Patenting Genetically Engineered Plants

Profession:Herbert Smith
 
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The US perspective

It has been a long-standing practice in the US to allow the grant of utility patents for plants. The large biotech companies have sought to patent their genetically engineered ("GE") hybrids or lines in order to protect and exploit their investment in the technology. The outcome of the recent case of Pioneer1 has therefore provided reassurance to the agri-bio industry after the Supreme Court of the United States reaffirmed its earlier decision in Chakrabarty (supra) that utility patents are available for plants.

Pioneer Hi-Bred International ("Pioneer"), a subsidiary of DuPont, and the world's largest producer of seed corn, had obtained 17 utility patents for its inbred and hybrid corn seed products under the US Code at 35 U.S.C. Section 101 (1994 ed) ("Section 101")2. Pioneer sells its patented hybrid seeds to merchants and growers under a limited licence, the terms of which only permit the production of grain and/or forage from that seed and prohibits re-sale and use of that seed for propagation, seed multiplication or the production or development of a new hybrid or variety.

J.E.M. Ag Supply (trading as "Farm Advantage") bought patented seed from Pioneer under the above licence and then resold it. Pioneer bought proceedings against Farm Advantage alleging patent infringement by Farm Advantage in selling or offering for sale the patented seed outside the scope of the licence agreement. In reply, Farm Advantage counterclaimed, arguing that Pioneer's patents were invalid, because sexually reproducing plants were not patentable subject-matter within the scope of Section 101. In particular, Farm Advantage argued that the exclusive statutory means for the protection of plant life were set out in the Plant Patent Act 1930 ("PPA") and the Plant Variety Protection Act 1970 ("PVPA"): in effect, there was no residual discretion for the grant of plant patents under Section 101. Farm Advantage sought this restrictive ruling on the basis that the PVPA's coverage is generally less extensive (for example, it allows exemptions for research and also for a farmer replanting farm saved seed) and also for the tactical reason that Pioneer had not obtained protection for the hybrid seed under the PVPA.

The District Court granted Pioneer summary judgment relying upon the broad construction of Section 101 in Diamond v. Chakrabarty3 in finding that Section 101 covered plant life and that in enacting the PPA and PVPA, Congress had not expressly or impliedly removed plants from Section 101's ambit. In fact, it found that there was no conflict between the two statutes. The United States Court of Appeals for the Federal Circuit affirmed this decision. Farm Advantage then appealed to the Supreme Court.

The majority decision of the Supreme Court referred to its previous decision in Chakrabarty that: "Congress plainly contemplated that the patent laws would be given broad scope" by casting the provisions in broad terms to fulfil the constitutional and statutory goal of promoting the progress of science, and the associated social and economic benefits envisaged by Jefferson. The Supreme Court had in its earlier decision found nothing in the PPA or PVPA to limit the application of Section 101 to living things. Similarly, the fact that Congress could not have foreseen genetic engineering did not mean that the wide language of the provision could not embrace living things, without the need for further express authorisation from Congress.

The Supreme Court then went on to examine the relevant sections of the PPA and PVPA. It saw no reason why these various forms of protection for plants should not co-exist.

The PPA4 expressly allows protection for the asexual reproduction of a variety of plant (i.e. a clone produced, such as by grafting, budding or the like)5. Less stringent requirements are provided than for Section 101 utility patents, in that no plant patent can be declared invalid on the basis of non-compliance with the section, provided the description is made as complete as reasonably possible. The Supreme Court concluded its analysis by finding that nowhere did it state that plant patents are the exclusive means of granting intellectual property protection to plants.

In 1970, Congress expressly authorised limited patent-like protection for certain sexually reproduced plants under...

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