Patenting life n legal protection of biotechnological inventions

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PATENTING LIFE (?!!) & LEGAL PROTECTION OF BIOTECHNOLOGICAL INVENTIONS SUSAN ANN JAYAN II M.Sc., BIOTECHNOLOGY BHARATHIAR UNIVERSITY 1

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

Transcript of Patenting life n legal protection of biotechnological inventions

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PATENTING LIFE (?!!) &LEGAL PROTECTION OF BIOTECHNOLOGICAL INVENTIONS

SUSAN ANN JAYANII M.Sc., BIOTECHNOLOGYBHARATHIAR UNIVERSITY

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PATENTING LIFE

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What is a Patent?•Patents are government guarantees that

provide an inventor with exclusive rights to use, sell or manufacture an invention for a set period of time

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•There are actually three different kinds of patents under U.S. law▫Utility patent

a new and inventive useful object ▫Design Patent

new and inventive ornamental designs for articles of manufacture

▫ Plant Patent new and inventive plant varieties

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What is ‘Patenting life’?•Patenting of plants, animals and

individual parts of DNA•Patenting allows industry to take control

of and exploit organisms and genetic material as exclusive private property that can be sold to or withheld from farmers, breeders, scientists and  doctors

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Why Patent?• Patents were historically developed to insure that

inventors could share in the financial returns and benefits deriving from the use of their inventions. With the development of the modern corporation, patent rights were always assigned to the company rather than an individual.

• This gives the patent holder a form of monopoly control for 20 years from the filing of the patent, and creates a legal means of limiting competition. Private investors generally regard such monopolies as favorable to their interests, so in many industries patents aid in the development of new products.

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What can be patented?• In order to patent an object, the inventor has to

prove 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 animals as well as their genes, are of course no-one's invention and should therefore, by definition, never be patented and put under private control.

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BUT IN 1980…•In the landmark case of Diamond v

Chakrabarty, the US Supreme Court ruled that a living organism, a bacterium that could digest oil, could be patented. Chief Justice Warren Burger declared that the "relevant distinction is not between animate and inanimate things but whether living products could be seen as human-made inventions".

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EVER SINCE…•This heralded a new era in which living

organisms could be patented, and paved the way for the enclosure of the biological commons

•Once a shared heritage, the gene pool of plants, animals and humans was now a commodity waiting to be bought and sold

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Impact on companies• A few months later, on October 14th, a recently

formed biotech company called Genentech offered a million shares of stock to the market at $35 per share. After just 20 minutes, the shares were being sold at $89. By the end of the day, the company had raised $36 million. Genentech had not yet introduced a single product onto the market.

• In the words of Jeremy Rifkin, president of the Foundation on Economic Trends, genes had been identified as the "raw resource for future economic activity". For those with the necessary technology and capital, the race to patent life had begun.

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The Implication•A patent, which usually lasts for 17-20

years, gives the patent holder exclusive rights to exploit an invention for commerical gain. What this means in the case of genetically engineered crops, for example, is that farmers have to pay a license fee and royalties for the use of GE seed and all seed produced from the plants for duration of the patent.

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The Plant Patent Act (PPA) of 1930, USA

• A plant patent gives its owner the “the right to exclude others from asexually reproducing the plant, and from using, offering for sale, or selling the plant so reproduced, or any of its parts, throughout the United States, or from importing the plant so reproduced, or any parts thereof, into the United States.”

• In short, a plant patent covers a single new plant and its asexually reproduced offspring.

• The courts have construed the word “plant” in the PPA to have its common meaning, rather than a strict scientific meaning. Thus, for example, the courts decided that bacteria are not eligible for plant patent protection under § 161

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“Biocolonialism” ?!• The open exchange of seeds and plant material over

the centuries has given the U.S. and Europe potatoes and tomatoes from Latin America, soybeans from China, and wheat, rye and barley from the Middle East, to name but a few. The developing world has never received compensation or recognition for these intellectual and technological contributions.

• Patenting plant life will intensify the inequality between the developing and industrialized nations.

• While centuries of innovation by indigenous farmers have created most of the food crops grown today, the tinkering by agribusiness entitles them to claim a plant as their own invention, and receive all profits from its use.

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INDIA (Azadirachtin) Vs W. R. GRACE (US Company)

•It was possible that Indian citizens would have been required to pay royalties on the products produced from the Neem, since a patent had been granted to the U.S. company W.R. Grace on a compound in the tree (azadirachtin) for the production of a biopesticide. In 1993, over five hundred thousand South Indian farmers rallied to protest foreign patents on plants such as the neem, and launched a nation-wide resistance movement.

•The patent was revoked later

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Animal Patenting• In 1987 a Harvard biologist was granted the first patent

for an animal. The �oncomouse� was genetically engineered to predispose it, and all its offspring, to develop cancer, so they can be used for research. The patent on the oncomouse, which is licensed to DuPont (the corporation that financed the research), extends to any other animal genetically engineered to contain genes that cause cancer.

• By 1997, over forty animals had been patented, including turkeys, nematodes, mice and rabbits. Hundreds of other patents are currently awaiting approval, including patents on pigs, cows, fish, sheep and monkeys.

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• Tracey the sheep has had human genes introduced into her mammary glands so that she produces a human blood-clotting agent called alpha-1-antitrypsin in her milk. The patent is held by Pharmaceutical Proteins Ltd. (PPL). Their spokesperson described sheep like Tracey as "furry little factories walking around in fields." Tracey's success was said to provide "a strong impetus to the further exploitation of transgenic sheep as bioreactors for the production of large amounts of pharmacologically active proteins"

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Human Gene Patenting•It is difficult to estimate how many human

genes have been patented, but one company estimates that the U.S. Patent and Trademark Office has issued more than 1,250 patents on human gene sequences (?!!)

•In 1991, the European Patent Office granted a patent on a human gene for the first time, defending its position to the European Parliament by arguing that �DNA is not life�

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A weird example..• A Massachusetts corporation called Athena Diagnostics,

wrote to laboratories informing them of its "exclusive rights to certain tests in the diagnosis of late-onset Alzheimer�s disease. These tests are covered under US patent number 5,508,167, a copy of which is enclosed." Athena went on to say that it would be pleased to perform the tests for the published price of $195 per specimen. That is more than twice the price previously being charged by some university medical laboratories, and way beyond the means of some of the researchers operating on government grants, who examine hundreds of samples in the search for new mutations and possible therapies.

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Another example..• In 1976, a leukemia patient named John Moore

had surgery at the University of California to remove his cancerous spleen. The University was later granted a patent for a cell line called “Mo,” removed from the spleen, which could be used for producing valuable proteins. The long term commercial value of the cell line was estimated at over one billion dollars. Mr. Moore demanded the return of the cells and control over his body parts, but the California Supreme Court decided that he was not entitled to any rights to his own cells after they had been removed from his body.

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The broad species patent• It is extraordinary that a company can make a single genetic

alteration to a plant, and claim private ownership to it as their invention, when the very plants that are being engineered result from thousands of years of careful selection and breeding by farmers around the world.▫ In 1994, the company Agracetus was awarded a European patent

which covered all genetically engineered soybeans. Rival companies, including Monsanto, were outraged and immediately challenged the patent, saying that it would result in just one company having an effective monopoly over all GE soybeans. Monsanto argued that "the alleged invention lacks an inventive step" and was "not ... novel". In the end the solution for Monsanto was to buy Agracetus, together with the patent, and drop the complaint. As well as the patent on soya, Monsanto now holds a patent in both Europe and the US on all genetically engineered cotton (?!)

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TRIPS (Trade Related Aspects of Intellectual Property Rights)• TRIPS was the brainchild of a coalition of corporations who

called themselves the Intellectual Property Committee. It was vigorously opposed by the resource-rich countries of the Third World because it legitimises biopiracy, enshrines it in international law and undermines community rights.

• Monsanto's James Enyart describes how this happened: "Industry identified a major problem for international

trade. It crafted a solution, reduced it to a concrete proposal, and sold it to our own and other governments�The industries and traders of world commerce have played simultaneously the role of patients, the diagnosticians, and the prescribing physicians."

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TRIPS does not require biotech companies to ask for prior consent before accessing biological resources, nor does it demand that patent holders share their benefits with the people or lands from which the genes originate. Under the agreement, countries are obliged to bring their patent laws into line with the industrialised nations by extending them to include living organisms or by setting up equivalent systems of intellectual property rights. 

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LEGAL PROTECTION OF

BIOTECHNOLOGICAL INVENTIONS

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In Europe… the Directive 98/44/EC

Clear and effective legal protection in the field of biotechnology is essential for both techno-scientific research and economic development. That is the purpose of this Directive which also specifically bans human cloning and any modifications to germ line genetic identity. The ethical aspects are handled by an independent committee which has been given the task of advising the European Commission on these matters.Inventions which are new, involve an inventive step and are susceptible of industrial application are patentable even if they concern a product consisting of or containing biological material Biological material which is isolated from its natural environment or produced by means of a technical process may also be the subject of an invention.

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The objective of the Directive is to clarify the distinction between what is patentable and what is not. It particularly seeks to confirm that the human body at the various stages of its formation and development, and processes for cloning human beings and for modifying the germ-line genetic identity of human beings, may not be regarded as patentable inventions.In order to protect biotechnological inventions, Member States must ensure that their national patent laws conform to the provisions of the Directive.

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The following are not patentable:

plant and animal varieties; essentially biological processes for the production of plants or animals, such as crossing or selection. This exclusion from patentability does not, however, affect the patentability of inventions which 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 by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention. The following inventions include those that are unpatentable where their exploitation would be contrary to public policy 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 to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

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THANK YOU…