 315, 71st Congress, 2d Session, April 2, 1930. 31In Ex Parte Foster. 90 USPQ 16 (1951), the Patent Office Board of Appeals held unpatenta ble a plant which was asexually reproduced in Florida from a seedling discovered by a professional plant cultivator in Columbia, South America. The Board held that the words "invented or discovered" and "new" as utilized in Title 35 have the same meaning whether applied to plant or utility patents and hence that the seedling in question, because it had previously existed in nature, was unpatentable for lack of novelty. In 1954, 35 U.S.C. 161 was amended to afford patent protection for plants "found in an uncultivated state." The "Reviser's Note" accompanying the amendment states that its pur pose is "to provide that plant seedlings, discovered, propagated asexually and proved to have new characteristics distinct from other known plants are patentable." So construed, the amendment is of dubious validity because it permits patents on plants which are a "product of nature," and hence are not "novel" and not an "invention or discovery" within the scope of the constitutional patent clause. See also Section II-A-3, e.g. footnote 20.

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In 1940, the CCPA held in

In re Arzberger that bacteria are not plants and hence

not patentable subject matter within the meaning of the plant patent act.32 The Arzberger patent application contained the single claim: "Bacteria herein described and designated as

Clostridium saccharo-butyl-acetonicum-liqueJaciens. "33

The claimed bacteria were cultured from Louisiana cane field soil, reproduced asexually by binary fission, and shown to be useful to produce butyl alcohol, acetone,


and ethyl alcohol by fermentation of carbohydrates. The CCPA found that bacteria were not mentioned in the relevant congressional committee reports stating that the purpose of the plant patent bill was to aid agriculture.34 It concluded that agriculture would not necessarily be aided, and hence that the congressional purpose would not be served, by the grant of a patent for bacteria useful to produce organic solvents.35 The court acknowledged that bacteria "are scientifically classified as plants" but concluded because there is no congressional reference specifically to microorganisms that "Congress, in the use of the word 'plant' was speaking 'in the common language of the people' and did not use the word in its strict scientific sense" 112 F.2d at 838.36

The

Arzberger court's narrow interpretation of the word "plant"3? offends basic

principles of statutory construction, which require that the provisions pertaining to asexually reproduced plants be construed

in pari materia with the balance of the

32112 F.2d 834 (1940). The decision has been criticized: Parker (14) and Note (15). Daus et al (see footnote 13) suggests, on various grounds, that reconsideration and reversal of the

Arzberger decision is in order (2). nA

form of claim acceptable under the special statutes applicable to asexually reproduced

plant patents to obviate difficulties that would be encountered if the specificity of description and claim required by Section 122 for utility patents was also applied to plant patents. The present statute 35 U.S.C. 162 provides: Section 162. Description. claim No plant shall be declared invalid for noncompliance with section 112 of this title if the

description is as complete as is reasonably possible. The claim in. the specification shall be in fonnal tenns to the p lant shown and described. 34See Senate Report No. 315, 71st Congress, 2d Session (1930).

35The court also noted that the types of asexual propagation referred to in the congressional reports did not specifically include binary fission, but only "grafting, budding, cuttings, layer ing, division and the like ..." 36The reference to the "common language of the people" was quoted from Nix v.

Hedden.

149 U.S. 304 (1892), cited by the CCPA as authority "that the scientific meaning of a word is not always controlling in the interpretation of statutes" (112 F.2d at 838). The Supreme Court in Nix. however. used the "common language" only to hold that a tomato is a vegetable for purposes of the Tariff Act of 1883, because the sellers and consumers of provisions to whom that act was directed would so classify a tomato, notwithstanding its scientific classification as a fruit-and not to repudiate generally the use of scientific meanings in construing statutes. J7Applying the

Nix rationale, the word "plant" in the plant patent act should have been

construed to include bacteria, in accordance with the "common language" of the botanists and other technological specialists to whom that act was directed.

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patent laws codified in Title 35.38 Patents are not addressed to laymen but to persons "skilled in the art" to which the claimed invention "pertains." 35 U.S.C. 112. and are hence to be judged by scientific. as distinguished from lay. standards.39 The scope of the word "plant" as used in the statute is. therefore, to be determined by scientific criteria rather than by the "common language of the people."40 By this standard, bacteria are plants subject to patenting under Section 161 of the existing patent


code.41 It is reasonable to conclude that the CCPA as presently constituted would rule that microorganisms are "plants" within the meaning of 35 U.S.c. 161-164, and hence patentable subject matter under that statute. As Judge Giles S. Rich has emphasized, that court in recent years has not only overruled various of its own prior decisions, but also has departed from other legal doctrine with which it does not now agree.42

38The task of the courts in interpreting the separate provisions of a single act is to give the act the most harmonious, comprehensive meaning possible in light of the legislative policy and purpose. See Weinberger v. Hynson, Westcott & Dunning, 412 U.S. 609 (1973) and Oestereich v. Selective Service Boa;d, 393 U.S. 233 (1968). These principles were followed in Nix v. Hedden, (cited footnote 36) to classify tomatoes as vegetables for tariff purposes, but repudiated by the Arzberger court. 39"The description [sic] in patents are not addressed to the public generally . . . but, as section 112 says, to those skilled in the art to which the invention pertains or with which it is most nearly connected." Application 0/Nelson, 280 F.2d 172 (CCPA 1960). See also Application 0/ Borkowski, 442 F.2d 904 (CCPA 1970). 40This conclusion is consistent with the Supreme Court's 1892 interpretation of the Tariff Act of 1883 in Nix v. Hedden, 149 U.S. 304, discussed in footnote 36, to include tomatoes as "vegetables"-an undoubtedly correct result in the context of the sellers and consumers to whom the involved statute was addressed. It is also consistent with Supreme Court's use of the dictionary definition of "manufacture" in the cases cited in footnote 8, to construe the word "manufacture" as used in both the patent and tariff laws. Also consistent is the fact, acknowledged by the CCPA in Arzberger, that one then-current dictionary definition of "plant" was "a lengthy description of plants from a scientific stand point . . . [which mentioned] bacteria" (112 F.2d at 836). 41The Patent Office examiner, in rejecting the Arzberger application, stated that "The scientific classification of bacteria in the living kingdom is in doubt. The authorities recognize that bacteria are not plants in the strict sense," but did not "take issue" with authorities cited by Arzberger, who "state that bacteria are classified as plants and plants include bacteria" (112 F.2d at 835). While it is elementary that the scientific accuracy of the classification of bacteria as "plants" is to some extent "in doubt," e.g. Umbreit (J I), the dispositive fact here is that bacteria are so classified by those "skilled in the art." Plant patents 27 and 2050 for fungi (Agaricus) have been granted by the Patent Office, the latter after, and without citation of, the Arzberger decision. 42See the excerpt from the speech of Judge Giles S. Rich before the Rochester Patent Law Association reproduced in BNA's "Patent, Trademark & Copyright Journal" (12). Judge Rich (13) insists that the 1952 patent act, Title 35 of the United States Code, which he participated in drafting, creates a "law superior to that which may be derived from any prior court opinion," presumably including Arzberger.


331

In most instances, these CCP A departures from settled law are but expedient and questionable pronouncements by a pro-patent tribunal dominated by ex-patent lawyers. The

1940 Arzberger decision, however, is demonstrably erroneous. It

should, therefore, be expected that the federal district courts, the appellate courts, and the Supreme Court itself would agree with the CCPA that

Arzberger was

wrongly decided and that microorganisms per se are indeed proper subject matter


for plant patents.

PROMULGATION OF LEGISLATION AUTHORIZING MICROORGANISM PRODUCT PATENTS If Congress were now to enact patent legislation specifically authorizing the grant of patents on microorganisms per se, controversy would be obviated as to this aspect of the subject matter scope of the present patent statutes. The present climate in Congress, moreover, augurs toward such an enactment if professional and trade groups in the microbiological field take prompt action to sponsor it. A similar effort by such organizations as the American Seed Trade Association, the American Association of Nurserymen, and the National Council of Commercial Plant Breeders in cooperation was eminently successful in convinc ing Congress to enact the plant variety protection act of 1970.

7

U.S.c. 2231

et seq, 43

although more generalized patent legislation has not yet been finalized and despite a

1966 recommendation by President Johnson's Commission on the Patent System44

that all product patent protection for plants, whether sexually or asexually repro duced, should be eschewed. Since the Commission made no recommendation either favoring or disfavoring patents for microorganisms per se, microbiological groups would not face resistance on that premise. In addition, special microorganism legislation could advantageously, and should, be included in the general patent revision bill still under consideration, so that no extra congressional effort need be sought. Another plus factor relative to special microbiological patent legislation is that,

as reported by Stoy (16), certain other countries have recently made similar enact ments. In particular, the Soviet Union-an arch rival of the United States in what government agencies call the "technology race"-now grants inventors' certificates4S for new plants and new animals, as does Bulgaria. In addition, patents of the same subject matter scope are authorized by Hungary's new patent law. To the extent that patent laws are a real incentive to invent, it seems appropriate that the United States should do no less than the cited countries to further inventive advances in microbi ology.

43This act is unfortunately prima facie unconstitutional in that it authorizes the grant of patents for useless and noninventive seeds provided that mere novelty is demonstrated. See cases cited in footnote 6. "See footnote 4. "Inventors' certificates are akin to patents in that they reward an inventor of new technology for his contribution; however, in the USSR, Bulgaria, and some other Communist-bloc coun tries, only the government has the right to practice the invention and sell the product or to license others to do so.

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Literature Cited I. Edelblute, H., 1964. Microbiological

applications and patents. The Encyclo


pedia of Patent Practice and Invention Management, ed. R. Calvert, p. 567. New York: Reinhold 2. Da us, D. G., Bon d, R. T., Rose, S. K.

1966. Microbiological plant patents. IDEA 10:87 3. Levy, D., Wendt, L. 1955. Microbi ology and a standard format for infra red absorption spectra in antibiotic patent applications. J. Patent Office Soc.

37:855

4. Robbins, L. 1960. Patents for microbio logical transformations. J. Patent Office

Soc. 42:830

5. Woodruff, H., Currie, S., Hellada, T., Putter, I. 1973. Importance of the de

scription of the producing organisms in obtaining patent protection for fermen tation processes. Genetics of Industrial Microorganisms, ed. Z. Vanek, Z. Hol

stalek, J. Cudlin, 1:403. Amsterdam:El sevier 6. Kip, R. F. Jr. 1952. The patentability of natural phenomena. Geo. Wash. Law. Rev. 20:371 7. Note 1954. Can artificially created iso topes of chemical elements be patented? Calif. Law Rev. 42:676

8.

Hayman, E. A. 1962. Botanical Plant Patent Law. Cleveland-Marshall Law Rev. 3:430 9. Daus, D. G. 1967. Plant patents: A po

tentially extinct variety. J. Econ. Bot. (Oct-Dec.) 10. Magnuson, R. A. 1948. 9 short discus

sions on various aspects of plant patents. J. Patent Office Soc. 30:493 11. Umbreit, W. W. 1962. Modern Microbi ology. San Francisco:Freeman. 507 pp. 12. BNA's Patent Trademark Copyright (Nov. 7) 1974. 202:A-9-A-IS 13. Rich, G. 1960. P rincip les of paten tabi1ity. Geo. Wash. Law Rev. 28:393 14. Parker, C. 1940. Bacteria held not p atentable under the Plant Patent Act. J. Patent Office Soc. 22:622 IS. Note 33. 1949. Minn. Law Rev. 430 16. Stoy, A. 1973. Legal protection of in dustrial microorganisms in European

socialist countries. Genetics of Indus trial Microorganisms, Bacteria, ed. Z. Vanek, Z. Hostalek, J. Cudlin, 1:397401. Amsterdam: Elsevier

17. Wegner, H. 1974. Patent protection for

novel microorganisms useful for the

preparation of known products. Inter

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