Prior art: Including indigenous /traditional knowledge (IK/TK)

Copyright © Françoise Herrmann

Neem tree

Two out three determining criteria of patentability -- novelty and inventive step -- rely on an examination of what is termed prior art. Indeed, an inventor will have to search all prior art sources to make sure that the invention s/he is claiming does not exist elsewhere, in some published form. Similarly, examiners in charge of determining the patentability of an invention recited in a patent application will conduct prior art searches to make sure that the invention is indeed patentable. And finally, any litigation arising in the process of determining patentability, and in regards an infringement procedure, will also rely on prior art because the existence of this art will either deny novelty or demonstrate that the claims are infringing on some already existing form of the invention.  

So far, so good…This is all about prior art in a print tradition; knowledge in a language known to the Western world or for which there are printed records.

But what happens when knowledge has no written record? What happens when knowledge is shared by a community as an ancestral practice, handed down from one generation to the next in initiation and an oral tradition? How do you include this knowledge, and these practices, in the dataset that will serve to determine the patentability of an invention? How do you include this sort of prior art, termed traditional or indigenous knowledge [TK or IK], in the determination of novelty or inventive step of an invention?

Until fairly recently, the answers to these questions were simply ignored, or to put it less sweetly, this sort of prior art was largely illicitly appropriated and plundered, as Vandana Shiva has  pointed out, and extensively described in her work on biopiracy (Shiva, 1997, 2002).

In fact, it took a reversal of the decisions to grant two patents to set precedence: one reversal in 1997 of a decision the USPTO had previously taken to grant US 5401504; and another reversal in 2000 of a decision the EPO had previously taken to award EP436257.Thus, in recognizing the existence of traditional or indigenous knowledge as evidence of prior art, both revocations consequently laid the groundwork for a more equitable and fair evaluation of patentability. The first patent, EP436257, had been awarded for the use of Neem Tree oil (Azadirachta indica), as a pesticide, and it was revoked when traditional Indian knowledge was provided as evidence of prior art, existing for thousands of years in India. The second patent, US5401504, had been awarded for the healing properties of turmeric (Curcuma longa) a spice and plant used for healing since the dawn of time in India, and it was revoked when such prior knowledge was brought before the EPO as evidence of prior art. 

Add to the USPTO and EPO decisions to reverse patents they had previously awarded, passage of the TRIPS (Trade-related aspects of Intellectual Property Rights) agreement a few years earlier, in 1994, and you will begin to find answers to the questions posed previously in regard patentability, and the miss-appropriation of indigenous resources, including knowledge, practices, technologies and commodities.

You will find answers appearing as organized dissent in the 600-year, extraordinarily consensual, history of the patenting system; answers arising as the full-scale resistance of third world countries to certain provisions of the TRIPS agreement which incorporates patenting rights in the context of world trade and thus seeks to extend patenting rights on a global level. Answers in the form of new international conventions such as the 1992 UN Convention of biological diversity, set forth to guarantee and protect biological diversity, to promote sustainable practices and fair and equitable sharing of benefits, And, as part of this new, more genuine and more inclusive international dialogue, the clever compilation and recording of indigenous knowledge and practices in the form of databases and registries, under the auspices of such global international institutions as the UNESCO, the World Bank and WIPO (World Intellectual Property Office - the UN patent office).

Interestingly enough, the Indian TKDL – Traditional Knowledge Digital Library, initiated in 2001, within the previously mentioned context of dissent, under the auspices of the Indian government and several large public health institutions of India, has not only sought to record ancient knowledge, including 1200 Ayurvedic medicinal formulations, it has also digitized and translated this traditional knowledge into French, English, Japanese, German and Spanish. And, most importantly, the TKDL has devised a Traditional Knowledge Resource Classification (TKRC) system based on the 25,000 subgroups of the International Patent Classification System (IPC) to index all of the traditional knowledge recorded. Thus, the TDKL makes it easy to search IndianTK/IK, and indeed has signed agreements with the USPTO and other patenting Offices, allowing prior art searches to crawl into the TDKL.  

Conversely, the existence and development of the TKDL has also commissioned task forces for the re-examination of previously granted patents. Using TK as evidence of prior art, the task forces endeavor to further determine the validity of previously awarded patents, considering the sort of precedence afforded when the USPTO and EPO reversed their decisions to award turmeric and Neem tree patents.

Finally, to the extent that the new TK classification system incorporates the existing International Classification (IPC) system, the new TK system has also contributed to the expansion of the IPC system with the incorporation of 207 new and additional sub-categories for medicinal plants.

Thus, in the mighty scheme of the patenting system, the TKDL indeed appears as an exemplary manner of inclusion -- on more counts than one! ”.

So... consider this “making it right” -- much like former President Clinton speaks of “building better”!

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 Below, you will find listed a few links to available databases of Indigenous knowledge (IK), Traditional Knowledge (TK)  and Best practices of Indigenous/Traditional knowledge, under the auspices of The World Bank, UNESCO, WIPO, and in India at the TKDL – Traditional Knowledge Digital Library, under the auspices oftheIndian Council for Scientific and Industrial Research (CSIR], the Department of Ayurveda, Yoga, Naturopathy, Unani, Siddha and Homeopathy (AYUSH), the Ministry of Health & Family Welfare and the Government of India.

 The World Bank - Database of Indigenous Knowledge  - Sub-Saharan Africa  http://www.worldbank.org/afr/ik/datab.htm

UNESCO – Register of Best practices on Indigenous/Traditional Knowledge  http://www.unesco.org/most/bpikreg.htm

WIPO – World Intellectual Property Organization – Traditional Knowledge  http://www.wipo.int/tk/en/tk/

India – TKDL – Traditional Knowledge Digital Library    http://www.tkdl.res.in/tkdl/langdefault/common/

 References 

Shiva, V. (1997) Biopiracy: The plunder of nature and knowledge.   Cambridge, MA: South End Press.

Shiva, V. (2002)Protect or plunder: Understanding intellectual property rights (global issues).London, UK: Zed Books.

Monfils, L.(2008)  Flower of the curcuma longa. Photograph at Wikimedia Commons:http://commons.wikimedia.org/wiki/File:Curcuma_longa.jpg

Neem Tree – Courtesy of Google images

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 Turmeric (Curcuma longa)

Animal patents, huh? Humanized transgenic mouse model

Copyright © Françoise Herrrmann -        You, my friend, are crossing the boundaries of your field…No one is going to believe you….! -        Ok, no one is obligated to believe me… But, when you do find someone that you believe, then everything will sound familiar; and you, dear friend, will remember what I’m telling you….! Hush now… and back to transgenic mice, those rodents with knocked out (KO) or knocked in (KI) genes that are perceived as the greatest and most promising avenue of research, for testing drug targets, in-vivo. Here are a few more of these patented creatures –three genotypes just don’t seem to build a big enough case for the existence of a transgenic rodent market and breeding industry.Besides, according to WHO, there are 6000 known rare diseases (with a prevalence of less than 200,000) and more than 12,000 diseases known to plague humans, which means plenty of drug targets to test for generations to come. And incidentally, these batches of mice are “humanized”… so sorry, if your heart is sinking anew… this is another interesting aspect of this type of breeding…  In patent application US2013291134 titled: Humanized transgenic mouse model, the mice are used to test vaccines in vivo. The argument mentioned in favor of humanized mice is that this kind of testing is far too dangerous to perform on humans. I am assuming this means no one would ever give an infectious disease to a human in order to test out a vaccine, which sounds reasonable enough. The point, however, is that no one seems to object to creating animal models of the disease instead. To the contrary, this is state of the art, path-breaking and heralded breakthrough science. In patent application US2013291135 titled: Transgenic model of ALZHEIMER'S DISEASE (AD), “the mice overproduce the amyloid-beta peptide (Abeta) and are deficient in CD45 (PSAPP/CD45-/-), which recapitulates AD neuropathology. The research points to a drug target that validates CD45-mediated microglial clearance of oligomeric Abeta”. Succinctly, this means a cure for AD, considering a mouse model of AD can be created, and the production mechanism can be targeted with a new drug. But this model also assumes that AD may be reduced to the overproduction of a peptide. And I am curious, how it is at all possible to tell that the mice have AD, since mice do little more than squeak, with no pun intended on “p”s and “q”s. But then again, I am not a neurologist…. I am just very worried that mice do not speak ….even if their biology can be engineered to overproduce the required Abeta peptide.  In patent application US2013288361 titled: Neurodegenerative diseases and methods of modeling,“the stem cells and motor neurons derived from mice engineered to carry transgenic alleles of the normal or mutant human SOD1 gene” are disclosed and “the SOD1 transgenic motor neurons are used for the study of neural degenerative diseases”. So, that’s mouse stem cells from mice with a knocked in (KI) human gene, a transgenic process with an additional step. Why not? Advertisements for the production of custom transgenic animals run:  “You think it up, we knock it in or out…”. This is a very creative field, and neurogenerative diseases plague humans in particularly insidious and fatal ways. What better justification could there be? --------------------- I am troubled with the justifications, the inevitability, and the absence of any better alternatives. Who would stop the march of science, and progress? No one. But I would like to build an analogy (with all of its blind spots) drawing on the work the French Nobel laureate Le Clézio, and in particular his work on the Aztec civilization (Le Clézio, 1988).  Le Clézio embarked on an in-depth and marvelous analysis of the Aztecs, including their ritual sacrifices. Although he found no good answer to the question of why the Aztecs felt so compelled to rip out the palpitating hearts of their fellow citizens to feed the hungry gods, he asked another admiring question. What would the world be like had the Aztecs never been exterminated?  Indeed, one might wonder whether the Aztec practices of ritual sacrifice would have survived? How the inevitability and justifications of ritual sacrifice might have evolved ? Whatever the compulsion, how might that have played out? These are obviously speculative questions…. But it makes me wonder whether in the next couple millennia we might not ask a similar question about breeding diseased or suffering animal models. I would dare to hope that either we have found all the cures to our plagues, or we have found ways of modeling (or printing) that no longer invoke sentient creatures and the justified and inevitable fabrication of suffering, even if it is just rodents. Who would stop the march of science and progress? Not I… and certainly not in this scenario…! References Le Clézio, 1988.Le rêve mexicain.France: Gallimard. US2013291134 Humanized transgenic mouse model US2013291135 Transgenic model of ALZHEIMER'S DISEASE US2013288361 Neurodegenerative diseases and methods of modeling Aztec calendar graphic - Carey Joliff Graphic Arts  http://careyjolliffe.wordpress.com/

Animal patents, huh? Ornamental fish

Copyright © Françoise Herrmann

So, let me count the ways we breed in our most sophisticated labs…. We have KO and KI mice. These are mice bred with a gene that is knocked-out or knocked in for the purposes of testing drugs. Remember, the CISD2-KNOCKOUT MICE, the ones bred to exhibit a mitochondrial breakdown and dysfunction, to model the Wolfman Syndrome of premature aging? (Yes, that was the basis of what Brad Pit showed us in The curious case of Benjamin Button, only that was just motion picture.) Remember also the ATRN AND ATRNL1 DOUBLE GENE-KNOCKOUT MICE modeling heart disease, and the NRIPKNOCKOUT MICE modeling muscular dysfunction? Yes, all those mice are circulating around the world for testing new molecules which might reverse, control or attenuate certain diseases that plague humans everywhere.

Well, there’s lots mo’ to this transgenic story. There is plenty of variation and creativity here, both in terms of the diversity of the knockouts or knockins, and the species of animals concerned. The difficulty lies only in how many and how much you can handle at a time…

 Take for instance the ornamental fluorescent fish marketed as GLOFISH®. These are also genetically modified creatures, designed to glow under ultraviolet or blue light in fish tanks. The fish species concerned are Zebrafish (Zebra danio). They have a gene knockedin that encodes various fluoresecent proteins such as the green fluorescent gene protein (GFP) found in jelly fish (Aequorea victoria), the green fluorescent gene protein (GPF) found in sea pansies (Renilla reiformis),  the dsRed fluorescent gene protein found in mushroom coral (Discosoma), the eqFP611 fluorescent gene protein found in sea anemones (Entacmea quadricolor), the RTMS5 fluorescent gene protein found in stony coral (Montipora efflorescens), the Dronpa fluorescent gene protein found in chalice  coral (Pectiniidae), the kindling fluorescent protein (KFP) found in Venus hair anemones (Anemonia sulcata), the eosFP gene found in open brain coral (Lobophyllia hemprichii), and the Dendra fluorescent gene protein found in actocoral (Dendronephthya).  Thus,  depending on the fluorescent gene knockedin, the fish glow in various colors such as green (Electric Green Glofish® ),  red (Starfire Red Glofish®), blue (Cosmic Blue Glofish ®), purple (Galactic Purple Glofish®), etc.

The patent for these fish is titled: CHIMERIC GENE CONSTRUCTS FOR GENERATION OF FLUORESCENT TRANSGENIC ORNAMENTAL FISH [WO0049150].

Below you will find the abstract for this genetically modified (GM) zebrafish patent:

Four zebrafish gene promoters, which are skin specific, muscle specific, skeletal muscle specific and ubiquitously expressed respectively, were isolated and ligated to the 5' end of the EGFP gene. When the resulting chimeric gene constructs were introduced into zebrafish, the transgenic zebrafish emit green fluorescence under a blue light or ultraviolet light according to the specificity of the promoters used. Thus, new varieties of ornamental fish of different fluorescence patterns, e.g., skin fluorescence, muscle fluorescence, skeletal muscle-specific and/or ubiquitous fluorescence, are developed.  [Abstract WO0049150 - Chimeric gene constructs for generation of fluorescent transgenic ornamental fish]

 PS. In 2003, the FDA cleared the sale of Glofish® in the US on the grounds these fish are not used for food purposes, and therefore pose no public health risk. In 2005, the lawsuit filed by The Center for Food Safety to block the sale of Glofish® in the US was found without merit. The Center argued that the sale of Glofish® would set precedence and open the floodgates for nonfood genetically modified animals.

Beyond the ornamental… and for what it’s worth… there are other experimental uses of fluorescence as bio-markers for the detection of pollution and chemicals, only this FISH (Fluorescence In Situ Hybridization)  is hardly sentient… In fact, that’s a whole other patent species… (!)

 References

-        The Center for food Safetyhttp://www.centerforfoodsafety.org/

-          The curious case of Benjamin ButtonThe curious case of Benjamin Button.(2008) directed by David Fincher, starring Brad Pitt and Cate Blanchett.  Based on the novel by Scott Fitzgerald
  

-         - Beskid, O., Binkova, B., Dusek, Z., Rossner, P., Solansky, I. Kalina, I., Zidzik, J., Popov, T.A., Farmer, P.B.  and R.J. Sram (2007) Chromosomal aberrations by fluorescence in situ hybridization (FISH) -- biomarker of exposure to carcinogenic PAHs. Journal of Mutation Research, Jul 1:620(1-2): 62-70. http://www.ncbi.nlm.nih.gov/pubmed/17412370

Oh, patents! Malicious Worms

Copyright ©  Françoise Herrmann Has your computer ever acted really crazy? Have you ever watched all the letters in your files delete as if Pacman was gobbling them up, or as if you had pressed the delete key and somehow it had gotten stuck? Have you ever downloaded a file that sets off virus protection alerts, while downloading malicious code faster than you can hit your browser to close it? If you have…. chances are that it could be a worm, a weasel, or a whole can of worms… Pesky, and spineless, little electronic creatures that can mess up your computer, and your whole life while they are at it. Mercifully, there is good virus protection software that can restore some measure of order and productivity on your desktop, and even repair all the damages incurred. The companies that produce the packages also have active networks allowing them to stay on top of worm attacks, Trojan vectors and hacker break-ins. The following is a prime Worm-defense patent – even if software is very hard to patent: US2013047257 Systems and Methods for computer worm defense, and below the abstract.  Abstract US2013047257 Systems and Methods for computer worm defense  A computer worm defense system comprises multiple containment systems tied together by a management system. Each containment system is deployed on a separate communication network and contains a worm sensor and a blocking system. In various embodiments, the computer worm may be transported from a production network, where the computer worm is not readily identifiable, to an alternate network in the worm sensor where the computer worm may be readily identifiable. Computer worm identifiers generated by a worm sensor of one containment system can be provided not only to the blocking system of the same containment system, but can also be distributed by the management system to blocking systems of other containment systems  Begone Worms and Weasels! Your place is in the bowels of nuclear warheads. That’s where you can have a field day!

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