Intellectual Property-Related Issues
A Public-Private Partnership and Humanitarian Licences
Patents are tools to protect commercial interests and investments, but as the Golden Rice example shows, they are not an impediment to the use and dissemination of a technology. Apart from being national in scope and limited in time, their owners can decide to whom to license and under what conditions. Notwithstanding the fact that a number of patented technologies were involved in the production of Golden Rice (Kryder et al. 2000), Syngenta Seeds AG was able to negotiate access to all pieces of the puzzle actively necessary for the intended humanitarian purposes, providing the Golden RiceHumanitarian Board with the right to sublicense breeding institutions in developing countries free of charge.

The patented key technology for Golden Rice production, invented by Prof emeritus Ingo Potrykus, of ETH-Zurich and Prof Peter Beyer, of the Univ of Freiburg, provided access to a package of ancillary technologies required to engineer the trait into rice. A license to those technologies was obtained from Syngenta. The package contained proprietary technologies belonging not only to Syngenta but also to Bayer AG, Monsanto Co, Orynova BV, and Zeneca Mogen BV.These companies provided access to the required technologies free of charge, for humanitarian purposes.

Eliminating reach-through rights and technologies that don't show up in the most recently developed Golden Rice versions leaves us with only a few patented technologies, all of which have been made available for humanitarian purposes free of charge. The licensing process was quick and simple, contrary to what many onlookers believe. Similar projects are looking at this licensing agreement as a good example of how this kind of arrangements between the public and the private sector can be made, especially for humanitarian purposes.

A PCT application
The heading of the PCT patent application representing the IP cornerstone of the Golden Rice Project. This one patent opened the door to a larger technology package.
 
Independent claims of Australian patent AU 776160 B2 issued to the Golden Rice inventors Ingo Potrykus and Peter Beyer. Independent claims define the scope of the patent in the broadest terms.

Title of the patent: Method for improving the agronomic and nutritional value of plants

CLAIMS

1.     A method of producing plant cells that accumulate carotenoids which cells are normally carotenoid-free, said method comprising transforming plant material with an isolated DNA molecule comprising a nucleotide sequence which comprises:

(a) an expression cassette capable of directing production in said cells of a phytoene synthase derived from a plant, a fungi or a bacteria; and

(b) an expresion cassette capable of directing production in said cells of phytoene desaturase derived from a plant, a fungi or a bacteria wherein when said phytoene desaturase is derived from a bacteria said phytoene synthase is not derived from a bacteria
and
selecting transformed plant material that comprises the cells that accumulate carotenoids.

16.    An isolated DNA molecule comprising a nucleotide sequence which comprises
(a) an expression cassette capable of directing production in said cells of a phytoene synthase derived from a plant; and
(b) an expression cassette capable of directing production in said cells of a phytoene desaturase derived from a bacteria.

The Basics of the Licensing Agreement between Syngenta and the inventors of Golden Rice
Universities are not set up to develop products. From the onset of the Golden Rice Project it was clear that in case of success during the research phase, a product should be developed, and that the product had to reach vitamin A-deficient people in developing countries. That means, it had to be a humanitarian project.

Industries are set up to develop products. Thus, an industrial partner was sought that would agree to the humanitarian purpose of the project. Such a partner was found with Syngenta, an agrichemicals and seeds company with headquarters in Switzerland. Syngenta was instrumental in converting the proof-of-concept results generated at the University of Freiburg and ETH Zurich into deliverable products. This contribution was based on the understanding that Syngenta would retain commercial exclusivity for the technology, including large agricultural setups in developing countries.

In 2005 Syngenta decided not to go commercial with Golden Rice in developed countries, a main reason being that there is practically no vitamin A deficiency in such countries. Thus, it would be probably a vitamin-enriched product with little commercial interest, even though antioxidants are very fashionable, and provitamin A is such an antioxidant. But still, Syngenta continues to support the project with advice and scientific knowhow.

The essence of the Sublicensing Agreement

  • The inventors have assigned their exclusive rights to the Golden Rice technology to Syngenta.
  • Syngenta added some further technologies, and arranged licences with other companies for some additional technologies to be included in the original Golden Rice.
  • Syngenta, in turn, has given the inventors a humanitarian licence with the right to sublicense public research institutions and low-income farmers in developing countries, to the full set of necessary technologies.
  • Syngenta retains commercial rights, although it has no plans to commercialize Golden Rice.
  • ’Humanitarian Use’ means (and includes research leading to):
    • Use in developing countries (low-income, food-deficit countries as defined by FAO)
    • Resource-poor farmer use (earning less than US$10,000 per year from farming)
    • The technology must be introduced into public germplasm ( = seed) only (see below).
    • No surcharge may be charged for the technology (i.e. the seed may cost only as much as a seed without the trait)
    • National sales are allowed by such farmers (in this way urban needs can also be covered)
    • Reusing the harvested seed in the following planting season is allowed (the farmer is the owner of his seeds
  • Regulatory imperative and national sovereignty, i.e. Golden Rice may not be released in a country lacking biosafety regulations, and the decision to adopt the technology is a national matter.
  • No export allowed (except for research to other licensees): this is a humanitarian project, i.e. the seeds are meant to cover the daily requirements of the poor populations that are deficient in vitamin A.
  • Improvements to licensed technology:
    • Commercial rights of improvements to the technology go to Syngenta, but
    • Humanitarian Use of such improvements is guaranteed under the same terms of the original agreement (in this way any improvements to the technology will serve the humanitarian purpose).
  • No warranties are given by licensor(s) (this is also related the fact that every receiving country will determine what biosafety and agronomic requirements to impose before approval of a Golden Rice variety.
  • Liabilities and costs — each party is responsible for what it controls (this follows also from the fact that this is a humanitarian project and not a commercial enterprise).

Selection of locally adapted varieties as receptors of the Golden trait:
While countries adopting the technology are free to introduce the trait into their preferred varieties, there are some criteria on which strategic decisions for selection should be based. For example, receptor rice varieties should preferably be widely used by farmers. Those varieties should also be expected to maintain prominence over time and be grown by most productive farmers in vitamin A deficiency-prone regions (for local and regional supply).

See also:
Kryder D, Kowalsi SP, Krattiger AF. 2000. 'The Intellectual and Technical Property Components of pro-Vitamin A Rice (GoldenRice™): A Preliminary Freedom-To-Operate Review', ISAAA Briefs No 20. ISAAA: Ithaca, NY. 56 p.