Testimony of

Peter T. DiMauro, Ph.D.

Director, PatentWatch Project

International Center for Technology Assessment

before the

Subcommittee on Courts, the Internet and Intellectual Property

 Committee on the Judiciary

U.S. House of Representatives

19 September 2002

 H.R. 5119, Plant Breeders' Equity Act of 2002


Mr. Chairman, Mr. Ranking Member, and all Committee members, thank you for inviting me to speak on the topic of H.R. 5119, the Plant Breeders Equity Act of 2002. My name is Peter DiMauro, I'm a Registered Patent Agent and Project Director of PatentWatch, a project of International Center for Technology Assessment (CTA) here in Washington. CTA is a nonprofit bipartisan organization committed to providing the public with assessments and analyses of the impact of the patent system upon society. CTA has a long history of work on the problems existing in and engendered by the patent system in areas as diverse as farmers' rights and human dignity, and we are increasingly concerned about the impact of plant intellectual property rights on U.S. agriculture and world food security.




Background


The Plant Patent Act, first enacted in 1930, has served as the prototype and template for the entire history of intellectual property coverage of living things, and while that Act itself may appear to offer only narrow coverage of asexually propagated plant varieties, changes thereto can have a dramatic effect on the much larger issues of patents on food, seeds, and crops both here in the US and worldwide.


The changes proposed in HR 5119, although styled as technical corrections, are unwarranted in terms of the rationale set forth for adoption, unjustified in terms of the relief which is sought, unprecedented even within the bounds of patent law, and are actually far reaching in their implications.


The Proposed Plant Patent Act Amendments are Unwarranted


The proposed changes to the Plant Patent Act are unwarranted even taking into account the reasons submitted, since:

            1. the US Patent and Trademark Office (USPTO) appears to be correct in its application of relevant case law Footnote by adopting Ex parte Thomson; and since

            2. the plant quarantine regulations for imported nursery stock do not generally require the extended multi-year quarantine periods which are claimed; and in fact, quarantine regulations themselves exist at the behest of, and for the benefit of, American nurseries and breeders. There is no "injustice" fostered by the USPTO that needs correction where the PTO is correctly applying the law, even if belatedly; and there is no regulatory burden that needs to be relieved when the government promulgates regulations that are solely for the benefit of domestic industry.

 

The Thomson decision, as interpreted by the USPTO, stands for the proposition that a printed publication of a given plant variety - when coupled with the availability of said variety - can constitute enabling prior art for purposes of defeating patent applications under 35 USC 102(b). That portion of the statute, which applies to both utility patents and plant patents, exists to enforce the manifest public policy that a patent shall only be granted for what is new, for what has novelty Footnote . Since 1939 Footnote , it has been law that no patent shall be granted on an invention which was described in a printed publication more than one year prior to the earliest effective filing date of a patent application. However, there is one exception: a printed publication which is merely prophetic or which is "science fiction", does not serve as effective prior art, since it is not "enabling"; as such it does not "enable" one to make and/or use the invention. This is not the case here, where the USPTO in its due diligence uncovers a plant breeders' right certificate, or equivalent documentation, which, when coupled with the public availability of the plant variety, would reasonably place the public at large in possession of that variety. One must recall that the patent laws are not crafted for the convenience of an industry, but exist to carry out the careful balancing acts of public policy. In the case of 35 USC 102(b), the policy behind barring the grant of patents for inventions which were previously described in a printed publication, is to enforce the novelty provision of Section 161, limiting patents only to those asexually produced plant varieties which are actually new. Legislative history, case law, and Constitutional analysis substantiate this policy. Footnote There is a policy against removing inventions from the public which the public has justifiably come to believe are freely available to all as a consequence of prolonged availability. Footnote One would think that a decade-old disclosure of a plant variety would create a reasonable expectation of free availability. Next, there is a policy favoring prompt and widespread disclosure of new inventions to the public. The inventor is forced to file promptly or risk possible forfeiture of his rights due to prior disclosure. Footnote


The Thomson decision, albeit one which did not concern a patent under the Plant Patent Act, would appear to be correct as applied to asexually reproduced plant patent applications, since the documents that the USPTO uses of late to make rejections all appear to be at least commensurately enabling as any Plant Patent has to be; in fact, Plant Patent applications have an express statutory waiver from the requirement of themselves being enabling documents Footnote . Thus, what is sauce for the goose would logically be sauce for the gander as well.


Finally, even if the Thomson decision were incorrect (a determination best left to appellate review), HR 5119 does not even legislatively overrule it! It would appear that the proponents of HR 5119 are perfectly willing to acquiesce to the USPTO applying printed publications against their applications, as long as such publications are more than a decade old. This inconsistency alone ought to reveal that the alleged incorrectness of Ex parte Thomson appears to be little more than a hollow plea for special treatment.


The Proposed Changes are Unjustified By Appeal to Quarantine Laws


Arguments made regarding how plant quarantine regulations necessitate these proposed changes, are similarly not persuasive. It has been asserted that this 10-year grace period is needed as a proxy for a plant patent term restoration, to compensate plant patent owners for the time that plant nursery stock must be quarantined for 2-8 years to obviate the importation of pests and viruses. However, firstly one must note that the nursery industry rightly takes great pride in being “responsible for initiating the commercial plant quarantine system”, Footnote designed to protect the US plant industry. It would be unwarranted to have to compensate for this with a patent term "restoration". Most plants under Plant Patent never have to undergo even a day of quarantine. Why would they get an extension? Plant quarantine regulations vary widely, can be waived if a phytosanitary certificate is presented, ordinarily only apply to imported plants, generally only are of very short duration, and in many cases are very permissive. USDA regulation Q37, Footnote which covers nursery stock, is based on an “enterable unless found unsafe” approach. If anything, judging from the invasive species plague in this country, plant quarantine regulations are not yet stringent enough. Footnote The present bill is thus unjustified in terms of the relief sought. Compare all this with the existing Hatch-Waxman regime Footnote for patent term extension for human and animal pharmaceuticals: the present term extension system gives only that amount of compensation Footnote which is warranted; is targeted only to those patents deserving of it; and was part of a larger social bargain promoting the entry of generic drugs into the market. HR 5119 is by contrast just a giveaway. Unlike Hatch-Waxman, the present bill is anti-competitive, since economists agree that patent expirations are the incentive for the release of much competitive energy; delaying expiry of any patent bottles up competition. Passage of this bill would engender endless copycat laws giving patent term extensions to any industry whose patent terms did not precisely match their windows of marketability. First copycats in line would be the seed companies, holders of regular utility patents, Footnote since seeds, too, come under quarantine Q37. HR 5119 may also create an administrative burden at the USPTO, since the extended grace period would likely foster a ten-fold increase in so-called interference proceedings between competing plant patent applicants. Footnote


Arguments have also been made on behalf of H.R. 5119 appealing to the authority of the UPOV Convention Footnote , which is one type of international agreement prescribing plant breeders’ rights. UPOV mentions grace periods, but these appear to only apply to foreign sales of plants, not printed publications; in any event, the Plant Patent Act itself does not appear to comport to UPOV, since the latter allows for a residual farmer’s right to save germplasm and allows for bona fide experimental exceptions. Yet, these provisions are entirely absent from the Plant Patent statutes. Thus calls for compliance with UPOV are hollow in this context. Furthermore, the United States actively lobbies other countries to accept UPOV version 1991 as being the only effective sui generis intellectual property regime for plants. Footnote And yet, the USPTO refuses to accept UPOV certificates as constituting intellectual property! Footnote Such incoherent policy means that appeals to UPOV’s authority should be discounted.




Future Consequences and Implications of Bill


Finally, HR 5119 is the functional equivalent of a ten-year patent term expansion for patents on life. History shows that every time plant intellectual property laws are amended it expands the scope of protection and rights of corporate breeders, at the expense of farmers, biological diversity and society. CTA feels that this bill has far-reaching consequences, that can extend to farmers in Eastern and Southern Africa. In contrast to laws such as the US Plant Patent Act and the UPOV convention, CTA strongly supports Rep. Maxine Waters in her proposed House Con. Resolution 260, which demands respect for farmer's rights to control seed, respect for the rights such peoples have over their own traditional knowledge, and respect for their right to control their own biological resources. Some might scoff and consider these concerns as out of bounds of patent law. They are wrong. Laws that permit biopiracy, and promote the patenting of the plants, biodiversity, and the indigenous knowledge of other countries foster the worst sort of free-riding, which entails riding on the backs of prior innovators with no compensation given them.


Possible Solutions


As one cure for biopiracy, some have begun to construct databases of traditional knowledge, so that such knowledge can be documented and used as prior art to defeat or correct biopiracy patents. However, H.R. 5119, which sets the goalposts back 10 years with respect to usage of prior art, would incinerate a decade of prior art documentation, and would moot all the efforts which have already been made to construct these traditional knowledge databases. This is precisely the wrong direction.


A better cure would be to adopt the Plant Breeders' Rights approach of the OAU (Organization of African Unity). Their approach addresses the rights of plant breeders, while at the same time takes into account the rights of local communities over their biological resources, knowledge and technologies. Unfettered access to biological resources may well prove essential to food security in eastern and southern Africa.


Conclusion


Thank you for giving me the opportunity to appear before this Subcommittee. We hope that you will use this hearing as a reference point for further debate and discussion on this issue, prior to taking further action on H.R. 5119.


Proposed amendments to the U.S. Plant Patent Act have implications far beyond our borders. What may, at first glance, appear to be an innocuous issue, is extraordinarily complex and controversial. There is a great deal of uncertainty, as well as conflict, regarding the potential impacts of both plant breeder's rights and plant patenting. In addition, new genetic technologies are being developed much faster than society can develop socially responsible policies to assimilate them. Already the Plant Patent Act has been amended Footnote (in 1998) to cover "plant parts", which could include seeds and genes.


CTA urges members of Congress to re-examine the Plant Patent Act within a broader context, and to carefully consider the social and economic implications of plant intellectual property rights for farmers, plant breeding and germplasm activities, and future access to and exchange of plant genetic resources, both domestically and internationally.

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