Edmund J. Sease
McKee, Voorhees & Sease, P.L.C.

Presented April 9, 2004 at University of Illinois,
"Seeds of Change" Symposium Banquet
www.ipagcon.uiuc.edu

ABSTRACT

Agricultural plant patenting history is traced from its origins through the 2001 United States Supreme Court decision, J.E.M. Ag Supply v. Pioneer Hi-Bred.  The current state of the law offers opportunities for plural regimes of protection as utility patents, Plant Patent Act (PPA) and Plant Variety Protection Act (PVPA).  No other country offers so many opportunities for intellectual property coverage of plants.  The concept of patenting living organisms, and plants in particular offers numerous questions of legal uncertainty that will only be resolved by Court decisions that modify, interpret and apply traditional legal doctrines to living plants.

I. INTRODUCTION

Since 1790, our patent laws have allowed the patenting of five categories of subject matter, namely machines, compositions of matter, articles of manufacture, processes, and improvements in each. The most remarkable thing about this Statute (now 35 U.S.C. § 101) is that it has hardly changed in substance since its inception.  Thus, the categories of patentable subject matter are nearly as old as our Constitutional Clause allowing the patent system to exist, Article 1, Sec. 8, Cl. 8. It is worthy to note that neither the Constitution nor the implementing statute defining the categories of patentable subject matter says anything about whether the subject matter is living.  Why then should it be remarkable for our Supreme Court to have concluded that whether an object for which a patent is sought is living, is an irrelevant consideration to patentability? An even more pointed question might be what difference does the living versus non-living issue make to plant patentability?  We already know that the Supreme Court in the 1980 Diamond v. Chakrabarty case, 447 US 303 (1980) answered that it makes no difference for bacteria? Why then in what seems such a clear and correct decision for plants as well has the issue been the subject of writings and debate for so many years?

The answer lies in part in religious and in ethical beliefs involving species integrity, in part in an idealistic American view of the independent entrepreneurial farmer, and in part in legislative history and government public policy. Since J.D. Watson and Francis Crick discovered the structure of DNA in 1953, the potential to alter living species to produce useful and beneficial results has leaped forward. It is inevitable that this leap was going to change our patent law regime in some ways. The question therefore became not whether there would be change, but rather what should the changes be?

II. EARLY HISTORY

This author has earlier outlined in some detail the history of biotechnology patent law in a law review article, From Microbes, to Corn Seeds, to Oysters, to Mice: Patentability of New Life Forms, 38 Drake Law Review 551 (1989). While the article is now outdated, its history remains accurate. If the reader wants more detail, it is recommended. It is wrong to say that prior to Diamond v. Chakrabarty, there were no new life form patents issued. Patent lawyers had been quietly drafting claims in order to accomplish their client's objectives for years. And in so doing, they were on occasion successful in getting patents on compositions of matter that included things that were living. Perhaps one of the early vivid examples is U.S. Patent 2,200,532, issued May 14, 1940. It was the subject of litigation that went all the way to the Supreme Court, Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948). The patent there concerned an inoculant for leguminous plants that contained six non-inhibitive strains of bacteria of the genus Rhizobium. The patentee took six different strains of bacteria, combined them all and then used the combined inoculant to aid in nitrogen fixation, all packaged in a single package which he sold. Ultimately the Supreme Court held the patent invalid, but only because it was an additive mixture of six bacteria, and as the Court pointed out, the combination of species produces no new bacteria, no change in the six species of bacteria, and no enlargement of their range of utility. Each species has the same affect it always had. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. at 132. No mention was made of the living organism issue. In a concurring opinion that has gotten little attention over the years, Justice Frankfurter criticized the product of nature doctrine pointing out that it only confuses to label something, "a product of nature," and that, in fact, everything may be deemed a work of nature. In that sense, he said, arguments drawn from such terms for ascertaining patentability could be fairly employed to challenge almost every patent. Over the years, the product of nature doctrine remained viable but with many exceptions. Thus, if products of nature were altered from the standpoint of purity, crystalline phase, optical isomer, admixture with diluents, or critical ranges needed for operability, patents were granted.

The early history ends with the 1980 decision in Diamond v. Chakrabarty, 447 U.S. 303 (1980) where 27 years after Watson & Crick unwound the DNA molecule, the Supreme Court acknowledged that living organisms could be potentially patentable, and that the categories of patentable subject matter should be interpreted broadly, citing with approval some legislative history that said the statute was intended to cover "anything under the sun made by man." 447 U.S. at 309.

III. POST DIAMOND v. CHAKRABARTY HISTORY OF PATENTABILITY OF LIFE FORMS

Taking its cue from the Supreme Court's expansive view of patentable subject matter endorsed in Diamond v. Chakrabarty, the United States Patent and Trademark Office (PTO) in a Board of Patent Appeals and Interference decision interpreted the subject matter of 35 U.S.C.
§ 101 to include plants, In re Hibberd, 227 U.S.P.Q. 443, 1985 WL71986 (1985). Amazingly, Hibberd continued as the primary precedent without court challenge from 1985 until J.E.M. Ag Supply v. Pioneer Hi-Bred in 2001! There is, of course, a reason for this. In patent battles between seed companies, no-one wanted to kill the goose that laid the golden egg! Put another way, while it was always lurking in the background that perhaps the PTO decision exceeded its authority or was at least on questionable ground, no-one challenged the entire concept of issuing the patents in the first instance. Rather, in the many litigations seed companies used more conventional affirmative defenses such as non-infringement, invalidity for inadequate written description or claim definiteness under 35 U.S.C. § 112, or lack of novelty under 35 U.S.C.
§ 102 or the ubiquitous defense of obviousness to one of ordinary skill in the art, 35 U.S.C.
§ 103.

Nevertheless, the highly visible decision in In re Hibberd led to the issuance of some 1,800 utility patents for plants between Hibberd (1985) and J.E.M. Ag Supply (2001).

In other areas, patentability went beyond plants to more complex life forms such as polyploid oysters, the Harvard mouse, cows, pigs, and poultry, all with particular genes to maximize one property or another, etc.

IV. J.E.M. AG SUPPLY V. PIONEER HI-BRED,
122 S.Ct. 593 (2001)

A. THE CASE

Pioneer Hi-Bred v. J.E.M. Ag Supply began winding its way through the court's in 1998. In August of that year, Senior Judge Donald O'Brien denied the defendant's summary judgment that as a matter of law, the corn plant utility patents at issue were invalid. Notice the parties to this litigation. It is Pioneer Hi-Bred, one of the major seed producers in the nation, and someone who is not in the business of seed production. Thus, the normal motive of not wanting to kill the goose that laid the golden egg was absent. This defendant, from the Plaintiff Pioneer's point of view was an illegal seed reseller. Not surprisingly then, the challenge that seed companies failed to raise in litigation was here raised. Both the District Court and the Court of Appeals for the Federal Circuit followed Hibberd and Chakrabarty giving predictable results favorable to patenting plants. To everyone's surprise, the United States Supreme Court grant certiorari to determine whether newly developed plant breeds fall within the subject matter of 35 U.S.C.
§ 101, or whether the alternative statutory regimes provided by Congress showed a legislative intent that the regular utility patent statute not cover plants.

The defendant's argument in J.E.M. Ag Supply was a slightly refined argument from Diamond v. Chakrabarty. To be honest, when I first heard the argument, I did not think that it even rose to the level or a recognizable affirmative defense. In the end, I was right, but it took a district court opinion, a Federal Circuit opinion and a Supreme Court opinion before this issue was clearly resolved! In Diamond v. Chakrabarty, the argument was that nothing living could be patentable because Congress had two specific statutory regimes that covered living things. Asexually reproduced plants under the Plant Patent Act (PPA) (35 U.S.C. 161-164) or sexually reproduced varieties under the Plant Variety Protection Act (PVPA) (7 USC §§ 2321-2582). Thus, there would have been no need for these two specific statutes if living organisms like the oil spill eating bacteria of Chakrabarty could have been covered under the general provisions of 35 U.S.C. § 101 either as a composition of matter or an article of manufacture. While the argument was rejected in Chakrabarty, it was resurrected in J.E.M. Ag Supply, which was arguably a much closer case. The reason J.E.M Ag Supply was argued as a much closer case, is because the specific subject matter was plants, not bacteria. And, it was plants after all that the other two statutory regimes (the PPA and the PVPA) specifically covered. Simply put, the argument of legislative intent based upon legislative history was much more persuasive in J.E.M. Ag Supply than in Chakrabarty.

One might well ask why wasn't the Plant Patent Act or the Plant Variety Protection Act (PVPA) satisfactory for seed companies? The answers were clear. The Plant Patent Act only covered asexually reproduced plants, which excludes most major domestic crops from any significant patent coverage. And the Plant Variety Protection Act did not have the same concept of scope of coverage for infringement, relying instead upon "essentially derived varieties." And, importantly, it also had both a saved seed exemption and a research exemption, not applicable to utility patents. Some commentators have likened the limitation of scope of protection under PVPA to a copyright, essentially protecting copying from a physically accessible plant (e.g. Imazio Nursery, Inc. v. Dania Greenhouses, 69 F.3d 1560 (Fed. Cir. 1995)). For these reasons, The J.E.M. Ag Supply v. Pioneer Hi-Bred case involved an extremely important bundle of rights that could potentially in one fell swoop wipe out any meaningful protection for billions of dollars of plant research.

Not realized or often discussed is that Diamond v. Chakrabarty was a close case! It was a 5-4 decision, and of the judges on the Court in 1980, only Rehnquist and Stevens were still on the court in 2001. Hardly a confidence builder for someone arguing Diamond v. Chakrabarty was correct and should be extended.

In the end, the Court held specifically and unambiguously that utility patents may be issued for plants. This means that the United States now has three separate regimes which may cover any particular plant. It may be patentable under the PPA if it is asexually reproduced; it may be patentable under the general utility patent statute if it is new, useful and nonobvious; and it may be eligible for PVPA protection if it is a new distinct, stable and uniform plant. In this position the U.S.A. is truly unique in the world. No one else offers this expansive an opportunity for plant protection.

B. WHY DID THE COURT GRANT CERTIORARI?

To the seed industry, the compelling question was simple: Why did the United States Supreme Court take this case? If Chakrabarty decided the law and settled it, i.e. the expansive view of 35 U.S.C. 101 controlled, what was the sense of taking another case to say the same thing 21 years later? And, if the Court did not believe Diamond v. Chakrabarty controlled, was it therefore inevitable that a retraction of the expansive view of patentable subject matter expressed in Diamond v. Chakrabarty was forthcoming? And if it was forthcoming, what would this mean to the seed industry? The questions seemed compelling.

If it truly was the Court's intent to merely rubber stamp Diamond v. Chakrabarty, why did the Court grant certiorari? I have been asked this question many times. My view, like yours, is only conjecture and probably no better than yours. But here it is. I believe certiorari was granted because it is a closer case than Diamond v. Chakrabarty, and because it gave the Court an opportunity to weigh in on the rapidly developing world of the biological sciences. And, finally, I believe that the Court wanted to express its willingness to endorse plural regimes of intellectual property protection. All of these reasons, if true, are good for patentees and good for agricultural biotechnology, if you believe that patent protection enhances industry in general. The ringing endorsement of plural regimes of protection for intellectual property may be the legacy of J.E.M. Ag Supply that has far reaching effects upon the patent law in general. In this regard, shouldn't ornamental flowers now be allowed design patents (35 U.S.C. §§ 171-173)?

V. FRONTIER ISSUES FOR LITIGATORS

Litigating seed and plant patents is unique. For one thing, it brings many interesting proof issues to the forefront, not commonly occurring in other types of patent cases. For example, plant breeding records and deciphering them often becomes critical, both for proof of copying and for proof of willful infringement. These records are most unlike business records of research in other industries. Often written in what seems like hieroglyphics, they are indecipherable without witness testimony assistance. They are, however, essential to understanding how an accused infringer arrived at the parental lineage of the accused plant or seed product. And the absence of such records can often be an alarm signal of false assertions.

The fact that the patentable subject matter is alive and therefore capable of self replication also raises interesting legal questions. The closest analogous doctrine in current patent law is Repair v. Reconstruction. In the inanimate object world of, for example, machines, one may repair a patented object if the original use is rightful, but one may not reconstruct it once it is expended. Reconstruction is infringing. Is reproduction by a plant similar to reconstruction and therefore infringing? Is there room in the patent law for some doctrine relating to accidental and unintentional infringement? For example, what if an infringing act occurs because of pollen drift? Do we need legislation to prevent species contamination from GMO's to naturally occurring plants? And if we do, how can it be implemented and where? Put another way, was the Star Link situation a harbinger of difficulties to come? How and in what manner should GMO fields be isolated? Are we already too late to preserve species integrity?

In the plant world, compliance with 35 U.S.C. 112 is often achieved by depositing seed with a legitimate depository such as the American-Type Culture Collection in Rockville, Maryland. These seed deposits have been held to satisfy 35 U.S.C. 112. Members of the public can access a competitor's seed deposit by simply paying a fee to get 25 seeds. What may those seed deposit samples be legitimately used for? Can they be used only to check whether someone is an infringer? Can they be used to grow and then bulk up the amount of seed product that you have? Can they be used to confirm what in fact was patented? And, what if the seed is both patented and protected by a PVPA that has a research exemption, can it then be used in research in a breeding program? All of these and many more questions will have to be answered in the exciting years of seed patent law litigation ahead of us.

A. CONSTITUTIONAL CLAUSE CASE

As most of you know, our Constitutional Clause is both a patent clause and a copyright clause. It makes specific reference to "inventors," i.e. by securing for limited times to authors and inventors (emphases added) the exclusive rights . . . . Can one really be an inventor if the thing you say you invented is not something you can make from scratch? No one can make a plant or mouse or any other living organism from scratch. Is it therefore possible that the product of nature doctrine as originally conceived was correct? Perhaps unless someone can demonstrate the capability of going into the laboratory, starting from nothing but chemicals, and ending up with a life form it does not meet the Constitutional standard? An interesting thought, and perhaps another Supreme Court case in the making.

VI. THE FUTURE OF AGRICULTURE AND PATENTS TOGETHER – A  GOOD MARRIAGE OR A SHOTGUN WEDDING?

As one who believes in the patent system, I believe it is a good marriage even though forced by the decisions of the United States Supreme Court. As said in Chakrabarty and as reaffirmed in J.E.M. Ag Supply, the limits of patentability are up to Congress. The Supreme Court's job is to interpret laws, not expand them. Thus, the ultimate destiny of application of the patent laws to any industry is completely dependant upon Congress. It is possible and likely that changes will occur in the future. For example, the religious and ethical views of species integrity are not to be taken lightly. While the anti-GMO view is stronger in Europe than here in the United States, it is present here and offers the potential to drastically change the landscape if politicians support legislative change. As plants are more and more viewed as a renewable resource for raw materials to be harvested and developed into not only food, but products such as new drugs for the health care, raw materials for the chemical industry, etc., the worth of patents will become more and more apparent. Perhaps soybean and corn fields will no longer be viewed as simply rows of soybeans and corn, but rather as a factory of raw materials to supply the world with new drugs, chemicals and products. This far broader view of current day farming offers the potential for a Midwest economic explosion. One which could dwarf the Silicone Valley phenomenon, if it happens.



Edmund J. Sease is a Partner in the Intellectual Property Law Firm, McKee, Voorhees & Sease, P.L.C., Des Moines, Iowa, and attorney who successfully argued the J.E.M. Ag Supply v. Pioneer Hi-Bred International patent seed case at the United States Supreme Court.