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Patenting of genes and related technology

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Patenting of genes and related technology

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Patenting of genes and related technology

  1. 1. CHENNAI III Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 24984821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com Y.TEJASWINI PATENT ASSOCIATE PATENTING OF GENES AND RELATED TECHNOLOGY
  2. 2. CHENNAI III Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 24984821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com PATENTING GENES What are genes?  Genes are functional units of heredity , made up of DNA and are transferred from one generation to other generation.  Every person has two copies of each gene, one inherited from each parent.  Small differences in genes contribute to each person’s unique physical features. What is gene patent? A gene patent is the exclusive rights to a specific sequence of DNA (a gene) given by a government to patentee who claims to have first identified the gene. • Once gene patent is granted, the holder of the patent dictates how the gene can be used, in both commercial settings, such as clinical genetic testing, and in noncommercial settings, including research, for 20 years from the date of the patent.
  3. 3. CHENNAI III Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 24984821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com Can genes be patented?  Arguments against Gene Patenting: • The heart of this issue revolves around the distinction between an invention and a discovery.  That genetic material exists as part of a natural and no amount of manipulation can confer the status of a human invention.  Another major problem in patenting a gene is that, its sequence can vary in limitless ways.  Patents restrict the use of genes in diagnosis, since the patent holders are collecting high prices.  Arguments supporting Gene Patenting:  Patents do not produce secrecy, but rather encourage openness . Patents are beneficial because they encourages inventor to do further research.
  4. 4. CHENNAI III Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 24984821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com IPO • Section 3 of The Indian Patents Act, 1970 describes What are not inventions • In accordance with 3 (i) any process for the medicinal, surgical, curative, prophylactic ,diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products. • In accordance with Section 3(j) plants and animals in whole or any part thereof other than micro-organisms ..
  5. 5. CHENNAI III Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 24984821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com Diamond vs chakraborthy case (US) (1980) • It was a United States Supreme Court case dealing with whether genetically modified organisms can be patented • The Inventor had developed a bacterium capable of breaking down crude oil, which is used for treating oil spills. a patent application for the bacterium in the United States was filed and was rejected by a patent examiner, because at that time, living things were generally understood to not be patentable subject matter under Section 101 of Title 35 U.S.C. • however, the United States Court of Customs and Patent Appeals overturned the case in Chakrabarty's favor saying that geneticlly modified organisms can be patented as there is a involvement of human intervention. • Genes that are to be patented shows following characters:  Genetic sequence should be novel.  Specify the product of that sequence.  Specify the function of the product.  Enable, skilled person in that field to use the sequence for its stated purpose.  In1999, USPTO claimed that “ The usefulness & the function of the product (gene) should be shown before patenting genes.”
  6. 6. CHENNAI III Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 24984821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com Patenting Relaxin genes (EPO)  Relaxin, is a hormone which relaxes the uterus during child birth, and which, it was hoped, could have medical application in reducing the need for caesarean deliveries in difficult pregnancies.  In order to obtain sufficient quantities of the hormone to explore its therapeutic use, it was necessary to manufacture it in synthetic form. So recombinant DNA techniques were used to produce synthetic relaxin.  A patent on synthetic relaxin hormone was issued to Howard Florey Institute in Europe in 1991, but opposed in 1992 by members of the Green Party in the European Parliament.
  7. 7. CHENNAI III Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 24984821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com Legal and ethical issues addressed by EPO Challenges by the opponents The claimed invention was not novel. Relaxin was a mere discovery. The patent was contrary to morality. Isolating a gene from tissue taken from a pregnant women was an offence to human dignity. Patenting human genes was considered equivalent to patenting human life, and it is immoral . Response by the EPO the gene sequence was itself novel, as it was in the form of complementary DNA, which does not exist in nature. if the substance was newly isolated and characterized, then it was not a mere discovery; it was an industrially applicable technical solution to a technical problem. The tissue was donated with consent within the framework of gynaecological operations. Many life-saving substances were isolated in this way.  patenting of a single human gene has nothing to do with the patenting of human life. Even if every gene in the human genome were cloned it would be impossible to reconstitute a human being from the sum of its genes".
  8. 8. CHENNAI III Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 24984821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com Gene therapy & Gene Editing • Gene therapy, a technology involving adding extra genes for correcting defected gene to cure people in 1990s. • It is mainly useful for treating rare genetic disorders. • In contrast, gene-editing is a technology wherein, naturally occurring gene sequence is modified (edited) in a beneficial way for detecting or treating a particular disorder. • It is a promising treatment for a wider range of conditions, from HIV infection to high blood cholesterol.
  9. 9. CHENNAI III Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 24984821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com Gene Editing Technology (CRISPR-Cas9) • CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats of DNA sequences) come from the DNA of viruses. • Bacterial defense systems fight of virus by silencing the genes in virus’s DNA using a component called Cas9 hence called CRISPR-Cas9 mechanism. • This mechanism is a highly adaptable, heritable hence, scientists have developed it into most powerful and revolutionary technology to edit the human genome for curing genetic diseases by silencing the genes causing genetic disorders. • up until this point, gene editing technologies are labour-intensive and are not specific in action CRISPR-Cas9 is easier to manipulate much simpler and faster than the existing ones. • This improvement is crucial for high throughput gene editing tests to adapt treatments quickly to fit the needs of a patient.
  10. 10. CHENNAI III Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 24984821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com CRISPR Space: Major Players in Market & Current status First Patent for CRISPR technology was filed in 2012. There are three major players in the race to bring CRISPR therapy to market: • Editas • Intellia Therapeutics, and • CRISPR Therapeutics. • Among the three main competitors, Editas is currently leading the race to the clinic with clinical trials scheduled to start in 2017. • Subsidiaries of patent holders are quickly establishing themselves. But none of the companies’ CRISPR therapies have yet reached the clinic. • A team at U. Penninslavia attained the first National Institute of Health approval for a CRISPR trial in June. It is planning to use CRISPR-Cas9 for better detection of cancer cells and suppress cancer by gene editing. It still needs FDA approval (Food and Drug Administration), but this is a huge step closer to the market. • The target conditions including breast, prostate, bladder, oesophageal, kidney, colorectal and Epstein-Barr virus-associated cancers.
  11. 11. CHENNAI III Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 24984821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com List of significant patents applications claiming CRISPR Gene Editing technology
  12. 12. CHENNAI III Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 24984821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com Conclusion • Soon after the completion of Human Genome Project in 2001, the U.S. Patent Office has granted nearly 60,000 DNA-based patents covering genetic and related gene technologies. • Potential investments in biotech firms for development of gene-based therapies and screening technologies has been drawing much attention. • About 20 percent of all human genes are patented, according to the National Society of Genetic Counselors. • In the 21st century- sequenced genomes, transgenics has become the norm but Still there are lot of complications with regard to ethical issues and morality concerns revolving around patenting gene technologies. • For persistence of progress in medical research& treatment to continue, Patent offices must keep granting patents for genes & related technologies.
  13. 13. CHENNAI III Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 24984821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 65462400 COIMBATORE #1533, Trichy Road, Coimbatore – 641018. Tel: +91 - 422 - 6552921 HYDERABAD Flat No. A-701, Brindavan Apartments, Niloufer Hospital Road, Redhills, Hyderabad - 500034. Tel: +91 - 40 - 60506009 COCHIN Suite 49, 8th Floor, Centre A, Alapatt Heritage Building, MG Road, Cochin – 682035 Tel: +91 - 484 - 6506216 EMAIL info@altacit.com WEBSITE www.altacit.com THANKYOU

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