Source: http://biosink.blogspot.com/2007_12_16_archive.html
Timestamp: 2013-05-22 19:03:20
Document Index: 319511141

Matched Legal Cases: ['§101', '§101', '§101', '§8', '§101', '§101', '§14', '§1', '§101', '§101', '§112', '§162', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§2181', '§101', '§8', '§101', '§101', '§2402', '§101', '§101', '§102', '§161', '§2402', '§8']

biosink: 12/16/07 - 12/23/07
Diamond v. Chakrabartyr. Chief Justice Burger delivered the opinion of the Court. We granted certiorari to determine whether a live, human-made micro-organism is patentable subject matter under 35 U.S.C. §101 . I. In 1972, respondent Chakrabarty, a microbiologist, filed a patent application, assigned to the General Electric Company. The application asserted 36 claims related to Chakrabarty's invention of "a bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway." 1 This human-made, genetically engineered bacterium is capable of breaking down multiple components of crude oil. Because of this property, which is possessed by no naturally occurring bacteria, Chakrabarty's invention is believed to have significant value for the treatment of oil spills. 2 Chakrabarty's patent claims were of three types: first, process claims for the method of producing the bacteria;<447 U.S. 306> second, claims for an inoculum comprised of a carrier material floating on water, such as straw, and the new bacteria; and third, claims to the <206 USPQ 196> bacteria themselves. The patent examiner allowed the claims falling into the first two categories, but rejected claims for the bacteria. His decision rested on two grounds: (1) that micro-organisms are "products of nature," and (2) that as living things they are not patentable subject matter under 35 U. S. C. §101 . Chakrabarty appealed the rejection of these claims to the Patent Office Board of Appeals, and the Board affirmed the Examiner on the second ground. 3 Relying on the legislative history of the 1930 Plant Patent Act, in which Congress extended patent protection to certain asexually reproduced plants, the Board concluded that §101 was not intended to cover living things such as these laboratory created microorganisms. The Court of Customs and Patent Appeals, by a divided vote, reversed on the authority of its prior decision in In re Bergy, 563 F.2d 1031, 195 USPQ 344 (1977), which held that "the fact that microorganisms * * * are alive * * * [is] without legal significance" for purposes of the patent law. 4 Subsequently, we granted the Government's petition for certiorari in Bergy,vacated the judgment, and remanded the case "for further consideration in light of Parker v. Flook, 437 U.S. 584, 198 USPQ 193 ." 438 U.S. 902, 198 USPQ 257 (1978). The Court of Customs and Patent Appeals then vacated its judgment in Chakrabarty and consolidated the case with Bergy for reconsideration. After re-examining both cases in the light of our holding in Flook, that court, with one dissent, reaffirmed its earlier judgments. 596 F.2d 952, 201 USPQ 352 (1979). <447 U.S. 307> The Commissioner of Patents and Trademarks again sought certiorari, and we granted the writ as to both Bergy and Chakrabarty.444 U.S.924, 204 USPQ 608 (1979). Since then, Bergy has been dismissed as moot, 444 U.S. 1028 (1980), leaving only Chakrabarty for decision. II. The Constitution grants Congress broad power to legislate to "promote the Progress of Science and the useful Arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries." Art. I, §8. The patent laws promote this progress by offering inventors exclusive rights for a limited period as an incentive for their inventiveness and research efforts. Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 480-481, 181 USPQ 673 , 678 (1974); Universal Oil Co. v. Globe Co.,322 U.S. 471, 484, 61 USPQ 382, 388 (1944). The authority of Congress is exercised in the hope that "[t]he productive effort thereby fostered will have a positive effect on society through the introduction of new products and processes of manufacture into the economy, and the emanations by way of increased employment and better lives for our citizens." Kewanee, supra,at 480, 181 USPQ at 678 . The question before us in this case is a narrow one of statutory interpretation requiring us to construe 35 U. S. C. §101, which provides: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Specifically, we must determine whether respondent's microorganism constitutes a "manufacture" or "composition of matter" within the meaning of the statute. 5 <447 U.S. 308> III. In cases of statutory construction we begin, of course, with the language of the statute. Southeastern Community College v. Davis,442 U.S. 397, 405 (1979). And "unless otherwise defined, words will be interpreted as taking their ordinary, contemporary, common meaning." Perrin v. United States,444 U.S.37, 42 (1979). We have also cautioned that courts "should not read into the patent laws limitations and conditions which the legislature has not expressed." United States v. Dubilier Condenser Corp., 289 U.S. 178, 199, 17 USPQ 154, 162 (1933). Guided by these canons of construction, this Court has read the term "manufacture" in §101 in accordance with its dictionary definition to mean "the production of articles for use from raw materials prepared by giving to these <206 USPQ 197> materials new forms, qualities, properties, or combinations whether by hand labor or by machinery." American Fruit Growers, Inc. v. Brogdex Co. , 283 U.S. 1, 11, 8 USPQ 131, 133 (1931). Similarly, "composition of matter" has been construed consistent with its common usage to include "all compositions of two or more substances and * * * all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders, or solids." Shell Dev. Co. v. Watson, 149 F.Supp.279, 280, 113 USPQ 265, 266 (DC 1957) (citing 1 A. Deller, Walker on Patents §14, p.55 (1st ed. 1937)). In choosing such expansive terms as "manufacture" and "composition of matter," modified by the comprehensive "any," Congress plainly contemplated that the patent laws would be given wide scope. The relevant legislative history also supports a broad construction. The Patent Act of 1793, authored by Thomas Jefferson, defined statutory subject matter as "any new and useful art, machine, manufacture, or composition of matter, or any new or useful improvement [thereof]." Act of Feb. 21, 1793, ch.11, §1, 1 Stat. 318. The Act embodied Jefferson's philosophy that "ingenuity should receive a liberal encouragement." <447 U.S. 309> 5 Writings of Thomas Jefferson, at 75-76. See Graham v. John Deere Co.,383 U.S. 1, 7-10, 148 USPQ 459, 462-464 (1966). Subsequent patent statutes in 1836, 1870 and 1874 employed this same broad language. In 1952, when the patent laws were recodified, Congress replaced the word "art" with "process," but otherwise left Jefferson's language intact. The Committee Reports accompanying the 1952 act inform us that Congress intended statutory subject matter to "include anything under the sun that is made by man." S. Rep. No. 1979, 82d Cong., 2d Sess., 5 (1952); H.R. Rep. No. 1923, 82d Cong., 2d Sess., 6 (1952).6 This is not to suggest that §101 has no limits or that it embraces every discovery. The laws of nature, physical phenomena, and abstract ideas have been held not patentable. See Parker v. Flook ,437 U.S. 584, 198 USPQ 193 (1978);Gottschalk v. Benson, 409 U.S . 63, 67, 175 USPQ 673, 674-675 (1973); Funk Seed Co. v. Kalo Co. , 333 U.S. 127, 130, 76 USPQ 280, 281 (1948);O'Reilly v. Morse, 15 How. 61, 112-121 (1853);Le Roy v. Tatham,14 How. 155, 175 (1852). Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc 2;nor could Newton have patented the law of gravity. Such discoveries are "manifestations of * * * nature, free to all men and reserved exclusively to none." Funk, supra,at 130, 76 USPQ at 281 . Judged in this light, respondent's micro-organism plainly qualifies as patentable subject matter. His claim is not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter – a product of human ingenuity "having a distinctive name, character [and] <447 U.S. 310> use." Hartranft v. Wiegmann,121U.S. 609, 615 (1887). The point is underscored dramatically by comparison of the invention here with that in Funk. There, the patentee had discovered that there existed in nature certain species of root-nodule bacteria which did not exert a mutually inhibitive effect on each other. He used that discovery to produce a mixed culture capable of inoculating the seeds of leguminous plants. Concluding that the patentee had discovered "only some of the handiwork of nature," the Court ruled the product nonpatentable: 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 the six species produces no new bacteria, no change in the six 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 same ends nature originally provided and act quite independently of any effort by the patentee. 333 U.S.,at 127, 76 USPQ at 280 . Here, by contrast, the patentee has produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility. His discovery is not nature's handiwork, but his own; accordingly it is patentable subject matter under §101. <206 USPQ 198> IV. Two contrary arguments are advanced, neither of which we find persuasive. (A) The Government's first argument rests on the enactment of the 1930 Plant Patent Act, which afforded patent protection to certain asexually reproduced plants, and the 1970 Plant <447 U.S. 311> Variety Protection Act, which authorized patents for certain sexually reproduced plants but excluded bacteria from its protection. 7 In the Government's view, the passage of these Acts evidences congressional understanding that the terms "manufacture" or "composition of matter" do not include living things; if they did, the Government argues, neither Act would have been necessary. We reject this argument. Prior to 1930, two factors were thought to remove plants from patent protection. The first was the belief that plants, even those artificially bred, were products of nature for purposes of the patent law. This position appears to have derived from the decision of the Patent Office in Ex parte Latimer, 1889 C. D. 123 , in which a patent claim for fiber found in the needle of the Pinus australis was rejected. The Commissioner reasoned that a contrary result would permit "patents [to] be obtained upon the trees of the forests and the plants of the earth, which of course would be unreasonable and impossible." Id.,at 126 . The Latimer case, it seems, came to "set forth the general stand taken in these matters" that plants were natural products not subject to patent protection. H. Thorne, Relation of Patent Law to Natural Products, 6 J. Pat. Off. Soc. 23, 24 (1923). 8<447 U.S. 312> The second obstacle to patent protection for plants was the fact that plants were thought not amenable to the "written description" requirement of the patent law. See 35 U.S.C. §112 .Because new plants may differ from old only in color or perfume, differentiation by written description was often impossible. See Hearings on H.R. 11372 before the House Committee on Patents, 71 Cong., 2d Sess., 4 (1930), p. 7 (memorandum of Patent Commissioner Robertson). In enacting the Plant Patent Act, Congress addressed both of these concerns. It explained at length its belief that the work of the plant breeder "in aid of nature" was patentable invention. S. Rep. No. 315, 71st Cong., 2d Sess., 6-8 (1930); H.R.Rep.No. 1129, 71st Cong., 2d Sess., 7-9 (1930). And it relaxed the written description requirement in favor of "a description * * * as complete as is reasonably possible." 35 U.S.C. §162. No Committee or Member of Congress, however, expressed the broader view, now urged by the Government, that the terms "manufacture" or "composition of matter" exclude living things. The sole support for that position in the legislative history of the 1930 Act is found in the conclusory statement of Secretary of Agriculture Hyde, in a letter to the Chairmen of the House and Senate committees considering the 1930 Act, that "the patent laws * * * at the present time are understood to cover only inventions or discoveries in the field of inanimate nature." See S. Rep. No. 315, supra, at Appendix A; H.R. Rep. No. 1129, supra, at Appendix A. Secretary Hyde's opinion, however, is not entitled to controlling weight. His views were solicited on the administration of the new law and not on the scope of patentable <447 U.S. 313> subject matter – an area beyond his competence. Moreover, there is language in the House and Senate Committee reports suggesting that to the extent Congress considered the matter it found the Secretary's dichotomy unpersuasive. The reports observe: <206 USPQ 199> There is a clear and logical distinction between the discovery of a new variety of plant and of certain inanimate things, such, for example, as a new and useful natural mineral. The mineral is created wholly by nature unassisted by man. * * * On the other hand, a plant discovery resulting from cultivation is unique, isolated, and is not repeated by nature, nor can it be reproduced by nature unaided by man. * * * S. Rep. No. 315, supra, at 6; H.R. Rep. No. 1129, supra, at 7 (emphasis added). Congress thus recognized that the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human made inventions. Here, respondent's microorganism is the result of human ingenuity and research. Hence, the passage of the Plant Patent Act affords the Government no support. Nor does the passage of the 1970 Plant Variety Protection Act support the Government's position. As the Government acknowledges, sexually reproduced plants were not included under the 1930 Act because new varieties could not be reproduced true-to-type through seedlings. Brief for United States 27, n. 31. By 1970, however, it was generally recognized that true-to-type reproduction was possible and that plant patent protection was therefore appropriate. The 1970 Act extended that protection. There is nothing in its language or history to suggest that it was enacted because §101 did not include living things. In particular, we find nothing in the exclusion of bacteria from plant variety protection to support the Government's position. See supra, at n.7. The legislative history gives no reason for this exclusion. As the Court of Customs and <447 U.S. 314> Patent Appeals suggested, it may simply reflect congressional agreement with the result reached by that court in deciding In re Arzberger ,112 F.2d 834, 46 USPQ 32 (1940), which held that bacteria were not plants for the purposes of the 1930 Act. Or it may reflect the fact that prior to 1970 the Patent Office had issued patents for bacteria under §101. 9 In any event, absent some clear indication that Congress "focused on [the] issues * * * directly related to the one presently before the Court," SEC v. Sloan,436 U.S. 103, 120-121 (1978), there is no basis for reading into its actions an intent to modify the plain meaning of the words found in §101. See TVA v. Hill,437 U.S. 153, 189-193 (1978); United States v. Price, 361 U.S. 304, 313 (1960). (B) The Government's second argument is that microorganisms cannot qualify as patentable subject matter until Congress expressly authorizes such protection. Its position rests on the fact that genetic technology was unforeseen when Congress enacted §101. From this it is argued that resolution of the patentability of inventions such as respondent's should be left to Congress. The legislative process, the Government argues, is best equipped to weigh the competing economic, social, and scientific considerations involved, and to determine whether living organisms produced by genetic engineering should receive patent protection. In support of this position, the Government relies on our recent holding in Parker v. Flook,437 U.S. 584, 198 USPQ 193 (1978), and the statement that the judiciary "must proceed cautiously when * * * asked to extend <447 U.S. 315> patent rights into areas wholly unforeseen by Congress." Id.,at 596 . It is, of course, correct that Congress, not the courts, must define the limits of patentability; but it is equally true that once Congress has spoken it is "the province and duty of the judicial department to say what the law is." Marbury v. Madison,1 Cranch 137, 177 (1803). Congress has performed its constitutional role in defining patentable subject matter in §101; we perform ours in construing the language Congress has employed. In so doing, our obligation is to take statutes as we find them, guided, if ambiguity appears, by the legislative history and statutory purpose. Here, we perceive no ambiguity. The subject matter provisions of the patent law have been cast in broad terms to fulfill the constitutional and statutory goal of promoting "the Progress of Science and the useful Arts" with all that means for the social and economic benefits envisioned by Jefferson. Broad general language is not necessarily ambiguous when congressional objectives require broad terms. Nothing in Flook is to the contrary. That case applied our prior precedents to determine that a "claim for an improved method of calculation, even when tied to a <206 USPQ 200> specific end use, is unpatentable subject matter under §101." 437U.S., at 595, n.18, 198 USPQ at 199, n.18 . The Court carefully scrutinized the claim at issue to determine whether it was precluded from patent protection under "the principles underlying the prohibition against patents for 'ideas' or phenomena of nature." Id., at 593, 198 USPQ at 198 . We have done that here. Flook did not announce a new principle that inventions in areas not contemplated by Congress when the patent laws were enacted are unpatentable per se. To read that concept into Flook would frustrate the purposes of the patent law. This Court frequently has observed that a statute is not to be confined to the "particular application[s] * * * contemplated by the legislators." Barr v. United States, 324 U.S. 83, 90 (1945). Accord, Browder v. United States, 312 U.S. 335, 339 (1941); Puerto Rico v. Shell Co., <447 U.S. 316> 302U.S. 253, 257 (1937). This is especially true in the field of patent law. A rule that unanticipated inventions are without protection would conflict with the core concept of the patent law that anticipation undermines patentability. SeeGraham v. John Deere Co., 383 U.S.,at 12-17, 148 USPQ at 464 . Mr. Justice Douglas reminded that the inventions most benefiting mankind are those that "push back the frontiers of chemistry, physics, and the like." A. & P. Tea Co. v. Supermarket Corp., 340 U.S . 147, 154, 87 USPQ 303, 306-307 (1950) (concurring opinion). Congress employed broad general language in drafting §101 precisely because such inventions are often unforeseeable. 10 To buttress its argument, the Government, with the support of amicus, points to grave risks that may be generated by research endeavors such as respondent's. The briefs present a gruesome parade of horribles. Scientists, among them Nobel laureates, are quoted suggesting that genetic research may pose a serious threat to the human race, or, at the very least, that the dangers are far too substantial to permit such research to proceed apace at this time. We are told that genetic research and related technological developments may spread pollution and disease, that it may result in a loss of genetic diversity, and that its practice may tend to depreciate the value of human life. These arguments are forcefully, even passionately presented; they remind us that, at times, human ingenuity seems unable to control fully the forces it creates – that, with Hamlet, it is sometimes better "to bear those ills we have than fly to others that we know not of." It is argued that this Court should weigh these potential hazards in considering whether respondent's invention is <447 U.S. 317> patentable subject matter under §101. We disagree. The grant or denial of patents on microorganisms is not likely to put an end to genetic research or to its attendant risks. The large amount of research that has already occurred when no researcher had sure knowledge that patent protection would be available suggests that legislative or judicial fiat as to patentability will not deter the scientific mind from probing into the unknown any more than Canute could command the tides. Whether respondent's claims are patentable may determine whether research efforts are accelerated by the hope of reward or slowed by want of incentives, but that is all. What is more important is that we are without competence to entertain these arguments – either to brush them aside as fantasies generated by fear of the unknown, or to act on them. The choice we are urged to make is a matter of high policy for resolution within the legislative process after the kind of investigation, examination, and study that legislative bodies can provide and courts cannot. That process involves the balancing of competing values and interests, which in our democratic system is the business of elected representatives. Whatever their validity, the contentions now pressed on us should be addressed to the political branches of the government, the Congress and the Executive, and not to the courts. 11 <206 USPQ 201> <447 U.S. 318> We have emphasized in the recent past that "[o]ur individual appraisal of the wisdom or unwisdom of a particular [legislative] course * * * is to be put aside in the process of interpreting a statute." TVA v. Hill, 437 U.S. 153, 194 (1978). Our task, rather, is the narrow one of determining what Congress meant by the words it used in the statute; once that is done our powers are exhausted. Congress is free to amend §101 so as to exclude from patent protection organisms produced by genetic engineering. Compare 42 U.S.C. §2181, exempting from patent protection inventions "useful solely in the utilization of special nuclear material or atomic energy in an atomic weapon." Or it may choose to craft a statute specifically designed for such living things. But, until Congress takes such action, this Court must construe the language of §101 as it is. The language of that section fairly embraces respondent's invention. Accordingly, the judgment of the Court of Customs and Patent Appeals is affirmed. Affirmed. Mr. Justice Brennan, with whom Mr. Justice White, Mr. Justice Marshall, and Mr. Justice Powell join, dissenting. I agree with the Court that the question before us is a narrow one. Neither the future of scientific research, nor even the ability of respondent Chakrabarty to reap some monopoly profits from his pioneering work, is at stake. Patents on the processes by which he has produced and employed the new living organism are not contested. The only question we need decide is whether Congress, exercising its authority under Art. I, §8, of the Constitution, intended that he be able to secure a monopoly on the living organism itself, no matter how produced or how used. Because I believe the Court has misread the applicable legislation, I dissent. <447 U.S. 319> The patent laws attempt to reconcile this Nation'sdeepseated antipathy to monopolies with the need to encourage progress. Deepsouth Packing Co. v. Laitram Corp., 406 U.S. 518, 530-531, 173 USPQ 769 , 773-774 (1972); Graham v. John Deere Co.,383 U.S. 1, 7-10, 148 USPQ 459 , 462-464 (1966). Given the complexity and legislative nature of this delicate task, we must be careful to extend patent protection no further than Congress has provided. In particular, were there an absence of legislative direction, the courts should leave to Congress the decisions whether and how far to extend the patent privilege into areas where the common understanding has been that patents are not available. 12 Cf. Deepsouth Packing Co. v. Laitram Corp., supra. In this case, however, we do not confront a complete legislative vacuum. The sweeping language of the Patent Act of 1793, as re-enacted in 1952, is not the last pronouncement Congress has made in this area. In 1930 Congress enacted the Plant Patent Act affording patent protection to developers of certain asexually reproduced plants. In 1970 Congress enacted the Plant Variety Protection Act to extend protection to certain new plant varieties capable of sexual reproduction. Thus, we are not dealing – as the Court would have it – with the routine problem of "unanticipated inventions." Ante,at 12, 206 USPQ at 200 .In these two Acts Congress has addressed the general problem of patenting animate inventions and has chosen carefully limited language granting protection to some kinds of discoveries, but specifically excluding others. These Acts strongly evidence a congressional limitation that excludes bacteria from patentability. 13 <447 U.S. 320> First, the Acts evidence Congress' understanding, at least since 1930, that §101 does not include living organisms. If newly <206 USPQ 202> developed living organisms not naturally occurring had been patentable under §101, the plants included in the scope of the 1930 and 1970 Acts could have been patented without new legislation. Those plants, like the bacteria involved in this case, were new varieties not naturally occurring. 14 Although the Court, ante, at 7, 206 USPQ at 198, rejects this line of argument, it does not explain why the Acts were necessary unless to correct a pre-existing situation. 15 I cannot share the Court's implicit assumption that Congress was engaged in either idle exercises or mere correction of the public record when it enacted the 1930 and 1970 Acts. And Congress certainly thought it was doing something significant. The committee reports contain expansive prose about the previously unavailable benefits to be derived from extending patent protection to plants. 16 H.R. <447 U.S. 321> Rep.No . 91-1605, 91st Cong., 2d Sess., 1-3 (1970); S. Rep. No. 315, 71st Cong., 2d Sess., 1-3 (1930). Because Congress thought it had to legislate in order to make agricultural "human-made inventions" patentable and because the legislation Congress enacted is limited, it follows that Congress never meant to make patentable items outside the scope of the legislation. Second, the 1970 Act clearly indicates that Congress has included bacteria within the focus of its legislative concern, but not within the scope of patent protection. Congress specifically excluded bacteria from the coverage of the 1970 Act. 7 U.S.C. §2402(a). The Court's attempts to supply explanations for this explicit exclusion ring hollow. It is true that there is no mention in the legislative history of the exclusion, but that does not give us license to invent reasons. The fact is that Congress, assuming that animate objects as to which it had not specifically legislated could not be patented, excluded bacteria from the set of patentable organisms. The Court protests that its holding today is dictated by the broad language of §101, which "cannot be confined to the 'particular application[s] * * * contemplated by the legislators.'" Ante,at 12, 206 USPQ at 200 , quoting Barr v. United States , 324 U.S. 83, 90 (1945). But as I have shown, the Court's decision does not follow the unavoidable implications of the statute. Rather, it extends the patent system to cover living material <447 U.S. 322> even though Congress plainly has legislated in the belief that §101 does not encompass living organisms. It is the role of Congress, not this Court, to broaden or narrow the reach of the patent laws. This is especially true where, as here, the composition sought to be patented uniquely implicates matters of public concern. 1 Plasmids are hereditary units physically separate from the chromosomes of the cell. In prior research, Chakrabarty and an associate discovered that plasmids control the oil degradation abilities of certain bacteria. In particular, the two researchers discovered plasmids capable of degrading camphor and octane, two components of crude oil. In the work represented by the patent application at issue here, Chakrabarty discovered a process by which four different plasmids, capable of degrading four different oil components, could be transferred to and maintained stably in a single Pseudomonas bacteria, which itself has no capacity for degrading oil. 2 At present, biological control of oil spills requires the use of a mixture of naturally occurring bacteria, each capable of degrading one component of the oil complex. In this way, oil is decomposed into simpler substances which can serve as food for aquatic life. However, for various reasons, only a portion of any such mixed culture survives to attack the oil spill. By breaking down multiple components of oil, Chakrabarty's micro-organism promises more efficient and rapid oil-spill control. 3 The Board concluded that the new bacteria were not "products of nature," because Pseudomonas bacteria containing two or more different energy-generating plasmids are not naturally occurring. 4 Bergy involved a patent application for a pure culture of the microorganism Streptomyces vellosus found to be useful in the production of lincomycin, an antibiotic. 5 This case does not involve the other "conditions and requirements" of the patent laws, such as novelty and nonobviousness. 35 U.S.C. §§102, 103 . 6 This same language was employed by P. J. Federico, a principal draftsman of the 1952 recodification, in his testimony regarding that legislation: "[U]nder section 101 a person may have invented a machine or manufacture, which may include anything under the sun that is made by man. * * *" Hearings on H.R. 3760 before Subcommittee No. 3 of the House Committee on the Judiciary, 82d Cong., 1st Sess., 37 (1951). 7 The Plant Patent Act of 1930, 35 U.S.C. §161, provides in relevant part: Whoever invents or discovers and asexually reproduces any distinct and new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings, other than a tuber propogated plant or a plant found in an uncultivated state, may obtain a patent therefore. * * * The Plant Variety Protection Act of 1970, provides in relevant part: The breeder of any novel variety of sexually reproduced plant (other than fungi, bacteria, or first generation hybrids) who has so reproduced the variety, or his successor in interest, shall be entitled to plant variety protection therefor. * * * 7 U. S. C. §2402(a). See generally, 3 A. Deller, Walker on Patents, Chapter IX (2d ed. 1964);R. Allyn The First Plant Patents (1934). 8 Writing three years after the passage of the 1930 Act,R.Cook,Editor of the Journal of Heredity, commented: "It is a little hard for plant men to understand why [Article I §8] of the Constitution should not have been earlier construed to include the promotion of the art of plant breeding. The reason for this is probably to be found in the principle that natural products are not patentable." Florists Exchange and Horticultural Trade World, July 15, 1933, at 9. 9 In 1873, the Patent Office granted Louis Pasteur a patent on "yeast, free from organic germs of disease, as an article of manufacture." And in 1967 and 1968, immediately prior to the passage of the Plant Variety Protection Act, that office granted two patents which, as the Government concedes,state claims for living microorganisms. She Reply Brief of United States, at 3, and n.2. 10 Even an abbreviated list of patented inventions underscores the point: telegraph (Morse, No. 1647); telephone (Bell,No. 174,465); electric lamp (Edison,No. 223,898); airplane (the Wrights; No. 821,393); transistor (Bardeen & Brattain, No. 2,524,035); neutronic reactor (Fermi & Szilard, No. 2,708,656); laser (Schawlow & Townes, No. 2,929,922). See generally Revolutionary Ideas, Patents & Progress in America,Office of Patents (1976). 11 We are not to be understood as suggesting that the political branches have been laggard in the consideration of the problems related to genetic research and technology. They have already taken action. In 1976, for example, the National Institutes of Health released guidelines for NIH-sponsored genetic research which established conditions under which such research could be performed. 41 Fed. Reg. 27902, In 1978 those guidelines were revised and relaxed. 43 Fed. Reg. 60080, 60108, 60134. And committees of the Congress have held extensive hearings on these matters. See, e.g., Hearings on genetic engineering before the Subcommittee on Health of the Senate Committee on Labor and Public Welfare, 94th Cong., 1st Sess. (1975); Hearings before the Subcommittee on Science, Technology, and Space of the Senate Committee on Commerce, Science, and Transportation, 95th Cong., 1st Sess. (1978); Hearings before the Subcommittee on Health and the Environment of the House Committee on Interstate and Foreign Commerce, 95th Cong., 1st Sess. (1977). 12 I read the Court to admit that the popular conception, even among advocates of agricultural patents, was that living organisms were unpatentable. See ante, at 7-8, 206 USPQ at 198 and n.8 . 13 But even if I agreed with the Court that the 1930 and 1970 Acts were not dispositive, I would dissent. This case presents even more cogent reasons than Deepsouth Packing Co. not to extend the patent monopoly in the face of uncertainty. At the very least, these Acts are signs of legislative attention to the problems of patenting living organisms, but they give no affirmative indication of congressional intent that bacteria be patentable. The caveat of Parker v. Flook, 437 U.S. 584, 596, 198 USPQ 193, 200 (1978), an admonition to "proceed cautiously when we are asked to extend patent rights into areas wholly unforeseen by Congress," therefore becomes pertinent. I should think the necessity for caution is that much greater when we are asked to extend patent rights into areas Congress has foreseen and considered but has not resolved. 14 The Court refers to the logic employed by Congress in choosing not to perpetuate the "dichotomy" suggested by Secretary Hyde. Ante, at 9, 206 USPQ at 198 .But by this logic the bacteria at issue here are distinguishable from a "mineral * * * created wholly by nature" in exactly the same way as were the new varieties of plants. If a new act was needed to provide patent protection for the plants, it was equally necessary for bacteria. Yet Congress provided for patents on plants but not on these bacteria. In short, Congress decided to make only a subset of animate "human-made inventions," ibid., patentable. 15 If the 1930 Act's only purpose were to solve the technical problem of description referred to by the Court, ante,at 8, 206 USPQ at 198 most of the Act, and in particular its limitation to asexually reproduced plants, would have been totally unnecessary. 16 Secretary Hyde's letter was not the only explicit indication in the legislative history of these Acts that Congress was acting on the assumption that legislation was necessary to make living organisms patentable. The Senate Judiciary Committee Report on the 1970 Act states the Committee's understanding that patent protection extended no further than the explicit provisions of these Acts: Under the patent law, patent protection is limited to those varieties of plants which reproduce asexually, that is, by such methods as grafting or budding. No protection is available to those varieties of plants which reproduce sexually, that is, by seeds. S. Rep. No. 91-1246, 91st Cong., 2d Sess., 3 (1970). Similarly, Representative Poage, speaking for the 1970 Act, after noting the protection accorded asexually developed plants, stated that "for plants produced from seed, there has been no such protection." 122 Cong. Rec. 40295 (1970). Posted by
Patenting Life - New York Times - Sent Using Google Toolbar
Patenting Life - New York Times Patenting Life Sign In to E-Mail or Save This Print Share Del.icio.usDigg FacebookNewsvinePermalink By MICHAEL CRICHTON Published: February 13, 2007 YOU, or someone you love, may die because of a gene patent that should never have been granted in the first place. Sound far-fetched? Unfortunately, it's only too real. Skip to next paragraph Raymond Verdaguer Readers' Opinions Forum: Bioethics Gene patents are now used to halt research, prevent medical testing and keep vital information from you and your doctor. Gene patents slow the pace of medical advance on deadly diseases. And they raise costs exorbitantly: a test for breast cancer that could be done for $1,000 now costs $3,000. Why? Because the holder of the gene patent can charge whatever he wants, and does. Couldn't somebody make a cheaper test? Sure, but the patent holder blocks any competitor's test. He owns the gene. Nobody else can test for it. In fact, you can't even donate your own breast cancer gene to another scientist without permission. The gene may exist in your body, but it's now private property. This bizarre situation has come to pass because of a mistake by an underfinanced and understaffed government agency. The United States Patent Office misinterpreted previous Supreme Court rulings and some years ago began — to the surprise of everyone, including scientists decoding the genome — to issue patents on genes. Humans share mostly the same genes. The same genes are found in other animals as well. Our genetic makeup represents the common heritage of all life on earth. You can't patent snow, eagles or gravity, and you shouldn't be able to patent genes, either. Yet by now one-fifth of the genes in your body are privately owned. The results have been disastrous. Ordinarily, we imagine patents promote innovation, but that's because most patents are granted for human inventions. Genes aren't human inventions, they are features of the natural world. As a result these patents can be used to block innovation, and hurt patient care. For example, Canavan disease is an inherited disorder that affects children starting at 3 months; they cannot crawl or walk, they suffer seizures and eventually become paralyzed and die by adolescence. Formerly there was no test to tell parents if they were at risk. Families enduring the heartbreak of caring for these children engaged a researcher to identify the gene and produce a test. Canavan families around the world donated tissue and money to help this cause. When the gene was identified in 1993, the families got the commitment of a New York hospital to offer a free test to anyone who wanted it. But the researcher's employer, Miami Children's Hospital Research Institute, patented the gene and refused to allow any health care provider to offer the test without paying a royalty. The parents did not believe genes should be patented and so did not put their names on the patent. Consequently, they had no control over the outcome. In addition, a gene's owner can in some instances also own the mutations of that gene, and these mutations can be markers for disease. Countries that don't have gene patents actually offer better gene testing than we do, because when multiple labs are allowed to do testing, more mutations are discovered, leading to higher-quality tests. Apologists for gene patents argue that the issue is a tempest in a teapot, that patent licenses are readily available at minimal cost. That's simply untrue. The owner of the genome for Hepatitis C is paid millions by researchers to study this disease. Not surprisingly, many other researchers choose to study something less expensive. But forget the costs: why should people or companies own a disease in the first place? They didn't invent it. Yet today, more than 20 human pathogens are privately owned, including haemophilus influenza and Hepatitis C. And we've already mentioned that tests for the BRCA genes for breast cancer cost $3,000. Oh, one more thing: if you undergo the test, the company that owns the patent on the gene can keep your tissue and do research on it without asking your permission. Don't like it? Too bad. The plain truth is that gene patents aren't benign and never will be. When SARS was spreading across the globe, medical researchers hesitated to study it — because of patent concerns. There is no clearer indication that gene patents block innovation, inhibit research and put us all at risk. Even your doctor can't get relevant information. An asthma medication only works in certain patients. Yet its manufacturer has squelched efforts by others to develop genetic tests that would determine on whom it will and will not work. Such commercial considerations interfere with a great dream. For years we've been promised the coming era of personalized medicine — medicine suited to our particular body makeup. Gene patents destroy that dream. Fortunately, two congressmen want to make the full benefit of the decoded genome available to us all. Last Friday, Xavier Becerra, a Democrat of California, and Dave Weldon, a Republican of Florida, sponsored the Genomic Research and Accessibility Act, to ban the practice of patenting genes found in nature. Mr. Becerra has been careful to say the bill does not hamper invention, but rather promotes it. He's right. This bill will fuel innovation, and return our common genetic heritage to us. It deserves our support. Michael Crichton is the author, most recently, of the novel "Next." Posted by
Patent Docs: In Support of Gene Patents - Sent Using Google Toolbar
Patent Docs: In Support of Gene PatentsIn Support of Gene Patents By Kevin Noonan Once again, the popular press, aided and abetted by academics more interested in career advancement than the facts, have sounded the clarion call against patenting genes (see "Gene Patenting in the News Again"). For anyone interested in a reasoned debate on an important topic, the resulting articles are disheartening. For those interested in advancing progress and U.S. economic interests, they are infuriating. The latest jeremiad comes courtesy of Parade magazine, a popular component of Sunday section in many local newspapers. It is helpful at the start to set out (and refute) the many factual misstatements in the article: "A fifth of your genes belong to someone else." Besides being contrary to the 13th amendment (banning having a property right in a person), no patent in the U.S. (or anywhere else) claims ownership of "your" genes. All U.S. patents require that compositions of matter comprising "genes" are "isolated and purified." So no one is going to knock on your door and ask for a royalty for using your genes. "No one should own a disease" - and no one does. There have been patents on isolated microorganisms, but this is not new: Louis Pasteur had patents on yeasts useful for wine and beer-making, and before the genetics revolution of the last half century, the only way to make useful antibiotics was to isolate the microorganism that happened to make the drug. "Countries where they haven't patented genes have better genetic testing." Correction: cheaper genetic testing, not better. Where did the genetic test come from? Not France, because they can't protect their genetic inventions in France. The U.S. leads the world in biotechnology and is responsible for most of the "better genetic testing" that now exists. There are many reasons why, but one important reason is that the companies that have developed those tests could get the economic support needed to take a scientific discovery and turn it into a useful test. This is so because of patent protection. If France can offer a cheaper test, it's because the French government permits companies in France to use technology without paying for it. This is a good deal only if someone else is paying for it; Dr. Andrews' comments are a little like parents who don't get their children vaccinated, and then benefit from the vaccination of all the other kids in the neighborhood. "Researchers are claiming they don't have to report deaths from genetic studies, calling them 'trade secrets'" and "[s]ome companies are willing to put people at risk to have an advantage." Unlikely to be true. But even if it is, human testing is not within the purview of the patent system. The Food and Drug Administration controls clinical trials, and human testing in a university setting is governed by several levels of review boards enforced by Federal granting agency oversight. The University of Illinois hospitals lost all Federal funding several years ago because they hadn't maintained proper records (i.e., paperwork); it is irresponsible to imply that people are dying without any evidence that it is so. "You don't even have control over your own tissue or blood once it's donated for research." The falsity of this statement is evidenced in the very next line of the article: "What can the public do? Read consent forms at the hospital and doctor's office, and specify that you don't want your blood or tissue used for patented genetic research." If you don't want your DNA to be used to fight diseases, by all means refuse to consent. But then don't complain that your particular illness is an "orphan" that no one is interested in. "Gene patenting is like someone owning the alphabet and charging you each time you speak." In reality, since gene patents are all limited to isolated and purified DNA, the information contained in DNA is freely available. No gene patent owner can "charge" you for using the genetic sequence - which is the key to the scientific information contained in your genes - in any way you wish. Paradoxically, the economic interest and value produced in permitting companies to protect their investment in genetic technology has had the consequence of producing the greatest increase in biological knowledge in history. The information generated on genes from humans, primates, mice, dogs, cats, horses, cows, pigs and many other species, including both useful and harmful microorganisms, is provided without charge to any researcher, capitalist or homemaker having and interest and a computer. It is the equivalent of having publicly-accessible the blueprints of every machine ever made. The problem with the misinformation contained in these articles is that they ignore important limitations imposed by the patent system. As mentioned, individuals cannot be patented. Human "body parts" can't be, either, just like it is illegal to sell a kidney. (Ironically, in one of Dr. Andrews' books she advocates people having a property right in their DNA. By that thinking, there is no legal justification to prevent an individual from deciding to sell a kidney, since it is his or her "property.") No one owns your genes, or anyone else's. Moreover, the patent right is finite - it expires. That's one of the beauties of the patent system, since it is a limited right, and one of those limitations is time. Presently, a U.S. patent expires 20 years from its earliest filing date. For many of the earliest gene patents, that day is or soon will be here. For the vast majority of gene patents, expiration will occur by 2020. The biological reality is that, given the immense number of new genes identified (and still being identified), and publication of the genetic sequences of these genes in databases around the world, patent protection will expire before we have determined the usefulness of most of human genes. Just as in the generic drug debate, there is a balance to be struck between rewarding companies and universities that expend vast amounts of money, time and resources in discovering the genetic information necessary to produce a genetic test, and the cost of those tests to the public. The answer is not to declare the underlying technology off-limits to patent protection. That way leads to a real "tragedy of the commons" where no one has the economic incentive to develop a test that can be stolen by a competitor without compensation. There are many ways to make testing available to those who cannot afford it; for those who can afford to pay, objections to paying for such testing is a fancy variant of "free-riding" on the time, efforts and accomplishments of others. (At least those Americans looking for cheaper genetic testing in France can afford to support the airline industry in going there.) There are many facets to the legal implications of the revolution in genetics, including many included in the "Genetics Bill of Rights." It does a disservice to the civil libertarian aspects of the debate - freedom from discrimination, freedom from prosecution, privacy rights over having yourself or your tissues used in research - to conflate them with gene patenting. It is even more of a disservice to reasoned debate on the topic to misstate the issues to make political or rhetorical points, particularly when those misstatements are willful rather than misinformed. Gene patenting is not a scourge and does not impose undue burdens on the public. In fact, it is an important contributor to results desired by all: better technology to provide better prevention and treatment for human diseases. It is a shame that some will obscure the facts to sell books or make headlines. Posted by
Patent Docs: Science Fiction in The New York Times - Sent Using Google Toolbar
Patent Docs: Science Fiction in The New York TimesScience Fiction in The New York Times By Kevin Noonan Michael Crichton has always hated - or feared - technology. In his novels The Andromeda Strain, The Terminal Man, and Jurassic Park, he has been a technology Cassandra, a modern-day Luddite warning that technology would get us if we weren't very careful. And while space viruses, inhuman cyborgs, and thunder lizards are entertaining as fiction, they shouldn't inform national policy. That is what Dr. Crichton has been trying to do recently, neatly dovetailing these efforts with promoting his latest book, Next . The bogeyman this time is DNA patenting, which he assails in an OpEd piece in The New York Times today. Unfortunately, the misstatements and exaggerations in the piece make it closer to fiction than it has any right to be, appearing in the pages of the "paper of record." The problems begin with the title, "Patenting Life." Patenting life isn't what he is concerned with - it is patenting DNA. DNA is not life, any more than patenting Vitamin B12, proteins, or hormones isolated from animal (or human) material. Writers like Dr. Crichton (particularly academics, who should know better) have created a "new vitalism;" in this philosophy DNA is "different" and patenting DNA should be prohibited. One problem with their position is its intellectual dishonesty: as Dr. Crichton does here, they accuse gene patentees of having ownership rights to "your" DNA (the DNA in the cells of a person's body). This is nonsense, since anyone familiar with this space or any other truthful description of DNA patenting knows that patented DNA must be "isolated" or "isolated and purified." In short, no one has ownership rights over "your" DNA (or mine, or Dr. Crichton's). Dr. Crichton chooses an easy target as "bad guys" in his fiction: the oft-maligned patent examiners that he holds responsible for gene patenting. If there are culprits, of course, it would be the U.S. Supreme Court who in the Diamond v. Chakrabarty decision opened the doors for patenting genes and a host of other things that have been important components of the biotech industry. Dr. Crichton would have you believe that the "good guys" are those commercial interests in the rest of the world who provide genetic testing using patented DNA more cheaply than in the U.S. What Dr. Crichton doesn't say is that these "free-riders" on American innovation only exist due to their governments' tardiness in protecting biotechnology inventions. Dr. Crichton characterizes as a "disaster" the decision to permit gene patents in the U.S. The real disaster has been in the rest of the world, particularly Europe, where they are paying the price today of their political decisions that frustrated patent protection for biotechnology. As recently reported in The Washington Post, European pharmaceutical companies have suffered both economically and in their drug product pipeline: where a generation ago the Europeans predominated, now it is American inventions and American companies that lead the world. Much of this advantage stems directly from patent protection available for the biotechnology industry. There are a host of other pertinent facts omitted from the piece. Examples include: that the patent right is limited (to 20 years from the initial filing date), so that the invention becomes freely available to the public for eternity once the patent expires (the robust generic drug industry depends on this fact). That DNA is both a patented chemical compound (that can be infringed) and genetic information, which information is freely available upon publication. That no one "owns" a disease nor has inhibited research on a disease. That DNA patenting has not encumbered research; indeed, despite fears (voiced, famously, by Rebecca Eisenberg) that patenting DNA would lead to a "tragedy of the anticommons," research shows that gene patents have not impeded DNA research in academia. See "The 'Anti-Commons' Aren't So Tragic, After All ." What patents do is protect inventors from commercial infringement of their inventions, and permit small companies to obtain the financial backing necessary to develop the very genetic tests and therapeutic drugs Dr. Crichton complains about. The pages of the Times recently provided stark evidence of the economic advantages of patents in the U.S., in a profile of Xoma Corporation. The Times writer decried the amount of investment ($700 million) in a company that in 25 years had not developed a successful commercial product. Paradoxically, this demonstrates the genius and strength of the patent system, since it is only with this type of investment that companies like Xoma (and a host of more successful biotechnology companies) have been able to survive. What the piece shows is how difficult and expensive it is to develop a biotechnology product; no sane investor would place his bets on such companies without patent protection, and without investment the industry could not survive. Dr. Crichton's attack is political, as is the bill introduced on Friday by Representatives Becerra of California and Weldon of Florida, which would ban gene patenting (more on that in a later post). This is a mistake, and there is ample evidence from our recent history that it is a mistake. At least one reason why the U.S. did not become the country Dr. Crichton described in another of his books, Rising Sun - an aging, rust-bucket, economic wreck that could not compete with the facile new democracies of Europe and Asia - is that America was quick to protect its innovators and innovative industries like telecommunications, computers and biotechnology. Thirty years ago, everyone had a Sony Walkman, today it's an iPod. And thirty years ago Europeans were producing most new drugs; today, it is America. Whether the political motivations are "Green" or religious or merely careerism (by either novelists or academics), the mistake would be to ignore the lessons of history. We shouldn't be killing the golden goose of American innovation. Dr. Noonan has written a number of Patent Docs articles on the issue of gene patenting, including: "In Support of Gene Patents," December 7, 2006. "Anti-Patent (Sullivan?) Malice by the New York Times," January 29, 2007. "The Continuing Value of Biotech Patenting," February 4, 2007. Posted by