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- Dinoglyfs - Esihistorialliset eläimet historiankirjoissa - Prehistoric Creatures Documented by the Ancient Man

 

A CASE STUDY ON SEQUENCE PATENTING

 

There are over 40 million patent publications in the world, and the number increases with 1 million publications each year. About four million patents are enacted, whereas the rest of them are free to be exploited.

 

When is patenting justified in basic research? If a sequence patent is granted to an application, when is it worth taking into account in practice? These questions are of current interest as a great deal of the emerging high throughput genome projects are being taken over by commercial companies and venture capital.

 

It is reasonable that the current legislation, albeit unsettled, restricts the time span of patents to twenty years and twenty five years concerning medicinal products (Supplementary Protection Certificate). It also helps the issue that there are attempts to prohibit patenting gene sequences, variation of organisms etc., at least without a claim of direct application. The justification for patenting for the sake of publicity does not hold here, as the sequences would be public even without a public patent.

 

In essence, a patent is a negative liberty, which can only be used to prevent others from free commercial exploitation of the same target to reach the same aims. Besides, the coverage of application is not universal, but depends on the legislation in different countries or federations. Finland has signed the European Patent Convention (EPC), which differs from that of the United States, as the most apparent example.

 

European legislation for a qualified patent presumes the fulfillment of three basic requirements. The invention 1) must be new; 2) must involve an inventive step; and 3) must be suitable for industrial application. Under American law, which interprets the concepts more superficially, patent protection may be granted if the “inventive find” is 1) novel, 2) not obvious, or 3) useful (novelty, inventiveness and utility).

 

Regarding the European legislation and its three items, (1) Beeler et al were the original inventors, not us; (2) EPC emphasizes the difference between the terms “invention” and “discovery”. Twinfilin, for the time being, fits only the latter category. In a strict sense, neither is the United States Patent patent number 5,573,935 a’la Beeler et al, nor our research, a genuine invention. Both are mere descriptions of nature. (3) The putative therapeutic applications in neoplastic growth, atherosclerosis and psoriasis were naive promises not supported by the reproduced experiments.

 

The main difference regarding the differences between the US and EU legislation are striking in the case of A6/twinfilin. Regarding the American item 2), the phosphorylation activity without an apparent sequence alignment to known kinases was certainly not obvious. This is the very issue, however, that we have now refuted. Despite the acceptance in November 1996, the patent did not utilize the US "grace period", as the application was filed in January 18, 1994, before the peer reviewed MCB-article. It is hard to see how this patent met the justification of promoting scientific inquiry. (I found the patent in 2001, four years after Pekka Lappalainen had made his sequence retrieval discovery, actually).

 

The most successful applications in biotechnology such as PCR, versatile antibody-based technology etc. have their core in natural teleonomy. If a patent is put forward with modification, application or combination, it is more justified. Research could be, and should be, rewarded - but only proportional to the extent of human innovation subtracted by the information content in the wild type.

 

Public HGP and private Celera announced their draft human sequences at the same time in the spring 2001. When Science published the articles on human genome draft sequenced by the latter, it was the first time of acceptance without public access to the original data. There is no doubt that the work was done properly, as shown before in the case of the refutation of the widely popularized statement of HGP regarding “223 laterally transferred bacterial genes in human beings”, on the basis of more thorough database mining amongst other organisms (Salzberg et al 2001; Andersson et al 2001).

 

Companies such as Celera or Incyte profit, basically, from selling of the sequence data to medical companies just a few years ahead of the public projects. Much of the controversial patent applications pending are based on the discovered or predicted functions of the genes in these draft sequences. According to the report by the Temporary Committee on human genetics and other new technologies in modern medicine (set up by the European Parliament), the total number of sequence patents granted or pending from USA, EU or Japan was 161,195 in June 2001, but the amount was increasing rapidly. (http://www.europarl.eu.int/meetdocs/committees/gene/20010618/440768FI.pdf; the document also covers the European directives of targets forbidden for patenting.)

 

If post-genomic sequence patent applications filed just prior to public consortia were to be put into action, would it not be tantamount to the era when navigational maps and pilots were kept as government secrets - in striking contrast to the ideal mission of public patenting? Genome projects and SNiPs (small nuclear polymorphisms) lay the foundation for the practice of medicine in the distant future. They are changing the field from curiosities of rare genetic disorders to real national diseases such as blood pressure or Alzheimer's.

 

If patents for sequence data and descriptive analysis from genome projects were to be granted real economical value, it would be an interesting situation historically. Even San Francisco 1849’ers made claims for the individual specimens they found, not for the matter per se. Philosopher’s Stone would have inflated the economic value of the matter, rather than deflate the royalties paid for the stones.

 

If value is given for a patent in correlation to a mere sequence found in nature, does it not defy the lesson learned from colonialism? Great voyages were expensive, toilsome and preceded by frequent shipwrecks. When a safe haven was finally found, was a continent discovered a continent conquered? How much does the effort of exploration justify? Monetary promises do accelerate the enquiry, but it is unsound if commercial companies take over the patents after the basic research has been done at the universities. The metaphora of ships and snips tells that for a native (patient), it does not matter if a Dutch ship was competing with a Spanish one before the conquistadors came.

 

Richard Dawkins is the professor for the public understanding of science at the Oxford University, UK. "The blind watchmaker” with its "biomorphs" drawn by Desmond Morris on its cover, held the number one position on the London Observers’ paperback nonfiction bestseller list for the first six months of 1988. When professor Dawkins entitled his best-selling book, he was referring to the historical controversy over natural theology between the arguments of William Paley (1743-1805) and David Hume (1711-1776). According to current opinion the concept of teleology versus teleonomy in nature seems to be considered paramount to the concept of astrology versus astronomy. Regarding ethics in patenting in biosciences, however, I think the distinction between teleonomy and teleology when analyzing bioinformation is worth paying attention to.

 

I recommend Hubert Yockey's book Information theory and molecular biology (1992).