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Patent Law: How Patents Grew Over Time To Include Living Organisms-2

Joe MillerPart 2: In my first post in this series, I talked about the regular utility patent’s four categories of patentable subject matter in Section 101 of the Patent Act: processes, machines, manufactures, and compositions of matter. I also discussed two statutes that Congress enacted to provide patent (or patent-like) protection to plants: the Plant Patent Act of 1930 (covering asexually reproduced plants), and the Plant Variety Protection Act of 1970 (covering seed reproduced plants). Finally, I suggested two big questions that these new statutes left unanswered: (1) does a living organism other than a plant fall within the patentable subject matter categories for regular utility patents?; and (2) do plants, and seeds, fall within the patentable subject matter categories for regular utility patents? These questions, especially the second, are pressing because utility patent protection is stronger than either of the special protections designed just for plants.

It is easy to see, in outline form, what the basic logical arguments would be for answering each of these questions “no.” As to Question 1, we could conclude that Congress, by passing a separate statute for plant patents in 1930, showed that Congress thought that living things did not already fall within Section 101. (If living things already fell within Section 101, Congress would not have needed to change the law.) As to Question 2, we could conclude that Congress, by passing separate statutes for plants with somewhat different rules offering less sweeping protection (compared to utility patents), excluded plants from utility patent protection. (If a special route is set up for an item, the item doesn’t travel the regular route.) As it turns out, the Supreme Court answered both our questions “yes,” rejecting the basic arguments just outlined.

Living Things Can Be “Manufactures” for Purposes of Section 101

Almost 30 years ago, the case of Diamond v. Chakrabarty, 447 U.S. 303 (1980), pitted the Patent Office – which had rejected the applicant’s patent claims – against microbiologist Ananda Chakrabarty and his employer, General Electric. Chakrabarty had developed a “human-made, genetically engineered bacterium [that was] capable of breaking down multiple components of crude oil.” Id. at 305. The Patent Office, “[r]elying on the legislative history of the 1930 Plant Patent Act … concluded that § 101 was not intended to cover living things such as these laboratory created micro-organisms.” Id. at 306. The Supreme Court, in a 5-4 decision, disagreed. It upheld the patentability of Chakrabarty’s new living bacterium.

As a general matter, the Court concluded that the text of Section 101 sweeps broadly: “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.” Id. at 308. In addition, quoting the legislative history that accompanied the most recent major rewrite of the Patent Act (in 1952), the Court put a gloss on the text of the statute that has proved, in subsequent cases, to be quite powerful: “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.’” Id. at 309 (quoting Senate and House reports). This “made by man” gloss effectively resolved the case in favor of Chakrabarty: “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 ….” Id. The Court focused on Chakrabarty’s contribution as an inventor, which distinguished his new bacterium from a product of unaided nature: “His discovery is not nature’s handiwork, but his own; accordingly it is patentable subject matter under [Section] 101.” Id. at 310. The Court thus concluded that the fact that Chakrabarty’s manufacture was also a living organism was irrelevant.

In the years since the Chakrabarty case, the Patent Office has stated that it “consider[s] nonnaturally occurring, nonhuman multicellular living organisms, including animals, to be patentable subject matter within the scope of 35 U.S.C. § 101.” Manual of Patent Examining Procedure § 2105. The Patent Office thus has granted patents on things like the Leder/Stewart “Harvard oncomouse,” a lab mouse line genetically modified to be more susceptible to cancer (and thus a better means for determining carcinogenicity). The oncomouse patent, U.S. Patent No. 4,736,866, issued in 1988 and expired in 2005. Interestingly, the Patent Office has also stated, equally clearly, that “[i]f the broadest reasonable interpretation of the claimed invention as a whole encompasses a human being, then a rejection under 35 U.S.C. § 101 must be made indicating that the claimed invention is directed to nonstatutory subject matter.” MPEP § 2105. (“Nonstatutory subject matter” is patent law lingo for “not within the categories that Section 101 says are patentable.”) It’s not clear what the basis is, in the statute, for this Patent Office policy, although one can readily understand the moral repugnance of something akin to owning human life.

Plants Can Also Be “Manufactures” for Purposes of Section 101

Utility patent protection remained an attractive goal for large commercial seed companies, because it does not come with the exceptions protecting farmers and researchers that were built into the Plant Variety Protection Act of 1970. The seed companies successfully obtained utility patents by showing the Patent Office that they could meet all the requirements for such protection, including the stringent written disclosure requirements that had been a barrier to plant patents decades before. In 2001, 21 years after Chakrabarty, a patent enforcement case involving the alleged infringement of such patents reached the Supreme Court and called the basic validity of these utility patents on plants and seeds into question. The case is J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc., 534 U.S. 124 (2001).

In this case, Pioneer, a seed company, had asserted several of its corn seed patents against JEM Ag Supply, a supply company in Iowa, and several of JEM’s distributors and farmer-customers in Iowa. These defendants argued, unsuccessfully, that Pioneer’s utility patents on seeds and plants were invalid. According to the defendants, the PPA and the PVPA “set forth the exclusive statutory means for the protection of plant life because these statutes are more specific than §101, and thus each carves out subject matter from §101 for special treatment.” 534 U.S. at 129. All three levels of the federal courts – the trial court, the circuit court of appeals, and a seven-justice majority of the Supreme Court – disagreed with the defendants’ argument. All relied on both the broad language of Section 101 (a construction emphasized in the Chakrabarty case), and the assumption courts generally make that Congress doesn’t repeal a statute (in this case, Section 101) indirectly. Both these ideas point to the conclusion that there’s not a direct conflict between plant patenting under Section 101 and plant rights under the PPA or PVPA.

What’s odd about this line of thinking is that, as I described in my first post, Congress enacted the PPA in 1930 in part to overturn the view, widely believed at that time, that the Patent Act did not apply to plants at all (even human-bred ones) because plants were products of nature. The PPA expanded the patent law where it had not been thought to reach. Given this belief about the Patent Act, and the apparent scope of Section 101 in 1930, it’s not surprising that Congress failed to expressly state the exclusivity of the PPA (and later, the PVPA). (If Congress had enacted the PPA or the PVPA after the Chakrabarty decision upholding the patentability of a living bacterium, the failure expressly to exclude utility patent protection for plants would, of course, be quite significant. But Congress enacted the PPA 30 years before Chakrabarty!)

The Supreme Court acknowledged this quirk in its decision in JEM Ag Supply, but wasn’t deterred by it. According to the Court, the 1930 enactment of the PPA

illustrates only that in 1930 Congress believed that plants were not patentable under § 101, both because they were living things and because in practice they could not meet the stringent description requirement. Yet these premises were disproved over time. … Whatever Congress may have believed about the state of patent law and the science of plant breeding in 1930, plants have always had the potential to fall within the general subject matter of § 101, which is a dynamic provision designed to encompass new and unforeseen inventions. … Petitioners essentially ask us to deny utility patent protection for sexually reproduced plants because it was unforeseen in 1930 that such plants could receive protection under § 101. Denying patent protection under § 101 simply because such coverage was thought technologically infeasible in 1930, however, would be inconsistent with the forward-looking perspective of the utility patent statute. …

534 U.S. at 134-35. Justice Breyer dissented from the decision in JEM Ag Supply, in an opinion joined only by Justice Stevens. He, unlike the majority, was persuaded that the PPA and PVPA were the only means for patenting plants.

Where do these decisions leave us? Living things are patentable. Genetically modified bacteria, and higher life forms like mice, are considered “manufactures” under the Patent Act. Plants, too, are patentable; indeed, plant breeders have three options to consider (plant patents, plant variety protection certificates, or utility patents). We arrived here primarily through statutes enacted by Congress, which has both maintained the expansive Patent Act language first passed in 1793 and twice expanded the law to cover plants. The courts, especially the Supreme Court, have also played role. In split decisions, the Court has construed Congress’ broad language expansively. Congress can change these constructions if it wants, although – to be realistic – there are enormous barriers to doing so. (If Congress abrogates granted property rights, it’s required to compensate the property holder. And those who would stand to lose patent rights are a discrete, highly organized lobbying force, relative to the diffuse public that might gain from the abrogation.)

In my final post in this series, I will shift to an issue that the Court will consider in its upcoming term – namely, the question whether abstract business methods are patentable subject matter under Section 101. This question is important in its own right, and has implications for the way software makers can patent their innovations and enforce such rights. It may also have implications for the patentability of medical diagnostic methods and other processes.

In Part 3, on Tuesday August 4, I’ll explore wrap up this series with my final post.

Joe Miller has worked in U.S. patent law since 1994, and has been a law professor since 2001. He teaches at Lewis & Clark Law School in Portland, OR, where he has lived since 2002. He loves enjoying delicious food and great wine with friends, so Portland is a wonderful place to live!

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