Guest Post: Purpose-bound patent protection and lessons for India by Dr Rca Godbole

Spicy IP is pleased to bring you a special guest post on a recent decision of the European Court of Justice on a DNA patent held by global seed company Monsanto, which has raised some flags in the biotechnology industry, particularly on how it could narrow the protection currently available to companies in Europe.

This very crisp yet succinct post is authored by Dr Rca Godbole, who has done her doctoral work in the field of Plant Molecular Biology, has worked as a scientist. Now based in Mumbai, she advises law firms and corporate houses in matters related to patents and patent based business strategy.

Purpose-bound patent protection and lessons for India

Future standards in patentability in India, as they relate to living organisms, plants and animals already are a matter of some debate, and there is no home grown case law to refer to. Leads per force, would be taken from cases decided at the USPTO/ EPO/ JPO.

On this background, the case Monsanto v. Cefetra is very interesting. The Advocate General Mengozzi of the Court of Justice of the EU had rendered his opinion on this case, and which the European Court of Justice — Europe’s top court, based in Luxembourg — seems to have been affirmed on 6th July 2010. Monsanto had already withdrawn its complaint against Cefetra after an undisclosed out-of-court settlement in June, following a preliminary opinion on the case. Still, the court continued with its final ruling in order to clarify and harmonize decisions on purpose-bound patent protection across the European Union — and to remove any doubts within the biotech industry. Image from here.

The issue

The dispute concerns the shipment of soya meal from Argentina to the EU. The soya meal was obtained from genetically modified soya tolerant to the herbicide glyphosate due to the presence of a specific gene. The gene is not patent protected in Argentina and recombinant soybeans are legally planted there without permission from Monsanto. The relevant patent falls under the category, or patents that are already issued in a foreign country and revalidated in Argentina, and thus regarded to be unpatentable in Argentina after the advent of TRIPS compliance there or 1st January 1995.

In several EU countries, however, the DNA sequence utilized in the RR soybeans is covered by European patent EP 0 546 090 B1 (090 patent). To increase pressure on Argentinean growers, Monsanto sued various importers of soya meal into the UK, Spain, Denmark, and The Netherlands for infringement of the 090 Patent.

Consequently, the customs authorities in some of the jurisdictions sampled several shipments of soybean meal and found the DNA sequence specified in the 090 Patent was shown to be present in the samples.

The DNA molecules differ from a chemical compound, in so far that they can serve as a template to create further entities, rather than as simple constituents in a reaction. There is no physical continuum between the stretches of DNA and the protein formed from it, and the informational content of a DNA molecule is rather more complex than that of a chemical molecule.

The opinion

Advocate General Mengozzi maintained in his opinion that the patented DNA is protected as such – that is, as a chemical substance – only where it performs the function for which it was patented. In his view, those are the only circumstances in which the protection also covers the ‘material’ in which the DNA sequence is contained. The Advocate General therefore concluded that the protection for a patent relating to a DNA sequence is limited to the situations in which the genetic information is currently performing the functions described in the patent. That holds true both as regards the protection of the genetic information as such and as regards the protection of the materials in which the genetic information is contained.

This opinion is viewed to be too restrictive or narrow by a number of commentators, mostly from the EU. To quote Dr. Michael Kock in Journal of Intellectual Property Law & Practice 2010 5(7):495-513; doi:10.1093/jiplp/jpq059:

“Most experts reject a basis for purpose-bound protection in the Directive (Directive 98/44 adopted by The European Parliament). There seems to be no reason to raise purpose-bound protection specifically for DNA sequences. The argument of over-rewarding can be made for composition claims in general. Special treatment for DNA sequences would conflict with the intention of the Biopatent Directive not to provide a special body of law for DNA sequences.”

What does it mean for India?

The other major India specific point, apart from the precedent setting one, worthy of consideration here is a hypothetical scenario with Bt cotton in India. It is estimated the Bt seed that is sold with a patentee premium in India is hardly 60% of the total Bt seed sold here. We have a thriving woven cotton industry exporting to many parts of the world including the EU, where the Bt gene is under patent protection. Had the ruling gone against this for the DNA stretches, the importers of such cotton material might have faced lawsuits from the inventor company in an attempt to recoup payments it has not managed to get from some Indian growers. This situation can be extrapolated on any number of derivative products from plants containing patented genes.

Since it is not possible to say for how long, or up to which stage of the food and derived product chain, traces of the genetic material of the recombinant plant are still identifiable, its very presence – even though it would no longer be performing any function –would mean that an unspecified number of derivative products could have come under the control of whoever had patented the DNA sequence of a plant. The impact of such a development on the economy in a country like ours, where the recombinant DNA product seeds are legally planted, and where there is a vast variety of crops in which future recombinant introductions could occur, would have been sizable, to say the least.