Intellectual Property Rights(IP) Are the really Intellectual ??

Prologue 1) Introduction 2) Patent 3) Bio-Piracy 4) Breast Cancer (Mastec-tomy)/ Case of Hollywood Actress Angelina Jolie 5) Myrid Genetics 6) Case Myriad Genetics vs Association of Molecular Pathology 7) Novartis vs Supreme Court of India (Land Mark Judgement by Supreme Court) 8) Bayer Cancer Drug 9) What is TRIPS

Introduction

Intellectual property rights are the rights given to persons over the creations of their minds. They usually give the creator an exclusive right over the use of his/her creation for a certain period of time. IP are divided into 2 main areas

a)

Industrial property, which includes inventions (patents), trademarks, industrial designs, and geographic indications of source; and Copyright, which includes literary and artistic works such as novels, poems and plays, films, musical works, artistic works such as drawings, paintings, photographs and sculptures, and architectural designs. Rights related to copyright include those of performing artists in their performances, producers of phonograms in their recordings, and those of broadcasters in their radio and television programs

b)

Patent It is an exclusive right granted for an invention, which is a product or a process that provides, in general a new way of doing something that offers a new technical solution to a problem. A patent provides protection for the invention to the owner of a patent which is granted for a limited of 20 years. Patent protection means that invention cannot be commercially, made, used, distributed or sold with the patent owners concern.

Gene Patent

It is a patent on a specific isolated gene sequence, its chemical composition, the process for obtaining or using it or combination of such claims. Geographical Indications

A geographical indication is a sign used on goods that have a specific geographical origin and possess qualities, reputation or characteristics that are essentially attributable to that place of origin. Most commonly, a geographical indication includes the name of the place of origin of the goods. Agricultural products typically have qualities that derive from their place of production and are influenced by specific local factors, such as climate and soil. Whether a sign is recognized as a geographical indication is a matter of national law. An appellation of origin is a special kind of geographical indication. It generally consists of a geographical name or a traditional designation used on products which have a specific quality or characteristics that are essentially due to the geographical environment in which they are produced. The concept of a geographical indication encompasses appellations of origin.

E.g Darjeeling Tea, Kullu Shawl of Himachal and Mysore Sandal Soap of Karnataka

Bio-Piracy Bio-Piracy is the unauthorized use of the genetic resources & the knowledge associated with genetic resources held by the communities living from Bio-diversity rich countries, which may be infringed upon illegally by industrial enterprises Bio-piracy is a part of a larger problem whereby developing countries rich in biodiversity, are exploited by transnational corporations and industries that make use of these resources. Bio-piracy, refers to the appropriation, generally by means of patents of legal rights over biological materials by international companies to develop food or medicines, without recompensing the countries from which they are taken

Breast Cancer

Breast cancer is a type of cancer originating from breast tissue, most commonly from the inner lining of milk ducts or the lobules that supply the ducts with milk. Breast cancer occurs in humans (men also) and other mammals. A distinct sequence of nucleotide forming part of a chromosome is known as gene. Protein controls structure & function of all the cells that make up the body.

The complete DNA instruction book or GNOME for humans contain 3 billion bases & about 20,000 genes on 23 pair of chromosomes. And abnormalities in the DNA or abnormal changes may provide wrong set of instructions leading to faulty cell growth and function. Most inherited( mostly from parents) cases of Breast cancer are associated with 2 abnormal genes BRC -A1 & BRC-A2 (BR=BREAST & C=CANCER) Function of BRC-A genes is to repair cell damage & keep the breast cells growing normally, but when these genes contain abnormality or mutation(The changing of the structure of a gene, resulting in a variant form that may be transmitted to subsequent generations) these genes do not function normally & breast cancer risk increases Mastectomy ( Greek word: breast + removal )

A mastectomy is surgery to remove a breast. It is performed either to treat or to prevent breast cancer. Only high-risk patients have surgery to prevent cancer. There is a relationship between diet and breast cancer, including an increased risk with a high fat diet, alcohol intake, and obesity. Other risk factors include radiation and shiftwork

There are four main types: (Not important)

Total mastectomy - removal of breast tissue and nipple Modified radical mastectomy - removal of the breast, most of the lymph nodes under the arm and often the lining over the chest muscles Lumpectomy - surgery to remove the tumor and a small amount of normal tissue around it Radical mastectomy - the removal of the breast, lymph nodes and chest muscles. This is no longer common Case of Angelina Jolie

Angelina Jolie drew headlines with her announcement that she has undergone a preventative double mastectomy. A blood test revealed that she carries a damaged BRCA1 gene -- a defect that greatly increases the odds of a woman getting breast cancer. She had an 87 percent chance of developing the disease, she decided to undergo a prophylactic double mastectomy, an operation that reduced her risk to 5 percent. The first issue is the test. The BRCA1 and BRCA2 tests, which may have saved Jolie's life, cost $3,000 to administer (Please note this Its very costly not affordable by everyone.)

Myriad Genetics Myriad genetics is a molecular diagnostic company based in salt lake city in U.S.A Myriad was having exclusive licensing right in the U.S for breast cancer analysis & testing- this is a molecular diagnostic product used for analysis of BRC-A1 & BRC-A2 to evaluate a womens risk of developing hereditary breast cancer. It helps women to determine if they have BRC-A1 & BRC-A2 gene mutations which will be helpful in determining the preventive & guiding therapy. Myriad genetics for its breast cancer risk assessment involving the genes BRC-A1 & BRC-A2 was charging significantly about $3000, those arguing against the patenting of the genes claimed that the high cost of the test was due to the monopoly over it by Myriad genetics, so a case was filed against Myriad genetics in the U.S court

Case Myriad Genetics vs Association of Molecular Pathology

The Association for Molecular Pathology along with several other medical associations, doctors and patients sued the United States Patent and Trademark Office (USPTO) and Myriad Genetics to challenge several patents related to human genetics. The patents

cover the BRCA1 and BRCA2 genes and certain mutations that indicate a high risk of developing breast cancer. The suit also challenged several method patents covering diagnostic screening for the genes. They also argued that the patents limit scientific progress. Limits patents to any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof. By patenting the genes, Myriad had exclusive control over diagnostic testing and further scientific research for the BRCA genes. Myriad argued that once a gene is isolated, and therefore distinguishable from other genes, it could be patented. Holding: A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but synthetic complementary DNA ("cDNA") is patent eligible because it is not naturally occurring. Judgment: Affirmed in part and reversed in part., 9-0, in an opinion by Justice Thomas on June 13, 2013. Justice Scalia filed an opinion concurring in part and concurring in the judgment. Because of these ruling patients will have greater access to genetic testing & scientists can engage in research on these genes without the fear of being sued.

Novartis vs Supreme Court of India (Land Mark Judgement by Supreme Court)

Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland, ranking number two in sales (46.806 billion US$) among the world-wide industry in 2010. It had developed a ground breaking super expensive cancer drug called Gleevac( Novartis Had gained patent protection for this drug in some 40-odd countries) for which it wanted patent rights in India(patent rights are different for different countries) Case was filed and Supreme court of India rejected the application which was a landmark judgment

Reasons for Rejection Novartis failed to prove the drug was patentable, the drug under review did not demonstrate any significant of efficacy(capability to produce an effect) over available generics & its active ingredient was already known

This is a pretty common method by Pharmaceutical companies to evergreen patent protection by making minor modifications to drugs approaching Patent expiry ( 20 years . Hope u remember or getting bored??) And in this way for many American Pharmaceutical companies it is easy to make market in India (India is huge market. An average man spends around 70% of his income on medicines and health problems) Existence of Robust property rights are a key bench mark for development as they reflect institutional strength (via a judiciary) India has over 28 lakh cancer patients. Supreme Court judgment can make a way for cancer patients getting cheaper drugs as a 1-month dose of Gleevec costs around Rs 1.2 Lakh and the same generic drugs manufactured by Indian company for the same period is priced at Rs 8000.

Bayer Cancer Drug

An Indian patent appeals Board upheld a decision to allow a domestic company to sell a generic version of BAYER AG(German chemical and pharmaceutical company) cancer drug NEXAVAR, in blow for global drug makers efforts to hold on to monopolies on high price medicine. This ruling was again a landmark as it paves the way for the issue of more so called compulsory licenses as governments particularly in emerging markets such as China & Thailand, battle to bring down health care costs & provide access to affordable drugs to treat diseases such as cancer, HIV-AIDS. The Indian Patent Office(IPO) is administered by the Office of the Controller General of Patents, Designs & Trade Marks (CGPDTM). This is a subordinate office of the Indian Government and administers the Indian law of Patents, Designs and Trade Marks IPO allowed NATCO Premium Pharma (Indian Company) to sell the generic Nexavar at Rs 8800 or $160 for a months dose but for which Bayer was charging Rs 2,80000(only .. lolz) Bayer challenged it & the board did order NATCO Pharma to pay a royalty of 7% on sales of generic Nexaver to Bayer

Indias vision = Kidney & Liver cancer drug should be available at an affordable price to everybody What is Trips?

The Agreement on Trade Related Intellectual Property Rights (TRIPS) was negotiated with other international trade agreements during the Uruguay Round trade negotiations of the GATT (General Agreement on Tariffs and Trade) from 1986 to 1994. As one of the World Trade Organization (WTO) agreements, it is totally binding for all WTO Member States (whether a previous GATT Member or a new WTO one) Taking into account the transitional periods allowed to developing and least-developed countries by the TRIPS Agreement. The TRIPS Agreement sets minimum standards in the field of intellectual property (IP) protection (such as copyrights, patents, and trademarks) that all WTO Member countries have to respect. To achieve this goal, WTO Members have to modify their intellectual property laws to make them consistent with the new WTO standards. For instance, the TRIPS Agreement states that all patents shall be available for at least 20 years from the filing date, whereas before TRIPS the patent term varied greatly among countries (7, 10, 17 or 20 years). All WTO Members have to incorporate this 20-year patent term in their own patent law.

References - The Hindu

www.google.com www.wipo.int www.wto.org Name Arun Chettiar