Patenting life n legal protection of biotechnological inventions

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A concise blood boiling presentation on patenting life and legal protection of biotechnological inventions

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Patenting life n legal protection of biotechnological inventions

  1. 1. PATENTING LIFE (?!!) &LEGAL PROTECTION OFBIOTECHNOLOGICAL INVENTIONSSUSAN ANN JAYANII M.Sc., BIOTECHNOLOGYBHARATHIAR UNIVERSITY1
  2. 2. PATENTING LIFE2
  3. 3. What is a Patent?• Patents are government guarantees that providean inventor with exclusive rights to use, sell ormanufacture an invention for a set period oftime3
  4. 4. • There are actually three different kinds ofpatents under U.S. law▫ Utility patent a new and inventive useful object▫ Design Patent new and inventive ornamental designs for articles ofmanufacture▫ Plant Patent new and inventive plant varieties4
  5. 5. What is „Patenting life‟?• Patenting of plants, animals and individual partsof DNA• Patenting allows industry to take control of andexploit organisms and genetic material asexclusive private property that can be sold to orwithheld from farmers, breeders, scientistsand doctors5
  6. 6. Why Patent?• Patents were historically developed to insure thatinventors could share in the financial returns andbenefits deriving from the use of their inventions.With the development of the modern corporation,patent rights were always assigned to the companyrather than an individual.• This gives the patent holder a form of monopolycontrol for 20 years from the filing of the patent,and creates a legal means of limiting competition.Private investors generally regard such monopoliesas favorable to their interests, so in many industriespatents aid in the development of new products.6
  7. 7. What can be patented?• In order to patent an object, the inventor has toprove that▫ it has never been made before,▫ involves a �non-obvious� inventive step,▫ and that it serves some useful purpose• Patents are to be granted only on human inventions,not on discoveries.• Existing living organisms, like plants and animalsas well as their genes, are of course no-onesinvention and should therefore, by definition, neverbe patented and put under private control.7
  8. 8. BUT IN 1980…• In the landmark case of Diamond v Chakrabarty,the US Supreme Court ruled that a livingorganism, a bacterium that could digest oil,could be patented. Chief Justice Warren Burgerdeclared that the "relevant distinction is notbetween animate and inanimate things butwhether living products could be seen as human-made inventions".8
  9. 9. EVER SINCE…• This heralded a new era in which livingorganisms could be patented, and paved the wayfor the enclosure of the biological commons• Once a shared heritage, the gene pool of plants,animals and humans was now a commoditywaiting to be bought and sold9
  10. 10. Impact on companies• A few months later, on October 14th, a recentlyformed biotech company called Genentech offered amillion shares of stock to the market at $35 pershare. After just 20 minutes, the shares were beingsold at $89. By the end of the day, the company hadraised $36 million. Genentech had not yetintroduced a single product onto the market.• In the words of Jeremy Rifkin, president of theFoundation on Economic Trends, genes had beenidentified as the "raw resource for future economicactivity". For those with the necessary technologyand capital, the race to patent life had begun.10
  11. 11. The Implication• A patent, which usually lasts for 17-20 years,gives the patent holder exclusive rights to exploitan invention for commerical gain. What thismeans in the case of genetically engineeredcrops, for example, is that farmers have to pay alicense fee and royalties for the use of GE seedand all seed produced from the plants forduration of the patent.11
  12. 12. The Plant Patent Act (PPA) of 1930,USA• A plant patent gives its owner the “the right toexclude others from asexually reproducing the plant,and from using, offering for sale, or selling the plantso reproduced, or any of its parts, throughout theUnited States, or from importing the plant soreproduced, or any parts thereof, into the UnitedStates.”• In short, a plant patent covers a single new plantand its asexually reproduced offspring.• The courts have construed the word “plant” in thePPA to have its common meaning, rather than astrict scientific meaning. Thus, for example, thecourts decided that bacteria are not eligible for plantpatent protection under § 16112
  13. 13. “Biocolonialism” ?!• The open exchange of seeds and plant material overthe centuries has given the U.S. and Europe potatoesand tomatoes from Latin America, soybeans fromChina, and wheat, rye and barley from the MiddleEast, to name but a few. The developing world hasnever received compensation or recognition for theseintellectual and technological contributions.• Patenting plant life will intensify the inequalitybetween the developing and industrialized nations.• While centuries of innovation by indigenous farmershave created most of the food crops grown today, thetinkering by agribusiness entitles them to claim aplant as their own invention, and receive all profitsfrom its use.13
  14. 14. INDIA (Azadirachtin) Vs W. R. GRACE(US Company)• It was possible that Indian citizens would havebeen required to pay royalties on the productsproduced from the Neem, since a patent hadbeen granted to the U.S. company W.R. Grace ona compound in the tree (azadirachtin) for theproduction of a biopesticide. In 1993, over fivehundred thousand South Indian farmers ralliedto protest foreign patents on plants such as theneem, and launched a nation-wide resistancemovement.• The patent was revoked later14
  15. 15. Animal Patenting• In 1987 a Harvard biologist was granted the first patentfor an animal. The �oncomouse� was geneticallyengineered to predispose it, and all its offspring, todevelop cancer, so they can be used for research. Thepatent on the oncomouse, which is licensed to DuPont(the corporation that financed the research), extends toany other animal genetically engineered to contain genesthat cause cancer.• By 1997, over forty animals had been patented, includingturkeys, nematodes, mice and rabbits. Hundreds of otherpatents are currently awaiting approval, includingpatents on pigs, cows, fish, sheep and monkeys.15
  16. 16. • Tracey the sheep has had human genes introducedinto her mammary glands so that she produces ahuman blood-clotting agent called alpha-1-antitrypsin in her milk. The patent is held byPharmaceutical Proteins Ltd. (PPL). Theirspokesperson described sheep like Tracey as "furrylittle factories walking around in fields." Traceyssuccess was said to provide "a strong impetus to thefurther exploitation of transgenic sheep asbioreactors for the production of large amounts ofpharmacologically active proteins"16
  17. 17. Human Gene Patenting• It is difficult to estimate how many human geneshave been patented, but one company estimatesthat the U.S. Patent and Trademark Office hasissued more than 1,250 patents on human genesequences (?!!)• In 1991, the European Patent Office granted apatent on a human gene for the first time,defending its position to the EuropeanParliament by arguing that �DNA is not life�17
  18. 18. A weird example..• A Massachusetts corporation called AthenaDiagnostics, wrote to laboratories informing them ofits "exclusive rights to certain tests in the diagnosisof late-onset Alzheimer�s disease. These tests arecovered under US patent number 5,508,167, a copyof which is enclosed." Athena went on to say that itwould be pleased to perform the tests for thepublished price of $195 per specimen. That is morethan twice the price previously being charged bysome university medical laboratories, and waybeyond the means of some of the researchersoperating on government grants, who examinehundreds of samples in the search for newmutations and possible therapies.18
  19. 19. Another example..• In 1976, a leukemia patient named John Moore hadsurgery at the University of California to remove hiscancerous spleen. The University was later granted apatent for a cell line called “Mo,” removed from thespleen, which could be used for producing valuableproteins. The long term commercial value of the cellline was estimated at over one billion dollars. Mr.Moore demanded the return of the cells and controlover his body parts, but the California SupremeCourt decided that he was not entitled to any rightsto his own cells after they had been removed fromhis body.19
  20. 20. The broad species patent• It is extraordinary that a company can make a single geneticalteration to a plant, and claim private ownership to it as theirinvention, when the very plants that are being engineeredresult from thousands of years of careful selection andbreeding by farmers around the world.▫ In 1994, the company Agracetus was awarded a European patentwhich covered all genetically engineered soybeans. Rivalcompanies, including Monsanto, were outraged and immediatelychallenged the patent, saying that it would result in just onecompany having an effective monopoly over all GE soybeans.Monsanto argued that "the alleged invention lacks an inventivestep" and was "not ... novel". In the end the solution forMonsanto was to buy Agracetus, together with the patent, anddrop the complaint. As well as the patent on soya, Monsanto nowholds a patent in both Europe and the US on all geneticallyengineered cotton (?!)20
  21. 21. TRIPS (Trade Related Aspects ofIntellectual Property Rights)• TRIPS was the brainchild of a coalition of corporationswho called themselves the Intellectual PropertyCommittee. It was vigorously opposed by the resource-rich countries of the Third World because it legitimisesbiopiracy, enshrines it in international law andundermines community rights.• Monsantos James Enyart describes how this happened:"Industry identified a major problem for internationaltrade. It crafted a solution, reduced it to a concreteproposal, and sold it to our own and othergovernments�The industries and traders of worldcommerce have played simultaneously the role ofpatients, the diagnosticians, and the prescribing21
  22. 22. TRIPS does not require biotech companies toask for prior consent before accessing biologicalresources, nor does it demand that patentholders share their benefits with the people orlands from which the genes originate. Under theagreement, countries are obliged to bring theirpatent laws into line with the industrialisednations by extending them to include livingorganisms or by setting up equivalent systems ofintellectual property rights.22
  23. 23. LEGAL PROTECTIONOFBIOTECHNOLOGICALINVENTIONS23
  24. 24. In Europe… the Directive 98/44/ECClear and effective legal protection in the field ofbiotechnology is essential for both techno-scientificresearch and economic development. That is the purposeof this Directive which also specifically bans humancloning and any modifications to germ line genetic identity.The ethical aspects are handled by an independentcommittee which has been given the task of advising theEuropean Commission on these matters.Inventions which are new, involve an inventive step andare susceptible of industrial applicationare patentable even if they concern a product consistingof or containing biological materialBiological material which is isolated from its naturalenvironment or produced by means of a technical processmay also be the subject of an invention.24
  25. 25. The objective of the Directive is to clarify thedistinction between what is patentable and whatis not. It particularly seeks to confirm that thehuman body at the various stages of itsformation and development, and processes forcloning human beings and for modifying thegerm-line genetic identity of human beings, maynot be regarded as patentable inventions.In order to protect biotechnological inventions,Member States must ensure that their nationalpatent laws conform to the provisions of theDirective.25
  26. 26. The following are not patentable:plant and animal varieties;essentially biological processes for the production of plants oranimals, such as crossing or selection. This exclusion frompatentability does not, however, affect the patentability of inventionswhich concern a microbiological process ;the human body and the simple discovery of one of its elements,including the sequence or partial sequence of a gene.However, an element isolated from the human body or produced bymeans of a technical process, including the sequence or partialsequence of a gene, may constitute a patentable invention.The following inventions include those that areunpatentable where their exploitation would be contrary to publicpolicy or morality:processes for cloning human beings;processes for modifying the germ-line genetic identity of human beings;uses of human embryos for industrial or commercial purposes;processes for modifying the genetic identity of animals which are likely tocause them suffering without any substantial medical benefit to man oranimal, and also animals resulting from such processes.26
  27. 27. REFERENCES• Patent Law: How Patents Grew Over Time ToInclude Living Organisms-1,2 and 3. By JoeMiller• http://archive.greenpeace.org/geneng/reports/pat/intrpat.htm• http://www.actionbioscience.org/genomic/crg.html• http://www.innovaccess.eu/documents/protectionBiotechnological_0000001089_00.xml.html27
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